Virtual Library

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    ES05 - Collaboration Between Stakeholders to Improve Lung Cancer Research (ID 773)

    • Event: WCLC 2018
    • Type: Educational Session
    • Track: Advocacy
    • Presentations: 4
    • Now Available
    • Moderators:
    • Coordinates: 9/25/2018, 15:15 - 16:45, Room 205 AC
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      ES05.01 - Linking the Stakeholders: Can Patient Groups, Clinical Researchers and the Pharmaceutical Industry Collaborate to Accelerate Research? (Now Available) (ID 11370)

      15:15 - 15:35  |  Presenting Author(s): Janet Freeman-Daily

      • Abstract
      • Presentation
      • Slides

      Abstract not provided

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      ES05.02 - Can Patient Groups and Regulatory Bodies Work Together to Make Clinical Research Easier? (Now Available) (ID 11371)

      15:35 - 15:55  |  Presenting Author(s): Andrea Ferris

      • Abstract
      • Presentation
      • Slides

      Abstract

      BACKGROUND: The lung cancer treatment landscape has rapidly evolved over the past five years, with the U.S. Food and Drug Administration (FDA) approving more than 15 new treatments for advanced-stage non-small cell lung cancer (NSCLC) -- more than in the prior 15 years combined. However, for multiple reasons, including the routine use of overly restrictive eligibility criteria and the difficulty of opening clinical trials in community oncology settings, too many advanced-stage NSCLC patients are unable to participate in clinical trials. As a result, patients do not have early access to potentially life-saving treatments. LUNGevity Foundation is committed to making lung cancer clinical trials more patient-centric and accessible by streamlining the process of conducting studies.


      APPROACH: In 2015, LUNGevity Foundation began convening multi-stakeholder meetings, the LUNGevity Scientific and Clinical Research Roundtables (SCRTs,) in order to address this complex problem and determine innovative and timely solutions. These Roundtables bring together senior leaders of domestic and international regulatory agencies, clinicians, payers, patient advocates, patients, CROs and trial sponsors to ideate on the most pressing issues confronting the clinical trial landscape, focusing on lung cancer trials as case studies and pilots. The roundtables provide a platform for top officials across sectors to discuss challenges and develop concrete approaches for designing and executing clinical trials that facilitate patient participation and provide earlier access to promising new treatments.


      PROGRESS-TO-DATE: Since its inception, the SCRT program has advanced progress in multiple important areas, developing multi-stakeholder working groups, hosting five in-person stakeholder meetings and three interactive webinars. These efforts have focused on the following workstreams aimed at improving clinical trials from the patient perspective:

      Streamlining Lung Cancer Clinical Trials:
      The goal of this roundtable series is to streamline clinical trials and make them more accessible to patients. The three active workstreams include:
      • Expanding eligibility criteria to allow access to patients that have been historically excluded from lung cancer trials - A manuscript was recently published in the Journal of Thoracic Oncology1 presenting recommendations from the multi-stakeholder Expanded Eligibility Working Group on relaxing eligibility criteria to include advanced-stage patients with brain metastasis, poor performance status, and prior malignancies. This Working Group has also identified outdated or unnecessary exclusion criteria frequently seen in lung cancer trial protocols, especially those that may no longer be relevant to current classes of drugs with new mechanisms of action. The group continues to work with regulators and industry partners to revise clinical trial protocols to ensure that such criteria are no longer included in lung cancer trials.
      • Streamlining reporting of suspected unexpected serious adverse reactions (SUSARs) and adverse events. This Working Group has been cataloguing anticipated adverse drug events (ADRs) observed in clinical trials with a goal of advancing understanding of the different types of ADRs and how they should be reported to eliminate excessive and unnecessary reporting.
      Creating a prospective real-world control arm for a histological subtype of lung cancer, such as small cell lung cancer (SCLC), where the standard-of-care hasn’t changed over the past few decades and the natural history of the disease is well-characterized. The goal of this effort is to reduce the numbers of patients needed to complete enrollment for certain trials and maximize the opportunities for patients to access novel therapies. The Working Group is collaborating with health informatics companies to develop and pilot this novel control arm for SCLC trials in the first-line setting.

      Patient-Reported Outcomes:
      Due to more patient centric health systems, there has been an increased use and interest in patient-reported outcomes (PROs) to include the patient’s perspective in research and clinical practice. With the passage of the 21st Century Cures Bill, there is a renewed focus and urgency on gathering and incorporating PROs and real-world evidence (RWE) into the drug development process. While PROs have been used for reimbursement decisions outside of the US for many years, there is still limited utilization of PROs to help inform treatment decisions.

      The Working Group has been focused on improving efforts to gather patient-reported outcomes (PROs) that are meaningful to patients and ensure the information is communicated to patients in a way that is useful in their decision making. The specific questions being asked in this workstream include:
      • Why collect PROs and other patient-experience data in cancer trials?
      • What PRO concepts should be measured?
      • How can PROs be best measured?
      • How can we analyze and communicate this data?
      Findings from a patient advisory board (comprising 17 lung cancer patients and leaders from the FDA), designed to elicit feedback regarding the core elements of clinical outcome assessments (COA) that FDA previously proposed, will be presented in a manuscript (submitted to The Journal of Thoracic Oncology). The Working Group will continue to synergize with the FDA and industry partners on PRO data collection and use.

      Veterans’ Access:
      The goal of this roundtable series is to identify barriers and opportunities to ensure that veterans have access to clinical trials through a two-pronged approach –standing up more industry trials within the VA Health Care System and facilitating veteran access to trials outside of the VA health system. These roundtables engage with senior leadership from the Veterans Health Administration, practicing clinicians within the VA, National Association of Veterans’ Research and Education Foundations (NAVREF), and industry partners. Ongoing activities include working with the National Program Director for Oncology at the VA on guidance on policies that allow veterans to be referred out to participate in trials outside the VHA, and with the VHA Office of Research & Development and NAVREF on their newly formed Clinical Trials Steering Committee to work on increasing clinical trials within the VHA.

      NEXT TOPICS FOR ACTION: LUNGevity Foundation is beginning new workstreams focused on efforts to 1) bring more clinical trials to the community setting, and 2) improve expanded access programs for novel therapies.

      REFERENCES:

      1. Bonomi P, et al. Making Lung Cancer Clinical Trials More Inclusive: Recommendations for Expanding Eligibility Criteria. Journal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer. Jun 2018;13(6):748-751.

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      ES05.03 - Discrepancies and Sustainable Access to Innovative Therapies: Transforming Patient Experience in to Patient Voice (Now Available) (ID 11372)

      15:55 - 16:15  |  Presenting Author(s): Jesme Fox

      • Abstract
      • Presentation
      • Slides

      Abstract

      Background

      Recent years have seen an explosion in new therapies in lung cancer. Research has given us Targeted Therapies, Immunotherapies, minimally invasive thoracic surgery and better directed radiotherapy techniques The challenge is to ensure patients have equitable access to up to date best practice treatment and care, taking advantage of the research developments. There are many reasons for variability in such access - in the main, new therapies cost and Healthcare systems are under enormous financial pressure; resource availability, priority setting and pressures differ between healthcare systems. Furthermore, the pace of change in lung cancer is such that it is difficult to keep up with new developments. Health systems are inherently slow to enact change.

      Each healthcare system will have its own unique approach to ensuring access to innovative new therapies. In dealing with the reality of finite and scares resources, many countries have developed formal decision making bodies, undertaking Health Technology Assessment (HTA). These processes interrogate both clinical and health economic data. Ethical considerations and patient preference can also be taken in to account.

      Advocates can work with HTA agencies to ensure that the experience of the patient population impacted by the therapy under review, is part of the assessment. Where assessment processes are not present, advocates can also use the patient experience to work with policymakers in ensuring that a particular disease has enough resources devoted to it.

      Using Patient Experience in improving access to new therapies

      Through patient experience, advocates have a voice in shaping the process whereby patients access new therapies. There is potential to input across the whole process – designing clinical trials; regulation/licencing; HTA and access procedures.

      Only people living with a particular health condition can truly describe the challenges they face and the impact that a new therapy will have upon them. Quality of life scores and clinical trial data do not fully reflect patient priorities on aspects of their health and wellbeing. Hence the reason that formal and informal processes have been developed to allow patient advocates to submit the patient perspective to decision makers. In so doing, advocates need to

      Know the process that is required in their own healthcare system – many Regulators (eg, the FDA) and HTA bodies offer information, training and support to advocates

      1. Have the credibility to speak on behalf of their patient community - the ability to contact and survey appropriate patients.

      2. Understand the experience of the patient group, receiving the therapy under review. What are the needs and experiences of this patient group?

      3. Share patient experience of the therapy under review. What information and data is required to make a contribution? What other therapy options are available? Patient stories can be very powerful.

      Measuring the value which patients attribute to individual therapies, is an area of current interest [1], [2]. This is complex. It can be difficult to define a single set of patient values on a particular therapy. There are many individual patient variables – age, education, expectation, personal finances, social/religious/cultural factors. The focus, therefore, needs to be on inputing a broad range of outcomes, which patients regard as most relevant.

      Lung Cancer Patient Specific Issues to consider

      In lung cancer, we have a number of specific challenges. Globally, there is a lack of lung cancer patient advocate organisations, who have the ability to engage with this. Lung cancer patients tend to be older, have poorer Performance Status and other co-morbidities. It is often difficult to reach a representative patient group. A better understanding of lung cancer biology and the targeting of therapies, means that new therapies and indications tend to be for smaller, more segmented patient groups. It can be challenging for advocacy organisations to reach these patients in significant numbers.

      This presentation will, therefore, expand on the areas above and encourage advocates to engage with policy makers to ensure that the lung cancer patient experience is incorporated into decision making on access to new therapies.

      References

      [1] Narbutas et al, Overview on Patient Centricity in Cancer Care. Frontiers in Pharmacology, Oct 2017; 8: Article 698

      [2] Addario et al, Patient value: Perspectives from the advocacy community. Health Expectations. 2018; 21: 57-63.

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      ES05.04 - Challenges and Solutions in Engaging with the Health Technology Assessment Process in Canada (Now Available) (ID 11373)

      16:15 - 16:35  |  Presenting Author(s): Christina Sit

      • Abstract
      • Presentation
      • Slides

      Abstract

      Treatment advances in lung cancer have helped increase Qol and survival for lung cancer patients. However, with list prices of over $8000 Cdn per month for recent lung cancer treatments,1-4 cost can be an insurmountable barrier access for patients. Public coverage offers patients a chance at life-extending treatments that they may not have ability to access. Health Technology Assessment (HTA) bodies are called to answer the value of the new treatment within a context of responsibility to public taxpayer funds. The patient voice within this process is critical to give a “true” assessment of the disease burden which goes beyond ICER’s, QALY’s and include real world considerations of caregiver time off, and ability to go to treatments by themselves.

      However patient input into HTA is not standardized and varies across the world. Some countries only accept patient-based evidence that meets scientific standards of collection, or quality of life measures within clinical trials.5 Canada is fortunate as the Pan Canadian Oncology Drug Review (PCODR-CADTH) is a leader in providing an opportunity for the patient voice in its deliberations by accepting patient group input. HTA within PCODR’s deliberative frameworks is based on four quadrants: 1) clinical benefit 2) alignment with patient values 3) cost effectiveness 4) feasibility of adoption into the health system.6

      However treatment advances have challenged the traditional framework, and disease realities have imposed limitations on the patient voice into HTA. These include:

      1) Health Canada approval on phase 2 data but positive reimburse recommendations not issued until the release of phase 3 data resulting in coverage delays (some in excess of more than 1000 days) and is challenging in the era of targeted medicine when for some smaller targets, phase 3 trials are not possible

      2) Gaps in timing between the trial and HTA submission in a disease with a high mortality

      3) Small numbers of patients with experience using the treatment under consideration - especially in the case of targeted medicines

      4) Randomized double-blinded trials. Patients who are on treatment cannot be distinguished from those on comparator

      By using strategies such as alliances with other cancer patient groups, Lung Cancer Canada has been able to successfully advocate for change to the system. Collaborations with clinicians and using new data sources such as data mining from social media have helped to increase the patient voice within the patient group submission. Other methodologies such as sharing HTA submissions from different countries and strategies employed by other cancer patient groups such as involvement in patient registries can help capture patient reported outcomes and assist in both adopting and increasing the patient voice in HTA deliberations.

      1. Canadian Agency for Drugs and Technologies in Health (2018). Alectinib (Alecensaro) NSCLC (second line)- pERC Final Recommendation. Retrieved from https://www.cadth.ca/alecensaro-locally-advanced-or-metastatic-non-small-cell-lung-cancer-second-line-details.

      2. Canadian Agency for Drugs and Technologies in Health (2017). Dabrafenib (Tafinlar) Trametinib (Mekinist) NSCLC- pERC Final Recommendation. Retrieved from https://www.cadth.ca/tafinlar-mekinist-combo-non-small-cell-lung-cancer-details.

      3. Canadian Agency for Drugs and Technologies in Health (2017). Osimertinib (Tagrisso) NSCLC-pERC Final Recommendation. Retrieved from https://www.cadth.ca/tagrisso-non-small-cell-lung-cancer-details.

      4. Canadian Agency for Drugs and Technologies in Health (2016). Nivolumab (Opdivo) Non-Small Cell Lung Cancer- pERC Final Recommendation. Retrieved from https://www.cadth.ca/opdivo-non-small-cell-lung-cancer-details.

      5. Facey K, Plough Hansen H, Single A (Eds) (2017) Patient Involvement in Health Technology Assessment. Singapore: Springer-Nature

      6. pCODR-CADTH (2016, March). pCODR Expert Review Committee Deliberative Framework. Retrieved from https://www.cadth.ca/sites/default/files/pcodr/The%20pCODR%20Expert%20Review%20Committee%20%28pERC%29/pcodr_perc_deliberative_frame.pdf

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    MA07 - Towards Survivorship: The Landscape, Supports and Barriers (ID 904)

    • Event: WCLC 2018
    • Type: Mini Oral Abstract Session
    • Track: Advocacy
    • Presentations: 12
    • Now Available
    • Moderators:
    • Coordinates: 9/24/2018, 13:30 - 15:00, Room 205 AC
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      MA07.01 - No Longer Outliers: Understanding the Needs of Long-Term Lung Cancer Survivors (Now Available) (ID 12955)

      13:30 - 13:35  |  Presenting Author(s): Maureen Rigney  |  Author(s): Jennifer C King, Andrew Ciupek

      • Abstract
      • Presentation
      • Slides

      Background

      Lung cancer is the leading cause of cancer death in most developed and developing countries. But people do survive, sometimes for many years. Those diagnosed with lung cancer experience higher levels of distress and have greater unmet physical and emotional needs compared with other types of cancer. But what of long-term survivors?

      Globally, The Cancer Atlas reported an estimated 1,878,000 people were living with lung cancer in 2012. With the introduction of screening and rapid treatment advancements, that number is only expected to increase. Are we prepared to meet the long term and late effects of lung cancer? First, we must better understand the experiences and identified needs of long-term survivors.

      Method

      820 people responded to a 120 question online survey that was distributed via social media and targeted outreach. 471 identified as lung cancer patients/survivors and 349 as loved ones. 21% of survivor-respondents indicated they had been diagnosed 5+ years prior.

      Queried on treatment and smoking histories, long-term survivors identified their most prevalent and problematic symptoms and side effects experienced during treatment, shortly after treatment ended and at 5+ years post-diagnosis. They also answered questions regarding treatment decision-making and palliative care discussions and provision of post-treatment survivorship plans.

      Result

      74% of long-term survivors had surgery, 43% had experienced a recurrence and 5% had participated in a clinical trial. None were current smokers.

      The most common (and problematic) late and long term symptoms and side effects were shortness of breath (39%), fatigue (28%) and anxiety (24%). Memory problems were also rated as common (27%).

      Long-term survivors indicated that during treatment, physical side effects were most problematic but post-treatment and long-term, emotional effects were more difficult. Financial issues were also more problematic 5+ years after treatment compared with other time periods. Both discussions of palliative care and provision of survivorship care plans were rare.

      Conclusion

      Long-term lung cancer survivors were once considered ouliers but today those diagnosed are increasingly living five years and longer. How do the late and long-term physical effects of lung cancer and its treatments differ from survivors of other types of cancer? How do long-term survivors manage stigma and survivor guilt? What physical and emotional support and services do they need? This survey provides initial insights into the physical. emotional and financial effects of living longer with lung cancer but more research is needed to allow us to more fully understand how we can support our long-term survivors.

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      MA07.02 - Line of Therapy and Patient Preferences Treating Lung Cancer: A Discrete-Choice Experiment (Now Available) (ID 14107)

      13:35 - 13:40  |  Presenting Author(s): Andrea Ferris  |  Author(s): John F.P. Bridges, Upal Basu Roy, Ellen Janssen

      • Abstract
      • Presentation
      • Slides

      Background

      Patient preferences now play an important role in cancer research, regulatory science, and value assessment. While there is a growing literature exploring the preference of patients with lung cancer, few studies have explored how preferences vary with patients’ treatment experience. We sought to quantify patient preferences for the benefits and risks of therapy and explore how they vary across line of treatment.

      Method

      Preferences were estimated using a discrete choice experiment (DCE) developed in partnership with a patient and stakeholder advisory boards. A D-optimal experimental design was used to generate 3 blocks of 9 choice tasks spanning five attributes: progression-free survival (PFS), short-term side effects, long-term side effects, risk of developing late-onset side effects, and mode of administration – each defined across 3 relevant levels. A diverse sample was recruited via email sent to the LUNGevity lung cancer patient database and via social media. A choice mode was estimated use a conditional logistic regression where the dependent variable was the respondents preferred treatment in each profile. The relative attribute importance (conditioned on the chosen attribute levels) was then compared across the respondents’ self-reported line of treatment.

      Result

      In total we had 350 eligible respondents, of which 279 (80%) completed as least on DCE task of which 3% did not receive a pharmacotherapy, 39% received first line therapy, and 58% had two or more lines of theory. As with previous studies, PFS was the most important attribute for patients and was similarly valued (P=0.406) among first- and later (second lines and more) lines of treatment (33.4% v 33.8%). Patients on first-line treatment placed great emphasis (P<0.001) on long-term side (18.9% v 14.1%) and late onset side effects (15.3% v 10.3%), but less emphasis (P<0.001) on short-term side effects (27.8% v 29.8 %) and mode of administration (4.6% v 12.0%) than those on later lines.

      Conclusion

      Population estimate of patient preference remain important, but more effort is needed to understand how patient preference vary across patient with different backgrounds and treatment experiences. We show that line of treatment does not effect how patients value time, but their experience may have an impact on treatment characteristics. Latent class analysis may allow for the identification of groups with similar preferences that could allow for multivariate analyses to explain preference heterogeneity.

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      MA07.03 - Attitudes to Lung Cancer in Europe: Findings from a Global Consumer Survey (Now Available) (ID 12579)

      13:40 - 13:45  |  Presenting Author(s): Jesme Fox  |  Author(s): Aoife McNamara, Maureen Rigney, Greg Manuel, Sarah Winstone

      • Abstract
      • Presentation
      • Slides

      Background

      If lung cancer is diagnosed early, patients’ chances of successful treatment are increased. Stigma
      around lung cancer, as a tobacco-related cancer, can discourage patients from talking to their doctor
      about potential symptoms. In 2017, the GLCC commissioned Populus to undertake an international
      consumer survey in each of the 25 countries of the GLCC members.

      Method

      1,000 adults, in 16 European countries, participated via an online survey in July 2017. To assess
      attitudes to lung cancer, they were told that lung cancer is mainly caused by smoking and other
      tobacco products. They were then asked the extent to which they agreed or disagreed with the
      statement: “I have less sympathy for people with lung cancer than for people with other cancers.”

      Result

      One in five (20%) people in Europe agreed that they have less sympathy for people with lung cancer
      than other forms of cancer (Chart 1). There was variation between countries with 30% of people in
      Portugal agreeing they have less sympathy in comparison to only 17% agreeing in Denmark, the
      Netherlands, Norway, Russia, Slovenia and Spain. Men in Europe are generally less sympathetic
      than women, and those aged over 55 are most sympathetic. In addition, there was a statistically
      significant correlation between those countries with lower cigarette consumption and people agreeing
      that they have less sympathy for people with lung cancer.

      Chart 1: European attitudes to lung cancer

      glcc - european attitudes - chart 1.png

      Conclusion

      Everyone - no matter what the cause of their cancer - deserves to have high quality treatment and
      care. The persistent and varied levels of stigma associated with lung cancer across Europe needs to
      be addressed, so that people experiencing symptoms are not discouraged from seeking early
      intervention.

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      MA07.04 - Discussant - MA 07.01, MA 07.02, MA 07.03 (Now Available) (ID 14596)

      13:45 - 14:00  |  Presenting Author(s): Kim Norris

      • Abstract
      • Presentation
      • Slides

      Abstract not provided

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      MA07.05 - Psychosocial Needs and Programs of Cancer Patients/Survivors and Their Relatives: Unmet Needs from an International Study (Now Available) (ID 12062)

      14:00 - 14:05  |  Presenting Author(s): Csaba László Dégi  |  Author(s): Samantha Serpentini, Savita Goswami

      • Abstract
      • Presentation
      • Slides

      Background

      In consideration of the dynamic nature of cancer patients’ needs, systematic understanding of their unmet needs from a socio-ecological perspective may be essential as the patients’ needs and available services are likely to vary by different healthcare systems in different countries. To investigate the role of geographical influence in cancer patients’ unmet needs, this study seeks to compare the unmet needs of and available programs for cancer patients/survivors and their family members by different types of healthcare systems across different countries.

      Method

      The IPOS Survivorship Online Survey is distributed to international and regional Psycho-Oncology organization members, which covers countries in six continents. Survey participants’ countries where they practice/research will be categorized into four groups by the types of healthcare system: Beveridge Model, Bismarck Model, National Health Insurance Model, and Out-of-Pocket Model.

      Result

      With estimated survey to be completed by August 30th, 2018, repeated measures ANOVA will be employed to test differences in patients’ unmet needs by the four healthcare system groups, separately for patients’ unmet needs and their family caregivers’. Differences by individual countries will also be explored.

      Conclusion

      Findings will provide a global overview and a specific knowledge of the geografical differences in the psychosocial unmet needs and psycho-oncological programs for cancer patients/survivors and their family members/caregivers. Findings will also guide how to prioritize areas of cancer care that require improvement in psycho-oncology interventions and practices; and to highlight critical aspects for delivering quality care that vary by healthcare systems.

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      MA07.06 - Telephonic Communication In Palliative Care For Better Management Of Terminal Cancer Patients In Rural India -  An NGO Based Approach.  (Now Available) (ID 11905)

      14:05 - 14:10  |  Presenting Author(s): Nabanita Mandal

      • Abstract
      • Presentation
      • Slides

      Background

      Due to financial incapability and absence of manpower poor families often fail to carry their advanced cancer patients to the nodal centres. This pilot study will explore whether communication by mobile phone can lessen this burden.

      Method

      Initially a plan was generated regarding management of an advanced cancer patient in a nodal centre at District Head Quarter. Subsequently every two week a trained social worker attached to nodal centre will follow up and give necessary advice and emotional support to the patients and their families through their registered mobile phone number. Patient’s family were also encouraged to communicate with the team by phone in case of fresh complain and urgency in between.

      Result

      Since initiation in January 2017, 210 cancer patients were contacted by mobile phone every two weeks to enquire about their difficulties. In 76% of the situation trained social workers could give necessary advice by phone regarding management of their physical symptoms. Moreover patient’s family were really overwhelmed by the emotional support offered by the team over phone. Only 24% of cancer patients has to attend the nodal centre for expert advice from Palliative Care specialists.

      Conclusion

      This novel approach helped
      * In providing regular physical and emotional support to the patients and their families.

      * In significantly reducing the financial and manpower problems of carrying patients to the nodal units.
      * In improve the quality of life of patients by continuous guidance.


      More and more team members can take help of this new strategy for better communication and uninterrupted care.

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      MA07.07 - Identifying the Severity of Psychosocial Symptoms Among Patients Diagnosed with Lung Cancer. Do We Really Need Emotional Support Groups? (ID 13701)

      14:10 - 14:15  |  Presenting Author(s): Arooj Fatima  |  Author(s): Syed Sammar Abbas Zaidi

      • Abstract
      • Slides

      Background

      Lung cancer is the second most common cancer among men and women. Most of the lung cancers are diagnosed at later stages among those patients who are underprivileged. The diagnosis and treatment of lung cancer is a continuous emotional distress for both patient and their family. We aim to identify the severity of depression, emotional distress, stress and mental fatigue among those patients who are diagnosed with lung cancer .

      Method

      A cross sectional study was conducted in Shaukat Khanum Hospital, Lahore from March 2014 to April 2015. Exclusion and Inclusion criteria were made. 150 were enrolled in the study. Socio demographic characteristics were evaluated using Beck Depression Inventory and socio demographic form. Severity of depression was estimated by using Hamilton D (HAM-D). Various variables were analysed including parent’s age, level of education, socioeconomic status, gender and number of children.

      Result

      68% of the participants exhibited severe range of depression. 27% showed moderate depression where as 5% participants were showing the mild range of depression. An inverse co relation was found between educational status, occupational status (paid or unpaid), their marital status, socioeconomic family status and depression. Women 71% were found be more depressed than males.

      Conclusion

      We concluded that majority of patients from psychosocial symptoms particularly depression and it is mainly associated with some factors. There is need to incorporate patients into the diagnosis and treatment process so that we can over come the effects of depression on the health outcomes of patients diagnosed with lung cancer. This can only be possible through appropriate education and emotional support programmes.

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      MA07.08 - Discussant - MA 07.05, MA 07.06, MA 07.07 (Now Available) (ID 14597)

      14:15 - 14:30  |  Presenting Author(s): Jennifer C King

      • Abstract
      • Presentation
      • Slides

      Abstract not provided

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      MA07.09 - Willingness to Perform Multiple Biopsies to Improve Quality of Lung Cancer Care: Understanding the Oncologists’ Perspective (Now Available) (ID 14096)

      14:30 - 14:35  |  Presenting Author(s): Upal Basu Roy  |  Author(s): Margery Jacobson, Andrea Ferris

      • Abstract
      • Presentation
      • Slides

      Background

      Biomarker testing of advanced-stage non-small cell lung cancer (NSCLC) at the time of diagnosis is required to determine if a patient will benefit from a targeted therapy or immunotherapy. A patient may, however, need additional biopsies (rebiopsy) if the cancer recurs to determine the next line of therapy or to determine eligibility for a new drug or participation in a clinical trial. A LUNGevity study, conducted with 340 patients, revealed that patients were willing to undergo rebiopsies if that meant access to additional treatment options at the time of recurrence. However, only 36% of patients reported that their doctors recommended repeat biopsies at progression.

      Method

      To understand this patient-physician communications gap, we conducted an IRB-approved semi-structured survey-based study of 130 oncologists from academic research centers, community cancer centers, and private practice.

      Result

      Of the 130 oncologists surveyed,

      - Ninety percent of oncologists reported recommending a rebiopsy to their patients. However, when stratified by advanced-stage patient volume, oncologists with higher advanced-stage patient volumes reported higher rebiopsy and testing rates than those with low volumes (95% vs. 78%, p<0.05). Only 29% of the oncologists prescribed a rebiopsy in the past one year.

      - Major barriers to rebiopsy reported by oncologists included cost/reimbursement of a rebiopsy and treatment delay for 2nd- or subsequent lines of therapy

      - Among the types of biomarker testing performed at the time of progression, oncologists were more likely to prescribe testing for biomarkers with approved treatments (driver mutations – 94%, PD-L1 – 85%) unlike biomarkers for treatments in clinical development (43%) (p<0.05).

      - A forward linear regression analysis revealed that positive predictors of rebiopsy included treatment at a NCI Designated Cancer Center, while treatment at a community cancer center or private practice, presence of driver mutations at the time of diagnosis, and performance status of patient were negative predictors of rebiopsy

      - When presented with specific treatment scenarios for biomarkers (EGFR and ALK) that have 2nd-line treatment options, oncologists differed in their approach, suggesting a need for oncologist education about rebiopsying and subsequent biomarker testing

      Conclusion

      Our study demonstrates that rebiopsy practices vary by practice settings and volume of advanced-stage lung cancer patients. Even when rebiopsies are prescribed, a comprehensive biomarker profile of the tumor may not be obtained, due to variations in tests requested. A major implication is the need for appropriate oncologists’ education to ensure practice change for delivery of optimal care to lung cancer patients.

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      MA07.10 - Utilizing a Personalized Navigation Program to Identify Barriers and Increase Clinical Trial Participation Among Lung Cancer Patients (Now Available) (ID 13482)

      14:35 - 14:40  |  Presenting Author(s): Andrew Ciupek  |  Author(s): Tara Perloff, Achintya Jaitly, Jennifer C King

      • Abstract
      • Presentation
      • Slides

      Background

      Only about 5% of cancer patients participate in clinical trials. We previously conducted a survey of U.S. lung cancer patients and found that only 22% reported discussing clinical trials with their oncologist at the time of making treatment decisions. We hypothesized that a personalized navigation program could both increase rates of trial discussion and identify barriers to participation among lung cancer patients.

      Method

      We asked callers to Lung Cancer Alliance's 1-800 support line if they had considered clinical trial participation and referred willing callers to a navigator for further discussion. Navigators provided basic clinical trial education and a personalized list of trial matches. Patients were encouraged to discuss these trials with their treating oncologist. Navigators then regularly followed up with participants, via email or phone, at two to four-week intervals, to offer further support and collect outcomes information.

      Result

      We referred sixty callers to a navigator. Only 43% of callers reported a prior clinical trials conversation with their provider. Patients who had not started treatment or were on first-line treatment reported lower discussion rates (30%) than those on later treatment lines (60%). Among patients with follow up, 13 of 20 patients who had not discussed trials with their provider reported doing so after navigation. Ten of eleven patients that had a previous trial conversation initiated an additional one. Primary reasons given for not talking discussing after navigation were having stable disease on a current treatment or waiting for a clinical result. Ten patients reported contacting a trial. Primary reasons for not contacting a trial after discussion were disease progression, choosing a standard of care alternative, or waiting for a clinical result. Four patients have enrolled on a trial. Two patients were determined ineligible for a trial they approached for not meeting listed eligibility criteria and two for reasons not appearing in public trial information.

      Conclusion

      We identified barriers throughout the clinical trials consideration and enrollment process. One set of barriers was related to care coordination, as exemplified by low rates of trial discussion during early stages of treatment and patient reports of delayed trial consideration when currently receiving treatment or waiting on a clinical result. Communication of trial information was another area presenting barriers, as exemplified by exclusion of patients from trials for reasons not readily apparent from public trial information. Improving integration of trial discussion during care and ensuring availability of accurate, updated trial information may be essential to increase trial participation.

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      MA07.11 - Drug Price Comparison in Advanced Lung Cancer – High Cost Prices is Accompanied by Patient Benefits? (Now Available) (ID 14015)

      14:40 - 14:45  |  Presenting Author(s): Luciene Bonan

      • Abstract
      • Presentation
      • Slides

      Background

      In our recent decade we are seen new drugs coming up with high speed development to attend personalized conditions in lung cancer treatment. After the first TKI for EGFR mutation, many other target drugs such as TKI for ALK/ROS1 alteration, third-generation EGFR TKI, anti-PD-1/PD-L1 immunotherapies bring together an improvement in survival with better quality of life than chemotherapies. But this new specialty drugs are also testing the affordability of the market with new launched ceiling prices. Frequently, their prices have been settled down in a context of an unmet condition appeal rather than the truly health benefits. In pricing it is a common practice to use the external reference price between countries to align the prices based on international market. But if the first price is launched (frequently in USA) in countries that don’t use metrics based on evidence or clinical benefits, the price plateau could be replicated even without necessarily deserving this price. The objective of this presentation is to show the price comparison of drugs included in TKI class and immunotherapy class between high and middle-income countries. Then to compare the cost-treatment of therapies commonly used in advanced lung cancer and their magnitude of clinical benefit.

      Method

      All local currencies were converted to US dollars using PPP factor. The magnitude of effect was evaluated based on the ESMO Magnitude of Clinical Benefit Score.

      Result

      USA has the highest drug price followed by Brazil, especially in recent launched drugs. Costs of advanced lung cancer treatment significantly increase 5 times more when compared first-generated TKI and new generation TKI. Immunotherapy for second line costs 6 times more than first line with EGFR TKI and could cost more than 7 to 130 times the chemotherapy with docetaxel. Clinical benefits do not reach the same scale.

      Conclusion

      The market of anticancer drug increasing 10% annually, but clinical benefits don’t advance in the same compass. Specialized drugs come into the market with pricing warrant of unmeet conditions, but if we think in precision medicine all new drug-target biomarker could be priced higher because it will cover a rare or unmet condition. In the context of precision medicine, is it fear a patient pays more because he has a different biomarker for the same clinical condition? If countries do not start to evaluate and pricing drugs based on value, market strategists will continue to test the ceiling price that health systems can(not) afford.

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      MA07.12 - Discussant - MA 07.09, MA 07.10, MA 07.11 (Now Available) (ID 14598)

      14:45 - 15:00  |  Presenting Author(s): Govind Babu Kanakasetty

      • Abstract
      • Presentation
      • Slides

      Abstract not provided

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    MA17 - New Methods to Improve Lung Cancer Patients Outcomes (ID 918)

    • Event: WCLC 2018
    • Type: Mini Oral Abstract Session
    • Track: Nursing and Allied Professionals
    • Presentations: 12
    • Now Available
    • Moderators:
    • Coordinates: 9/25/2018, 13:30 - 15:00, Room 205 AC
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      MA17.01 - A Sense of Understanding and Belonging When Life Is at Stake – Operable Lung Cancer Patients’ Lived Experiences of Participation in Exercise (Now Available) (ID 13162)

      13:30 - 13:35  |  Presenting Author(s): Malene Missel  |  Author(s): Mai Nanna Schoenau, Britt Borregaard

      • Abstract
      • Presentation
      • Slides

      Background

      Exercise has been introduced to improve physical capacity and quality of life and to reduce symptoms and side effects of treatment in surgically treated non-small cell lung cancer (NSCLC) patients. The effects of an exercise programme for this patient group has been tested in a randomized controlled trial – the PROLUCA study. The questions though, of how patients experience participation in group-based exercise studies and the impact of the shared community with fellow patients has not been previously examined. The objective was to explore lived experiences and social benefits among patients with operable NSCLC who participated in an exercise programme (the PROLUCA study) post-surgery.

      Method

      Nineteen patients enrolled in an exercise intervention two weeks post-surgery participated in qualitative interviews at three time points. A phenomenological hermeneutical approach comprised the epistemological stance and the methodological basis was Ricoeur’s narrative philosophy. The goal of the analysis and interpretation was to provide descriptions that captured the meaning of the lived experiences of the patients.

      Result

      Patients included in this qualitative study had a mean age of 63 years (range 48-75), 58% were female, and 68% was retired. Eighty-four percent had performance status 0 (WHO) and almost all patients were used to some kind of physical activity. The analysis revealed social benefits of taking part in the group-based exercise intervention. The patients experienced themselves as part of a community, and the physical exercise intervention was significant in terms of the patients’ social capital. In this sense, patients gained access to resources that derived from human interaction in the exercise group, and their illness and treatment became easier to manage when shared with others in the same situation. The exercise intervention helped to create a community for patients after lung cancer surgery, and the patients experienced a feeling of belonging and equality with the other participants.

      Conclusion

      The group based exercise intervention created opportunities for mutual understanding between patients, making illness and treatment easier to manage. The patients experienced support to gain renewed balance in life during the exercise intervention in the interaction with peers in the group. It is relevant to inform operable NSCLC patients about the potential community of understanding and belonging in group-based exercise interventions.

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      MA17.02 - Early Accrual to a Precision Lung Cancer Survivorship Intervention: The Kentucky LEADS Collaborative Lung Cancer Survivorship Care Program (Now Available) (ID 14179)

      13:35 - 13:40  |  Presenting Author(s): Jamie L Studts  |  Author(s): Jessica L Burris, Michael A Andrykowski, Tara Schapmire, Barbara Head, Maureen Rigney, Angela Meredith Criswell, Susanne M Arnold, Allyson R Yates, Courtney Blair, Amy Christian

      • Abstract
      • Presentation
      • Slides

      Background

      Recent advances in early detection and treatment of lung cancer have created a need for survivorship care interventions to reduce the psychosocial and symptom burden of lung cancer, but few interventions address the unique experience of lung cancer survivors and their caregivers. Leveraging shared decision making and motivational interviewing, the Kentucky LEADS Collaborative developed a precision psychosocial intervention addressing the unique experiences and challenges of individuals diagnosed with lung cancer and their caregivers. This sub-study describes the demographic, diagnostic, and psychosocial characteristics of the initial participants in the Kentucky LEADS Collaborative Lung Cancer Survivorship Care Program.

      Method

      Participants include 61 lung cancer survivors across 9 lung cancer care sites in Kentucky, USA. Data were drawn from baseline surveys of demographic characteristics, disease/treatment information, symptom burden, psychosocial functioning and quality of life administered to lung cancer survivors and caregivers enrolled in the single-arm intervention trial.

      Result

      Of the first 61 LC survivors enrolled, 32 had a caregiver join them as participants in the intervention (53%). Participants had a mean age of 62 years. Approximately 20% of LC survivors did not have a caregiver available to participate, and 27% declined to invite a caregiver join the program. Most participating caregivers were spouses (63%), but siblings (10%) and children (19%) were also included. Most survivors were female (66%), Caucasian (97%), and covered by health insurance (95%), and 59% were married or living in a committed relationship. Most participants had been diagnosed with non-small cell lung cancer (84%) and late-stage disease (IIIB-IV; 53%). Most participants had a history of smoking (95%); 30% had smoked within the past 30 days, and 29% were current smokers. Among current smokers, participants reported very high levels of quit planning (9.23±2.77) and quitting confidence (9.14±2.89). Finally, approximately 55% reported clinically significant distress, with a mean level of distress of 3.98 (2.99) on a scale from 0-10.

      Conclusion

      Early accrual to the trial has exceeded expectations. Most survivors had advanced disease and reported significant distress. A substantial minority continued to use tobacco. Data suggest that modifications made to the survivorship approach emphasizing empathy and patient preference may help improve intervention acceptability and feasibility. Subsequent analyses will evaluate the impact of the intervention on quality of life, psychosocial functioning, and symptom burden. Data will also be collected regarding acceptability of the intervention and potential program changes to optimize benefits.

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      MA17.03 - Shared Decision-Making for Patients with Advanced Non-Small Cell Lung Cancer (Now Available) (ID 12426)

      13:40 - 13:45  |  Presenting Author(s): Mette Kargo Jensen  |  Author(s): Karin Piil, Gitte Fredberg Persson, Seppo W Langer, Mette Vinter, Katrina Pitt Winther, Susanne Friis-Haché, Mette Pøhl

      • Abstract
      • Presentation
      • Slides

      Background

      Lung cancer is the leading cause of cancer-related death in the world and more than half of the patients have metastatic disease at the time of diagnosis. Although, treatment options are developing rapidly, most patients are facing a poor prognosis. The role of 3rd or 4th line treatment with chemotherapy remains controversial with sparse evidence of efficacy. Therefore, the patient’s preferences become central. Shared decision-making enables the patients to be actively involved in choosing the treatment option that best reflects both medical evidence and individual preferences.

      This study examines how patients with lung cancer and their relatives are empowered and supported when they have to make informed choices regarding 3rd or 4th line of treatment. The aim was to develop a model for shared decision-making and to test decision aid tools that enable a collaborative process that takes into account the best available scientific evidence, as well as the patient's values and preferences.

      Method

      Patients diagnosed with advanced non-small cell lung cancer, their relatives and the health care professionals were involved in the process that included: 1) Multidisciplinary workshops and workshops with patients and relatives, 2) Training course in communication on existential issues and shared decision-making for health care professionals, 3) Designing and testing five decision aid tools, 4) Creating a Podcast and 5) Evaluation by patient satisfaction surveys.

      Result

      Three strategic focus areas were identified: 1) The meaningful service, 2) considerations in end-of-life care and 3) patient involvement in decision making. The patient reported quality of communication was increased during the study period. The patient satisfaction surveys (n=77 baseline) and (n=60 final evaluation) demonstrated statistical significant improvements from baseline to final evaluation in regard to:1) involving patients in the treatment decisions to the extent they prefer (Pearson Chi-Square, P=0.048) and 2) encouraging patients to ask questions (Pearson Chi-Square, P=0.008). The study improved the health care professionals understanding of the importance of incorporating patients in shared decision-making processes in clinical practice. However, some barriers for implementation were identified, such as changing established behaviour among health care professionals.

      Conclusion

      The findings indicate that decision aid tools are useful and related to significant changes in patient experience of the quality of communication. We suggest investigating the feasibility and potential concerns of integrating these tools to a larger extend in clinical practice.

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      MA17.04 - Discussant - MA 17.01, MA 17.02, MA 17.03 (Now Available) (ID 14648)

      13:45 - 14:00  |  Presenting Author(s): Anne Fraser

      • Abstract
      • Presentation
      • Slides

      Abstract not provided

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      MA17.05 - Development of a Telephone Clinic for Patients Undergoing Long Term Follow-Up After Thoracic Surgery (Now Available) (ID 12598)

      14:00 - 14:05  |  Presenting Author(s): Jenny Mitchell  |  Author(s): Calum Buchanan, Sarah Malone, Francesco Di Chiara, Dionisios Stavroulias, Elizabeth Belcher

      • Abstract
      • Presentation
      • Slides

      Background

      Patients undergoing long term follow-up after lung cancer surgery in our institution follow an imaging based follow-up programme. Protocol led CT imaging followed by an out-patient appointment is undertaken every 6 months for two years after surgery then annually until year 5. Feedback from patients indicated they find two trips to the hospital burdensome and they frequently requested results of surveillance imaging over the telephone. Limited capacity in the thoracic surgery clinics led to long waits for an appointment to be informed of imaging results. To address these issues, we developed a model of nurse led telephone follow-up after surveillance imaging.

      Method

      A proposal to hold one telephone clinic per week was made to commissioners in the autumn of 2016. Following approval, the telephone clinic commenced in April 2017. Patients are triaged by the specialist nurse when CT results are available and allocated to the telephone clinic if appropriate. They are given a timed appointment and the telephone number they will be contacted on is confirmed prior to the appointment. A database is completed during the appointment, a record of the consultation is made in both paper and electronic patient records and a letter is sent to the GP and other teams who have contact with the patient. Patients with significant abnormalities on CT imaging are referred for discussion by the multidisciplinary team and seen in a face to face clinic.

      Result

      In the first twelve months (April 2017 to March 2018) there were 254 patient appointments in 51 telephone clinics. Average call length is 10 minutes with a range of 3 to 22 minutes. One patient scheduled for a telephone appointment was not contactable at the appointed time (0.4%). Satisfaction with the clinic is high with 98% of patients requesting their next follow-up appointment in the telephone clinic. Clinic capacity was increased at reduced cost to commissioners as a telemedicine appointment is charged at £25.34 compared to £70.16 for a face to face appointment.

      Conclusion

      Early results suggest nurse led telephone clinics are an effective way of providing follow-up to patients on an imaging based follow-up programme after surgery. They are well received by patients. We aim to introduce an online tool to objectively assess symptoms in this patient group. Further evaluation of patient experience in this clinic would be beneficial, along with an evaluation of the impact of introduction of telephone follow-up on the rest of the service.

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      MA17.06 - The Specialist Lung Cancer Nurse and Self-Management for People Living with Lung Cancer: A Model of Engagement (Now Available) (ID 13060)

      14:05 - 14:10  |  Presenting Author(s): Vanessa Nicole Brunelli  |  Author(s): Patsy Yates, Carol Windsor

      • Abstract
      • Presentation
      • Slides

      Background

      There is increasing evidence that patient self-management strategies, used as adjuncts to traditional pharmacological interventions, can improve symptom control for people living with lung cancer. While it is acknowledged that the specialist lung cancer nurse (SLCN) is well positioned in the multidisciplinary team to facilitate patient self-management education (PSME), limited guidance is available to SLCNs on this role.

      The aim of this study was to understand the knowledge and skills required of SLCNs to facilitate PSME and how such skills might best be developed. The intent was to develop a pedagogy that enhances SLCN-patient interactions so that patients can be better supported to make self-care decisions and to act on these decisions.

      Method

      The epistemological lens of the study drew on the sociocultural works of Vygotsky and Leontiev. Fifteen participants were purposively recruited through the Australia and New Zealand Lung Cancer Nurses Forum. The sample comprised Australian registered nurses employed at the level of clinical nurse consultant. Eligibility for the study required participants have a minimum of 5 years lung cancer nursing experience. Of the sample, the average was 13 years’ experience.

      Through individual, face to face interviews, a biographical approach to data collection focused on participants’ work and non-work lives. The theoretically informed analysis generated understanding about the salient influences on SLCN learning and how and why these influences shaped PSME.

      Result

      PSME is an inherently complex activity. Although seeking to facilitate patient learning to empower patients to self-manage, the SLCN experiences challenges in the contemporary health care environment. Entrenched power relations, professional boundaries, minimal practice guidelines and issues of resourcing of lung cancer and lung cancer nursing are key factors that shape PSME.

      A model of engagement was designed to reflect the pedagogy that underpins optimal interactions between SLCNs and patients. The model brings forth the socially situated contexts of the SLCN and patient as central to the interaction. A reflective mode of practice creates a teaching and learning environment inclusive of sociocultural and individual processes on learning and thus the mechanisms of co-constructing knowledge for the purpose of shaping patient behaviour.

      Conclusion

      The study assumes the strategic importance of addressing how best the SLCN workforce can support people living with lung cancer to self-manage. A key strength of the research is the focus on understanding the individual and social interrelatedness of SLCN learning for the purpose of enhancing educational interactions in complex environments with people living with lung cancer.

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      MA17.07 - Nurse-Led Telehealth Clinic in Treatment Monitoring and Follow Up (Now Available) (ID 12335)

      14:10 - 14:15  |  Presenting Author(s): Sarah Louise Cubbin  |  Author(s): Michael Brada

      • Abstract
      • Presentation
      • Slides

      Background

      A clinical consultation is usually physician led and traditionally carried out in a direct person-person interaction in an outpatient clinic. The alternative is replacing it through electronic means via telehealth. This has already been exploited as a phone consultation and is gaining momentum as a video based consultation although it has not been widely introduced into oncology.

      Method

      The aim was to ascertain the acceptance of the video consulting technology in real clinical settings and the effectiveness of video consultation in replacing conventional consultation.

      Eligible patients who attended a pre-existing nurse led clinic completed a checklist to ensure access to appropriate IT equipment. Those able to participate were asked to replace two nurse led appointments with nurse led teleheath appointments using iKonsult video consultation platform. After each consultation a satisfaction questionnaire was completed.

      Result

      Patients were recruited from a protocolised nurse led clinic for mutation driven NSCLC on oral tyrosine kinase inhibitors (TKI). 42 patients were approached over a three month period; only 6 agreed and were followed up via the telehealth platform. 4 patients considered it as a possibility, 4 did not feel confident and 3 did not have the correct equipment. The remaining patients cited numerous reasons for not taking up this service.

      In the satisfaction analysis of 17 initial telemedicine consultations 5/6 patients (81%) were very satisfied with telemedicine follow up. 4 patients (66%) found the platform extremely easy and 2 (34%) easy to use.

      Conclusion

      On treatment monitoring of oral TKI therapy could be effectively carried out using video consultation platform reducing the number of hospital visits. The consultations provided necessary information and allowed for adequate clinical assessment. However the initial take up rate is low mostly due to patient reluctance rather than unavailable technology. The overall feedback from participants was very positive and accepting of the service. The iKonsult video consultation is being introduced into other oncology settings.

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      MA17.08 - Discussant - MA 17.05, MA 17.06, MA 17.07 (Now Available) (ID 14649)

      14:15 - 14:30  |  Presenting Author(s): Melissa Culligan

      • Abstract
      • Presentation
      • Slides

      Abstract not provided

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      MA17.09 - Remote Symptom Reporting for Tele-Nursing Team in Thoracic Oncology Clinics: Environmental Scan and Stakeholder Engagement (Now Available) (ID 12226)

      14:30 - 14:35  |  Presenting Author(s): Simranjit Kooner  |  Author(s): Jennifer Harris, Suheon Lee, Catherine De Guia, Doris Howell, Geoffrey Liu

      • Abstract
      • Presentation
      • Slides

      Background

      50+% of cancer-related toxicities are under-reported. A real-time Remote (i.e., at-home) Symptom Reporting (RSR) system could help patients seek help when symptoms exceed thresholds, mitigating unplanned clinic/emergency room visits. A RSR system for solid-tumor patients undergoing chemotherapy is associated with improved health-related quality of life and survival (Basch et al, 2017). Adapting RSR into the thoracic cancer clinic environment requires assessments of potential implementation barriers, and tailoring of the RSR-system.

      Method

      Over a five month period, we performed an environmental scan to determine readiness of RSR implementation in our comprehensive thoracic oncology outpatient clinic. A qualitative assessment of potential RSR integration into the telephone triage environment was performed through one-on-one interviews and focus groups, followed by thematic analysis. Discussions were held with multiple stakeholders; key implementation champions were identified. We utilized the Canadian Institutes of Health Research Knowledge-to-Action Framework, Steps 2-4 as our guide.

      Result

      In the environmental scan, 125 telephone triage calls were logged over randomly-chosen days in a 6-week period. The mean ± SEM call duration was 5.4 ± 0.62 minutes. Mean time until response was 44.4 ± 3.8 minutes. Nurses spent on average 2.7 ± 0.2 minutes documenting into the electronic-patient-record. The mean duration from initial contact to completion was 24.1 ± 4.5 minutes. Resolution of the triage calls involved telephone advice alone (87%; n=109), unplanned clinic visits (6%; n=8), and emergency visits (6%; n=7).

      In the qualitative analyses, top stakeholder-identified issues were: lack of assessment standardization; wasted time transcribing paper triage notes to electronic records; and a high patient/family burden in terms on understanding when to seek help. There was universal interest in adopting a RSR system from administrative assistants, nursing administration, clinic nurses, physicians and trainees. Perceived benefits of RSR were: standardized, focused telephone assessments; tailored symptom assessments in the thoracic setting (i.e., dyspnea, coughing, hemoptysis); patient empowerment; and improved efficiency in patient contact, intra-team communication, and documentation. Key stakeholder RSR features were: a phone/web application that assesses symptom severity and indicates when to contact the triage team; one-touch feature to reach team; longitudinal symptom trend display for tele-nursing team; and embedding of the COSTaRS framework to facilitate tele-nursing interventions and documentation.

      Conclusion

      Integration of a RSR system integration was perceived favorably by stakeholders to increase nursing efficiency and improve health related patient outcomes, but success hinges on an identified set of key requirements.

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      MA17.10 - The Use of Technology in the Delivery of Supportive Care of Lung Cancer Patients After Treatment (Now Available) (ID 11186)

      14:35 - 14:40  |  Presenting Author(s): Pamela Rose  |  Author(s): Heather Quail, John McPhelim, Mhairi Simpson

      • Abstract
      • Presentation
      • Slides

      Background

      The NHS Lanarkshire Lung Cancer Project is part of the Transforming Care after Treatment (TCAT) programme.

      During phase one 58 patients participated in the project. 88% of patients opted for a telephone consultation, which was more time effective taking only on average 20 minutes compared to 48 minutes for a face to face consultation. 90% of patients rated the service as excellent and a review of additional Patient Reported Outcome Measures demonstarted an improvement in overall quality of life.

      Further funding was secured as part of Phase 3 of the TCAT programme allowing for continued testing.

      Method

      Between November 2017 – May 2018 lung cancer patients living in Lanarkshire were offered two monthly SPARC assessments on completion of treatment . This was followed up with and a telephone consultation from a lung cancer clinical nurse specialist, the provision of a personalised care plan and access to self-management information. The choice of an electronic or paper SPARC assessment was offered.

      To support the evaluation a Functional Assessment of Cancer Therapy – Lung (FACT-L), Memorial Symptoms Assessment Scale (MSAS) and Supportive Care Needs Survey Long-Form 59 (SCNS) were completed prior to their first and after their final assessment. A patient experience questionnaire was also provided on completion of their final assessment.

      Result

      24 patients participated in phase 3. 53% opted to complete their assessment electronically with 47% preferring the paper option.

      15 patients (63%) completed both assessments resulting in a total of 582 concerns being identified. Data analysis of these patients shows a 27% reduction in concerns with the number of high concerns falling by 62% between the first and second assessment. The average length of time for telephone review remained similar phase one at 22 minutes ranging from 7 minutes to 55 minutes.

      Patient satisfaction in the project continued to be high with 82% rating the service as excellent and 18% as good.. Data analysis for 15 patients’ who had completed 2 FACT-L, MSAS and SCNS yielded a significant reduction in symptom burden and psychological distress with a significant improvement in quality of life.

      Conclusion

      Findings from this project are encouraging that this model of working is not only acceptable to patients but time efficient and clinically effective. However, a limitation of this project is its small sample size. Therefore, further work is needed to explore its transferability and cost effectiveness to allow it to be considered for implementation in standard practice.

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      MA17.11 - Multi-Centred, Prospective, Audit to Identify Readmission Causes and Complications Within 30 of Primary Lung Cancer Surgery (Now Available) (ID 11916)

      14:40 - 14:45  |  Presenting Author(s): Amy Kerr  |  Author(s): Maureen King, Sandra Dixon, Sarah Taylor, Alison Smith, Charlotte Merriman, Jenny Mitchell, Verity Hunter

      • Abstract
      • Presentation
      • Slides

      Background

      Surgery remains the first choice of curative treatment, for patients with non-small lung cancer, the proportion of patients undergoing surgery has risen in recent years. Post-operative complications are well recognised following curative lung cancer surgery but there is limited data on readmission rates and causes . The UK Thoracic Surgery Group (TSG), a subgroup of the National Lung Cancer Forum (NLCNF) conducted a multicentre audit to assess readmission potential causes and patient experience.

      Method

      The audit involved 6 UK thoracic surgical centres with prospective data collection over 3 months from primary lung cancer resection patients. Patients were contacted 1 month post discharge by telephone. Data collection included demographics, socioeconomic, smoking status, comorbidities, surgery, postoperative recovery, discharge satisfaction and readmission details.

      Result

      268 patients underwent thoracic surgery, the overall readmission rate was 11% (30), with variable readmission rate across the centres (range 3-24%), most readmission occurred within 7 days of discharge 47% (14) with patients being readmitted to a hospital that did not performed the procedure 43%(17). The most common cause of readmission was mainly pulmonary related with chest infections being largest cause, pain, wound infection and pneumothorax were also common. Length of stay following readmission was longer than initial surgical stay median 8 (range 0-94) vs 5 (range 2-27).Type of surgical approach had no impact on readmission. However readmission was associated with smoking, post-operative complications, discharge with drain, length of stay post-surgery and the patient’s readiness for discharge (see table 1).

      table 1.png

      Conclusion

      This audit provides a broad overview of the pattern and trend of readmissions rates within 30 days post discharge following lung cancer resection. Whilst not every readmission can be avoided, there is opportunity to identify and prevent patient readmission. Listening to patient’s assessment of their readiness for discharge is crucial to facilitating patient compliance with discharge and confidence in community carers.

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      MA17.12 - Discussant - MA 17.09, MA 17.10, MA 17.11 (Now Available) (ID 14650)

      14:45 - 15:00  |  Presenting Author(s): Mary Duffy

      • Abstract
      • Presentation
      • Slides

      Abstract not provided

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    MS26 - From Textbook to Practice Around the World (ID 804)

    • Event: WCLC 2018
    • Type: Mini Symposium
    • Track: Treatment in the Real World - Support, Survivorship, Systems Research
    • Presentations: 4
    • Now Available
    • Moderators:
    • Coordinates: 9/26/2018, 10:30 - 12:00, Room 205 AC
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      MS26.01 - Translation of Clinical Data to Real World - Asia (Now Available) (ID 11511)

      10:30 - 10:45  |  Presenting Author(s): Dae Ho Lee

      • Abstract
      • Presentation
      • Slides

      Abstract

      Real world evidence (RWE) research becomes more important than before since data about real-world effectiveness and safety might impact the reimbursement and utilization of new but pretty expensive drugs or medical devices in precision medicine and immune-oncology era. The data are requested more by regulators, public and private payers as well as patients and physicians, all of whom seek to better understand the impact or usefulness of the drugs or medical devices either already approved for the indication or under approval process for the expansion of the indication in a real-world setting.

      Ministry of Food and Drug Safety (MFDS) formerly known as Korean Food and Drug Administration requires post-approval research or post-market surveillance to determine real world safety due to concerns about unexpected safety and complications in a larger population while it does not require the data about real world efficacy and cost-effectiveness after approval. However, National Health Insurance Service (NHIS) and Health Insurance Review and Assessment Service (HIRA), only one governmental payer in Korea, may need real world clinical effectiveness and cost-effectiveness of both drugs, especially molecular-targeted agents and immune checkpoint inhibitors, and medical devices, such as next generation-sequencing, after the coverage. Actually, the decision whether to approve or reimburse a drug or medical device is usually made based on a prior large clinical trial(s) which have already given both clinical efficacy and safety profile but not cost-effectiveness and/or budget impact on the healthcare system. Cost-effectiveness can often be addressed in a longer time or from assumptions based on the results of prior clinical trials. Nevertheless, the Korean reimbursement system has to decide whether to cover drugs or medical devices for patient’s request as well as company’s one without solid cost-effectiveness data. In addition, most of the trials were conducted outside Korea or included a few Korean patients, requiring more information from a larger Korean population who might different age groups, different genders and different molecular backgrounds in the real world from the population included in the clinical trials. Therefore, the data about real-world Korean patient experience have the potential to improve the quality and delivery of medical care in Korea but also reduce overall costs by reducing or fixing gaps between clinical trials and real clinical practice. Especially, as some immune checkpoint inhibitors or next generation sequencing has been reimbursed since 2017, the NHIS and HIRA recognizes the importance of RWE and need of RWE research or comparative effectiveness research. However, there are some barriers to be overcome for the research.

      First of all, all of clinical data which are needed for the research should be collected well. All claims from providers in Korea are submitted electronically to the NHIS using a computer with software that meets electronic filling requirements, which are later reviewed by the HIRA. Fortunately, since there is only one insurance system run by government in Korea, therefore the claims seem good as clinical data. However, the requirement is rather optimized to or fitted more in with billing service while personally identifiable information on beneficiaries is obtained as little as possible, which, makes electronic data captured less useful for real world evidence research. Some clinical data, such as demographic or survival related data, are also collected by another governmental organization, Statics Korea, but electronic data interchange between the organizations is rather difficult due to enforced domestic laws, personal information protection act. Merging clinical data already electronically obtained has one of the barriers to be overcome. Sometimes more data should be captured separately or in addition to those from the current electronic health claims or governmental organization. Therefore, we have to overcome barriers related to collection of clinical data. Fortunately, all providers in Korea use electronic medical records. Secondly, resources for the research including research personnel, funding process and supporting infrastructures, are also a big issue. Most of clinical trials for developing drugs or medical devices are initiated or sponsored by companies which are very familiar to clinical trials from designing through conducting to analyzing and reporting steps. However, real world evidence research is usually initiated, sponsored or supported by the organizations running health care reimbursement system which are not familiar as much as companies. The research itself are not familiar to most investigators or contract research organizations as well. The research budget is not also easily estimated and therefore funding for each research becomes another problem. In addition, the funding source is also debatable. Thirdly, generation of a high level of trust from stakeholders is another issue. Due to the nature of real world evidence research such as data collection and research design, studies in general could not yield definitive conclusions because of the many confounding factors. Therefore, a framework should be in place to facilitate the development of trust and to reduce the uncertainty. Establishment of independent organizations, such as Patient-Centered Outcomes Research Institute (PCORI), can be considered. A kind of credit or incentive can considered as well for stakeholders The participation of all stakeholders mght be important for a high level of traust.

      The governmental organizations in Korea, NHIS and HIRA as well as Ministry of Health and Welfare, have already started consultation to and discussion with healthcare sector stakeholders including academic researchers and product developers as well as patient advocacy groups to develop draft guidance of the use of RWE and then to embed the evidence in the reimbursement and regulations. Although there still remain many challenges or barriers to be overcome at many different levels, it is kept in our mind that quality and transparency at each stage of RWE generation will be critical for all stakeholders.

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      MS26.02 - Translation of Clinical Data to Real World - North America (Now Available) (ID 11512)

      10:45 - 11:00  |  Presenting Author(s): Cheryl Ho

      • Abstract
      • Presentation
      • Slides

      Abstract

      Clinical trials assist oncologic treatments in moving forward; enabling the creation of new benchmarks for quality care for lung cancer patients. Beyond the demonstration of efficacy however, is the implementation of change in the real world. For some nations, the health care structure is responsive and for others there are multiple steps required to introduce new treatments into standard practice.

      Within North America there are three dominant countries; Canada, the United States and Mexico. Each has a unique health care system with many complexities that influence access to oncologic care.

      The Canada Health Act governs the delivery of all medical care in Canada.It emphasizes five key aspects; public administration, comprehensiveness, universality, portability and accessibility. The federal government provides transfer payments to the respective provinces and the provinces manage local administration of health care services. The medical system is funded through provincial and federal general tax revenue. As a result, there is a centralized system for health care that involves no direct payment by the patient for care.

      The provision of care in the US is multi-faceted. Government sponsored programs include Medicaid, aimed at individuals with low income or certain medical conditions and Medicare for people aged >= 65. The Affordable Health Care Act, introduced in 2010, aimed to expand Medicaid coverage, make affordable health insurance available through subsidies based on income and ensure that insurance premiums were reasonable regardless of pre-existing health care conditions. The current US administration has eroded the initial goals of the program. Employed individuals may opt for private health care insurance however, there is a significant proportion of the population that do not have insurance. The different health care coverage options result in multiple tiers of access to care.

      The Mexican medical system has three public health care delivery programs; Instituto Mexicano del Seguro Social (IMSS) for employed citizens of private companies, Instituto de Seguridad y Servicios Sociales de los Trabajadores del Estado (ISSSTE) for civil servants and the Seguro Popular for the remainder of the population. The former two programs have tripartite funding from the employee, employer and government, the latter relies on the individual and government support.

      The health care systems employed by the respective countries have a significant impact on the adoption of new therapies for thoracic malignancies. The translation of clinical trials evidence to the real world is hampered by the practicalities of administration and funding of the specified therapies. The introduction of immunotherapy into the treatment algorithm for NSCLC provides some insight into the process involved in each country.

      In Canada, the introduction of new cancer therapies involves Health Canada approval, a national health technology assessment (HTA) through the pan Canadian Oncology Drug Review (pCODR) process and national price negotiations through pan Canadian Pharmaceutical Alliance (pCPA). Once a therapy has been deemed clinically and cost effective, the individual provinces are able to negotiate local contracts and add new oncologic agents to their respective formularies. This national process, while ensuring cost effectiveness and a degree of drug price negotiation power, results in significant delays in access to new therapies. The advantage however, is that in a universal health care system, all Canadians have access to approved oncologic drugs regardless of their employment status or income. The disadvantage lies with the therapies that do not meet the bar for approval due to evidence or cost effectiveness issues and that the system is not nimble and responsive. In the example of immunotherapy, nivolumab was first approved by Health Canada in the post-platinum metastatic setting in February 2016. The review by pCODR was completed with approval provided that it was cost effective in June 2016. The longest aspect of the funding for nivolumab was the national price negotiations that took 9 months to reach an agreement that was agreeable to pCPA and the company in March 2017. Subsequently, nivolumab has been funded for all Canadians who meet the listed Health Canada indication.

      Medicaid/Medicare and private insurance decisions regarding funding of cancer therapies in the US are based on guidelines provided by the National Comprehensive Cancer Network (NCCN). Unlike Canada, the US oncology drug funding model operates on a free market basis and the price of therapy is determined by what the market will bear. Furthermore, the 2003 Medicare law prohibits Medicare from negotiating drug prices which presents significant challenges for patients with a co-pay or those that pay fee for service. Despite the financial hurdles posed by immunotherapy, the US system is responsive to clinical trials evidence. The Food and Drug Administration (FDA) promptly approved nivolumab in the platinum treated second line setting for squamous and non squamous NSCLC in March and October 2015 respectively based on data presented in that year. The NCCN issued revised treatment algorithms incorporating nivolumab for squamous in May 2015 and non squamous disease in October 2015, the result being government and private insurance coverage within 1-2 months of FDA approval.

      In Mexico, COFEPRIS, the Comisión Federal para la Protección contra Riesgos Sanitarios, similar to Health Canada and the FDA, approved nivolumab for NSCLC in September 2016. However, as of September 2017 nivolumab was not listed on the Basic Table of Drugs covered by IMSS. For Seguro Popular, the Federal Fund for Protection against Catastrophic Health Expenditures (FPCHE) covers high-cost health interventions. This program covers six types of malignant conditions; breast cancer, cervical cancer, prostate cancer, testicular cancer, non- Hodgkin’s lymphoma, and childhood cancers. Unfortunately, lung cancer treatment is not covered by this plan as of 2015. While immunotherapy is approved for use in Mexico, there is no government funded mechanism to access therapy rendering it outside the reach of many of the citizens of the country.

      The practicalities of the transition of clinical trials data to the real world can be challenging at many levels. Depending on the national infrastructure, patients are faced with affordability and timely access issues. Navigating the health care system is the first, critical step of treatment adoption which subsequently enable an understanding of the efficacy and toxicity of providing new therapies to our real-world lung cancer patients.

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      MS26.03 - Translation of Clinical Data to Real World - Europe (Now Available) (ID 11513)

      11:00 - 11:15  |  Presenting Author(s): Fabrice Barlesi

      • Abstract
      • Presentation
      • Slides

      Abstract not provided

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      MS26.04 - Translation of Clinical Data to Real World - Latin America/Africa (Now Available) (ID 11514)

      11:15 - 11:30  |  Presenting Author(s): Luis Ubillos

      • Abstract
      • Presentation
      • Slides

      Abstract not provided

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    MS31 - Clinical Science in Mesothelioma (ID 809)

    • Event: WCLC 2018
    • Type: Mini Symposium
    • Track: Mesothelioma
    • Presentations: 5
    • Now Available
    • Moderators:
    • Coordinates: 9/26/2018, 13:30 - 15:00, Room 205 AC
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      MS31.01 - Mechanisms and Targets for BAP1 Activity (Now Available) (ID 11535)

      13:30 - 13:45  |  Presenting Author(s): Michele Carbone

      • Abstract
      • Presentation
      • Slides

      Abstract not provided

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      MS31.02 - Clinical Implementation of BAP1 Inhibitors (Now Available) (ID 11536)

      13:45 - 14:00  |  Presenting Author(s): Paul Baas  |  Author(s): Laurel Schunselaar

      • Abstract
      • Presentation
      • Slides

      Abstract

      Over the last few years BRCA associated protein 1 (BAP1) has attracted attention in the development of cancer[1-2].
      BAP1 is one of the molecular targets that has been identified as a novel target in this disease. The function of BAP1 is mainly regulatory, including its function as deubiquitinating enzyme (DUB) of H2A. Through its deubiquitinase activity and the effects on transcription, BAP1 functions as a tumor suppressor gene. It regulates transcription, cell cycle control, DNA damage repair and cellular differentiation [1-4].

      Patients with a BAP1 germline mutation often presents with skin disorders including skin tumors and uveal melanomas and are often diagnosed at an early age. BAP1 germline mutation in patients with mesothelioma was first reported in 2011 [5]. In these cases, prognosis seems to be better with a 5-year survival rate of 47%, as compared to 6,7% for patients who did not have the mutation [6].

      Although germline mutations are rare in mesothelioma [7], somatic BAP1 aberrations are more common in mesothelioma tumors. Studies showed that 47-67% of the mesothelioma tumors contain a BAP1 genetic aberration. BAP1 somatic mutations are more frequent in the epithelioid subtype than in the sarcomatoid subtype. Besides single point mutations in the BAP1 gene, copy number loss, rearrangements and multiple alterations have been reported. The somatic BAP1 mutation can easily be identified with immunohistochemistry.

      BAP1 as a drug target in mesothelioma

      The regulation of histones by BAP1 suggests that an interaction with histone deacetylase (HDAC) inhibitors could be beneficial. In mesothelioma, the effect of HDAC inhibitors on H2A is not known, but BAP1 knockdown in mesothelioma cell lines increases the sensitivity for HDAC inhibitors leading to cell death, a process known as synthetic lethality. In the VANTAGE 014 study, a phase III trial including 661 patients, the HDAC inhibitor vorinostat did not improve overall survival in an unselected group of patients compared to placebo [8].

      Enhancer of zeste homolog 2 (EZH2) is upregulated in mesothelioma and preclinical models have identified a possible association between BAP1 loss and EZH2 upregulation. Specific EZH2 inhibitors decreased cell proliferation, reduced invasion and reduced clonogenicity in mesothelioma cell lines and tumor bearing mice. Importantly, BAP1 mutant mice were more responsive to the EZH2 treatment compared to wild type mice. In different tumor types, phase I studies with EZH2 inhibitors showed promising results [9]. Currently a study in mesothelioma patients with the EZH2 inhibitor tazemetostat is ongoing (NCT02860286).

      Another interaction partner of BAP1 is host cell factor 1 (HCF1). This protein has a role in cell cycle progression by activating transcription of promotors bound by the E2F (transcription) family. BAP1 deubiquitinates HCF1 and recently multiple groups showed that BAP1 mutation results in increased HCF1 ubiquitination, impairing E2F activation. Decreased activation of E2F causes problems in cell cycle progression and results in the inhibition of cell growth. Although there are no drugs yet available to inhibit E2F, these interaction partners may provide options for new therapeutic interventions.

      Synthetic lethality.
      Due to its regulatory function in DNA repair damage, it is expected that in BAP1 mutated cases the homologous recombination (HR) DNA repair system is impaired. The use of PARP1 inhibitors could therefore be promising as is shown in ovarian and mammary carcinoma. Preclinical studies of nirapanib and olaparib in mesothelioma cell lines proved to inhibit the cell growth, but this effect was independent of the BAP1 mutation status [10]. Therefore it is expected that other pathways are more important in this approach.

      Conclusions.

      For the treatment of tumors with BAP1 protein loss, it is important to identify therapeutic agents that reverse the phenotypic effects. Multiple interaction partners and proteins under influence of BAP1 are reported and (pre)clinical data of new inhibitors targeting these partners is promising. Further research on BAP1 action is required before we define an optimal treatment plan. Due to the many interaction partners and different functions of BAP1 the future we will probably end up with a combination of agents to reverse the phenotypic effect of BAP1 protein loss.

      Reference

      1. Wang, A., et al., Gene of the month: BAP1. J Clin Pathol, 2016. 69(9): p. 750-3.

      2. Bononi, A., et al., Latest developments in our understanding of the pathogenesis of mesothelioma and the design of targeted therapies. Expert Rev Respir Med, 2015. 9(5): p. 633-54.

      3. Misaghi, S., et al., Association of C-terminal ubiquitin hydrolase BRCA1-associated protein 1 with cell cycle regulator host cell factor 1. Mol Cell Biol, 2009. 29(8): p. 2181-92.

      4. Scheuermann, J.C., et al., Histone H2A deubiquitinase activity of the Polycomb repressive complex PR-DUB. Nature, 2010. 465(7295): p. 243-7.

      5. Testa, J.R., et al., Germline BAP1 mutations predispose to malignant mesothelioma. Nat Genet, 2011. 43(10): p. 1022-5.

      6. Baumann, F., et al., Mesothelioma patients with germline BAP1 mutations have 7-fold improved long-term survival. Carcinogenesis, 2015. 36(1): p. 76-81.

      7. Sneddon, S., et al., Absence of germline mutations in BAP1 in sporadic cases of malignant mesothelioma. Gene, 2015. 563(1): p. 103-5.

      8. Krug, L.M., et al., Vorinostat in patients with advanced malignant pleural mesothelioma who have progressed on previous chemotherapy (VANTAGE-014): a phase 3, double-blind, randomised, placebo-controlled trial. Lancet Oncol, 2015. 16(4): p. 447-56.

      9. Kim, K.H. and C.W. Roberts, Targeting EZH2 in cancer. Nat Med, 2016. 22(2): p. 128-34.

      10. Gayathri Srinivasan et al. Synthetic lethality in malignant pleural mesothelioma with PARP1
      inhibition.
      Cancer Chemother Pharmacol. 2017; 80(4): 861–867.

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      MS31.03 - Targeting the Hippo Pathway (Now Available) (ID 11537)

      14:00 - 14:15  |  Presenting Author(s): David Mark Jablons  |  Author(s): Gavitt A. Woodard

      • Abstract
      • Presentation
      • Slides

      Abstract

      The prognosis for malignant pleural mesothelioma (MPM) remains poor and many anticipated advances in MPM treatment have been disappointing. One reason for the failure of conventional cytotoxic drugs is that they do not address the cancer stem cell population or the stem cell pathways that drive tumor resistance and resurgence following treatment. Cancer stem cells are defined by their properties of self-renewal, pluripotency, a high proliferative capacity and the ability to resist standard chemotherapy and radiation. Among the stem cell pathways, Hippo has proven to be critical to driving growth in MPM with mutations along this pathway implicated in the majority of MPM tumors.

      The Hippo pathway is a highly conserved regulator of organ size by regulating contact inhibition and of stem cell proliferation and maintenance.(1) The largest and most comprehensive genomic analysis to date of transcriptomes, whole exomes and targeted exomes from 216 MPM samples found Hippo pathway signaling to be the number one most significantly mutated pathway in mesothelioma with a Q-value of 1.70E-17, driven by mutations, copy number variations and fusions in NF2, LATS1, LATS2 and MST1.(2) One of the most frequently mutated genes in MPM is Neurofibromatosis type 2 (NF2) tumor suppressor, located at chromosome 22q12, and is detected in 40% to 50% of MPM tumors.(3) Large tumor suppressor homolog 2 (LAST2) gene, which is located at chromosome 13q12, is another frequently inactivated gene that is detected in 13% of MPM tumors. (3, 4) Inactivation of NF2 and LATS2 by deletion and/or mutation often contribute to dysregulation of Hippo pathway.(5) In addition to LATS2, its closest gene family member LATS1 another Hippo pathway gene, has also recently been identified to be dysregulated in MPM, though less commonly than LATS2. LATS1 is located on chromosome 6 and changes in copy number variation and fusions to Presenilin 1 (PSEN1) on chromosome 14 have been observed in MPM.(2, 3) Mammalian sterile-20 like kinase 1 (MST1) is an important upstream kinase in the Hippo pathway that has also been found to be dysregulated in MPM.(2) Given the high frequency of mutations and dysregulation in the Hippo pathway, it is a promising potential area of drug development.

      One specific target along the Hippo pathway is blocking Yes-associated protein (YAP) activity. In normal cells, Merlin, a protein encoded by NF2, and LATS2 contribute to the phosphorylation of the transcription factor YAP at S127,(6) resulting in YAP ubiquitination and activation of Hippo pathway to control cell proliferation. In MPM tumor cells, inactivation of NF2 and LATS2 prevent the phosphorylation of YAP at S127, which results in YAP relocation from the cytosol to nucleus where it interacts with TEA domain transcription factors (TEAD). In addition, constitutively activation of YAP has been identified in over 70% of primary MPM tumors, (3, 5, 7) and YAP activation leads to Hippo signaling attenuation and transcription of downstream target genes, such as connective tissue growth factor (CTGF) and Cyr61.(8) Low Merlin expression (NF2), results in YAP1 activation, and has been shown to be associated with worse clinical outcomes with shorter times to recurrence and shorter overall survival times in patients with MPM.(9) Blocking YAP activity, either via upstream inhibition of one of the several pathways that regulate YAP and Hippo or via direct YAP/TEAD inhibition is an area of active interest.(10) Several novel small molecule YAP inhibitors are in preclinical development with promising results and may enter clinical trials in the near future.

      FIGURE: Hippo Pathway Potential Drug Targets

      figure.jpg

      References

      1. Ramos A, Camargo FD. The Hippo signaling pathway and stem cell biology. Trends in cell biology. 2012;22(7):339-46.

      2. Bueno R, Stawiski EW, Goldstein LD, Durinck S, De Rienzo A, Modrusan Z, et al. Comprehensive genomic analysis of malignant pleural mesothelioma identifies recurrent mutations, gene fusions and splicing alterations. Nature genetics. 2016;48(4):407-16.

      3. Miyanaga A, Masuda M, Tsuta K, Kawasaki K, Nakamura Y, Sakuma T, et al. Hippo pathway gene mutations in malignant mesothelioma: revealed by RNA and targeted exon sequencing. Journal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer. 2015;10(5):844-51.

      4. Murakami H, Mizuno T, Taniguchi T, Fujii M, Ishiguro F, Fukui T, et al. LATS2 is a tumor suppressor gene of malignant mesothelioma. Cancer research. 2011;71(3):873-83.

      5. Felley-Bosco E, Stahel R. Hippo/YAP pathway for targeted therapy. Translational lung cancer research. 2014;3(2):75-83.

      6. Zhao B, Wei X, Li W, Udan RS, Yang Q, Kim J, et al. Inactivation of YAP oncoprotein by the Hippo pathway is involved in cell contact inhibition and tissue growth control. Genes & development. 2007;21(21):2747-61.

      7. Wang Y, Dong Q, Zhang Q, Li Z, Wang E, Qiu X. Overexpression of yes-associated protein contributes to progression and poor prognosis of non-small-cell lung cancer. Cancer science. 2010;101(5):1279-85.

      8. Harvey KF, Zhang X, Thomas DM. The Hippo pathway and human cancer. Nature reviews Cancer. 2013;13(4):246-57.

      9. Meerang M, Berard K, Friess M, Bitanihirwe BK, Soltermann A, Vrugt B, et al. Low Merlin expression and high Survivin labeling index are indicators for poor prognosis in patients with malignant pleural mesothelioma. Molecular oncology. 2016;10(8):1255-65.

      10. Woodard GA, Yang YL, You L, Jablons DM. Drug development against the hippo pathway in mesothelioma. Transl Lung Cancer Res. 2017 Jun;6(3):335-342.

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      MS31.04 - CAR-T and ADC's in MPM (Now Available) (ID 11538)

      14:15 - 14:30  |  Presenting Author(s): Prasad S. Adusumilli

      • Abstract
      • Presentation
      • Slides

      Abstract

      Novel immunotherapies for malignant pleural mesothelioma (MPM) include Antibody-drug conjugates (ADCs) and Chimeric antigen receptor (CAR) T cells, both of which are in early-phase clinical trials with promising results. CAR T cells are patient T cells that are transduced with genetically engineered synthetic receptors to target a cancer cell surface antigen. The remarkable clinical response rates achieved by adoptive transfer of T cells that target CD19 in patients with leukemia and lymphoma have led to a growing number of clinical trials exploring CAR T-cell therapy for solid tumors including in MPM. Herein, I will review the evolution of ADCs and adoptive T-cell therapy; highlight advances in CAR T-cell therapy for MPM; and summarize the antigen targets being investigated in clinical trials. I will further discuss the barriers to successfully translating ADCs and CAR T-cell therapy for solid tumors and present strategies that have been investigated to overcome these hurdles.

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      MS31.05 - Vaccination and Antibody-Based Therapy in Mesothelioma (Now Available) (ID 11539)

      14:30 - 14:45  |  Presenting Author(s): Joachim G.J.V. Aerts

      • Abstract
      • Presentation
      • Slides

      Abstract

      The concept of antibody based therapy hints on two concepts, on the one hand precluding the function of the ligand it binds to, which is for instance the case in VEGF targeting antibodies. And on the other hand the induction of antibody dependent cellular toxicity (ADCC) which may be induced by these antibodies. The latter is caused by activation of the immune system after an antibody binds to its ligand. Here I will focus on the role of antibodies targeting the immune checkpoints.

      Immunotherapy is now considered a standard treatment in many malignancies. Also in mesothelioma, different antibodies are now being explored [Yap 2017]. The most clinically used type of immunotherapy in oncology are checkpoint inhibitors, mostly PD-(l)1 and CTLA-4 directed antibodies. Concerning the latter, a recently published randomised trial failed to show an benefit of the anti-CTLA-4 antibody tremilimumab, compared to placebo in second and third line treatment in mesothelioma [Maio 2017]. Small and single arm studies on PD-(l)1 have been presented and did show clinical meaningful responses in patients. However this was only present in a minority of patients [Lievense 2017]. The role of ADCC in the functioning of the antibodies is not well established nor investigated, but for instance a regulatory T-cell depletion due to CTLA-4 antibodies has been described.

      The lack of benefit in the majority of patients is ascribed to the absence of a tumor directed T-cell response present in the majority of mesothelioma patients [Aerts 2013, Yap 2017]. This lack of tumor directed T-cells is related to the immunosuppressive environment caused by mesothelioma. One way of increasing the tumor directed T-cell responses is via vaccination. However in thoracic malignancies the effects of peptide vaccinations were found to be rather limited again due to the immunosuppressive environment created by the tumor. Cellular vaccinations were found to be more effective in this setting [Dammeijer 2016].

      In mesothelioma studies on cellular vaccination with dendritic cell vaccination have indeed shown that an increase in tumor directed T-cells can be achieved with clinically relevant responses [Le 2012, Peikert 2016, Aerts 2018]. This concept is now taken forward in a large randomised trial comparing dendritic cell vaccination with best supportive care as maintenance treatment after chemotherapy in patients with mesothelioma.

      In conclusion antibody based therapy and vaccination hold promise in mesothelioma, and given the dismal prognosis of these patients these options should be investigated and explored further.

      Tremelimumab as second-line or third-line treatment in relapsed malignant mesothelioma (DETERMINE): a multicentre, international, randomised, double-blind, placebo-controlled phase 2b trial. Maio M, Scherpereel A, Calabrò L, Aerts J, Cedres Perez S, Bearz A, Nackaerts K, Fennell DA, Kowalski D, Tsao AS, Taylor P, Grosso F, Antonia SJ, Nowak AK, Taboada M, Puglisi M, Stockman PK, Kindler HL. Lancet Oncol. 2017 Sep;18(9):1261-1273

      A live-attenuated Listeria vaccine (ANZ-100) and a live-attenuated Listeria vaccine expressing mesothelin (CRS-207) for advanced cancers: phase I studies of safety and immune induction. Le DT, Brockstedt DG, Nir-Paz R, Hampl J, Mathur S, Nemunaitis J, Sterman DH, Hassan R, Lutz E, Moyer B, Giedlin M, Louis JL, Sugar EA, Pons A, Cox AL, Levine J, Murphy AL, Illei P, Dubensky TW Jr, Eiden JE, Jaffee EM, Laheru DA.Clin Cancer Res. 2012 Feb 1;18(3):858-68.

      Autologous Dendritic Cells Pulsed with Allogeneic Tumor Cell Lysate in Mesothelioma: From Mouse to Human. Aerts JGJV, de Goeje PL, Cornelissen R, Kaijen-Lambers MEH, Bezemer K, van der Leest CH, Mahaweni NM, Kunert A, Eskens FALM, Waasdorp C, Braakman E, van der Holt B, Vulto AG, Hendriks RW, Hegmans JPJJ, Hoogsteden HC. Clin Cancer Res. 2018 Feb 15;24(4):766-776

      Checkpoint Blockade in Lung Cancer and Mesothelioma.Lievense LA, Sterman DH, Cornelissen R, Aerts JG. Am J Respir Crit Care Med. 2017 Aug 1;196(3):274-282.

      Efficacy of Tumor Vaccines and Cellular Immunotherapies in Non-Small-Cell Lung Cancer: A Systematic Review and Meta-Analysis. Dammeijer F, Lievense LA, Veerman GD, Hoogsteden HC, Hegmans JP, Arends LR, Aerts JG. J Clin Oncol. 2016 Sep 10;34(26):3204-12.

      Harnessing the Power of the Host: Improving Dendritic Cell Vaccines for Malignant Pleural Mesothelioma. Peikert T, Sterman DH.

      Am J Respir Crit Care Med. 2016 May 1;193(9):943-5

      Novel insights into mesothelioma biology and implications for therapy. Yap TA, Aerts JG, Popat S, Fennell DA. Nat Rev Cancer. 2017 Jul 25;17(8):475-488.

      Tumor-specific cytotoxic T cells are crucial for efficacy of immunomodulatory antibodies in patients with lung cancer.

      Aerts JG, Hegmans JP. Cancer Res. 2013 Apr 15;73(8):2381-2382

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    MTE04 - Comparison of Various Risk Models (Ticketed Session) (ID 814)

    • Event: WCLC 2018
    • Type: Meet the Expert Session
    • Track: Screening and Early Detection
    • Presentations: 2
    • Now Available
    • Moderators:
    • Coordinates: 9/24/2018, 07:00 - 08:00, Room 205 AC
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      MTE04.01 - Comparisons of Risk Models (Now Available) (ID 11552)

      07:00 - 07:30  |  Presenting Author(s): Christine Berg

      • Abstract
      • Presentation
      • Slides

      Abstract

      Lung cancer unfortunately remains the leading cause of cancer death in the world. Lowering lung cancer mortality in the near term while efforts continue to halt the tobacco use epidemic would result from early detection with low-dose helical CT screening in countries with the health care resources to support this complex endeavor. Current guidelines from groups like the United States Preventive Services Task Force (USPSTF), the Centers for Medicare and Medicaid Services (CMS) and the Canadian Task Force on Preventive Health Care follow criteria for entry to screening that mimic the National Lung Screening Trial entry criteria. Many researchers have shown that these guidelines may not be optimal for achieving the maximal lung cancer mortality reduction attainable through screening. Also, there is variability from country to country in lung cancer risk depending upon demographics, ethnic and racial mix, smoking intensity patterns and types of tobacco products. Individual risk models that have been validated in the country and population group in which they will be used will assist in optimizing effectiveness and efficiency. Where to set the risk-threshold will be a function of cost-effectiveness and other considerations and will be the subject of a separate presentation.

      What are the components of a risk model and how do the various risk models compare, and which ones are available to use? This talk will review the risk models published to date. Also, several groups have compared several of the risk models with each other demonstrating some advantages to certain models. The complexities of these model comparisons will be elucidated. Country to country variability will also be discussed. Models also differ in the number of variables they include. There are advantages to the parsimonious models as they may be easier to use in practice. However, they may do less well in better defining risk. Given that different racial and ethnic groups have different risk profiles it should be important to characterize this risk and have one useable model that incorporates it rather than separate models for different groups. Another major issue is how to incorporate risk models into facilitating entry into screening programs. What are the strengths and limitations of electronic medical records for this process? CMS requires an “informed decision making” visit with a health-care provider prior to lung cancer screening. What ideally should this include and how should risk be discussed?

      As the field of oncology moves to a “precision medicine” approach lung cancer screening can be at the forefront of this effort. The goal of an effective and efficient strategy will hopefully translate into the most numbers of lives saved for the screenings done. It is a challenge our community can meet.

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      MTE04.02 - Where Should Health Programs Set Threshold for Tailored Screening? (Now Available) (ID 11553)

      07:30 - 08:00  |  Presenting Author(s): James L Mulshine

      • Abstract
      • Presentation
      • Slides

      Abstract

      Since the publication of the U.S. Preventive Services Task Force recommendation statement on lung cancer screening much discussion has focused on what is the critical information required to make an informed decision regarding the benefit of undergoing thoracic CT screening (1). Ever more sophisticated modeling approaches are being developed to better characterize the risk: benefit consequences of screening. This session will explore the current state of this complex issue. Yet as screening implementation builds momentum, more information is emerging about the information gleaned from thoracic CT obtained in a population of heavily tobacco-exposed individuals that may profoundly effect the screening health benefit discussion.

      A comprehensive analysis of diseases, injuries and risk factors across the United States from 1990 to 2016 was recently reported by a jointly sponsored consortium from the National Institutes of Health and The Bill and Melinda Gates Foundation, as a guide to investment for research, care and public health policy in the United States (2). According to that report, lung cancer including both the trachea and the bronchi was and remains the second leading cause of years of life lost across the 26 year time interval of that study due to an increase by 26.8% in the number of lung cancer deaths. In that analysis, the most lethal disease process was ischemic heart disease (IHD) which accounted for over 544,000 deaths in 2016. Even though, there was a 15% reduction in IHD mortality since 1990, ischemic heart disease still results in over 2.84 times more deaths than lung cancer. However, for both of these diseases, the age-standardized death rate is fortunately declining.

      In contrast for the third leading cause of death, chronic obstructive pulmonary disease (COPD), over that same 26 year interval, the total number of deaths has increased by 86.9%. Collectively, these three diseases, IHD, lung cancer and COPD account for over 44% of the mortality from the top 25 causes of years of life lost in 2016.

      As we consider risk developing risk models for lung cancer screening, it is useful to step back and consider the information being shared with the individual considering their screening benefit. Currently, in the United States that person being screened is most likely an over 55 years old, current or former smoker with over 30 pack year exposure to tobacco combustion products. As we have just reviewed, the most likely determinants of that individual’s life expectancy are the three most lethal diseases, IHD, lung cancer and COPD.

      Even as we are beginning to screening tobacco-exposed populations, we know that there large numbers of individuals found in the course of their lung cancer screening CT, who will also be found that have asymptomatic but objective evidence of COPD or coronary calcification (3-7). For both IHD and COPD, NIH is encouraging measures to improve the early detection of these two major diseases so that pre-emptive strategies can be employed, before the development of symptoms and avoid the disabling burden of largely incurable advanced disease. Guidelines have already been published for managing the extent of coronary calcium found on thoracic CT scans as promulgated by cardiac professional societies (8). In parallel developments, the pulmonary community is also finding compelling evidence for cardiovascular disease when evaluating for COPD (9). Finding from both of these thoracic CT-detected diseases are frequently being reported on the radiologists’ report for lung cancer screening.

      Considerable progress has been made in developing predictive risk models for lung cancer in the screening setting (10, 11). However, from a screening subjects’ perspective, a lung cancer-only risk analysis does not include the vast majority of risk-for-death information that is relevant to a heavy smoker that could be available on their screening CT in regard to the first and third leading cause of death (IHD or COPD) (2-9). Therefore when considering developing future risk outcomes tools for an individual deciding on whether or not to undergo CT screening for lung cancer, we perhaps need a more inclusive evaluation of health outcomes that consider the major knowable consequences of extensive tobacco exposure. The most recent Surgeon General's Report released in 2014 and summarizing 50 years of studying tobacco health consequences, reaffirmed the causal inference of tobacco smoke to a lengthy list of diseases including most prominently, cancers, cardiovascular disease and chronic obstructive pulmonary disease (12). In discussions about other major chronic diseases such as diabetes or hypertension, people are educated about the multi-organ involvement of these diseases, so they have the information to better protect their health.

      The three leading causes of loss of life (IHD, lung cancer and COPD) in the United States cumulatively account for over 13,500 years of loss of life per year. However, from a heavily tobacco-exposed individual’s perspective, lung cancer only accounts for 26% of this mortality burden. A thoracic CT scan can provide actionable risk information for all three leading tobacco-related causes of death. The most recent draft research plan for the United States Preventive Services Task Force is explicitly evaluating lung cancer screening outcomes for impact on all-cause mortality. It is a critical time to consider more comprehensive tools to transparently inform about the relevant health information available with the use of thoracic CT imaging in heavily tobacco-exposed individuals.

      References:

      1) Moyer VA; U.S. Preventive Services Task Force. Screening for lung cancer: U.S. Preventive Services Task Force recommendation statement. Ann Intern Med. 2014 Mar 4;160(5):330-8. doi: 10.7326/M13-2771.

      2) PMID: 24378917The Burden of Disease Collaborators; Mokdad AH, Murray CJL, Khan AR, et al. The state of US health, 1990-2016: burden of diseases, injuries, and risk factors among US states. JAMA. doi:10.1001/jama.2018.0158.

      3)Seijo LM and Zulueta JJ. Understanding the links between lung cancer, COPD and emphysema: A key to more effective treatment and screening. Oncology 2017; 31: 93-100.

      4) Shemesh J, Henschke CI, Shaham D, et al. Ordinal scoring of coronary artery calcifications on low-dose CT scans of the chest is predictive of death from cardiovascular disease. Radiology. 2010;257(2):541-548.

      5) Chiles C, Duan F, Gladish GW, et al. Association of Coronary Artery Calcification and Mortality in the National Lung Screening Trial: A Comparison of Three Scoring Methods. Radiology. 2015;276(1):82-90.

      6) Takx RA, de Jong PA, Leiner T, et al. Automated coronary artery calcification scoring in non-gated chest CT: agreement and reliability. PLoS One. 2014 Mar 13;9(3):e91239. doi: 10.1371/journal.pone.0091239. eCollection 2014.

      7) Malcolm KB, Dinwoodey DL, Cundiff MC et al. Qualitative coronary artery calcium assessment on CT lung screening exam helps predict first cardiac events. J Thorac Dis. 2018. 10: 2740-2751 doi: 10.21037/jtd.2018.04.76.

      8) Harvey S. Hecht, Paul Cronin, et al.SCCT/STR guidelines for coronary artery calcium scoring of noncontrast noncardiac chest CT scans: A report of the Society of Cardiovascular Computed Tomography and Society of Thoracic Radiology. Journal of Cardiovascular Computed Tomography, Volume 11: 74-84, 2016.

      9) Bhatt SP, Kazerooni EA, Newell JD Jr et al. Visual estimate of coronary artery calcium predicts cardiovascular disease in COPD, CHEST (2018), doi: 10.1016/j.chest.2018.05.037.

      10) ten Haaf K, Jeon J, Tammemägi MC et al. Risk prediction models for selection of lung cancer screening candidates: a retrospective validation study., PLoS Med, 2017, vol. 14 pg. e1002277.

      11) Katki HA, Kovalchik SA, Petito LC, et al. Implications of Nine Risk Prediction Models for Selecting Ever-Smokers for Computed Tomography Lung Cancer Screening. Ann Intern Med. 2018 May 15. doi: 10.7326/M17-2701. [Epub ahead of print].

      12) US Department of Health and Human Services, The Health Consequences of Smoking: 50 Years of Progress: a Report of the Surgeon General, 2014 Atlanta, GAUS Department of Health and Human Services, Centers for Disease Control and Prevention, National Center for Chronic Disease Prevention and Health Promotion, Office on Smoking and Health.

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    MTE16 - What Is Changing in the Management of Pulmonary Neuroendocrine Tumours? (Ticketed Session) (ID 829)

    • Event: WCLC 2018
    • Type: Meet the Expert Session
    • Track: Small Cell Lung Cancer/NET
    • Presentations: 2
    • Now Available
    • Moderators:
    • Coordinates: 9/25/2018, 07:00 - 08:00, Room 205 AC
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      MTE16.01 - Proper Treatment of LCNEC; Chemotherapy or Targeted Therapy (Now Available) (ID 11579)

      07:00 - 07:30  |  Presenting Author(s): Sumitra Thongprasert

      • Abstract
      • Presentation
      • Slides

      Abstract

      Neuroendocrine Tumors of the Lung consisted of two subtypes which is small cell lung cancer (SCLC) and large cell neuroendocrine carcinoma (LCNEC). Both subtypes represent around 15% of all Lung Cancer. The incidence of LCNEC was quite low as compare to SCLC. However both are aggressive and poor prognosis. The treatment of LCNEC was usually followed the SCLC. In early stages (I-II-III), surgery is recommended but does not seem to be sufficient. Platinum-based adjuvant chemotherapy may be useful while the role of neoadjuvant chemotherapy is still not well defined. In patients with advanced stage LCNEC, the chemotherapy regimens used in SCLC which is cisplatin plus etoposide remain the standard of treatment, but results are not satisfactory. Due to their peculiar clinical and biological features and the lack of literature data, there is an emerging need for a consensus on the best treatment strategy for LCNEC and for the identification of new therapeutic options. In this review, we will discuss the key aspects of LCNEC management and the possibility of using the gene sequencing to clarify the selection of chemotherapy regimen.

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      MTE16.02 - The Management of Small Cell Lung Cancer following First Line Treatment Failure (Now Available) (ID 11580)

      07:30 - 08:00  |  Presenting Author(s): Glenwood Goss

      • Abstract
      • Presentation
      • Slides

      Abstract

      SCLC remains a clinical challenge that has not benefited from the same medical advances in recent years as non-small cell lung cancer (NSCLC). Beyond first line chemotherapy, there are few approved therapies for recurrent small cell lung cancer (SCLC). A multitude of agents have been tested over the past decades, yet little improvement has been made in survival rates. This talk will review previous efforts in treating SCLC upon progression after first-line therapy, the current science that is changing our understanding of the biology of SCLC and will discuss the evidence for new agents in this indication, by reviewing recent and current clinical trials.

      The addition of platinum agents to first-line chemotherapy regimens in the 1980’s improved overall response (OR) and complete response (CR) rates, and thus platinum doublet chemotherapy, most commonly in combination with etoposide, is the current standard of care.1 SCLC is initially very chemosensitive, OR rates to platinum-etoposide chemotherapy in the first line setting for limited disease (LD) are between 60-90% with CR rates of 40-70%2, and one third of patients will survive 5 years and be considered cured. The prognosis is far less optimistic for the two thirds of patients with SCLC who are diagnosed with extensive-stage (ES) disease. OR rates for ES SCLC are 40-70%2, and CR rates are 10-20%.3,4 The median progression-free survival (PFS) in the first-line setting is in the order of 15 months for LD5 and 6 months for ES.6

      Unfortunately, the high response rate seen in the first line setting is not maintained when patients are retreated. Patients can be classified into three groups based on their response to initial chemotherapy: sensitive (tumor response ≥ 90 days), resistant (recurrence within 90 days of completing primary therapy) and refractory (non-responders and progression on treatment).2 Therapeutic options therefore include re-challenge for those patients with sensitive disease or a change of regimen. Topotecan has been approved by the FDA since 1996 for the second-line treatment of SCLC following first-line relapse.7 There are additionally several guideline-recommended therapies that are not FDA/EMA approved, such as cyclophosphamide/doxorubicin/vincristine (CAV), irinotecan (Japan), docetaxel, paclitaxel, gemcitabine, temozolomide and nivolumab with ipilimumab.8 Response rates to second line therapy are 27% at best and less than 15% in chemo-refractory cases9, with a median time to progression of only 13 weeks.10 Despite decades of testing with multiple agents, there have been no new drug approvals in over 20 years and improved therapy is urgently needed.

      With the advent of targeted therapies over the past decades, there has been no shortage of early phase clinical trials in SCLC. However, these agents have yet to demonstrate success in phase II-III evaluation. The lack of progress in improving survival rates for SCLC led to its inclusion in the U.S. Congress’ Recalcitrant Cancer Research Act in 2012. Subsequent comprehensive molecular characterization of the disease has led to a better understanding of known molecular vulnerabilities and has pointed to new areas requiring therapeutic interrogation. Examples include developmental regulatory pathway abnormalities, DNA damage repair aberrations, and the manipulation of the immune response. Fundamental to further therapeutic progress remains the challenge of understanding the mechanisms that underlie the rapid emergence of chemo-resistance in SCLC. Recent reports of early phase clinical trials with immune checkpoint inhibitors documenting important response and survival rates, provide tangible hope for the approval of new treatment options. However, immune strategies should exclude the empiric testing of new monotherapies and combinations in the absence of strong pre-clinical science. This will necessitate the development of next generation pre-clinical models, that are biologically representative of the human immune system and disease. Finally, improved translational research will inform more rational clinical trial design, and concentrate resources towards the most promising therapeutic avenues.

      References:

      1. Sundstrøm S, Bremnes RM, Kaasa S, et al. Cisplatin and etoposide regimen is superior to cyclophosphamide, epirubicin, and vincristine regimen in small-cell lung cancer: Results from a randomized phase III trial with 5 years’ follow-up. J Clin Oncol. 2002;20(24):4665-4672. doi:10.1200/JCO.2002.12.111.

      2. Cheng S, Evans WK, Stys-Norman D, Shepherd FA. Chemotherapy for relapsed small cell lung cancer: A systematic review and practice guideline. J Thorac Oncol. 2007;2(4):348-354. doi:10.1097/01.JTO.0000263720.15062.51.

      3. Alvarado-Luna G, Morales-Espinosa D. Treatment for small cell lung cancer, where are we now?-a review. Transl lung cancer Res. 2016;5(1):26-38. doi:10.3978/j.issn.2218-6751.2016.01.13.

      4. Van Meerbeeck JP, Fennell DA, De Ruysscher DKM. Small-cell lung cancer. Lancet. 2011;378(9804):1741-1755. doi:10.1016/S0140-6736(11)60165-7.

      5. Faivre-Finn C, Snee M, Ashcroft L, et al. Concurrent once-daily versus twice-daily chemoradiotherapy in patients with limited-stage small-cell lung cancer (CONVERT): an open-label, phase 3, randomised, superiority trial. Lancet Oncol. 2017;18(8):1116-1125. doi:10.1016/S1470-2045(17)30318-2.

      6. Foster NR, Renfro LA, Schild SE, et al. Multitrial evaluation of progression-free survival as a surrogate end point for overall survival in first-line extensive-stage small-cell lung cancer. J Thorac Oncol. 2015;10(7):1099-1106. doi:10.1097/JTO.0000000000000548.

      7. Ardizzoni A, Hansen H, Dombernowsky P, et al. Topotecan, a new active drug in the second-line treatment of small-cell lung cancer: a phase II study in patients with refractory and sensitive disease. The European Organization for Research and Treatment of Cancer Early Clinical Studies Group and New Dr. J Clin Oncol. 1997;15(5):2090-2096. doi:10.1200/JCO.1997.15.5.2090.

      8. Sabari JK, Lok BH, Laird JH, Poirier JT, Rudin CM. Unravelling the biology of SCLC: implications for therapy. Nat Rev Clin Oncol. 2017. doi:10.1038/nrclinonc.2017.71.

      9. Owonikoko TK, Behera M, Chen Z, et al. A systematic analysis of efficacy of second-line chemotherapy in sensitive and refractory small-cell lung cancer. J Thorac Oncol. 2012;7(5):866-872. doi:10.1097/JTO.0b013e31824c7f4b.

      10. von Pawel J, Schiller JH, Shepherd FA, et al. Topotecan Versus Cyclophosphamide, Doxorubicin, and Vincristine for the Treatment of Recurrent Small-Cell Lung Cancer. J Clin Oncol. 1999;17(2):658-667.

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    MTE19 - How I Treat Advanced Stage Thymic Malignancy Patients (Ticketed Session) (ID 826)

    • Event: WCLC 2018
    • Type: Meet the Expert Session
    • Track: Thymoma/Other Thoracic Malignancies
    • Presentations: 1
    • Now Available
    • Moderators:
    • Coordinates: 9/26/2018, 07:00 - 08:00, Room 205 AC
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      MTE19.01 - How I Treat Advanced Stage Thymic Malignancy Patients (Now Available) (ID 11574)

      07:00 - 08:00  |  Presenting Author(s): Heather A Wakelee

      • Abstract
      • Presentation
      • Slides

      Abstract

      Given the rarity of thymic epithelial tumors (thymoma and thymic carcinoma) accumulation of clinical trial data to guide management has been challenging, yet the chemo-sensitivity of these malignancies is clearly established. As with most solid tumors it is important to fully assess for any chance of locally aggressive therapy with surgery or radiation for a curative intent. Thymic malignancies are often very radiation sensitive as well and I am quick to refer to radiation oncology for localized disease progression or any symptomatic areas. The high rates of paraneoplastic syndromes and autoimmunity adds to the complexity of management of this disease, especially thymoma.1I am grateful for the support of neurology colleagues and immunology colleagues to help with myasthenia gravis and immunotherapy/rheumatology management of these complex patients.

      Once the disease has spread extensively in the pleural or metastases have developed, systemic therapy will be essential. I tend to start with a platinum based regimen initially. For young and fit patients the three drug CAP regimen of cyclophosphamide, doxorubicin and cisplatin has a very high response rate.2 Given the cumulative cardiotoxicity of the anthracycline in the regimen, I usually stop at 4 and no more than 6 cycles. Most patients are then able to enjoy a chemotherapy holiday for several months, and even up to a year or longer. I will consider cisplatin/etoposide3if anthracyclines are contraindicated, and especially if any concurrent radiation is under consideration. Carboplatin/paclitaxel was also studied prospectively and remains the most studied regimen for thymic carcinoma.4The response rates with all of these regimens are approximately 50%, somewhat higher with the platinum/anthracycline combinations, though given low numbers in trials the precise response rates are difficult to state with certainty. None of these regimens include a maintenance component, yet the PFS can be 1-2 years. I will also consider giving platinum/pemetrexed as a first line regimen given the improved tolerability, despite limited data. This is primarily focused in thymoma patients, though activity in a limited number of thymic carcinoma patients has been noted despite the usual squamous histology.5

      Once a patient has progressed on first line treatment one may choose between a number of single chemotherapeutic agents with activity including 5-FU and derivatives, gemcitabine, pemetrexed, taxanes and others. I choose between these based on toxicity profiles and prior regimens for the patient and do not have a single standard approach. For younger and fit patients, especially if they have a high disease burden, I will consider combination regimens. There is also growing evidence for activity of agents with mechanisms of action that differ from those of traditional cytotoxic drugs. One of the first of these was octreotide with or without prednisione.6I have used this regimen rarely and in the setting of a positive octreotide scan, or a patient with autoimmune diarrhea where the octreotide was also effective in controlling symptoms of disease.

      More recently I have begun to use the mTOR inhibitor everolimus in my thymic malignancy patients based on a 51 patient trial with the compound.7At 10 mg/day oral dosing the drug had a disease control rate of 88%, which was slightly higher for the thymoma subgroup. There was a complete response in a thymic carcinoma patient and partial responses observed in a minority of both thymoma and thymic carcinoma patients. Median PFS exceeded a year in the thymoma patients. However, significant toxicity was seen with serious drug related adverse events in 14 of the 51 patients including 3 events of fatal pneumonitis. In my practice I have found that most patient do require a dose reduction to 7.5 or 5 mg daily. Pneumonitis remains a risk with this agent, but can be managed if discovered early.

      More specifically for thymic carcinoma emerging data with sunitinib has been very encouraging. In a trial that included 23 evaluable thymic carcinoma patients (as well as 16 with thymoma) the partial response rate was 26% for the thymic carcinoma patients with a further 65% with stable disease. Again toxicity is a concern with 13% rate of cardiac toxicity (reduction in ejection fraction).8

      Detailed molecular analysis of a large group of thymic malignancies was published by the TCGA study group and confirmed GTF2I as the most common mutation in thymoma, as well as revealing 4 distinct categories in the primarily early stage thymoma samples analyzed. Unfortunately no obvious new therapeutic options emerged from this work, but this deeper understanding of the molecular underpinnings of the disease will hopefully allow us to improve our therapeutic options.9The low tumor mutation burden of thymomas was also confirmed in the TCGA effort.

      Thymic malignancies, however, are known to have high PD-L1 expression as shown by multiple groups and that led to the first trials of immunotherapy in thymic malignancy patients. A phase II trial with pembrolizumab, restricted to thymic carcinoma patients without any evidence of autoimmunity, enrolled 41 patients.10 The overall response rate was 22.5% including a complete response, however 15% of patients had severe autoimmune toxicity, which involved grade 4 myocarditis in 2 of the patients and myositis (elevated CPK) in an additional 3 patients. Taken together I am still very cautious in considering PD-(L)1 inhibitors in thymic carcinoma patients as the risk/benefit ratio (23% response and 15% severe autoimmune toxicity) is much closer than we have with many other therapeutic options. The risks in patients with thymoma or any underlying paraneoplastic autoimmunity limits our utility of these drugs at this time.

      Thymic malignancy patients have multiple treatment options and many can have long periods of disease control with the traditional cytotoxic options available and a growing number of targeted therapeutics.

      REFERENCES:

      1. Padda SK J Thorac Oncol13(3):436-446;2017

      2. Loehrer PJJ Clin Oncol 12:1164-1168;1994

      3. Giaccone GJ Clin Oncol 14: 814-820;1996

      4. Lemma GLJ Clin Oncol 29:2060-2065;2011

      5. Liang Y Lung Cancer87(1):34-8;2015

      6. Loehrer PJ J Clin Oncol22:293-299;2004

      7. Zucali PA J Clin Oncol36 (4); 342-349;2018

      8. Thomas A Lancet Oncol16(2):177-186;2015

      9. Radovich M Cancer Cell33:244-258;2018

      10. Giaccone G Lancet Oncol19:347-55;2018

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    PC01 - Controversies in Mesothelioma (ID 840)

    • Event: WCLC 2018
    • Type: Pro-Con Session
    • Track: Mesothelioma
    • Presentations: 6
    • Now Available
    • Moderators:
    • Coordinates: 9/24/2018, 10:30 - 12:00, Room 205 AC
    • +

      PC01.01 - PRO Intrapleural Chemotherapy Is It the Future? (Now Available) (ID 11598)

      10:30 - 10:45  |  Presenting Author(s): Isabelle Opitz, Alessandra Curioni Fontecedro

      • Abstract
      • Presentation
      • Slides

      Abstract

      Considerable progress was achieved in the field of mesothelioma (MPM) research and treatment over the last decades. However, high local recurrence rates – even after aggressive treatment - remain an unresolved problem. Based on anatomic constraints, it is impossible to leave adequate safety margins - usually required for oncological surgery - when resecting mesothelioma, therefore leading to only macroscopic – but not microscopic - complete resection (MCR). The remaining microscopically small tumor residuals are most probably the origin of later recurrence.

      Intracavitary local treatment modalities target this hypothesis. Substances can be applied locally in desired high doses, while side effects can be reduced by decreased systemic absorption. Several intracavitary approaches have been evaluated to try to reduce local recurrence and were mostly applied after MCR, either lung sparing (extended) pleurectomy / decortication ((e)P/D) or extrapleural pneumonectomy (EPP). Intracavitary chemotherapy has been successfully applied in peritoneal carcinomatosis1-4 and the knowledge gained transferred to MPM because of certain similarities of both tumors. Adding hyperthermia to the concept is based on the principle that hypothermia leads to increased penetration depth of the chemotherapeutic agent into the tissue and therefore a maximized cytotoxic effect on tumor cells.

      Looking at current guidelines, intracavitary treatments have not yet entered routine treatment regimens for mesothelioma patients. The recommendation of the American Society of Clinical Oncology Clinical Practice Guideline (ASCO)5 summarizes: Intracavitary therapies (chemotherapy or photodynamic therapy) may be administered safely in experienced centers of excellence, preferably in the context of a clinical trial. Their role in improving outcome is indeterminate (Type of recommendation: evidence based; Evidence quality: low; Strength of recommendation: weak).

      Hyperthermic intraoperative chemotherapy (HIOC) with cisplatin has demonstrated safety and some efficacy in two phase I or II prospective clinical trials in patients undergoing EPP and P/D immediately after surgery6, 7. A safe maximally tolerated dose and the methodology to reduce associated complications have been established (table 1).

      Another technique to reduce systemic side effects and simultaneously increase the local concentration of the drug is to combine cisplatin with a fibrin glue. Cisplatin-fibrin can be sprayed on the resection surface of the chest wall and the lung after surgery (figure 1)8.The pharmacokinetic advantages and efficacy to reduce tumor recurrence have been demonstrated in several preclinical studies9-11. In a phase I dose escalation trial (INFLuenCe-Meso) safety was confirmed, and currently further tested in a phase II clinical trial (NCT01644994).

      Addionally to intracavitary applied chemotherapeutics which are mainly platinum based other substances were tested. Tada et al recently published the results of a phase I clinical trial using zoledronic acid12. This intrapleuraly applied drug is a third generation bisphosphonate and was used in patients with inoperable MPM. Prior to this, the efficacy was equally demonstrated in preclinical studies12, 13.

      figure 1.png

      Figure 1: Application of cisplatin-fibrin after MCR

      Table 1: intracavitary chemotherapy

      n

      Histology

      N2 or Nx

      IMIG stage

      intraoperative regimen

      HIPEC

      Surgery type

      Peri-op Mortality

      Morbidity / Toxicity

      Adjuvant systemic CTX

      Adjuvant RT

      Median OS (months)

      Median PFS (months)

      Opitz 2016

      12

      8 epithelioid

      4 biphasic

      3

      I-II: 3

      III-IV: 9

      Cisplatin + fibrin

      no

      P/D

      0%

      33%

      None

      None

      21

      8

      Sugarbaker 2013

      72

      63 epithelioid

      9 biphasic

      46

      I-II: 14

      III-IV: 60

      cisplatin

      yes

      P/D or EPP

      4.2%

      NR

      57%

      57%

      35.3

      27.1

      Tilleman 2009

      92

      53 epithelioid

      39 non-epithelioid

      NR

      I-II: 14

      III-IV: 78

      cisplatin

      Yes

      EPP

      4.3%

      49%

      NR

      NR

      13.1

      15.3

      Zellos 2009

      29

      24 epithelioid

      5 non-epithelioid

      9

      I-II: 18

      III: 11

      cisplatin

      Yes

      NR

      7%

      NR

      NR

      NR

      20

      16

      Richards 2006

      44

      24 epithelioid

      17 biphasic

      3 sarcomatoid

      33

      I-II: 27

      II-III: 17

      cisplatin

      Yes

      P/D

      11%

      25%

      None

      None

      13

      7.2

      Lu 2005

      33

      23 epithelioid

      2 biphasic

      3 sarcomatoid

      5 unspecified

      NR

      I-II: 11

      III-IV: 17

      Liposomal entrapped cisplatin analogue

      No

      NA

      9%

      NR

      None

      None

      13.2

      5

      Chang 2004

      50

      NR

      31

      I-II: 19

      III: 31

      cisplatin

      Yes

      EPP

      2%

      60%

      Unknown

      Unknown

      NR

      NR

      Monneuse 2003

      17

      NR

      NR

      I-II: 10

      III-IV: 7

      mitomycin C and/or cisplatin

      Yes

      P/D or pleurectomy

      6%

      29%

      NR

      NR

      18

      NR

      Van Ruth 2003

      20

      16 epithelioid

      4 biphasic

      0

      NR

      cisplatin + doxorubicin

      Yes

      12 P/D

      8 EPP

      0%

      65%

      None

      Thoracotomy scar and drainage ducts

      11

      8

      Ratto 1999

      10

      4 epithelioid

      6 biphasic

      0

      I-II: 10

      cisplatin

      Yes

      P/D or EPP

      0%

      20%

      None

      55 Gy to chest wall incision

      NR

      NR

      Colleoni 1996

      20

      10 epithelioid

      7 biphasic

      3 sarcomatoid

      2

      NR

      cisplatin + cytarabine

      No

      P/D

      0%

      NR

      Epirubicin, mitomycin

      None

      11.5

      7.4

      Colleoni 1996

      14

      NR

      NR

      NR

      Cisplatin + interferon α

      No

      pleurectomy

      0%

      7%

      29% carboplatin + interferon α

      None

      NR

      NR

      Sauter 1995

      13

      NR

      NR

      NR

      cisplatin + cytosine arabinoside

      No

      Subtotal pleurectomy

      8%

      23%

      Cisplatin + mitomycin C

      9

      6

      Lee 1995

      15

      7 epithelioid

      4 biphasic

      4 sarcomatoid

      0

      NR

      cisplatin + cytosine arabinoside

      No

      P/D

      0%

      13%

      46%

      73%

      11.5

      NR

      Rusch 1994

      27

      19 epithelioid

      6 biphasic

      2 sarcomatoid

      16

      I-II: 9

      III-IV: 18

      cisplatin + mitomycin

      No

      P/D

      3.7%

      None

      Cisplatin, mitomycin

      None

      18.3

      13.6

      Rice 1994

      19

      10 epithelioid

      7 biphasic

      2 sarcomatoid

      5

      I: 13

      III: 6

      cisplatin + mitomycin C

      No

      P/D or EPP

      5%

      32%

      Cisplatin

      None

      13

      11

      Literature:

      1. Spratt JS, Adcock RA, Muskovin M, et al. Clinical delivery system for intraperitoneal hyperthermic chemotherapy. Cancer Res 1980;40:256-260.

      2. Spratt JS, Adcock RA, Sherrill W, et al. Hyperthermic peritoneal perfusion system in canines. Cancer Res 1980;40:253-255.

      3. Sugarbaker PH. Surgical management of peritoneal carcinosis: diagnosis, prevention and treatment. Langenbecks Arch Chir 1988;373:189-196.

      4. Sugarbaker PH, Gianola FJ, Speyer JL, et al. Prospective randomized trial of intravenous v intraperitoneal 5-FU in patients with advanced primary colon or rectal cancer. Semin Oncol 1985;12:101-111.

      5. Kindler HL, Ismaila N, Armato SG, 3rd, et al. Treatment of Malignant Pleural Mesothelioma: American Society of Clinical Oncology Clinical Practice Guideline. J Clin Oncol 2018;36:1343-1373.

      6. Zellos L, Richards WG, Capalbo L, et al. A phase I study of extrapleural pneumonectomy and intracavitary intraoperative hyperthermic cisplatin with amifostine cytoprotection for malignant pleural mesothelioma. J Thorac Cardiovasc Surg 2009;137:453-458.

      7. Richards WG, Zellos L, Bueno R, et al. Phase I to II Study of Pleurectomy/Decortication and Intraoperative Intracavitary Hyperthermic Cisplatin Lavage for Mesothelioma. J Clin Oncol 2006;24:1561-1567.

      8. Opitz I, Kostron A, Lauk O, et al. Intracavitary Cisplatin-Fibrin After Resection of Malignant Pleural Mesothelioma. ORAL 14.05. JTO; 2015;10(9), Supplement 2.

      9. Lardinois D, Jung FJ, Opitz I, et al. Intrapleural topical application of cisplatin with the surgical carrier Vivostat increases the local drug concentration in an immune-competent rat model with malignant pleuromesothelioma. J Thorac Cardiovasc Surg 2006;131:697-703.

      10. Opitz I, Lardinois D, Arni S, et al. Local recurrence model of malignant pleural mesothelioma for investigation of intrapleural treatment. Eur J Cardiothorac Surg 2007;31:773-778.

      11. Opitz I, Erne BV, Demirbas S, et al. Optimized intrapleural cisplatin chemotherapy with a fibrin carrier after extrapleural pneumonectomy: a preclinical study. J Thorac Cardiovasc Surg 2011;141:65-71.

      12. Tada Y, Hiroshima K, Shimada H, et al. An intrapleural administration of zoledronic acid for inoperable malignant mesothelioma patients: a phase I clinical study protocol. Springerplus 2016;5:195.

      13. Scheller EL, Hankenson KD, Reuben JS, et al. Zoledronic acid inhibits macrophage SOCS3 expression and enhances cytokine production. J Cell Biochem 2011;112:3364-3372.

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      PC01.02 - CON Intrapleural Chemotherapy Is It the Future? (Now Available) (ID 11599)

      10:45 - 11:00  |  Presenting Author(s): David Rice

      • Abstract
      • Presentation
      • Slides

      Abstract not provided

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      PC01.03 - PRO IO in Mesothelioma Should Only Be Given on Clinical Trials (Now Available) (ID 11600)

      11:00 - 11:15  |  Presenting Author(s): Penelope Bradbury

      • Abstract
      • Presentation
      • Slides

      Abstract

      It is 15 years since the pivotal study of pemetrexed and cisplatin versus cisplatin in inoperable pleural mesothelioma was reported, demonstrating a median overall survival (OS) improvement for the combination (pemetrexed/cisplatin 12.1 months vs. cisplatin 9.3 months) [1]. Since that time the only trial to demonstrate a further improvement in OS has been with the addition of bevacizumab to standard chemotherapy (median OS 18.8 months vs. 16.1 (hazard ratio [HR] 0·77 [0·62–0·95]; p=0·0167) [2]. IO is showing promise in mesothelioma. The PD-1 inhibitors, pembrolizumab and nivolumab as single agents have response rates ranging from 18-29% (Table), with prolonged duration of responses reported. In combination, nivolumab and ipilimumab has a disease control rate (DCR) at 12 weeks of 50%, and the combination of durvalumab and tremelimumab had response rate of 28%. In combination with chemotherapy durvalumab, pemetrexed and cisplatin had a 65% 6 month progression free survival and 55% response rate (Table). While these results are encouraging, the majority of reported trials are small, single arm, with response or disease control rates as the primary endpoints. The only randomized control trial to have been completed so far, evaluated tremelimumab as a single agent in patients with previously treated mesothelioma following encouraging results from two single arm single institution studies of tremelimumab (9). Unfortunately, the primary endpoint of OS was not met (tremelimumab vs. placebo median OS 7.7 months vs. 7.3 months (0·92 [95% CI 0·76−1·12], p=0·41). It is notable that the DCR on the placebo arm (defined as CR, PR or SD of at least 12 weeks) was 21·7% (16·0–28·3) highlighting some patients have indolent disease and the need for randomized trials comparing with standard of care. There are a number of randomized trials currently accruing, which will address the role of checkpoint inhibitors for the treatment of mesothelioma and may establish a new standard of care in the future.

      1. Phase III study of pemetrexed in combination with cisplatin versus cisplatin alone in patients with malignant pleural mesothelioma. Vogelzang NJ, Rusthoven JJ, Symanowski J et al. J Clin Oncol. 2003 Jul 15;21(14):2636-44.

      2.Bevacizumab for newly diagnosed pleural mesothelioma in the Mesothelioma Avastin Cisplatin Pemetrexed Study (MAPS): a randomised, controlled, open-label, phase 3 trial. Zalcman G, Mazieres J, Margery J et al. French Cooperative Thoracic Intergroup (IFCT). Lancet. 2016 Apr 2;387(10026):1405-1414.

      3. Clinical safety and activity of pembrolizumab in patients with malignant pleural mesothelioma (KEYNOTE-028): preliminary results from a non-randomised, open-label, phase 1b trial. Alley EW, Lopez J, Santoro A et al. Lancet Oncol. 2017 May;18(5):623-630

      4. A Phase II Study of Nivolumab: A Multicenter, Open-Label, Single Arm Study in Malignant Pleural Mesothelioma (MERIT). Goto Y, Okada M, Kijima T et al. WCLC 2017 MA 19.01

      5.Avelumab (MSB0010718C; anti-PD-L1) in patients with advanced unresectable mesothelioma from the JAVELIN solid tumor phase Ib trial: Safety, clinical activity, and PD-L1 expression. Hassan R, Thomas A, Patel MR. et al. J Clin Oncol 34, 2016 (suppl; abstr 8503)

      6. Tremelimumab combined with durvalumab in patients with mesothelioma (NIBIT-MESO-1): an open-label, non-randomised, phase 2 study. Calabrò L, Morra A, Giannarelli D et al. Lancet Respir Med. 2018 Jun;6(6):451-460. doi: 10.1016/S2213-2600(18)30151-6. Epub 2018 May 15.

      7. Second- or third-line nivolumab (Nivo) versus nivo plus ipilimumab (Ipi) in malignant pleural mesothelioma (MPM) patients: Results of the IFCT-1501 MAPS2 randomized phase II trial. Scherpereel A, Mazieres J, Greillier L et al. French Cooperative Thoracic Intergroup (IFCT). J Clin Oncol 35, 2017 (suppl; abstr LBA8507)

      8. DREAM: A phase II study of durvalumab with first line chemotherapy in mesothelioma—First results. Nowak AK, Lesterhuis WJ, Maxwell Hughes BG et al. J Clin Oncol 36, 2018 (suppl; abstr 8503)

      9. Efficacy and safety of an intensified schedule of tremelimumab for chemotherapy-resistant malignant mesothelioma: an open-label, single-arm, phase 2 study. Calabrò L, Morra A, Fonsatti E et al. Lancet Respir Med 2015;3: 301–09

      10. Tremelimumab as second-line or third-line treatment in relapsed malignant mesothelioma (DETERMINE): a multicentre, international, randomised, double-blind, placebo-controlled phase 2b trial. Maio M, Scherpereel A, Calabrò L et al. Lancet Oncol 2017; 18: 1261–73

      Trial

      Drug

      Trial design

      Patient population (patient number)

      Endpoint

      Efficacy

      KeyNote 0-28

      Alley et al. [3]

      Pembrolizumab

      1B, single arm

      Post chemotherapy or unable to receive (N=25)

      Safety/tolerability

      ORR

      PR=20%; SD 52% Clinical Benefit 40% (95% CI 21·1–61·3) Median PFS 5.4 months (3.4-7.5)

      MERIT

      Goto et al. [4]

      Nivolumab

      Single arm

      2nd or 3rd line (N=34)

      ORR

      ORR 29% (16.8-46.2) DCR 67.6% (50.8-80.9%)

      PFS 6.1 (95%CI: 2.9, NR)

      JAVELIN

      Hassan et al. [5]

      Avelumab

      Single Arm

      2nd Line

      (N=53)

      ORR

      ORR 9.4% (42.3-3.1-20.7)

      DCR 56.6% (42.3-70.2)

      NIBIT-MESO1

      Luana Calabrò et al. [6]

      Tremelimumab/ Durvalumab

      Single arm

      2nd line or first line N=40

      Immune OR

      28% [95% CI 15–44])

      Median duration of immune response 16.1 months (IQR 11·5–20·5).

      MAPS-2

      A Scherpereel et al. [7]

      Nivolumab

      Nivolumab/

      Ipilimumab

      Non-comparative randomized

      2nd or 3rd Line

      (N=129)

      DCR at 12 weeks

      44.4% (31.2-57.7)

      50% (36.7-67.3)

      DREAM

      Nowak et al. [8]

      Pemetrexed/ cisplatin/ durvalumab

      Single arm

      First line, inoperable (N=31)

      PFS at 6 months

      65% PFS at 6 months

      Confirmed ORR 55%

      Tremelimumab Intensified schedule. Luana Calabrò et al. [9]

      Tremelimumab

      Single arm

      2nd Line

      (N=29)

      iORR

      4 PR (13·8%; 3·9–31·7)

      DCR 52%. median duration 10·9 months (95% CI 8·2–13·6).

      DETERMINE

      Michele Maio et al. [10]

      Tremelimumab vs. placebo

      Phase IIB randomized

      2nd or 3rd line

      (N=571)

      OS

      median OS 7.7 vs. 7.3 months (0·92 [95% CI 0·76−1·12], p=0·41)

      DCR (CR, PR or SD of at least 12 weeks). (27·7%, 23·3–32·5 versus 21·7%, 16·0–28·3)

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      PC01.04 - CON in Mesothelioma Should Only Be Given on Clinical Trials (Now Available) (ID 11601)

      11:15 - 11:30  |  Presenting Author(s): Evan Alley

      • Abstract
      • Presentation
      • Slides

      Abstract

      Malignant pleural mesothelioma (MPM) is a relatively rare malignancy that is considered to be incurable despite advances in surgery, radiation, and chemotherapy. For patients with disease progression after primary platinum/pemetrexed-based therapy, there are limited options for treatment and no approved second-line agents. Recent data from several studies have demonstrated clinically meaningful, and sometimes remarkable activity of checkpoint inhibitors in patients with MPM that has failed first-line therapy. Although the data sets are relatively small, response and survival rates are consistent across studies and appear to be better than those seen in historical controls. Undoubtedly, larger trials with randomized cohorts would provide more robust data. However, access to clinical trials for rare diseases such as MPM is limited in many parts of the world. Therefore, the use of checkpoint inhibitor therapy is a reasonable and medically appropriate option for patients with MPM, especially when a clinical trial is unavailable.

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      PC01.05 - PRO Radiation Options: Are We SMART Enough? (Now Available) (ID 11602)

      11:30 - 11:45  |  Presenting Author(s): John Cho

      • Abstract
      • Presentation
      • Slides

      Abstract

      Malignant pleural mesotheliomas (MPM) are rare but aggressive tumours involving the pleura associated with prior asbestos exposure. Although asbestos use has been significantly curtailed, the latency period between asbestos exposure and development of MPM is long, ranging up to 40 years [1]. The incidence of MPM is still increasing and expected to peak by the 2020s.

      The prognosis of MPM is grim with disappointing treatment outcomes. The median survival is 4 to 12 months without treatment [2] and the 2-year overall survival is 0 to 12% [3]. Its management is controversial without consensus as to what constitutes the best treatment. There is still debate as to the type of resection these patients should receive. Previous enthusiasm for aggressive debulking resection using extra-pleural pneumonectomy (EPP) has been tempered by lack of benefit and the considerable toxicity seen [4].

      Several features unique to MPM has conspired to hamper the discovery of its optimal management. First, MPM is rare (with annual incidence of approximately 1 in 100, 000). Rare tumours are often left orphaned by pharmaceuticals due to the difficulty justifying the cost of drug development for such a small patient population. Furthermore, it is challenging to mount large scale clinical trials due to poor accrual rates. Outside of specialized MPM clinics, most clinicians see MPMs infrequently, greatly limiting the accumulation of clinical expertise and experience in its management.

      Second, MPM involves the entire hemithorax (pleural envelope). Large volume disease is, in general, more difficult to manage, both surgically and radiotherapeutically. EPP is a major surgical procedure associated with significant perioperative morbidity and mortality. Hemithoracic radiation therapy (RT) needs to be planned carefully in order to avoid the risk of fatal radiation pneumonitis is the contralateral lung [5]. Patients must be carefully selected to ensure the disease is still resectable and patients must be sufficiently fit enough to tolerate and complete their treatment. As a result, only 20% of MPM patients are suitable for aggressive management at the time of assessment.

      Third, MPM is heterogeneous disease entity with heterogeneous management approaches, varying from best supportive care to aggressive trimodality treatment. Clinical heterogeneity introduces clinical variance and “noise” into its management which, in turn, makes identification of any therapeutic “signal” more difficult. Normally, this limitation can be mitigated by increasing the sample size and, thus, the power of the study but in rare tumours, this is not easily achieved.

      Surgery, by itself, is generally considered to be a palliative option, not a curative one. Even with an EPP, one cannot achieve complete microscopic resection (R0) due to the presence of malignant pleural effusions contaminating the pleural space and surgical bed. As a result, without additional therapy, most patients fail locally in the thoracic cavity. Adjuvant therapy is, thus, a critical component in managing MPM. EPP followed by adjuvant hemithoracic RT was the first treatment approach that was able to show local control in the hemithorax was possible [6].

      However, when their patterns of failure were analyzed more carefully, most of the recurrences were distant and usually involved the contralateral lung or abdomen. This suggested that a possible mechanism for distant failure could be from the tumour spillage into these compartments at the time of EPP during the removal of the diaphragm and pericardium.

      We hypothesized that altering the order of treatment to neoadjuvant hemithoracic RT followed by EPP would reduce the risk of distant metastases by preventing the irradiated clonogens from implanting and potentially improving survival. This provided the rationale for the Surgery for Mesothelioma After RT (SMART) study. This clinical trial is still on-going but our published interim results demonstrated a 3 year overall survival rate of 75% [7]. Other advantages to this approach are: the short accelerated treatment with an overall treatment time of 2 weeks from RT to EPP; excellent patient compliance with 100% completion rate; and acceptable treatment toxicity.

      As our understanding of the tumour microenvironment and the complex interaction between the tumour, host immune system, and therapy improves, we expect treatment outcomes will also improve. Newer targeted and immuno-oncologic agents show much promise and are an active topic of current research. In particular, we anticipate that the combination of immunotherapy agents and radiation will be an area of tremendous interest due to their synergistic effects and potentiation of the immune system [8].

      References:

      1. Bianchi C, Giarelli L, Grandi G, Brollo A, Ramani L, Zuch C. Latency periods in asbestos-related mesothelioma of the pleura. Eur J Cancer Prev. 1997;6(2):162-6.

      2. Ruffie P, Feld R, Minkin S, Cormier Y, Boutan-Laroze A, Ginsberg R, et al. Diffuse malignant mesothelioma of the pleura in Ontario and Quebec: a retrospective study of 332 patients. J Clin Oncol. 1989;7(8):1157-68.

      3. Curran D, Sahmoud T, Therasse P, van Meerbeeck J, Postmus PE, Giaccone G. Prognostic factors in patients with pleural mesothelioma: the European Organization for Research and Treatment of Cancer experience. J Clin Oncol. 1998;16(1):145-52.

      4. Treasure T, Lang-Lazdunski L, Waller D, Bliss JM, Tan C, Entwisle J, et al. Extra-pleural pneumonectomy versus no extra-pleural pneumonectomy for patients with malignant pleural mesothelioma: clinical outcomes of the Mesothelioma and Radical Surgery (MARS) randomised feasibility study. Lancet Oncol. 2011;12(8):763-72

      5. Allen AM, Czerminska M, Jänne PA, Sugarbaker DJ, Bueno R, Harris JR, Court L, Baldini EH. Fatal pneumonitis associated with intensity-modulated radiation therapy for mesothelioma. Int J Radiat Oncol Biol Phys. 2006 Jul 1;65(3):640-5.

      6. Rusch VW, Rosenzweig K, Venkatraman E, Leon L, Raben A, Harrison L, Bains MS, Downey RJ, Ginsberg RJ. A phase II trial of surgical resection and adjuvant high-dose hemithoracic radiation for malignant pleural mesothelioma.J Thorac Cardiovasc Surg. 2001 Oct;122(4):788-95.

      7. de Perrot M, Feld R, Leighl NB, Hope A, Waddell TK, Keshavjee S, et al. Accelerated hemithoracic radiation followed by extrapleural pneumonectomy for malignant pleural mesothelioma. J Thorac Cardiovasc Surg. 2016;151(2):468-73

      8. Sharon E, Polley MY, Bernstein MB, Ahmed M. Immunotherapy and radiation therapy: considerations for successfully combining radiation into the paradigm of immuno-oncology drug development. Radiat Res. 2014 Aug;182(2):252-7.

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      PC01.06 - CON Radiation Options: Are We SMART Enough? (Now Available) (ID 11603)

      11:45 - 12:00  |  Presenting Author(s): Charles B. Simone

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      Abstract not provided

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    PC03 - Controversies in Management of Resectable Thymoma (ID 842)

    • Event: WCLC 2018
    • Type: Pro-Con Session
    • Track: Thymoma/Other Thoracic Malignancies
    • Presentations: 6
    • Now Available
    • Moderators:
    • Coordinates: 9/24/2018, 15:15 - 16:45, Room 205 AC
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      PC03.01 - Post-Operative Radiation Therapy or NOT: PRO (Now Available) (ID 11608)

      15:15 - 15:25  |  Presenting Author(s): Conrad B Falkson

      • Abstract
      • Presentation
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      Abstract

      Thymic epithelial tumors are rare tumors which has been an obstacle to performing prospective randomized studies. There is definite evidence that these tumors are radio-responsive but the exact role of radiation remains unclear. An additional confounding factor is that until the proposed standardization of classification and staging by the International Thymic Malignancy Interest Group (ITMIG) there has been significant inconsistency of interpretation of both histology and staging leading to inconsistency in recommendation for post-operative radiation. Radiation fields, techniques and doses have also been very variable. Literature informing about post-operative radiation is largely reliant on single institution data and mostly retrospective work which introduces inherent bias. More recently consortiums (such as JART and ChART) were formed to try and combine data. Unfortunately most of these databases were primarily surgical based and indications for radiation and radiation techniques are not well defined. The largest data base of thymic tumors is the one established by ITMIG which has facilitated international collaboration and establishing of large retrospective and prospective databases.

      In this debate we will review the literature supporting the role of radiation in the post-operative setting after thymectomy. Recent studies from different institutions have produced very different results for post-operative radiotherapy and we will compare these to try to define why the results are different. The patient must have sufficient risk to justify radiation It has clearly been demonstrated that complete surgical resection is the most important prognostic factor. Improved outcomes with postoperative radiation will depend on appropriate patient selection. We will try to define the patient population that might benefit from treatment. We will also try to answer the question of routine postoperative treatment in more advanced stage disease, or only if resection is incomplete? We will explore how histology impacts on the decision to offer post-operative radiation?

      We will also try to define what fields would be appropriate, what techniques would be optimal and what doses should be delivered. The thymus resides in the mediastinum adjacent o heart, lungs and great vessels. Despite improved conformal techniques of radiation these organs still receive radiation and the potential damage from the radiation is not well quantified.

      International collaboration with standardization of definitions and complete radiation data is ultimately the only way we will achieve knowledge to advise the exact role of post operative radiation.

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      PC03.02 - Post-Operative Radiation Therapy or NOT: CON (Now Available) (ID 11609)

      15:25 - 15:35  |  Presenting Author(s): Daniel Gomez

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      • Presentation
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      Abstract

      The role of postoperative radiation therapy in the context of resectable thymoma remains controversial. Indeed, data is conflicting, with some historical studies demonstrating an advantage to this approach, and others failing to show a benefit over surgery +/- systemic therapy. In the absence of randomized studies, it is difficult to draw conclusions regarding the appropriate approach. However, available data do not support the routine use of postoperative radiation therapy in this context. Decisions regarding management after resection should be made with the input from the multidisciplinary team, with discussions focusing on margin status, histology, extent of disease, and intraoperative concerns.

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      PC03.04 - Debate on Standard Surgical Approaches - Minimally Invasive Thymectomy (Now Available) (ID 11610)

      15:45 - 15:55  |  Presenting Author(s): Shaf Keshavjee

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      Abstract not provided

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      PC03.05 - Debate on Standard Surgical Approaches - Open Thymectomy (Now Available) (ID 11611)

      15:55 - 16:05  |  Presenting Author(s): Meinoshin Okumura

      • Abstract
      • Presentation
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      Abstract

      The first case of total thymectomy for myasthenia gravis was done by Sauerbruch in 1911, which was through cervical incision. The first case of thymoma resection through median sternotomy was done by Blalock in 1934. Before video-assisted thoracoscopic surgery (VATS) was introduced to thymectomy by Yim et al in 1993, median sternotomy had been the main approach for resection of the thymus and thymic tumors.

      Approach through median sternotomy holds several variations, such as, partial sternotomy, full sternotomy, full sternotomy with lateral thoracotomy, and hemi-clam shell approach.

      Partial sternotomy usually splits the two thirds to three fourths of the caudal side of the sternum, resulting in difficulty in resecting the lesions near diaphragm. In case of thymectomy, however, for non-thymomatous myasthenia gravis, resection of peri-thymic fat tissue around the upper poles of the thymus is more important than the lower poles because of ontogeny of the thymus. Partial sternotomy requires skin incision of less than 10cm, and therefore, is less invasive compared to full sternotomy. Thus, it is reasonable to choose partial sternotomy in thymectomy for non-thymomatous myasthenia gravis. Actually, Masaoka adopted partial sternotomy for their original extended thymectomy, and Maggi also chose partial sternotomy for thymectomy for myasthenia gravis. In addition, partial sternotomy is sufficient for resection of a small non-invasive thymoma if not located near diaphragm. The advantage of sternotomy compared with unilateral or bilateral VATS approach is no need to access to the thoracic cavity, because the mediastinal pleura can be dissected from the fat tissue of the anterior mediastinum, which can reduce the possibility of intraoperative pleural implantation of tumor cells.

      Full sternotomy is the most commonly selected approach for resection of anterior mediastinal tumors, and especially, useful in resecting a large or invasive thymic tumor. Thymoma and thymic carcinoma often involve the superior vena cava or brachiocephalic vein, and cardio-pulmonary bypass is required in reconstruction of the great vessels. In these cases, median sternotomy is the most appropriate approach. While simple full sternotomy is sufficient for partial resection of the lung when involved by a tumor, lateral thoracotomy at the 4th intercostal space is sometimes added when concomitant upper lobectomy is required. When extrapleural pneumonectomy for stage 4A thymoma is intended, posterolateral thoracotomy is added in addition to full sternotomy by changing the patient’s position from the prone to the decubitus position.

      Hemi-clam shell approach is another variation of median sternotomy when combined resection of the involved organs is required. In this approach, sternum is split from the sternal notch to the level of 4th intercostal space, and there, lateral thoracotomy is added. This approach enables the procedures of various kinds of lung resection.

      Japanese Association for Thoracic Surgery (JATS) has conducted nation-wide survey of the general thoracic surgery in Japan annually since 1986. According to JATS survey, the number of VATS in surgery for thymic epithelial tumors has increased gradually since late 1990’s. In 2013, surgical resection of thymic epithelial tumor was done in 2230 cases in Japan. Approach through VATS or thoracotomy with VATS procedure was selected in 843 patients, indicating that the proportion of VATS rose up to 38% during 20 years. The remaining 1387 patients are presumed to experience median sternotomy, indicating that median sternotomy was chosen in 62% of operations of thymic epithelial tumors. In thymoma, median sternotomy was chosen in 1139 (60%) out of 1904 cases. On the other hand, in thymic carcinoma or neuroendocrine tumors, median sternotomy was chosen in 248 (76%) out of 326 cases, suggesting that invasive or aggressive tumors are resected using median sternotomy.

      Japanese Association for Research of the Thymus (JART) conducted Japanese nation-wide database study in 2013, and collected the clinical data of 2835 patients undergoing surgical treatment between 1991 and 2010. Because VATS thymectomy was introduced in the middle 1990’s in Japan, the patients treated from 2001 to 2010 were focused in this review. 1978 cases were treated during those 10 years among the JART database. 1542 patients experienced median sternotomy with or without addition of lateral thoracotomy, indicating that 78% of the entire cases were operated by median sternotomy-based surgery. Lateral thoracotomy was chosen in 92 patients, which corresponds to only 4.7% of the entire cases. The proportion of median sternotomy according to TNM-based pathological stage was 74% in stage I, 87% in stage II, 91% in stage IIIA, and 91% in stage IIIB, suggesting that VATS is likely to be indicated to less invasive tumors. Although a study using JART retrospective database revealed that the long-term outcome of VATS for thymic epithelial tumors is compatible with that by open procedure, recurrence after VATS resection for thymoma larger than 5cm was reported, suggesting limited indication of VATS thymectomy. Thus, further experience of VATS or RATS procedure is required to determine the definitive indication of thoracoscopic approach, and open surgery using median sternotomy has still its role as one of the standard procedures.

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      PC03.07 - Adjuvant Chemotherapy for Thymic Carcinoma - YES (Now Available) (ID 11612)

      16:15 - 16:25  |  Presenting Author(s): Giulia Pasello

      • Abstract
      • Presentation
      • Slides

      Abstract

      The role of postoperative treatment in thymic carcinoma is still a controversial issue, because of the low level evidence supporting clinical management of this cancer, made of cohort studies, retrospective studies and case reports, but no randomized clinical trials. Stage is not the only factor we should consider when the choice of postoperative chemotherapy is discussed; completeness of resection and histologic subtype have their own relevance. Thymic carcinoma accounts for about 20% of all thymic cancers, most cases diagnosed as Masaoka-Koga stage III. In this scenario, about 60% of the cases relapses at 10 years. Time of relapse and sites of disease progression should be carefully reviewed when we consider potential benefit of postoperative systemic treatment; thymic carcinomas relapse earlier and commonly at distant sites compared with thymoma, with significantly different 5 years overall survival and progression free survival. Histology preserves its association with progression free survival as radicality of resection. One reason for the controversies about the prognostic role of histology itself may be found in the difficult diagnosis of the specific subtypes as defined by WHO. Across series a complete Interobserver agreement was reported in 10 to 50% of the cases. Most difficulties seem to be the differential diagnosis among B tumors, and a better agreement was achieved when B2-B3 thymoma were grouped together with carcinoma, suggesting overlapping features among them and supporting evidence that type B3 thymomas and thymic carcinomas form a biologically different group. Complete resection of thymic carcinoma is possible in 60%-70% of the cases, achieving 5-Y and 10Y survival of 60% and 40% respectively. Type of resection and Masaoka stage seem to be correlated with survival and cumulative incidence of recurrences. However, a prognostic role of adjuvant treatment, particularly radiotherapy, is shown with possible effect not only in overall survival but also in relapse free survival. On the basis of the available data, it would be tempting to suggest a possible role for chemotherapy in R1-R2, independently by stage, preferably associated with radiation. On the other hand guidelines suggest a role for adjuvant chemotherapt in resectable thymic carcinoma R1 and, in R0 cases, in stage III or in those cases become resectable after induction chemo, independently by stage e type of resection, especially if not received before. The upcoming IASLC/ITMIG staging system, which re-defines Masaoka-Koga stage III downstaging some situations to stage I and II (as mediastinal pleural or pericardial involvement) could potentially influence adjuvant chemo in stage III thymic cancer. Stage III will be distinguished into T3, potentially resectable upfront, and T4, which might need induction chemo. Adjuvant chemoregimens may be chosen on the basis of drugs combinations effective in the palliative setting; platinum-based doublet plus etoposide or taxanes, or multiple drug regimens including anthracycles are the most used, no data favoring one regimen over the others. Response rates among 60 to 100% in main phase II trials are reported, with primary chemotherapy alone or plus concomitant radiotherapy, in all thymic malignancies. Higher response rates with anthracycles in thymoma and cisplatin in thymic carcinoma are suggested by literature evidence.

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      PC03.08 - Adjuvant Chemotherapy for Thymic Carcinoma - NO (Now Available) (ID 11613)

      16:25 - 16:35  |  Presenting Author(s): Sukhmani Kaur Padda

      • Abstract
      • Presentation
      • Slides

      Abstract

      Thymic carcinoma is a more aggressive neoplasm than its more common counterpart thymoma, with a higher cumulative incidence of recurrence and worse overall survival when matched by stage and complete resection status.1 Large retrospective database studies provide support for adjuvant radiation for completely resected thymic carcinoma. Therefore, the Thymic Carcinoma Working Group of the International Thymic Malignancy Interest Group (ITMIG) has recommended adjuvant radiation for completely resected Masaoka stage II and III thymic carcinoma.2 In a recent survey of thymic carcinoma management patterns among 100 ITMIG physicians, the role of adjuvant chemotherapy was highlighted as an area of controversy.2 The survey responders provided the following recommendations after completely resected stage II and III thymic carcinoma, respectively: 51% and 14% observation, 25% and 42% adjuvant radiation alone, 13% and 34% adjuvant radiation and chemotherapy, and 11% and 10% adjuvant chemotherapy alone. There is data that neoadjuvant chemotherapy may be useful for locally advanced thymic carcinoma, as it may facilitate surgical resection and improve the chances of a complete resection, a known strong prognostic factor.3 However, data supporting the use of adjuvant chemotherapy for thymic carcinoma is limited and its potential to decrease local recurrence and distant metastases after achievement of a complete resection is controversial.

      In one of the largest known datasets of thymic carcinoma, including 1042 cases pooled from the ITMIG and European Society of Thoracic Surgeons (ESTS) retrospective databases, 764 cases had available chemotherapy information. Sixty-one percent (n=463) of patients received neoadjuvant or adjuvant chemotherapy, with 22% receiving chemotherapy in the neoadjuvant setting, 31% in the adjuvant setting, and 8% in both the neoadjuvant and adjuvant setting.4 Chemotherapy was more frequently given to patients with Masaoka stage III-IV disease. The most common adjuvant treatment strategies included adjuvant chemotherapy and radiation (26%) and adjuvant radiation alone (22%), although 10% of patients received both neoadjuvant chemotherapy and adjuvant radiation. In a univariate analysis, chemotherapy was associated with an improved overall survival but was not associated with recurrence-free survival. Because of the limited sample size, it was unclear which multimodality treatment strategy improved overall survival such as delivery of chemotherapy in the neoadjuvant or adjuvant setting. However, chemotherapy was not a significant factor for clinical outcomes in a multivariate analysis.

      There are other smaller database studies investigating adjuvant chemotherapy for thymic carcinoma. Due to both the retrospective nature of the studies and small sample sizes, it is difficult to evaluate the independent impact of adjuvant chemotherapy on clinical outcomes, as chemotherapy was often given in conjunction with radiation. Across these studies, there is no clear indication of benefit of adjuvant chemotherapy for resected thymic carcinoma. In the Japanese Association for Research on the Thymus (JART) database report on 155 patients with stage II and III thymic carcinoma, adjuvant chemotherapy was not a significant factor for relapse-free survival in a multivariate model that also included adjuvant radiation, stage, and resection status.5 In the Chinese Alliance for Research of Thymoma Database (ChART) report on 329 patients with thymic carcinoma, there was no difference in overall survival between patients who received adjuvant chemotherapy and those who did not in the overall cohort and in Masaoka-Koga stage subsets and resection status categories.6 However, of the 148 patients who received adjuvant chemotherapy, 127 received sequential chemotherapy and radiation. In a study from the National Cancer Database, there were 468 patients with thymic carcinoma who underwent surgery alone and 557 who underwent surgery and adjuvant radiation, with 28% and 56% also receiving adjuvant chemotherapy, respectively.7 Chemotherapy was not associated with overall survival in both univariate and multivariate analyses. Finally, in a meta-analysis of 973 patients with thymic carcinoma, the rate of adjuvant chemotherapy was 21.2-61.5% among those who received adjuvant radiation and 6.7-50% among those who did not, with four of the studies demonstrating no significant association between adjuvant chemotherapy and survival in both univariate and multivariate analyses.8

      Several retrospective database studies have shown no clear benefit of adjuvant chemotherapy for patients with resected thymic carcinoma, although these datasets have their limitations. Many additional questions remain about adjuvant chemotherapy including the indications for recommending adjuvant chemotherapy; the details of the chemotherapy such as the regimen and number of cycles; and the timing of initiation of chemotherapy after surgery and how it should be integrated with perioperative radiation. In summary, there is lack of data to support the routine use of adjuvant chemotherapy after complete resection of thymic carcinoma and further study is required.

      References:

      1. Detterbeck FC, Stratton K, Giroux D, et al. The IASLC/ITMIG Thymic Epithelial Tumors Staging Project: proposal for an evidence-based stage classification system for the forthcoming (8th) edition of the TNM classification of malignant tumors. J Thorac Oncol 2014;9:S65-72.

      2. Shepherd A, Riely G, Detterbeck F, et al. Thymic Carcinoma Management Patterns among International Thymic Malignancy Interest Group (ITMIG) Physicians with Consensus from the Thymic Carcinoma Working Group. J Thorac Oncol 2017;12:745-751.

      3. Hamaji M, Ali SO, Burt BM. A meta-analysis of induction therapy for advanced thymic epithelial tumors. Ann Thorac Surg 2015;99:1848-1856.

      4. Ahmad U, Yao X, Detterbeck F, et al. Thymic carcinoma outcomes and prognosis: results of an international analysis. J Thorac Cardiovasc Surg 2015;149:95-100, 101 e101-102.

      5. Omasa M, Date H, Sozu T, et al. Postoperative radiotherapy is effective for thymic carcinoma but not for thymoma in stage II and III thymic epithelial tumors: the Japanese Association for Research on the Thymus Database Study. Cancer 2015;121:1008-1016.

      6. Fu H, Gu ZT, Fang WT, et al. Long-Term Survival After Surgical Treatment of Thymic Carcinoma: A Retrospective Analysis from the Chinese Alliance for Research of Thymoma Database. Ann Surg Oncol 2016;23:619-625.

      7. Jackson MW, Palma DA, Camidge DR, et al. The Impact of Postoperative Radiotherapy for Thymoma and Thymic Carcinoma. J Thorac Oncol 2017;12:734-744.

      8. Hamaji M, Shah RM, Ali SO, et al. A Meta-Analysis of Postoperative Radiotherapy for Thymic Carcinoma. Ann Thorac Surg 2017;103:1668-1675.

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