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Natasha B Leighl

Moderator of

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    MS 04 - Joint IASLC/GLCC Session Current Issues in Lung Cancer Advocacy (ID 526)

    • Event: WCLC 2017
    • Type: Mini Symposium
    • Track: Patient Advocacy
    • Presentations: 5
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      MS 04.01 - Lung Cancer Advocacy Tools for Everyone - The Use of GLCC Data (ID 7653)

      11:00 - 12:30  |  Presenting Author(s): Jesme Fox

      • Abstract
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      Abstract:
      Background: Despite recent advances, lung cancer remains a disease characterised by negativity, late diagnosis and poor outcomes. The need for advocacy in lung cancer is obvious. Recent years have seen an increase in the number of organisations and individuals advocating for improvements in this disease. With limited resources across all advocacy organisations, using external data and tools from other sources is welcome. Such a source is work undertaken by the Global Lung Cancer Coalition. The Global Lung Cancer Coalition: In 2001, a global search revealed the existence of only nine not-for-profit organisations with an interest in lung cancer advocacy. Of these, only two were lung cancer–specific, the others representing generic cancer or respiratory diseases. In coming together, these organizations established the Global Lung Cancer Coalition (GLCC), an allied group of registered not-for-profit, non-government organizations, dedicated to improving lung cancer outcomes. By 2017, the GLCC has grown to 36 member organisations, from 26 countries and provides a centralised communication and referral network. In recent years, the GLCC has undertaken a number of projects, creating data and tools, for all advocates to use, in their efforts to improve lung cancer outcomes. More information on all of these are available on the GLCC website – www.lungcancercoalition.org. Key Global Lung Cancer Coalition Projects - The Global Lung Cancer e-Atlas The e-Atlas is available on the GLCC website. It is an easily accessible source of international lung cancer data, including all WHO countries. The purpose was to collate lung cancer data from across the globe and uncover international variations. This includes incidence, mortality and survival data. Also, an indication of whether the country has Cancer Registry, has signed up to the WHO Framework on Tobacco and/or has a National Cancer Plan. The e-atlas brings all of this information together in an easily accessible place. This is a data resource for lung cancer professionals and campaigners. It is easy to compare data across countries and easy to create graphs, for download into powerpoint presentations and reports. This resource has already been used by many advocates, in discussions with politicians and health policy makers, to highlight differences in inter-country survival. The e-atlas will be updated, as international data sets are updated. Where possible, we will also add links to national lung cancer data sources. International Consumer Polls GLCC commissioned IPSOS/MORI to undertake two consumer polls in GLCC member countries in 2011 and 2013. These examined issues of stigma and also of general public awareness of lung cancer symptoms. In 2017, these two polls are being repeated by Populus and will be undertaken in 25 countries. This will provide update information in GLCC countries covered by the original polls and new information for newer GLCC member countries. Smoking stigma associated with lung cancer and poor public awareness of signs and symptoms of the disease are of obvious importance. Such polls provide valuable information for advocating and campaigning for improvement and change. Global Lung Cancer Research data The GLCC commissioned researchers at King’s College in London, to undertake some bibliometric research, to map published lung cancer research, across the globe. This type of research involves the quantitative analysis of publications and research activity, using complex bespoke algorithms This work was published, as an open access article, in June 2016 in the Journal of Thoracic Oncology. (Agarwal A, et al, ‘The State of Lung Cancer Research – A Global Analysis)’. Results of this work show the relative lack of lung cancer research globally. Individual Country Toolkits have been created to raise awareness of lung cancer research nationally and advocate for more. GLCC has commissioned further research in this area, investigating how published research is used – for example, does it change practice, how is the research implemented and what research is media reported. Information on Lung Cancer – Topical Factsheets GLCC has created factsheets in topical area, available for download from the GLCC website. These include Information on Clinical Trials and the relatively new therapy field of Immunotherapy. The Immunotherapy Factsheet is available in 16 languages. Factsheets are now also available on Lung Cancer Screening and Lung Cancer and Stopping Smoking. These are available for everyone to download and distribute. Lung Cancer Awareness Information Sheets The GLCC has created Awareness leaflets. These are designed for the general public, to inform on lung cancer – What to look out for? What to do? Where to go for help and support? The leaflets have been translated into 13 languages and are available for download on the Resource section of the website. In this presentation, all of the above will be expanded on. We invite all who advocate for improvements in lung cancer to use these resources.

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      MS 04.02 - Lung Cancer Advocates and Measuring Value in Healthcare (ID 7654)

      11:00 - 12:30  |  Presenting Author(s): Carolyn Aldige

      • Abstract
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      Abstract:
      The United States has no formal system of health technology assessment, compared to, for example, the system in the United Kingdom and many countries worldwide. In the U.S., certain federal agencies review and recommend approval of drugs and devices, while others make determinations regarding reimbursement of costs of treatment and other interventions. With the cost of health care in the U.S. skyrocketing in the absence of cost controls, many organizations, e.g., the American Society of Clinical Oncology, the National Comprehensive Cancer Network, Memorial Sloan Kettering Cancer Center and others, have developed “value frameworks”. In virtually all cases, however, the frameworks were developed without input from patients, their caregivers or patient advocates. They were developed from evidence obtained in randomized controlled trials and did not include real-world evidence, such as from observational studies or patient experience reports. Decisions about what patients value were often made by clinicians and economists and not by the patients whose lives would be impacted by the recommendations.The situation becomes even more complex when one considers that all patients do not share the same values with regard to outcomes. While a younger, otherwise healthy patient might accept significant treatment toxicity in order to extend life, an older, less healthy patient might choose treatment that is likely to be less toxic. As treatment costs escalate, financial toxicity is also a consideration and varies among individual patients. A treatment that imposes significantfinancial burden on one individual might not be perceived as overly costly by another.Family/caregiver preference also needs to be taken into consideration, as all demographic groups do not share the same preferences or values. Whereas in some groups, the patient’s preference is what counts, in others, family members are much more involved in decision making.In May 2015, researchers from the American Institutes for Research and the Mayo Clinic published a study based on extensive interviews with 721 patients.

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      MS 04.03 - Accessing New Lung Cancer Therapies - Challenges & Experience in Latin America (ID 7655)

      11:00 - 12:30  |  Presenting Author(s): Mirna Patricia Mondragon

      • Abstract
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      Abstract:
      Regarding the main disadvantages to access: 1. Where there are structural factors that grant the right and Promote coverage, bureaucratic issues arise that Complicate access. 2. There is in general an underutilization of the available public resource, for lack of information. 3. Many patients who depend on public coverage lack of an education from which they can empower themselves situation. Many times they lack the knowledge and Tools to expand their options. 4. The delay or inefficient response by the public coverage remains, even increases, or extent a claim made by patients and their relatives. 5. Delays both in the delivery of medicines and in obtaining shifts, in order to conduct a study. Problems of transfers, Great distances to treatment centers. Mexico, Brazil, Peru, Argentina and Chile to mention some examples in Latin America we have very fragmented health systems, little or no budget for avant-garde treatments like Immunotherapy or targeted therapies. Lung Cancer patients often do not know their rights, they do not empower themselves and require the inclusion of these therapies. While efforts have been made to tighten anti-smoking laws, there is a long way to go and educate to create awareness.

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      MS 04.04 - Patient Advocacy - Making a Difference for Lung Cancer Patients in Japan (ID 7656)

      11:00 - 12:30  |  Presenting Author(s): Toshiyuki Sawa

      • Abstract
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      Abstract:
      Background of Japanese lung cancer advocacy In Asian countries, the concept of cancer advocacy has not been sufficiently recognized. In Japan, there had been few groups of lung cancer patients for a long time, and West Japan Oncology Group (WJOG) has practiced cancer advocacy learned from the USA and Europe as a citizen lecture and a guidebook for patients. We noticed that interactive efforts involving patient groups, companies, academia and governments are necessary rather than providing one way information. In recent years, Lung Cancer Society (JLCS) has led the lung cancer advocacy, and adopted the 2014 Kyoto Declaration, which Representatives of the society, lung cancer patients, citizens, medical personnel, government, companies and research institutes, declared the will to the improvement of lung cancer medical care in cooperation. First, the medical improvement committee against lung cancer was organized to to realize the goal of the Kyoto Declaration, and The committee has carried out the following activities. Initially, the ambassador was commissioned to a lung cancer survivor, a futsal professional athlete and one medical school student of a leader of the idol singer group. In line, we currently commission six medical school students, students of pharmacy, and nursing students. One of our main activities is to provide information on lung cancer medical care using websites and events. In addition to the public lecture, medical workers seminar, the event by the patient association had been supported. These activities are open to the public so that citizens and medical staff can recognize widely in cooperation with medical media. Also, in collaboration with the Lung Cancer Society, we are also requesting early approval of new therapeutic agents. Evaluation of Japan's advocacy To evaluate the awareness and attitude of lung cancer advocacy activity among patients, medical workers, and the general population in Japan, web survey was planned for the perceptions of Kyoto declaration and JLCA (Japanese alliance for lung cancer advocacy) events which were carried out by JLCS in these 2 years. Furthermore, we tried to reflect the questionnaire result in the subsequent activity plan. An internet survey was conducted which contained 6 closed-ended (selection one or free answers) and open-ended questions, depending on the JLCA network population in June 2016. Results By October 2016, 109 people of responded involving 36% of patients and their family, 25% of MD and medical worker, 19% of pharmaceutical company officials and 16% of news media. Perception of Kyoto declaration was 21% of attendee, 27% of well-known, 13% of partial known and 39% of non-awareness. Also the number of participants to the events of JLCA is, 49% of 0 times, 17% 0f 1-2 times, 24% of 3-4 times and 11% of more than 5 times. The most sympathy events ware voted to 1) lecture by a physician 57%, 2) lecture by survivor and the participants WCLC of cancer patients 46%, 3) information in the facebook and the web site 46% 4) citizen open lecture of lung cancer 39%, 5) Performance by society ambassador 38%, 6) advocacy program in annual meetings 26% and 7) Medical seminars around the country 26%. The proportion of respondents who have a certain reputation in the activities of JLCA was 76%.The requests to JLCA is, 1) is the most participation opportunities for information of new treatment and participation opportunities to clinical trial, followed by 2) wish to participate to all the programs in the Society. Looking for the next difference 1. Activities in the next fiscal year, reflecting the results of the questionnaire, citizen public lectures consisted mainly of lectures by prominent oncologist, announcements of representative survivors, moderators and lectures by public ambassadors. Events were held in major cities and various places across Japan. Also The lung cancer society organizes the patient advocacy program throughout the annual meeting every year. We provide travel grants from 2016 to facilitate patient and family attendance. 2.The committee holds medical seminars in Tokyo four times a year. The theme was the latest current information surrounding lung cancer from time to time, introduction of new treatment and activity of patients group. In addition, journalists, television reporters and medical writers were invited to provide information to the public widely by articles posting. 3. Through the website, we provide topics on diagnosis and treatment for lung cancer using video, activity policy and advocacy activities of the lung cancer society, documentary on participation of the international conference of the patient association. In conclusion, participants from different professions gathered for the purpose of improving lung cancer medical care, shared recognition was born among the participants, and empathy was also obtained with the public relations ambassador. Meanwhile, because of different professions and position, the hope of the content of activities was diverse, and it seems necessary to enhance the priority business that can be shared.

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      MS 04.05 - Lung Cancer Patients and Stopping Smoking - What Advocates Need to Know (ID 7657)

      11:00 - 12:30  |  Presenting Author(s): Aoife McNamara

      • Abstract
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      Abstract:
      Smoking and lung cancer Since the 1950’s, smoking has been associated with lung cancer (US National Llibrary of Medicine, 2017). Lung cancer is the most common cancer worldwide and the biggest cancer killer (World Health Organisation, 2017). The majority of lung cancer diagnoses are due to smoking (US National Llibrary of Medicine, 2017), yet these frightening statistics have not deterred people around the globe from smoking. The World Health Organisation estimated that, in 2015, 1.1 billion people smoked tobacco. Within this cohort are lung cancer patients and their families, unable or unaware of why they should quit. This presents a great challenge to patient advocates worldwide. Awareness Awareness of the significant health risks associated with smoking vary around the world, so the role of the patient advocate also varies from country to country. In 2013 the Global Lung Cancer Coalition launched a survey, carried out by Ipsos MORI, investigating awareness of the symptoms of lung cancer and smoking prevalence in 21 countries. Researchers found that across all the countries, 22% of people surveyed admitted they could not name any symptoms of the disease. Over 17,000 people were surveyed, among them former smokers were slightly more likely to be aware of symptoms than current smokers or people who have never smoked. Multiple studies have replicated similar differences in awareness of the link between smoking and lung cancer across countries. Research performed by the Irish Cancer Society in 2015 found that; 92 out of 100 smokers know that smoking causes lung cancer. In contrast, the Global Adult Tobacco Survey (2010) found that in China; 23% of adults believe smoking causes stroke, heart attack, and lung cancer. While every country requires a message specific to their population, the common theme is stopping smoking is the most important thing the public can do to reduce their risk of lung cancer and it is never too late to benefit from stopping, even after a diagnosis of a smoking-related disease. Benefits of quitting Smoking not only increases your risk of lung cancer, but of multiple cancers, heart disease, stroke, lung disease, and fertility and pregnancy problems (US National Library of Medicine, 2017). Tobacco smoke contains around 7,000 chemicals. Many of these are poisonous and over 60 are known to be cancer causing. For people already diagnosed with lung cancer, smoking cessation can seem pointless but there are clear benefits to stopping smoking including better treatment efficacy, fewer side-effects, less risk of recurrence and less risk of developing other smoking-related health problems (American Society of Clinical Oncology, 2016). There are immediate and long-term health benefits of quitting for all smokers, including those already diagnosed with lung cancer, including (World Health Organisation, 2017): Within 20 minutes, your heart rate and blood pressure drop After 12 hours, the carbon monoxide level in your blood drops to normal Within 2-12 weeks, your circulation improves and your lung function increases At 1-9 months, coughing and shortness of breath decrease By 1 year, your risk of coronary heart disease is about half that of a smoker's Within 5-15years, your stroke risk is reduced to that of a non-smoker By 10 years, your risk of lung cancer falls to about half that of a smoker and your risk of cancer of the mouth, throat, oesophagus, bladder, cervix, and pancreas decreases Within 15 years, the risk of coronary heart disease is that of a non-smoker’s. Role of advocates Advocates have an opportunity to promote smoking cessation on a National scale as well as at an individual level. This can seem like an overwhelming task in light of the significant health burden smoking presents, however international support is available. In 2005 The World Health Organisation Framework Convention on Tobacco Control (WHO FCTC) was created. This evidence-based treaty reaffirms the right of people to the highest standard of health, provides legal dimensions for international health cooperation and sets high standards for compliance. Each MPOWER measure corresponds to at least 1 provision of the WHO Framework Convention on Tobacco Control. The 6 MPOWER measures are: Monitor tobacco use and prevention policies Protect people from tobacco use Offer help to quit tobacco use Warn about the dangers of tobacco Enforce bans on tobacco advertising, promotion and sponsorship Raise taxes on tobacco. At an individual level, advocates can play a vital role in encouraging lung cancer patients and their families to avail of behavioural support and medication to assist their smoking cessation efforts. Lung cancer patients are burdened with elevated levels of distress in comparison to other cancers (Zabora et al., 2001) and research suggests that stigma and the association with tobacco is a very real issue for lung cancer patients (Chapple et al., 2004). This is in addition to being diagnosed with the biggest cancer killer worldwide, a probable late stage diagnosis, poor prognosis and debilitating symptoms. For the lung cancer patient, advocate guidance and support is vital to successfully quit smoking. People diagnosed with cancer often keep quiet about their smoking because (American Society of Clinical Oncology, 2016): they fear judgement or blame from their family or doctor they think they might get less support for their cancer treatment the think it is pointless to stop as they already have cancer they believe smoking helps them cope with stress they have tried to stop before unsuccessfully. The challenge for patient advocates is balancing this support at an individual level with the need to evoke change at a National and International level.

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Author of

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    ES 06 - Communication Skills in the End of Life/ Symptom Management in Lung Cancer (ID 515)

    • Event: WCLC 2017
    • Type: Educational Session
    • Track: Nursing/Palliative Care/Ethics
    • Presentations: 1
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      ES 06.06 - Dignity Conserving Therapy (ID 7609)

      15:45 - 17:30  |  Presenting Author(s): Natasha B Leighl

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      Abstract:
      Dignity has been defined as the “quality or state of being worthy, honored or esteemed”[1]. While dignity-conserving therapy is popularly defined as assisted suicide in the setting of terminal illness, it may also be considered as a larger goal of palliation and achieving a “good death”. Chochinov has defined 8 subthemes in the conservation of dignity at the end of life, including continuity of self, role preservation, maintenance of pride, hopefulness, autonomy/control, generativity/legacy, acceptance and resilience or fighting spirit [1]. Based on how patients and their caregivers define dignity, different interventions may be used to target or support physical and/or psychological distress, a patient’s level of independence, patient perspectives and interactions with others. Dignity Therapy as developed by Chochinov involves a brief therapy session, which may be delivered at the bedside, transcribed and shared with friends and/or family, to support the patient in his or her desire to live in the moment, maintain normalcy as best as possible and to seek spiritual comfort. More commonly, however, dignity conserving therapy refers to physician-assisted death. This has been legalized in at least 8 countries, including the Netherlands, Belgium, Switzerland, Germany, Luxembourg, Columbia, Canada and 6 states in the USA [2]. In Canada, recent legislation decriminalized medically assisted death. Li et al have reported the University Health Network (UHN, Toronto, Canada) experience of establishing a hospital-based physician-assisted program of medical assistance in dying (MAiD) [2]. Three teams were developed including a clinical team, an assessment team and an intervention team. The clinical team is involved in the usual care of the patient, including nurses, allied health professionals, consulting physicians and the physician most responsible for the patient’s care. Upon patient request, the most responsible physician refers the patient to the hospital MAiD program. At this point, full palliative consultation and support is offered if not already in place. An assessment team of two physicians, with expertise in the assessment of prognosis, patient suffering and capacity or ability to provide informed consent, evaluate the patient (MAiD medical specialist, palliative care physician, psychiatrist). To be eligible for MAiD through the UHN program, a person is required to have health care services covered through the Canadian public healthcare system, to be at least 18 years old and capable of making his or her own health care decisions, and to have a grievous and irremediable medical condition. This includes a serious and incurable illness, disease or disability, to be in an advanced state of irreversible decline in capability, such that the illness or state of decline causes enduring physical or psychological suffering that is intolerable to the person and cannot be relieved by means that the person considers acceptable. Natural death must be reasonably foreseeable based on medical circumstances, the request for medical assistance in dying must be voluntary and the person is required to voluntarily provide informed consent after being informed of alternative means to relieve suffering including palliative care. Disagreements between assessors are resolved through discussion involving leaders of the MAiD program. Once deemed eligible for MAiD, the patient completes a request form for the procedures, followed by a mandatory reflection period of at least 10 days unless death or loss of capacity is imminent. The intervention team, comprised of physicians and/or a nurse practitioner, conducts a final evaluation of the person and ensures they retain capacity before obtaining final informed consent and providing the intervention. Psychosocial professionals are available to provide support to family as needed and to conduct debriefing sessions for staff before and after the intervention. A multidisciplinary quality committee provides oversite and reports to the hospital Medical Advisory Committee. Since the program’s inception in March 2016, 111 inquiries have been received, 39% information-seeking only [Dr. Madeline Li, personal communication]. Of these, 71% have a cancer diagnosis, commonly lung cancer. Other diagnoses include neurologic disorders such as ALS (14%), cardio-respiratory chronic disease including CHF, COPD, and interstitial lung disease (9%). Assessments have been conducted for 41 individuals, 7 were found ineligible, 35 have been approved and 24 have completed interventions. Many of these were already receiving specialty palliative care services. The most common reason for not proceeding with the intervention was clinical decline or loss of capacity. Those that received MAiD cited loss of autonomy as the main reason behind their request [2]. Preserving dignity in the face of incurable lung cancer remains a challenge for patients, families and their health care providers. An individualized approach and involving a multidisciplinary support team including palliative care remains key. References: 1. Chochinov HM. Dignity-conserving care – a new model for palliative care. JAMA 2002;282:2253-60. 2. Li M, Watt S, Escaf M, Garedam M, Heesters A, O’Leary G, Rodin G. Medical assistance in dying – implementing a hospital-based program in Canada. New Engl J Med 2017;376:2082-8.

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    MA 19 - Mesothelioma: Bench to Bedside (ID 680)

    • Event: WCLC 2017
    • Type: Mini Oral
    • Track: Mesothelioma
    • Presentations: 1
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      MA 19.03 - Nintedanib + Pemetrexed/Cisplatin in Malignant Pleural Mesothelioma (MPM): Phase II Biomarker Data from the LUME‑Meso Study (ID 8111)

      11:00 - 12:30  |  Author(s): Natasha B Leighl

      • Abstract
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      Background:
      Nintedanib is a triple angiokinase inhibitor. LUME-Meso (NCT01907100) is a randomised, Phase II/III study of ≤6 cycles of nintedanib+pemetrexed/cisplatin versus placebo+pemetrexed/cisplatin, followed by nintedanib or placebo maintenance, in chemo-naïve patients with MPM. In Phase II results, nintedanib+pemetrexed/cisplatin improved progression-free survival (PFS) versus control (hazard ratio [HR]=0.54; p=0.010), with a trend for prolonged overall survival (OS; HR=0.77; p=0.319). Benefit was most pronounced in patients with epithelioid tumours. Since no pharmacodynamic/predictive biomarkers are validated for anti-angiogenic therapies, exploratory analyses were conducted to investigate potential associations of plasma-derived angiogenic factors and genomic markers with treatment outcome in the LUME-Meso Phase II epithelioid population.

      Method:
      Blood samples were collected at baseline and, for patients receiving maintenance, at monotherapy Cycle 3 (C3mono) and end of monotherapy (EoTmono). Analyses focused on 58 angiogenic factors (Human AngiogenesisMAP[®] panel, Myriad RBM) and single-nucleotide polymorphisms (SNPs) in genes implicated in mesothelioma and/or associated with response to anti-angiogenic therapies in other tumour types (VEGFR1, VEGFR3 and mesothelin). Associations of biomarkers with treatment effect were evaluated by Cox regression and tested for interaction with false discovery rate (FDR) adjustment. Adjusted mean changes in angiogenic factor levels were compared between arms by ANCOVA. Analyses were exploratory, limited by small sample size, and considered hypothesis generating.

      Result:
      Of 77 patients with epithelioid tumours, angiogenic factor and genomic data were available for 71 and 67 patients, respectively. PFS/OS benefit of nintedanib appeared potentially more pronounced in patients with baseline plasma endoglin level below the median. There were possible weak associations between major homozygous genotypes for two VEGFR3 SNPs (rs307821 G/G and rs307826 A/A), and OS benefit and between VEGFR1 SNP rs9582036 A/A genotype and PFS benefit. Biomarker treatment associations were limited by small subgroup size, especially for low-frequency SNPs, and interaction tests were not significant after FDR adjustment. Regarding pharmacodynamic effects, adjusted mean change in interleukin-8 levels with nintedanib was greater from baseline to C3mono and lower from C3mono until EoTmono, compared with placebo. Nintedanib showed lower adjusted mean changes versus placebo for VEGFR2 from baseline to C3mono, and for VEGFR2 and VEGFR3 from baseline to EoTmono.

      Conclusion:
      These analyses represent the first biomarker results for nintedanib-treated MPM. While there seemed to be signals for greater PFS and OS improvement in patients with low plasma endoglin and major homozygous VEGFR1/3 genotypes, no biomarkers showed clear significant association with treatment benefit. These findings warrant further evaluation in the Phase III study.

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    MS 12 - Sustainable Care System in Each Region (ID 534)

    • Event: WCLC 2017
    • Type: Mini Symposium
    • Track: Regional Aspects/Health Policy/Public Health
    • Presentations: 1
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      MS 12.01 - Sustainable Care System in North America (ID 7698)

      11:00 - 12:30  |  Presenting Author(s): Natasha B Leighl

      • Abstract
      • Presentation
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      Abstract not provided

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    MS 22 - The Cost of Lung Cancer (ID 544)

    • Event: WCLC 2017
    • Type: Mini Symposium
    • Track: Epidemiology/Primary Prevention/Tobacco Control and Cessation
    • Presentations: 1
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      MS 22.01 - The Economic Burden of Lung Cancer (ID 7745)

      11:00 - 12:30  |  Presenting Author(s): Natasha B Leighl

      • Abstract
      • Presentation
      • Slides

      Abstract not provided

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    OA 05 - Next Generation TKI (ID 657)

    • Event: WCLC 2017
    • Type: Oral
    • Track: Advanced NSCLC
    • Presentations: 1
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      OA 05.05 - Brigatinib in Crizotinib-Refractory ALK+ NSCLC: Updated Efficacy and Safety Results From ALTA, a Randomized Phase 2 Trial (ID 8027)

      15:45 - 17:30  |  Author(s): Natasha B Leighl

      • Abstract
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      Background:
      Brigatinib, a next-generation ALK inhibitor, recently received accelerated approval in the United States for the treatment of patients with metastatic ALK+ NSCLC who have progressed on or are intolerant to crizotinib. We report updated data from the randomized phase 2 trial (ALTA; NCT02094573), which was designed to investigate the efficacy and safety of 2 brigatinib regimens in patients with crizotinib-refractory, advanced ALK+ NSCLC.

      Method:
      Patients were stratified by presence of brain metastases at baseline and best response to prior crizotinib and randomized 1:1 to receive brigatinib at 90 mg qd (arm A) or 180 mg qd with a 7-day lead-in at 90 mg (arm B). Investigator-assessed confirmed objective response rate (ORR) per RECIST v1.1 was the primary endpoint.

      Result:
      Among 222 patients (n=112/n=110, arm A/B), median age was 51/57 years; 71%/67% had brain metastases. As of February 21, 2017, 17 full months since the last patient enrolled, median follow-up was 16.8/18.6 months and 32%/41% of patients continued to receive brigatinib in A/B. The table shows brigatinib efficacy. Per independent review committee, confirmed ORR was 51%/55% and median PFS was 9.2/16.7 months in A/B. Among patients with measurable baseline brain metastases (n=26/n=18, A/B), confirmed intracranial ORR was 50%/67% as of January 24, 2017; median intracranial DoR was not reached/16.6 months. The most common treatment-emergent adverse events (TEAEs) were: nausea (38%/47%, A/B), diarrhea (28%/44%), cough (28%/40%), headache (30%/35%), and vomiting (36%/30%); the most common grade ≥3 TEAEs were: increased creatine phosphokinase (5%/13%), hypertension (6%/8%), pneumonia (4%/5%), and increased lipase (5%/4%). Dose reduction (9%/30%, A/B) or discontinuation (4%/11%) due to TEAEs was reported.

      Conclusion:
      In ALTA, brigatinib continues to show substantial efficacy and acceptable safety at both dose levels, with numerically longer PFS and higher intracranial ORR at the recommended dosing regimen of 180 mg qd (with lead-in) vs 90 mg qd.

      Investigator Assessment Independent Review[a]
      Arm A (n=112) Arm B (n=110) Arm A (n=112) Arm B (n=110)
      Confirmed ORR, % 46 (35–57[b]) 55 (44–66[b]) 51 (41–61[c]) 55 (45–64[c])
      Median DoR in responders,[d] months 12.0 (9.2–17.7[c]) 13.8 (10.2–17.5[c]) 13.8 (7.4–NR[c]) 14.8 (12.6–NR[c])
      Median PFS,[d] months [% of events] 9.2 (7.4–11.1[c]) [65] 15.6 (11.1–19.4[c]) [50] 9.2 (7.4–12.8[c]) [54] 16.7 (11.6–NR[c]) [41]
      Median OS,[d] months [% of events] NR (20.2–NR[c]) [38] 27.6 (27.6–NR[c]) [29]
      1-year OS probability,[d ]% 70 (61–78[c]) 80 (71–87[c])
      DoR, duration of response NR, not reached OS, overall survival PFS, progression-free survival [a]Last scan date: February 28, 2017 [b]97.5% CI for primary endpoint [c]95% CI [d]Kaplan-Meier estimate


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    OA 15 - Diagnostic Radiology, Staging and Screening for Lung Cancer II (ID 684)

    • Event: WCLC 2017
    • Type: Oral
    • Track: Radiology/Staging/Screening
    • Presentations: 1
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      OA 15.01 - Lung Cancer Screening: Participant Selection by Risk Model – the Pan-Canadian Study (ID 8466)

      14:30 - 16:15  |  Author(s): Natasha B Leighl

      • Abstract
      • Presentation
      • Slides

      Background:
      Retrospective studies indicate that selecting individuals for low dose computed tomography (LDCT) lung cancer screening based on a highly predictive risk model is superior to applying National Lung Screening Trial (NLST)-like criteria, which use only categorized age, pack-year and smoking quit-time information. The Pan-Canadian Early Detection of Lung Cancer Study (PanCan Study) was designed to prospectively evaluate whether individuals at high risk for lung cancer could be identified for screening using a risk prediction model. This paper describes the study design and results.

      Method:
      2537 individuals were recruited through 8 centers across Canada based on a ≥2% of lung cancer risk estimated by the PanCan model, a precursor to the validated PLCOm2012 model. Individuals were screened at baseline and 1 and 4 years post-baseline.

      Result:
      At a median 5.5 years of follow-up, 164 individuals (6.5%) were diagnosed with 172 lung cancers. This was a significantly greater percentage of persons diagnosed with lung cancers than was observed in the NLST(4.0%)(p<0·001). Compared to 57% observed in the NLST, 77% of lung cancers in the PanCan Study were early stage (I or II) (p<0.001) and to 25% in a comparable population, age 50-75 during 2007-2009 in Ontario, Canada’s largest province, (p<0·001).

      Conclusion:
      Enrolling high-risk individuals into a LDCT screening study or program using a highly predictive risk model, is efficient in identifying individuals who will be diagnosed with lung cancer and is compatible with a strong stage shift – identifying a high proportion at early, potentially curable stage. Funding This study was funded by the Terry Fox Research Institute and Canadian Partnership Against Cancer. ClinicalTrials.gov number, NCT00751660

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    P1.01 - Advanced NSCLC (ID 757)

    • Event: WCLC 2017
    • Type: Poster Session with Presenters Present
    • Track: Advanced NSCLC
    • Presentations: 2
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      P1.01-001 - Depth of Target Lesion Response to Brigatinib and Its Association With Outcomes in Patients With ALK+ NSCLC in the ALTA Trial (ID 8035)

      09:30 - 16:00  |  Author(s): Natasha B Leighl

      • Abstract
      • Slides

      Background:
      Depth of target lesion response to crizotinib has been associated with overall survival (OS) (J Clin Oncol 2016;34:abstract 2590). ALTA (NCT02094573) is an ongoing randomized phase 2 trial of brigatinib, an ALK inhibitor, in crizotinib-refractory advanced ALK+ NSCLC patients. As the ALTA primary endpoint of confirmed objective response rate (cORR), a binary outcome, might not fully capture clinical benefit, we examined the association of maximum decrease in target lesions with progression-free survival (PFS) and OS.

      Method:
      Patients were randomized to receive brigatinib at 90 mg qd (arm A; n=112) or 180 mg qd with a 7-day lead-in at 90 mg (arm B; n=110). Arms were pooled in this analysis. Patients with any target lesion shrinkage were sorted into 4 groups based on greatest decrease from baseline per RECIST v1.1; outcomes in these groups were compared with outcomes in patients with no shrinkage.

      Result:
      As of February 21, 2017, cORR in arm A/B (ITT population) was 46%/55% per investigators. 201/222 patients had ≥1 evaluable response assessment with 18.4-month median follow-up. Median age of these patients was 53 years; 57% were female. Patients with target lesion shrinkage (vs none) had numerically longer PFS (hazard ratios [95% CIs]: 0.61 [0.30–1.22], 1%–25% shrinkage; 0.47 [0.24–0.91], 26%–50%; 0.54 [0.28–1.05], 51%–75%; 0.30 [0.15–0.63], 76%–100%) and numerically higher estimated 1-year OS (Table). In a multivariable analysis, 76%–100% shrinkage (vs none) was independently associated with longer PFS/OS (hazard ratios [95% CIs]: 0.37 [0.18–0.76]/0.35 [0.14–0.89]); arm B (vs A) was independently associated with longer PFS.

      Conclusion:
      In this exploratory post hoc analysis, brigatinib-treated patients with target lesion shrinkage, including those without confirmed partial response, had improved PFS/OS vs patients without shrinkage. Patients with the deepest response (76%–100% shrinkage) appeared to have the longest PFS and higher estimated 1-year OS.

      Best Target Lesion Shrinkage n (%)[a] Median PFS,[b,c] Months (95% CI) Median OS,[b ]Months (95% CI) 1-year OS,[b ]% (95% CI)
      None 18 (9) 3.7 (1.9–11.0) 8.3 (4.7–NR) 48 (22–99)
      1%–25% 40 (20) 9.3 (4.0–21.2) NR (14.5–NR) 75 (58–99)
      26%–50% 60 (30) 12.8 (9.2–15.7) NR (NR–NR) 82 (70–99)
      51%–75% 44 (22) 11.1 (7.4–18.2) 27.6 (20.2–NR) 77 (62–99)
      76%–100% 39 (19) 19.5 (12.6–NR) NR (22.3–NR) 92 (78–99)
      NR, not reached [a]Evaluable patients [b]Kaplan-Meier estimate [c]Per investigator


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      P1.01-004 - Hypertension With Brigatinib: Experience in ALTA, a Randomized Phase 2 Trial in Crizotinib-Refractory ALK+ NSCLC (ID 8346)

      09:30 - 16:00  |  Author(s): Natasha B Leighl

      • Abstract
      • Slides

      Background:
      The next-generation ALK inhibitor brigatinib received accelerated approval in the United States in April 2017 for the treatment of patients with metastatic ALK+ NSCLC who have progressed on or are intolerant to crizotinib. Hypertension has been identified as an adverse event of interest with brigatinib treatment based on prior clinical data; here, we report incidence, management, and outcomes of hypertension in ALTA (NCT02094573).

      Method:
      In ALTA, 222 patients were randomized 1:1 to receive brigatinib at 90 mg qd (arm A; n=112 randomized, n=109 treated) or 180 mg qd with a 7-day lead-in at 90 mg (arm B; n=110 randomized and treated). A medical history of hypertension was allowed, but patients with significant, uncontrolled, or active cardiovascular disease were excluded. Blood pressure (BP) was measured at screening, on days 1, 8, and 15 of the first 28-day cycle, and then every 4 weeks (starting on day 1 of cycle 2).

      Result:
      Median age was 50/57 years in treated patients in A/B; 22%/25% of treated patients in A/B had a history of hypertension at baseline. As of February 21, 2017, hypertension was reported as a treatment-emergent adverse event (TEAE; any grade) in 17%/27% of patients (A/B) and as a grade 3 TEAE in 6%/8%; no grade 4 hypertension was reported. Few patients had dose interruptions (1%/2%, A/B) or reductions (1%/1%) due to hypertension; no patients discontinued brigatinib due to hypertension. Among patients with hypertension, median time to onset of first hypertension TEAE was 5.8 months/2.1 months in A/B. Among patients with baseline systolic BP <120 mmHg (n=50/n=48, A/B), 20%/42% had a maximum shift to 140–159 mmHg postbaseline (6%/10%, <120 mmHg to ≥160 mmHg); among patients with baseline diastolic BP <80 mmHg (n=68/n=72, A/B), 29%/35% had a maximum shift to 90–99 mmHg postbaseline (10%/8%, <80 mmHg to ≥100 mmHg). Among patients with hypertension TEAEs (n=19/n=30, A/B), 84%/80% started a new antihypertensive medication during the study. Among patients with hypertension TEAEs and no medical history of hypertension (n=11/n=20, A/B), 73%/70% started a new antihypertensive medication during the study. Cardiovascular events in patients with hypertension TEAEs included: angina pectoris in 1 patient without a medical history of hypertension and, in patients with a medical history of hypertension, hypertensive retinopathy (n=1), intermittent claudication (n=1), and peripheral artery stenosis (n=1).

      Conclusion:
      Hypertension was observed frequently with brigatinib, and appeared dose-related, but was managed with antihypertensive therapy and rarely led to dose modification or discontinuation.

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    P2.01 - Advanced NSCLC (ID 618)

    • Event: WCLC 2017
    • Type: Poster Session with Presenters Present
    • Track: Advanced NSCLC
    • Presentations: 2
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      P2.01-032 - A Randomized Phase Ii Trial of Selumetinib + Platinum-pemetrexed (Pem-c) in Kras Wildtype (Wt)/Unknown NSCLC: CCTG Ind219 (ID 9083)

      09:00 - 16:00  |  Author(s): Natasha B Leighl

      • Abstract
      • Slides

      Background:
      Selumetinib (SEL), an oral inhibitor of MEK 1 and 2, could be particularly effective in tumours with an activated Ras/Raf/MEK/ERK pathway, but has not been fully studied in KRAS WT nor in the first-line setting. The scheduling of SEL with chemotherapy might impact efficacy and/or toxicity.

      Method:
      IND219 is an open-label three-arm study of PEM-C±SEL. Arm A: PEM-C+SEL days 2-19; Arm B: PEM-C+SEL days 1-21; Arm C: PEM-C alone. Primary objective was response rate (ORR); secondary objectives were tolerability and progression-free survival (PFS). Pts were stratified by KRAS WT versus unknown and cisplatin versus carboplatin. Before the planned interim analysis (60 pts), pts were allocated 1:1:1 to arm A, B or C, with a plan to continue either Arm A or B plus Arm C a 3:1 ratio to ensure that the final analysis includes Arm A or B and Arm C in a 2:1 ratio. The trial would stop if neither Arm A or B had > 4 responses; if both did, the arm would be selected based on response and toxicity data. Correlative studies included genomic testing.

      Result:
      Arm A/B/C enrolled 20/21/21 pts. PEM-C exposure was lower with SEL (median cycles 5 versus 6 for Arm C). Seven pts on Arm A (35%; 95% CI 15-59% median duration 3.8m), 13 on Arm B (62%; 95% CI 38-82%; median duration 6.3m), and 5 on Arm C (24%; 95% CI 8-47%; median duration 11.6m) had PR, meeting the criteria to continue. PFS was 7.5m (95% CI 4.0 to 9.0 m) for Arm A, 6.7m (95% CI 4.1 to 8.2 m) on Arm B, and 4.0m on Arm C (95% CI 1.4 to 6.8 m). HR for PFS of Arm A over Arm C was 0.76 (95% CI 0.38 to 1.51, 2-sided p=0.42); HR for PFS of Arm B over Arm C was 0.75 (95% CI 0.37 to 1.54, p=0.43). After adjusting for age, performance status, gender and KRAS, PFS comparisons remained NS. Toxicity was most commonly grade 1-2, but more frequent with SEL especially mucositis, diarrhea, anorexia, dehydration, edema and rash. A high rate of venous thromboembolism (VTE) was seen in all arms, highest in Arm A (Arm A 45 % versus 14 % [p=0.11])

      Conclusion:
      SEL+PEM-C is associated with higher, but less durable ORR. In this small study, PFS is numerically prolonged adding SEL to PEM-C with expected additive toxicity. Further exploration of these intriguing results is ongoing.

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      P2.01-055 - Examining Metabolomics as a Prognostic Marker in Metastatic Non–Small Cell Lung Cancer Patients Undergoing First-Line Chemotherapy (ID 8685)

      09:00 - 16:00  |  Author(s): Natasha B Leighl

      • Abstract
      • Slides

      Background:
      The metabolome represents the endpoint of many cellular events; hence patients' baseline metabolomic profile may reveal specific prognostic markers of overall survival. In this study, we sought to characterize the serum metabolite signatures in patients with metastatic non-small cell lung cancer (mNSCLC) who underwent first-line therapy, using nuclear magnetic resonance (1H-NMR) spectroscopy and liquid chromatography mass spectrometry (LC-MS), and to explore their potential prognostic impact.

      Method:
      Serum samples were collected prospectively as part of a clinical trial in which patients were treated with systemic therapy including platinum-doublet chemotherapy. For each method of analysis, samples were divided into training (3/5) and validation (2/5) sets stratified by treatment received, stage (III vs. IV), and ECOG PS (0, 1, vs. ≥ 2). Exploratory analyses were performed to characterize the relationships between baseline lipid and polar levels and overall survival. Kaplan-Meier curves were used to estimate the distributions of time to event outcomes, and a Cox regression model was used to correlate marker levels while adjusting for baseline characteristics.

      Result:
      Using 1H-NMR, 16 out of 43 metabolites were significantly correlated with overall survival (OS) by univariate analysis (p < 0.025) and 4 metabolites were included in the final multivariate model. The median OS was 11.4 months in the low risk group vs. 6.6 months in the high risk group (HR=1.99, 95% C.I. 1.45 – 2.68; p<0.0001). Using LC-MS, 53 lipid species were correlated with OS by univariate analysis. Variables were then subjected to hierarchical cluster analysis resulting in 12 branches which were moderately to significantly correlated with lipid features. Principle component analysis (PCA) was performed and the first PC from each such branch was used (n=9). Using Cox regression modeling, median OS was 5.7 months vs. 11. 9 months for the low and high risk groups respectively, even after adjusting for baseline characteristics (HR: 2.23, 95% C.I. 1.55 – 3.20; p< 0.0001).

      Conclusion:
      Metabolite profiles from baseline pre-treatment serum samples have the potential to act as prognostic markers in patients with mNSCLC undergoing first-line chemotherapy. Serial metabolite measurements pre- and post-treatment may yield additional information and provide enhanced data for predicting clinical outcomes.

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    P3.01 - Advanced NSCLC (ID 621)

    • Event: WCLC 2017
    • Type: Poster Session with Presenters Present
    • Track: Advanced NSCLC
    • Presentations: 2
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      P3.01-019 - Canadian Multicentre Validation Study of Plasma Circulating Tumour DNA for Epidermal Growth Factor (EGFR) T790M Testing (ID 8878)

      09:30 - 16:00  |  Author(s): Natasha B Leighl

      • Abstract
      • Slides

      Background:
      Plasma detection of EGFR T790M mutations in circulating tumour DNA (ctDNA) of advanced lung cancer patients with acquired resistance to EGFR tyrosine kinase inhibitor (TKI) has been proposed as alternative to tumor re-biopsy. This national validation study across Canadian centres aimed to establish the sensitivity and specificity of plasma detection of T790M as a clinical test using digital droplet (dd)PCR and next generation sequencing (NGS) assays.

      Method:
      Canadian patients at 7 centres undergoing screening for ASTRIS (NCT02474355) were invited to participate in this companion blood-based study. Patients with acquired resistance to EGFR TKI consented to collection of blood samples and demographic data. Samples were analysed using ddPCR and/or NGS platforms available at 4 molecular diagnostic laboratories across Canada. Concordance between the results of plasma T790M assayed in these 4 laboratories with reference tissue/plasma testing conducted for ASTRIS was assessed.

      Result:
      63 patients participated; the median age was 64 years (range 31-87), 69%(40/58) were Asian; 55%(33/60) were male. All patients received prior EGFR TKI, 17%(10/60) also received prior chemotherapy. Reference testing for EGFR T790M for ASTRIS eligibility identified positive T790M(+) results for 31(49%), negative(-) for 30(48%) and indeterminate(i) results for 2(3%) patients. One laboratory tested all 63 patient samples using both ddPCR and NGS (Oncomine Lung cfDNA assay), another laboratory tested 18 samples using ddPCR and NextSeq, a third tested 10 samples using ddPCR and COBAS EGFRv2, and a fourth tested 6 samples using Ion Torrent PGM. A total of 188 tests were performed including 91 by ddPCR, 87 NGS and 10 COBAS assays. Combining test results for each patient, 60%(38/63) of patient plasma samples were T790M+, 23(37%) were T790M-, and 2(3%) were inconclusive. Of 31 patients with reference T790M+ results from ASTRIS, 23(74%) had T790M detected in plasma, 6(19%) did not (T790M-), and 2(7%) had indeterminate (T790Mi) plasma results. For 30 patients with T790M- reference results from ASTRIS, 13(43%) had plasma T790M+ and 17 plasma T790M- results. The 2 patients with T790Mi by reference testing both had T790M+ results from plasma. Altogether, 47%(15/32) of patients deemed to have T790M-/i tumours by reference testing were found to have T790M+ results by plasma in this multicentre study. Combining results from both tissue and plasma testing, 73%(46/63) of study patients had T790M+ results.

      Conclusion:
      Plasma ctDNA testing in this multicentre Canadian study identified a significant number of additional patients eligible for osimertinib therapy beyond routine biopsy tissue testing for EGFR T790M.

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      P3.01-062 - The Perceived Value of Avoiding Biopsy: Patients' Willingness to Pay for Circulating Tumour DNA T790M Testing (ID 10004)

      09:30 - 16:00  |  Author(s): Natasha B Leighl

      • Abstract
      • Slides

      Background:
      Plasma detection of circulating tumour DNA (ctDNA) with T790M mutation in the context of EGFR tyrosine kinase resistance has been shown to have high concordance with tissue biopsy specimens. In a public healthcare system, patients’ perceived value of a test and willingness to pay can inform policy decisions regarding implementation and funding of a novel technology.

      Method:
      As part of screening for the ASTRIS clinical trial (NCT02474355), Canadian patients were invited to participate in a national validation study of blood-based ctDNA T790M testing. Eligible patients had acquired resistance to EGFR TKI and consented to collection of blood samples, demographic data, and completion of a structured interview measuring their perceived value of blood-based ctDNA testing as an alternative to tumour biopsy. They were asked about their willingness to pay for testing using both open-ended and iterative bidding approaches. The study was supported by a grant from AstraZeneca.

      Result:
      60 patients were accrued to the study. Median age of the cohort is 64 years (range 31-87); 69% are Asian (40/58); 55% (33/60) are male. All patients had received prior EGFR kinase inhibitor treatment, with 67% (45/60) receiving gefitinib. 17% of patients also received chemotherapy (10/60). A median of 1 prior line of therapy had been received (range 1-6). All patients preferred to have the blood test over repeat tumour biopsy. Patients estimated a mean reasonable price to pay for the test of $954; median $300 (range 0-10,000; IQR 150-800). Patients were personally willing to pay a mean of $281; median $100 (range 0-2500; IQR 33-350).

      Conclusion:
      In a public health system that covers the cost of standard diagnostic tests, Canadian patients indicated a willingness to pay out of pocket for peripheral blood detection of ctT790M. Patients have high perceived value of ctDNA and prefer it to tumor biopsy.

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    P3.09 - Mesothelioma (ID 725)

    • Event: WCLC 2017
    • Type: Poster Session with Presenters Present
    • Track: Mesothelioma
    • Presentations: 1
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      P3.09-007 - Thoracic Asymmetry and Its Impact on Survival after Radiation and Surgery for Malignant Pleural Mesothelioma (ID 9086)

      09:30 - 16:00  |  Author(s): Natasha B Leighl

      • Abstract
      • Slides

      Background:
      Staging for malignant pleural mesothelioma (MPM) remains a challenge due to poor prognostic utility. Other clinical factors may improve and refine the staging system. We investigate the impact thoracic asymmetry at time of initial presentation prior to therapy on survival in MPM patients treated with multimodal therapy.

      Method:
      We reviewed 93 consecutive treatment naïve MPM patients treated with Surgery for Mesothelioma after Radiation Therapy (SMART protocol) from Sep 2008 to Jul 2015. The right and left axial thoracic areas (defined as the product of the ant-post and med-lat extent of hemithoraces at the level of carina) were used to calculate the asymmetric thoracic ratio (ATR, where 1 is more symmetric, Figure 1). Significant factors were determined using univariate (log rank), multivariate (Cox proportional hazards) as well as recursive partition analysis (RPA). Continuous variables were discretized into binary categories split by its median value.

      Result:
      After a median follow-up of 15.6 months, 63 (68%) patients recurred, 56 (60%) died. The median ATR was 0.85, ranging from 0.52 to 1.00. On univariate analysis, histology (p=0.003 and 0.0002), gross tumour volume (GTV, p=0.004 and 0.001), and ATR (p=0.00001 and 0.0000002) all significantly impacted both overall and disease free survival, respectively, while mediastinal nodal involvement (p=0.03) was significantly associated with DFS only. On multivariate analysis, histology (p=0.01 and 0.005) and GTV (p=0.02 and 0.016) significantly impacted both overall and disease free survival, respectively. ATR significantly impacted disease free survival (p=0.02, HR=0.06 95% CI 0.02-0.20) and was suggestive of a trend for overall survival (p=0.07). On RPA, ATR<0.848 was significantly (p<0.001) associated with poorer DFS.

      Conclusion:
      A low asymmetric ratio (ATR<0.848) is significantly associated with poorer outcomes, specifically disease free survival, and is independent of histology and tumor volume. Further study is needed to validate this parameter.

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    PL 04 - Closing Plenary: Where We Are Now, and Where We Will Be in 10 Years (ID 587)

    • Event: WCLC 2017
    • Type: Plenary Session
    • Track:
    • Presentations: 1
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      PL 04.04 - WCLC 2018 - Welcome to Toronto (ID 7844)

      16:30 - 17:45  |  Presenting Author(s): Natasha B Leighl

      • Abstract
      • Presentation
      • Slides

      Abstract not provided

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