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  • WCLC 2018

    19th World Conference on Lung Cancer

    Access to all presentations that occur during the 19th World Conference on Lung Cancer in Toronto, ON

    Presentation Date(s):
    • Sept 23 - 26, 2018
    • Total Presentations: 2384

    To review abstracts of the presentations below, narrow down your search by using the Filter options below, and then select the session listing of your choice. Click the "+" for a presentation to expand & view the corresponding Abstract details.

    Presentations will be available 24 hours after their live presentation time

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    MTE03 - Clinical Trial Design With Novel Lung Cancer Therapy (Ticketed Session) (ID 813)

    • Type: Meet the Expert Session
    • Track: Targeted Therapy
    • Presentations: 2
    • Now Available
    • Moderators:
    • Coordinates: 9/24/2018, 07:00 - 08:00, Room 105
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      MTE03.01 - Inclusion/Exclusion Updates (CNS Mets, Multiple Prior Cancers, Organ Dysfunction) (Now Available) (ID 11550)

      07:00 - 07:30  |  Presenting Author(s): Peter Michael Ellis

      • Abstract
      • Presentation
      • Slides

      Abstract

      Introduction

      Randomized clinical trials (RCTs) represent the gold standard trial design for the evaluation of treatment interventions. Advancing knowledge in oncology has relied heavily on data from high quality RCTs focusing on important outcomes such as overall survival (OS) and more recently progression free survival (PFS). Many examples exist, even in recent times, where the use of alternate study designs, such as cohort and case control series, have concluded benefit for a therapy that was subsequently disproven by RCTs. Nevertheless, an increasing number of therapies are being approved by licensing authorities such as the FDA, based on intermediate outcomes such as objective response rate (ORR) from phase II clinical trials.

      Pragmatic versus explanatory trials

      RCTs can be either explanatory or pragmatic. Explanatory trials evaluate a treatment intervention under ideal conditions. They tend to have more restrictive inclusion and exclusion criteria to minimize the potential for confounding due to coexistent health problems. Pragmatic trials, on the other hand, evaluate treatment interventions in real life practice conditions. Inclusion and exclusion criteria are generally less restrictive and the results are considered more generalizable to the broad population of people with the underlying condition.

      RCTs in oncology are often explanatory in design. Inclusion criteria generally limit eligibility to the highest functioning patients. They often specify the type of diagnostic material needed and require samples to be available for correlative studies. Trials are generally very restrictive in regard to prior therapy that patients may have received and most trials require normal, or near normal organ function for eligibility. Exclusion criteria contain lengthy lists of criteria that make patients ineligible. Many trials exclude patients with brain metastases unless they have been treated and stable for some time. There are often lengthy lists of coexistent health problems, such as cardiac disorders, that commonly coexist in patients with lung cancer, that make an individual ineligible. The end result is that the generalizability of many RCTs is limited and healthcare providers need to extrapolate trial findings to a large proportion of their patients who might not have met inclusion and exclusion criteria for the trial generating the evidence of efficacy.

      Why should we rethink our current approach

      Historically, most advances from RCTs in lung cancer have represented small incremental gains in OS or PFS. Under these conditions, dependence on explanatory trials with multiple inclusion and exclusion criteria may well have been appropriate to minimize the confounding effects from intercurrent problems. However, many changes have taken place in therapeutic options for lung cancer patients over the last decade. Our understanding of underlying molecular abnormalities important in lung cancer development and growth has increased greatly. Multiple agents targeting underlying molecular abnormalities have demonstrated ORR almost twice that of conventional chemotherapeutic agents, with similarly impressive improvements in PFS. Additionally, many newer agents have been developed that cross the blood brain barrier and have demonstrated significant anti-tumor activity in patients with CNS metastases as well. Given the improved tolerability of these agents and increased expectation of benefit from therapy, less stringent inclusion and exclusion criteria should be considered. Trials of targeted therapies should include a broader spectrum of patients including those with lower performance status and untreated CNS disease. Criteria focusing on organ function should be limited to known toxicity concerns for the therapy under evaluation.

      The emergence of treatments targeting activation of the immune system also represents a significant therapeutic advance. Some trials evaluating immune checkpoint inhibitors have been very restrictive for patients with CNS metastases. Nevertheless, responses are seen in patients with CNS metastases, questioning the need for such restrictive exclusion criteria. Patients with underlying autoimmune disorders are excluded from the majority of trials of immunotherapy agents. Some emerging data exists though suggesting that these agents may be safely given to patients with underlying autoimmune diseases. These findings highlight the need to modify inclusion and exclusion criteria for trials of immunotherapy agents to gain information of safety and efficacy in these populations of patients and to increase the generalizability of trial findings.

      Conclusions

      The advancement of knowledge in oncology remains dependent on well conducted RCTs. However, we need to question the rigidity of a number of common inclusion and exclusion criteria in an attempt to improve the pragmatic aspect of many trials and increase the generalizability of current RCTs.

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      MTE03.02 - Novel Trial Design for Precision Medicine (Now Available) (ID 11551)

      07:30 - 08:00  |  Presenting Author(s): Fiona Blackhall

      • Abstract
      • Presentation
      • Slides

      Abstract

      Trial design for precision medicines has shifted to increasing use of platform protocols, ‘liquid’ biopsy and the practice of co-clinical trials using patient or circulating tumour cell derived (PDX/CDX) models. Epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors were the first class of precision medicine approved for advanced non-small cell lung cancer (NSCLC) but initially for unselected patients following the traditional convention of phase I evaluation in heavily pretreated populations, phase II evaluation also in pretreated, ‘all comers’, and then in large, randomised, phase III, double blind, placebo controlled studies versus best supportive care. The linkage between sensitising EGFR mutations and their prediction for efficacy came later. It now seems remarkable that these agents made it through to standard of care and is questionable whether they would have been approved for all comers in the current health economic climate. The ‘EGFR story’ catalysed the current goal to integrate drug-target linkage early in clinical development. This was achieved for the first in class ALK inhibitor, crizotinib, initially developed as a MET inhibitor but on discovery of ALK gene fusion and its potency for ALK a strategy to enrich for patients with tumours positive for ALK gene fusion by fluorescent in situ hybridisation (FISH) ensued. The phase I trial (PROFILE 1001) led to accelerated approval within 4 years on the basis of response rate, setting the paradigm of ‘enrichment’ studies for precision medicine development. (2) In parallel, platform studies using ‘umbrella’ or ‘basket’ protocol designs emerged to screen prospectively for multiple targets simultaneously and enrol the patient to a study arm designed for the target/biomarker(s) present. The first of these studies to be conducted in lung cancer was the BATTLE (Biomarker-integrated Approaches of Targeted Therapy for Lung Cancer Elimination) trial (3) and subsequent examples ongoing are the Lung Master Protocol (Lung-MAP)-A Biomarker-Driven Protocol for Accelerating Development of Therapies for Squamous Cell Lung Cancer: SWOG S1400 (4) and the National Lung Matrix Trial in the UK (5). Obvious strengths for umbrella studies are a single protocol, screening for a panel of molecular alterations simultaneously and flexibility to add new study arms (and testing modalities) but criticisms include a high attrition rate both due to sample inadequacy for molecular testing and lack of a study arm for the biomarker(s) identified. Regardless of the study design, translational science to rigorously evaluate serial predictive biomarkers of response and resistance is crucial and in this regard new technologies for liquid biopsy are proving transformational, overcoming the reliance on tissue biopsy that can be a barrier to participation in trials (6), and in the resistance setting may not be representative due to evolution and heterogeneity. Of note the 3rd generation EGFR-TKI, osimertinib, designed to target the EGFR T790M resistance mutation, was developed in trials that included serial tissue and ‘liquid’ biopsy for analysis of plasma circulating tumor DNA (ctDNA). While the application of ‘liquid biopsy’ proved the clinical utility of this approach and is now a standard of care (7), the high response rate rendered the second biopsy on treatment uninformative in many patients (8). A further use of tissue and liquid biopsy in precision medicine trials that is likely to increase is the practice of so-called ‘co-clinical trials’. This involves obtaining a fresh tumour biopsy and/or a circulating tumour cell sample from blood to establish as a xenograft mouse model from a patient at study entry and again on progression. The resultant patient derived or CTC derived explant model (PDX or CDX) is used to identify molecular mechanisms and candidate predictive biomarkers for subsequent clinical validation and is particularly applicable to trials for patients with small cell lung cancer (SCLC) (9,10). Although traditional, all comer, early phase study designs may soon be obsolete new designs of precision medicine trials will only be as effective as the enrichment strategy, scientific rationale and pharmacology underpinning them. To this end ‘team science’ approaches with close collaboration between academia and pharma will be essential for the golden age of precision medicines to be fully realised for lung cancer.

      (1) Tan DSW et al. The International Association for the Study of Lung Cancer Consensus Statement on Optimizing Management of EGFR Mutation–Positive Non–Small Cell Lung Cancer: Status in 2016. JTO 2016 Vol 11, Issue 7, Pages 946–963

      (2) Blackhall F and Cappuzzo F. Crizotinib: from discovery to accelerated development to front-line treatment. Ann Oncol. 2016 Sep;27 Suppl 3:iii35-iii41.

      (3) Kim ES et al. The BATTLE trial: personalizing therapy for lung cancer. Cancer Discov. 2011 Jun;1(1):44-53.

      (4) Herbst RS et al. Lung Master Protocol (Lung-MAP)-A Biomarker-Driven Protocol for Accelerating Development of Therapies for Squamous Cell Lung Cancer: SWOG S1400. Clin Cancer Res. 2015 Apr 1;21(7):1514-24.

      (5) Middleton G et al. The National Lung Matrix Trial: translating the biology of stratification in advanced non-small-cell lung cancer. Ann Oncol. 2015 Dec;26(12):2464-9.

      (6) Lim C et al. Patients with Advanced Non-Small Cell Lung Cancer: Are Research Biopsies a Barrier to Participation in Clinical Trials? J Thorac Oncol. 2016 Jan;11(1):79-84.

      (7) Oxnard GR et al. Association Between Plasma Genotyping and Outcomes of Treatment With Osimertinib (AZD9291) in Advanced Non-Small-Cell Lung Cancer.

      J Clin Oncol. 2016 Oct 1;34(28):3375-82.

      (8) Thress KS et al. Modulation of Biomarker Expression by Osimertinib: Results of the Paired Tumor Biopsy Cohorts of the AURA Phase I Trial. J Thorac Oncol. 2017 Oct;12(10):1588-1594.

      (9) Lallo A et al. Circulating tumor cells and CDX models as a tool for preclinical drug development. Transl Lung Cancer Res. 2017 Aug;6(4):397-408.

      (10) Drapkin BJ et al. Genomic and Functional Fidelity of Small Cell Lung Cancer Patient-Derived Xenografts. Cancer Discov. 2018 May;8(5):600-615.

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

    • 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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    MTE05 - Role of Pneumonectomy in N2 Disease (Ticketed Session) (ID 815)

    • Type: Meet the Expert Session
    • Track: Treatment of Locoregional Disease - NSCLC
    • Presentations: 1
    • Now Available
    • Moderators:
    • Coordinates: 9/24/2018, 07:00 - 08:00, Room 202 BD
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      MTE05.01 - Role of Pneumonectomy in N2 Disease (Now Available) (ID 11554)

      07:00 - 07:30  |  Presenting Author(s): Jessica Donington

      • Abstract
      • Presentation
      • Slides

      Abstract

      Stage III non-small cell lung cancer (NSCLC) presents a significant treatment challenge. Patients are treated with curative intent, but only 20-30% achieve that goal, and acceptable treatment plans vary dramatically. Chemotherapy-based multimodality is the standard of care, but the ideal local therapy is unclear. Definitive concurrent chemo-radiotherapy without surgery is accepted by many as the treatment of choice, but local relapse is the first site of failure in up to >30%. Therefore, adding surgery to improve outcomes is attractive.

      Lung resection following induction chemo-radiotherapy to 45 Gy has been prospectively shown to be safe in numerous clinical trials. The use of pneumonectomy after induction therapy has been far more controversial. Multiple single institution series report on the safety of pneumonectomy following induction chemo-radiotherapy, even to doses of 60Gy, but results from multi-institutional prospective trials have not been as good, with reported peri-operative mortality up to 20-25%.

      The Intergroup trial 0139 was designed to evaluate the utility of adding surgery to chemo-radiotherapy for the treatment for N2+ IIIA NSCLC. The primary endpoint was improved overall survival, but was not met despite a significant improvement in progression-free survival. Some of this discrepancy was due to a high number of patients undergoing pneumonectomy and excessive mortality following pneumonectomy. Some of this was felt to be attributed to lack of surgical expertise both for pre-operative and intra-operative decisions.

      A recent evaluation of two prospective RTOG trials (0229 and 0839) which evaluated full-dose induction chemo-radiotherapy to 60 Gy followed by resection, reported increased peri-operative mortality (19%) with extended resections (pneumonectomy or bilobectomy). Results were complicated by the use of an EGFR antibody in the induction therapy, since 60% of grade 5 Adverse Events occurred in those who received both the EGFR antibody in addition to an extended resection.

      It is important to note that two large European prospective trials concentrated at experience surgical centers, reported excellent peri-operative outcomes with no increase in surgical mortality with use of pneumonectomy after induction chemo-radiotherapy.

      Stage IIIA NSCLC is a heterogeneous cohort of patients and treatment decisions need to be tailored to the individual patient and tumor. A pneumonectomy required for a large or central tumor with small volume nodal disease is distinct from tumors with bulky or infiltrative mediastinal nodes that require a pneumonectomy both in terms of short and long-term outcomes. Similarly outcomes vary by laterality, with mortality nearly twice as high for those on the right. While pneumonectomy needs to be used judiciously in this setting, eliminating it from all treatment decisions reduces the ability to achieve local control and long-term cure in a significant population.

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      MTE05.02 - Role of Pneumonectomy in N2 Disease (ID 11555)

      07:30 - 08:00  |  Presenting Author(s): Paula Ugalde

      • Abstract

      Abstract

      The therapeutic management of stage IIIA-N2 non-small cell lung cancer (NSCLC), which represents a locally advanced disease with ipsilateral mediastinal lymph node involvement, remains controversial despite the results of several randomized controlled trials [1-2]. By definition, stage IIIA-N2 represents a very heterogeneous population ranging from incidental discovery of N2 disease during surgery, through single mediastinal nodal involvement to bulky N2 disease where individual lymph nodes are difficult to identify and resect. Thus, treatment algorithms are controversial and guidelines are ambiguous.

      Patients with proven or suspected clinical stage IIIA-N2 NSCLC, are staged with contrast chest computed tomography (CT), integrated positron emission tomography – computed tomography (PET-CT) and brain magnetic resonance imaging (MRI) or CT. Additionally, before any treatment, histological proof of nodal involvement should be obtained either by a minimally invasive (EBUS) or invasive technique (mediastinoscopy). This is justified by the relatively high rate of false positive nodes [3] and also for complete mediastinal staging which includes the number of positive stations and the type of nodal infiltration. Proper lung cancer staging allows precise oncological treatment.

      When N2 disease is detected during surgery, in an entirely staged patient, this is referred as incidental, unsuspected or “surprise” N2 [4]. Here, if complete oncological resection can be achieved through lobectomy or pneumonectomy, the surgeon should proceed with the procedure. Adjuvant chemotherapy prolongs survival and is currently recommended in this setting. Major controversy occurs when N2 disease is confirmed either by staging EBUS or mediastinoscopy. A properly staged mediastinum has biopsies of stations 4R, 7 and 4L. Due to the absence of internationally accepted definition, the term “potentially resectable N2” is usually applied when mediastinal involvement is limited and surgery can potentially offer R0 resection.

      According to guidelines, patients in this sub-group should be treated by definitive concurrent chemo-radiotherapy or neoadjuvant therapy followed by surgery or definitive radiotherapy. In the recently published Swiss Cancer League trial, no significant difference was found when comparing those two strategies [5]. Specific controversy exists regarding the role of surgery versus radiotherapy and the acceptable extent of resection post-induction therapy.

      The Intergroup trial [6], a randomized study published in 2009 and comparing neoadjuvant chemoradiotherapy plus surgery to chemoradiotherapy alone, issued caution regarding pneumonectomy in the context of multimodality therapy. This was largely due to inexplicable surgical results in this series, which demonstrated morbidity and mortality higher than published averages (26%). Yet pneumonectomy continues to be advocated in this setting by high volume centers that achieve superior surgical morbidity and mortality [7-10]. A systematic review of pneumonectomy followed by neoadjuvant therapy was published in 2012 [11]. The report included 27 studies from 1990–2010, and included 4 randomized controlled studies, including the Intergroup trial. Mortality at 30 days was 7% and at 90 days was 12%, suggesting traditional reporting of 30-day mortality may not be the ideal marker of perioperative mortality for pneumonectomy patients. The ideal treatment for patients with locally advanced NSCLC, who require pneumonectomy for resection, remains controversial.

      Reference:

      1. Eberhardt WE, De Ruysscher D, Weder W, Le Péchoux C, De Leyn P, Hoffmann H et al. 2nd ESMO Consensus Conference in Lung Cancer: locally advanced stage III non-small-cell lung cancer. Ann Oncol 2015; 26:1573-88.

      2. Eberhardt WE, Pöttgen C, Gauler TC, Friedel G, Veit S, Heinrich V et al. Phase III study of surgery versus definitive concurrent chemoradiotherapy boost in patients with resectable stage IIIA-N2 and selected IIIB non-small-cell lung cancer after induction chemotherapy and concurrent chemoradiotherapy (ESPATUE). J Clin Oncol 2015; 33:4194-201.

      3. De Leyn P, Dooms C, Kuzdzal J, Lardinois D, Passlick B, Rami-Porta R et al. Revised ESTS guidelines for preoperative mediastinal lymph node staging for non-small-cell lung cancer. Eur J Cardiothorac Surg 2014; 45:787-98.

      4. Van Schil P. Stage IIIA-N2 non-small-cell lung cancer: from “surprise” involvement to surgical nightmare. Eur J Cardiothorac Surg 2016; 49:1613-4.

      5. Pless M, Stupp R, Ris HB, Stahel RA, Weder W, Thierstein S et al. Induction chemo-radiotherapy in stage IIIA/N2 non-small cell lung cancer: a phase 3 randomised trial. Lancet 2015; 386(9998):1049-56.

      6. Albain KS, Swann RS, Rusch VW, et al. Radiotherapy plus chemotherapy with or without surgical resection for stage III non-small-cell lung cancer: a phase III randomised controlled trial. Lancet 2009;374:379-86.

      7. Kim AW, Faber LP, Warren WH, et al. Pneumonectomy after chemoradiation therapy for non-small cell lung cancer: does "side" really matter? Ann Thorac Surg 2009;88:937-43; discussion 944.

      8. Weder W, Collaud S, Eberhardt WE, et al. Pneumonectomy is a valuable treatment option after neoadjuvant therapy for stage III non-small-cell lung cancer. J Thorac Cardiovasc Surg 2010;139:1424-30.

      9. Krasna MJ, Gamliel Z, Burrows WM, et al. Pneumonectomy for lung cancer after preoperative concurrent chemotherapy and high-dose radiation. Ann Thorac Surg 2010;89:200-6; discussion 206.

      10. Cerfolio RJ, Bryant AS, Jones VL, et al. Pulmonary resection after concurrent chemotherapy and high dose (60Gy) radiation for non-small cell lung cancer is safe and may provide increased survival. Eur J Cardiothorac Surg 2009;35:718-23; discussion 723.

      11. Kim AW, Boffa DJ, Wang Z, et al. An analysis, systematic review, and meta-analysis of the perioperative mortality after neoadjuvant therapy and pneumonectomy for non-small cell lung cancer. J Thorac Cardiovasc Surg 2012;143:55-63.

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    MTE06 - Symptom Management in Mesothelioma (Ticketed Session) (ID 816)

    • Type: Meet the Expert Session
    • Track: Mesothelioma
    • Presentations: 2
    • Now Available
    • Moderators:
    • Coordinates: 9/24/2018, 07:00 - 08:00, Room 206 BD
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      MTE06.01 - Role of Pleurectomy in Palliation of Symptoms (Now Available) (ID 11556)

      07:00 - 07:30  |  Presenting Author(s): John G Edwards

      • Abstract
      • Presentation
      • Slides

      Abstract not provided

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      MTE06.02 - How to Register Toxicity and Guide Patients (Now Available) (ID 11557)

      07:30 - 08:00  |  Presenting Author(s): Liz Darlison

      • Abstract
      • Presentation
      • Slides

      Abstract

      There are 125 million people exposed to asbestos in the workplace and it causes over 100,000 deaths annually (IOSH 2018). The UK has the highest incidence of Malignant Mesothelioma in the world with 2697 cases in 2015 (CRUK 2018).

      Approved treatment in the UK has not changed for over a decade with Pemetrexed and Cisplatin being the only standard treatment widely available. However the last 2 years has seen an increase in clinical trial opportunities using both targeted and immunotherapy drugs. To help promote equitable access, Mesothelioma UK publishes a regular clinical trials update listing all trials that are open to recruitment (Mesothelioma UK 2018).

      These new treatment options have brought with them new challenges in terms of patient expectation, accessing treatment and side effects.McCambridge et al (2018) describe 2017 as a year characterised by several important advances in the field although only a minority are considered practice changing. This results in patients feeling anxious about the ongoing limited treatment options and frustrated by difficulties experienced in trying to access new treatment modalities.

      This presentation will briefly review current treatment options in the UK and how patients and health care professionals are kept informed about treatment and trial opportunities. Approaches to managing treatment expectation are explored and finally how health care professionals and patients are educated about side effects from new treatment modalities in and out of clinical trials.

      References

      IOSH 2018 (Institute of Occupational Safety and Health) No Time to Lose Campaign https://www.iosh.co.uk/VP/Home/Toolkit/IOSH-No-Time-to-Lose-Campaign.aspx (Last viewed June 18th 2018)

      CRUK 2018 (Cancer Research UK) Mesothelioma Incidence Statistics https://www.cancerresearchuk.org/health-professional/cancer-statistics/statistics-by-cancer-type/mesothelioma/incidence (Last viewed June 28th 2018)

      Mesothelioma UK 2018 Clinical Trials http://www.mesothelioma.uk.com/information-support/information/clinical-trials/ (Last viewed July 4th 2018)

      McCambridge AJ, Napolitano A, Mansfield AS, Fennell DA, Sekido Y, Nowak AK, Reungwetwattana T, Mao W, Pass HI, Carbone M, Yang H, Peikert T, 2018. Progress in the Management of Malignant Pleural Mesothelioma in 2017. Journal of Thoracic Oncology Vol 13 No 5 606-623.

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    MTE07 - Management of Pleural Recurrence (Ticketed Session) (ID 817)

    • Type: Meet the Expert Session
    • Track: Thymoma/Other Thoracic Malignancies
    • Presentations: 2
    • Now Available
    • Moderators:
    • Coordinates: 9/24/2018, 07:00 - 08:00, Room 201 F
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      MTE07.02 - From Surgical Perspective (Now Available) (ID 11559)

      07:00 - 07:30  |  Presenting Author(s): Robert J Korst

      • Abstract
      • Presentation
      • Slides

      Abstract

      The pleural space represents the most common location for recurrence following resection of thymic epithelial tumors (TET). The rationale to include surgical resection in the management plan for these patients is based on small case series and reports, many of which demonstrate long periods of survival following pleural metastasectomy. Two large, retrospective series of patients with pleural disease have been recently published, both of which reflect pooled data from multiple institutions; one from Europe and the other from Japan1,2. Despite this, little prospective data address this issue. In addition, the management strategy for pleural disease in patients with TET is extrapolated from the management of primary TET in the mediastinum, where surgical resection plays an important role.

      Prognostic factors after surgical resection for pleural disease mirror those that are most consistently reported for primary mediastinal TET. Most case series of patients undergoing resection for pleural disease (either recurrence or initial presentation) suggest that the ability to completely resect the disease is an important prognostic factor. Indeed, both of the aforementioned larger series confirm that complete resection is associated with enhanced survival1,2. The Japanese report of 136 cases of pleural dissemination of thymoma at initial presentation (not recurrence) also determined that lower disease burden in the pleural space positively affects survival2. Although the large European Society of Thoracic Surgery (ESTS) Thymic Working Group Project (152 patients with either pleural recurrence and pleural disease at initial presentation) did not report disease burden, it confirmed the importance of complete resection in maximizing survival1. This later study also determined that thymic carcinoma patients experienced significantly shorter survival after resection of pleural disease than patients with thymoma. Thymic carcinoma, pleural disease burden and the ability to perform a complete resection can all be considered surrogates for individual tumor biology, which may be the most important underlying prognostic factor.

      Surgical approaches for patients with TET that has spread to the pleural space include metastasectomy and extrapleural pneumonectomy (EPP). The surgeon’s goal is the complete gross resection of disease, which is dependent on the burden and location of disease. In cases of pleural recurrence, the surgical approach is typically through a lateral thoracotomy since this incision provides the best exposure of the entire pleural space and the mediastinal tumor has already been resected at an earlier time. More recently, video assisted thoracic surgery (VATS) approaches have been used selectively to approach these patients depending on the expertise of the operator. The surgeon wishes to perform the least amount of resection possible while still rendering the patient grossly disease free. Metastasectomy may range from the resection of a single pleural lesion to an extensive parietal pleurectomy with or without pulmonary resection(s) for visceral pleural involvement of metastatic deposits. On occasion, the surgeon may explore the chest of a patient with the intent of performing metastasectomy, but instead encounters diffuse innumerable visceral and parietal pleural metastatic deposits. In this case, EPP may be the only option to render the patient grossly disease free. The surgeon should always be prepared for this development whenever operating on a patient for metastatic TET, so that an educated decision can be made to proceed with EPP at the time of exploration, if necessary. EPP, however, may not be a good option for patients with thymic carcinoma that has metastasized to the pleural space given the magnitude of this approach combined with the significantly worse survival after resection in patients with metastatic pleural disease, when compared to thymoma.

      Pleural treatments used as an adjunct at the time of surgical resection for patients with pleural metastases from TET are becoming more popular. Heated intrapleural chemotherapy (HIPC) represents the most commonly used modality in this regard. After resecting all gross disease, the surgeon perfuses the hemithorax with heated chemotherapy for a period of time ranging from one to two hours. This strategy has been demonstrated to be safe with an acceptable complication rate in several small case series of patients with TET3. Although survival rates appear to be encouraging, definitive data demonstrating a survival benefit to HIPC are lacking. Intrathoracic photodynamic therapy (PDT) has also recently been reported for patients with TET that has metastasized to the pleural space4.

      Although the use of neoadjuvant chemotherapy has been reported in several case series of patients with pleural metastases at the time of initial presentation5, data are lacking specifically in the scenario of pleural recurrence. The rationale for this approach mimics that for locally advanced TET in the mediastinum – to reduce the disease burden in hopes of increasing the likelihood of complete resection. Once again, this strategy appears to be safe and associated with encouraging rates of complete resection and survival, but definitive data confirming a benefit are lacking.

      In summary, the surgical resection of pleural recurrence of TET is associated with prolonged survival in selected patients, as reported in many case series. However, given the lack of controlled studies, it is unclear if prolonged survival is a direct result of the surgical approach or simply selection of patients with more forgiving tumor biology. Despite this, a rational approach may be to invoke a surgical approach as the initial strategy in patients with thymoma whose disease appears to be resectable. Once surgical options have been exhausted, or the disease is clearly unresectable, systemic therapy and/or radiotherapy can be utilized to achieve further disease control.

      References:

      1. Moser B, et al. Surgical therapy of thymic tumours with pleural involvement: an ESTS Thymic Working Group project. Eur J Cardiothorac Surg 2017;52:346-55.

      2. Okuda K, et al. Thymoma patients with pleural dissemination: Nationwide retrospective study of 136 cases in Japan. Ann Thorac Surg 2014;97;1743-9.

      3. Maury J-M, et al. Intra-thoracic chemo-hyperthermia for pleural recurrence of thymomas. J Thorac Dis 2017;9:E1137-9.

      4. Chen K-C, et al. Pleural photodynamic therapy and surgery in lung cancer and thymoma patients with pleural spread. PLOS one 2015;10:e0133230.

      5. Shapiro M, et al. Surgical Approaches for stage IVa thymic epithelial tumors. Front Oncol 2014;3:332.

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      MTE07.01 - From Radiation Oncology Perspective (Now Available) (ID 11558)

      07:30 - 08:00  |  Presenting Author(s): Andreas Rimner

      • Abstract
      • Presentation
      • Slides

      Abstract

      Radiation therapy (RT) plays an important role in the multimodality management of thymic malignancies and is an effective local treatment modality with the goal of reducing the risk of local recurrence. It can be employed in the neoadjuvant, adjuvant, definitive or palliative setting. It is important to evaluate the role of RT for pleural recurrence in the context of surgery and systemic treatment options as part of a multimodality approach and carefully coordinate the three modalities for optimal outcomes. Studies on the specific role of RT in pleural recurrences are sparse. However, there are several recent large database and population-based studies that indicate which patient subsets may benefit the most from RT.

      The indication and clinical setting for RT (perioperative versus definitive RT) depends on surgical resectability and operability of the patient. The adjuvant setting is the most extensively studied setting for RT in thymic malignancies. The greatest benefit of adjuvant RT appears to be in patients with newly diagnosed locally advanced stage III and IV thymomas, including patients with pleural dissemination.1-4 For thymic carcinomas the impact of adjuvant RT appears more significant.5-7 For incompletely resected thymic tumors there is a stronger rationale for adjuvant RT based on emerging data and general oncologic principles. The principles of adjuvant RT may be applied to surgically resected pleural recurrences as well.

      A range of modern radiation therapy techniques is available to aid the radiation oncologist in optimally targeting the tumor bed, while maximally reducing the radiation dose to surrounding organs at risk.8,9 The radiation technique should be uniquely tailored to the needs of each individual patient’s presentation. Techniques include 3D conformal radiation therapy, intensity-modulated radiation therapy, proton therapy and intraoperative radiation therapy using high dose rate brachytherapy or low dose rate seed implantation. The extent of the radiation treatment field will depend on the intraoperative findings, pathologic results, proximity to and dosimetric assessment of critical organs at risk. This may vary from treatment of a small tumor bed of a single pleural metastasis to hemithoracic pleural RT following an extrapleural pneumonectomy or lung-sparing pleurectomy/decortication in select cases.

      For inoperable or unresectable patients definitive RT is an excellent treatment option. A subset of patients is technically or medically inoperable, due to invasion of critical structures such as the heart, great vessels, spine, esophagus etc. or comorbidities. In general, thymic malignancies are radiosensitive, allowing for long-term local control rates, even when treated with definitive RT in the absence of surgery. Stereotactic ablative RT may be used for oligometastatic disease as an alternative to surgical resection and has been shown to be a highly effective treatment modality with >90% long-term local control rates and minimal morbidity in multiple histologies of intrathoracic metastases, including thymic tumors.10

      Lastly, palliative RT should be considered whenever surgical management or definitive radiation treatment options are not feasible. Conventional palliative RT is an important modality to improve quality of life by alleviating pain, treating SVC syndrome, airway compression and other symptoms.

      1. Fernandes AT, Shinohara ET, Guo M, et al. The role of radiation therapy in malignant thymoma: A surveillance, epidemiology, and end results database analysis. Journal of Thoracic Oncology. 2010;5(9):1454-1460.

      2. Rimner A, Gomez DR, Wu AJ, et al. Failure patterns relative to radiation treatment fields for stage II-IV thymoma. Journal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer. 2014;9(3):403-409.

      3. Rimner A, Yao X, Huang J, et al. Postoperative Radiation Therapy Is Associated with Longer Overall Survival in Completely Resected Stage II and III Thymoma-An Analysis of the International Thymic Malignancies Interest Group Retrospective Database. Journal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer. 2016;11(10):1785-1792.

      4. Modh A, Rimner A, Allen PK, et al. Treatment Modalities and Outcomes in Patients With Advanced Invasive Thymoma or Thymic Carcinoma: A Retrospective Multicenter Study. American journal of clinical oncology. 2016;39(2):120-125.

      5. Ahmad U, Yao X, Detterbeck F, et al. Thymic carcinoma outcomes and prognosis: results of an international analysis. J Thorac Cardiovasc Surg. 2015;149(1):95-100, 101.e101-102.

      6. 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(7):1008-1016.

      7. Ruffini E, Detterbeck F, Van Raemdonck D, et al. Thymic carcinoma: a cohort study of patients from the European society of thoracic surgeons database. Journal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer. 2014;9(4):541-548.

      8. Gomez D, Komaki R. Technical advances of radiation therapy for thymic malignancies. Journal of Thoracic Oncology. 2010;5(10 SUPPL. 4):S336-S343.

      9. Gomez D, Komaki R, Yu J, Ikushima H, Bezjak A. Radiation therapy definitions and reporting guidelines for thymic malignancies. Journal of Thoracic Oncology. 2011;6(7 SUPPL. 3):S1743-S1748.

      10. Baschnagel AM, Mangona VS, Robertson JM, Welsh RJ, Kestin LL, Grills IS. Lung metastases treated with image-guided stereotactic body radiation therapy. Clinical oncology (Royal College of Radiologists (Great Britain)). 2013;25(4):236-241.

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    MTE08 - Enhancing the Nurse's Role in Tobacco Prevention and Cessation: New Challenges (Ticketed Session) (ID 818)

    • Type: Meet the Expert Session
    • Track: Nursing and Allied Professionals
    • Presentations: 1
    • Now Available
    • Moderators:
    • Coordinates: 9/24/2018, 07:00 - 08:00, Room 205 BD
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      MTE08.01 - Enhancing the Nurse's Role in Tobacco Prevention and Cessation: New Challenges (Now Available) (ID 11560)

      07:00 - 08:00  |  Presenting Author(s): Linda Sarna

      • Abstract
      • Presentation
      • Slides

      Abstract

      The purpose of this presentation is to discuss strategies for enhancing the nurses’ role in tobacco control, including the implementation of smoking cessation interventions in oncology practice settings as part of routine care. The experiences of the Tobacco Free Nurses Initiative to accelerate nursing involvement in tobacco control in multiple countries will be used to illustrate key strategies.

      Healthcare professionals are effective in increasing quit attempts and long-term cessation; however, few patients receive the necessary support. Although more healthcare providers are identifying smoking status in the patient record and providing advice to quit, fewer actively assist patients who smoke with a quit attempt and arrange for follow-up. During this presentation, an evidence-based smoking cessation intervention based on the 5 As (i.e., Ask, Advise, Assess, Assist and Arrange) will be reviewed along with strategies for facilitating implementation in the clinical setting.

      The oncology team needs adequate knowledge and skills in the delivery of a tobacco dependence treatment intervention. Although many healthcare providers may know about the devastating health effects of smoking and tobacco use, including lung cancer, few received the necessary training to deliver an evidence-based intervention. Many educational resources are available as listed in Table 1.

      Basic content of educational programs to support delivery of a smoking cessation intervention includes information about health risks of smoking and exposure to secondhand smoke, nicotine dependence and withdrawal, health benefits of quitting, evidence-based methods for supporting tobacco dependence treatment including behavioral interventions (i.e., social support and skills training), identification of triggers for relapse and how to manage withdrawal symptoms and cravings, and knowledge of FDA-approved pharmacotherapy, including side effects and toxicity.

      With the advent of the electronic medical record (EMR), tobacco use is often included as core information at patient intake with reminders to providers increasing the rates of advice and assessment. The EMR may be tailored to include easy-to-use prepopulated “Smart sets” for intervention with information about approved medications and referral options as well as downloadable materials for patients and families. The EMR can push alerts to clinicians to prompt treatment. Inpatients who are identified as smokers can be offered nicotine replacement therapy (NRT) to alleviate withdrawal symptoms, regardless of their desire to quit long-term.

      Changes in the healthcare environment also can support implementation of these recommendations. These include adopting smoke-free policies in healthcare settings, beyond the inpatient hospital, and supporting quit efforts of healthcare providers. Although smoking is declining among healthcare providers, this may be an issue in some settings and in some geographic areas. Smoking of the healthcare provider has been associated with decreased interventions and confidence in providing a patient with intervention. Promoting the smoking cessation support services provides an opportunity to support the quit efforts of healthcare providers as well. Providers’ support of patient quit efforts is essential regardless of the smoking status of the individual clinician.

      Table 1. Resources to support implementation of tobacco dependence treatment in oncology clinical settings

      Title

      Organization

      Information

      Agency for Healthcare Research and Quality

      Treating Tobacco Use and

      Dependence: 2008 Update

      https://www.ahrq.gov/professionals/clinicians-providers/guidelines-recommendations/tobacco/index.html

      Section for clinicians and system decision makers, including systems change information for integration of tobacco dependence in clinical practice

      American Society of Clinical Oncology

      Tobacco cessation tools and resources

      https://www.asco.org/practice-guidelines/cancer-care-initiatives/prevention-survivorship/tobacco-cessation-control

      Comprehensive information regarding the 5 As for a cessation intervention and wide-ranging tobacco control policies

      Centers for Disease Control and Prevention

      Health Care Providers: How you can help patients quit

      https://www.cdc.gov/tobacco/campaign/tips/partners/health/hcp/index.html

      Provides general information for healthcare providers based on the Tips for Former SmokersRCampaign

      Centers for Disease Control and Prevention

      Smoking cessation and cancer

      https://www.cdc.gov/tobacco/campaign/tips/diseases/cancer.html

      Specific examples of the impact of smoking and exposure to second-hand smoke on cancer. Videos from the TIPs campaign with cancer to promote motivation to quit

      North American Quitline Consortium

      State telephone support lines for smoking cessation

      http://www.naquitline.org/

      Provides information about availability and details of telephone quitlines for smoking cessation across the United States including electronic referral, other resources, and availability of nicotine replacement

      Oncology Nursing Society

      Tobacco control policy recommendationsfor oncology nurses

      https://www.ons.org/advocacy-policy/positions/policy/tobacco

      Also endorsed by the International Society of Nurses in Cancer Care

      Smokefree partner toolkit

      Smoke-free.gov

      https://smokefree.gov/help-others-quit/health-professionals

      Provides comprehensive list of evidence-based resources, guides and government reports aimed for clinicians, including smokefree mobile interventions

      SRNT, Society for Research on Nicotine and Tobacco

      Resources for Clinicians

      https://www.srnt.org/?page=Resources_Clinicians

      Provides many science-based resources and a searchable index for abstracts related to cardiovascular disease

      Tobacco Free Nurses

      Resources for nurses to enhance to tobacco control

      https://tobaccofreenurses.org

      Multiple webcasts in different languages, including many focused on oncology nursing and tobacco control

      University of Wisconsin- Center for Tobacco Research and Intervention

      Providers overview of tobacco dependence treatment

      https://ctri.wisc.edu/providers/providers-overview/

      Offers tobacco treatment training through webinars, onsite videos or online programs.

      Updates on the evidence for electronic cigarettes, including vaping regulations by state

      References

      Treating Tobacco Use and Dependence:2008 Update. Clinical Practice Guideline.https://www.ahrq.gov/professionals/clinicians-providers/guidelines-recommendations/tobacco/index.html

      EK, Strouse R, Hall J, Kovac M, & Schroeder SA. (2010). National survey of U.S. health professionals’ smoking prevalence, cessation practices, and beliefs. Nicotine Tob Res, 12 (7), 724–733. doi: 10.1093/ntr/ntq071.

      Sharpe T, Alsahlanee A, Ward K & Doyle F. (2018). Systematic review of clinician-reported barriers to provision of smoking cessation interventions in hospital inpatient settings. J Smok Cessat, 1-11. Doi.10.1017/jsc.2017.25

      Sarna L, Bialous SA, Ong MK, Wells M, Kotlerman J. Increasing nursing referral to telephone Quitlines for smoking cessation using a web-based program. Nurs Res. 2012 Nov-Dec;61(6):433-40. doi: 10.1097/NNR.0b013e3182707237.

      Thomas D, Abramson MJ, Bonevski B, George J. System change interventions for smoking cessations. Cochrane Database Syst Rev.2017 Feb 10;2:CD010742. doi: 10.1002/14651858.CD010742.pub2.

      Boyle R, Solberg L, Fiore M. Use of electronic health records to support smoking cessation. . 2014 Dec 30;(12):CD008743. doi: 10.1002/14651858.CD008743.pub3. Review. PMID 25547090

      Rigotti NA, Regan S, Levy DE, Japuntich S, Chang Y, Park ER, Viana JC, Kelley JH, Reyen M, Singer DE. Sustained care intervention and postdischarge smoking cessation among hospitalized adults: a randomized clinical trial.JAMA.2014 Aug 20;312(7):719-28. doi: 10.1001/jama.2014.9237

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    MTE09 - Management of Advanced Wild-Type Lung Cancer in Special Situations (Ticketed Session) (ID 819)

    • Type: Meet the Expert Session
    • Track: Advanced NSCLC
    • Presentations: 2
    • Now Available
    • Moderators:
    • Coordinates: 9/24/2018, 07:00 - 08:00, Room 206 AC
    • +

      MTE09.01 - Evidence Based Management of the Patient over 80 (Now Available) (ID 11561)

      07:00 - 07:30  |  Presenting Author(s): Elisabeth Quoix

      • Abstract
      • Presentation
      • Slides

      Abstract

      Lung cancer is the first cause of death by cancer in the entire world. In US the estimated number of new lung cancer cases in 2018 is 234030 with an estimated number of deaths of 154050 (25% of all cancer deaths) (1).

      Due to the conjunction of two factors (increased incidence of cancer with age and increase of life expectancy), median age at diagnosis is now 70 years in the US. The probability of developing a lung cancer is 6.1% after 70 years of age in males and 4.8% in females to be compared with respectively 1.9% and 1.4% between 60 and 69 years (1).

      Seventy years is also the cutoff most frequently used to define older adults in clinical trials of systemic treatments (2) (3) (4)

      Although, octogenarians represent a non negligible part of the patients, lung cancer is most frequently diagnosed among people aged 65-74 years (33.4% of the cases) whereas 26.8% are diagnosed between 75 and 84 years and 9.4% after 84 years (https//seer.cancer.gov/statfacts/html/lungb.html) .

      Non-small cell lung cancer (NSCLC) represent 85% of the cases whatever the age of diagnosis and, between 2007 and 2013, 57% of them were diagnosed at a metastatic stage (1). Thus systemic treatment to be applied in older patients is of paramount importance.

      Patients without targetable mutations and with a PDL1 expression <50% should be considered for chemotherapy whereas those with a PDL1 expression > 50% should be considered for immunotherapy by Pembrolizumab as first line therapy (5). Recommendations for fit patients with no targetable mutations are to give a platin-based doublet (4 to 6 cycles ) followed by a maintenance therapy in patients with no progressive disease at the end of the induction cycles. In non-squamous cell carcinoma, bevacizumab may be added in the absence of contra-indication (5). Regarding chemotherapy for older adults, we have some specific trials (table 1). The first point of these studies is that elderly patients do beneficiate of chemotherapy. Second point is that a non platin-based doublet does not provide any survival benefit compared to single agent therapy and third, carboplatin-based doublet (especially monthly carboplatine + weekly paclitaxel) provides an important survival benefit over single agent alone for elderly patients with PS 0-2 (4). In this study subgroup analysis showed that the survival benefit of a doublet compared to single agent therapy was also observed in the octogenarians. We have no data regarding maintenance therapy in elderly patients. The benefit/risk ratio is not in favor of bevacizumab after 70 years (6).

      The case of immunotherapy in elderly patients is of importance as the increased incidence of cancers in this population may be due to immune dysfunction (7). However, we do not have studies dedicated to elderly patients and data are obtained from subgroup analyses of studies with no upper limit of age (with the risk of selection biases). Pembrolizumab was compared to chemotherapy in patients with PDL1 expression > 50% and resulted in a survival benefit (8). Moreover in a recently published trial, addition of Pembrolizumab to chemotherapy as first-line therapy resulted also in a survival benefit compared to chemotherapy alone (9). Although there were some patients aged 80 years and more in these trials, specific studies are lacking and should be implemented.

      With reference to second line treatment, there are also no specific trials for elderly patients although erlotinib was due as second line therapy in one randomized trial (10) with similar results as observed in the pivotal study (BR21 comparing placebo to erlotinib after a first line consisting in a platin-based doublet). Regarding immunotherapy as second line, 4 phase III trials (docetaxel versus nivolumab in squamous and non-squamous cell carcinoma, docetaxel versus pembrolizumab and docetaxel versus atezolizumab) which are all in favor of the immunotherapy, included some elderly patients but with a median age around 62-64 years and although the eldest patients were 85 years old the proportion of patients aged 75 and more was below 12%.

      Thus, if recommendations regarding chemotherapy in elderly patients are now clear, there is a need for specific studies of immunotherapy in elderly patients especially those aged over 75 years either in first line therapy or second line therapy.

      Table I Randomized trials dedicated to elderly patients with advanced NSCLC

      Author (year)

      Drugs

      N° patients

      Response rate (%)

      Median survival (months)

      1-year survival rate (%)

      P

      Gridelli (1999)

      VNR

      BSC

      76

      75

      19.7

      ------

      6.5

      4.9

      32

      14

      0.03

      Frasci (2000)

      VNR

      VNR+Gem

      60

      60

      15

      22

      4.5

      7

      13

      30

      <0.01

      Gridelli (2003)

      VNR

      Gem

      VNR+Gem

      700

      21

      16

      18.1

      8.5

      6.5

      7.4

      42

      28

      34

      Ns

      Kudoh (2006)

      VNR

      Doc

      92

      90

      9.9

      22.7

      9.9

      14

      NR

      NR

      Ns

      Quoix (2011)

      VNR or Gem

      Carbo + weekly Pacli

      226

      225

      10

      27

      6.2

      10.3

      25.4

      44.5

      0.0004

      Tsukada (2015)

      Doc

      CDDP + Doc

      63

      63

      26.2

      55

      10.7

      17

      45.2

      66.6

      0.0384

      Abe (2015)

      Doc

      CDDP + Doc

      134

      138

      24.6

      34.4

      14.8

      13.3

      58.2

      54.5

      Ns

      Corre (2016)

      CGA or standard allocation

      243

      251

      6.1

      6.4

      NR

      NR

      Abbreviations : VNR : vinorelbine; BSC : best supportive care; Gem : gemcitabine; Carbo : carboplatin; Doc : docetaxel; CDDP : cisplatin; CGA : comprehensive geriatric assessment; ns : not significant; NR : not reported

      References

      1. Siegel RL Cancer statistics, 2018. CA Cancer J Clin 2018;68:7‑30.

      2. Gridelli C. The ELVIS trial: a phase III study of single-agent vinorelbine as first-line treatment in elderly patients with advanced non-small cell lung cancer. Elderly Lung Cancer Vinorelbine Italian Study. The oncologist. 2001;6 Suppl 1:4‑7.

      3. Pallis AG. Management of elderly patients with NSCLC; updated expert’s opinion paper: EORTC Elderly Task Force, Lung Cancer Group and International Society for Geriatric Oncology. Ann Oncol 2014;25:1270‑83.

      4. Quoix E. Carboplatin and weekly paclitaxel doublet chemotherapy compared with monotherapy in elderly patients with advanced non-small-cell lung cancer: IFCT-0501 randomised, phase 3 trial. Lancet 2011;378:1079‑88.

      5. Hanna N. Systemic Therapy for Stage IV Non-Small-Cell Lung Cancer: American Society of Clinical Oncology Clinical Practice Guideline Update. J Clin Oncol 2017;35:3484‑515.

      6. Ramalingam SS. Outcomes for elderly, advanced-stage non small-cell lung cancer patients treated with bevacizumab in combination with carboplatin and paclitaxel: analysis of Eastern Cooperative Oncology Group Trial 4599 J Clin Oncol. 2008 Jan 1;26(1):60-5

      7. Ferrara R. Immunosenescence and immunecheckpoint inhibitors in non-small cell lung cancer patients: Does age really matter? Cancer Treat Rev 2017;60:60‑8.

      8. Reck M. Pembrolizumab versus Chemotherapy for PD-L1-Positive Non-Small-Cell Lung Cancer. N Engl J Med 2016;375:1823‑33.

      9. Gandhi L. Pembrolizumab plus Chemotherapy in Metastatic Non-Small-Cell Lung Cancer. N Engl J Med. 2018;378:2078‑92.

      10. Quoix E. Second-line therapy in elderly patients with advanced nonsmall cell lung cancer. Eur Respir J 2014;43:240‑9.

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      MTE09.02 - Management of the PS 2 Patient (Now Available) (ID 11562)

      07:30 - 08:00  |  Presenting Author(s): Joan Schiller

      • Abstract
      • Presentation
      • Slides

      Abstract

      Patients with poor performance status (PS) of 2 represent a heterogeneous group of patients and a large proportion of the non-small cell lung cancer patient population (about 30-40 percent). Assessment is complicated by the influence of comorbidities versus disease burden on performance status and treatment outcome.

      The treatment of PS 2 patients was of particular interest in the late 20th/early 21st century. Studies evaluating that impact of performance status on outcome have shown that a poor performance status is also a poor prognostic indicator. ECOG 1581 showed that patients with a performance status of 0, 1, or 2 and median survivals of 36 weeks, 26 weeks, and 10 weeks, respectively. The toxic death rate was 3 percent, 2 percent, and 10 percent respectively (1) .

      Despite their poor prognosis, studies have shown that PS 2 patients do benefit from chemotherapy. Gridelli et al randomized patients 70 years or older with a PS of 0-1 to best supportive care versus a single vinorelbine (2). A statistically significant improvement in overall survival was observed (relative hazard ratio of death for vinorelbine-treated patients was 0.65).

      Other studies compared single agent versus doublet therapy in PS2 patients. Obasaju et al (3) randomized patients to single agent gemcitabine versus gemcitabine plus carboplatin in a US oncology trial in PS2 non-small cell lung cancer patients. Median survival was 5.2 months in the single agent arm versus 6.9 months in the doublet arm; overall response rates were 11.5 % versus 36%, respectively. Another trial (4) (Reynolds, JCO, 2009) also randomized PS2 patients to gemcitabine versus carboplatin and gemcitabine and also found an improvement in response rate, progression free survival, and overall survival, although only the difference in response rate was statistically significant. Dr. Lilenbaum reported the results of CALGB9730, a study of single agent pemetrexed versus carboplatin and pemetrexed. Patients with PS 2 who were treated with carboplatin and paclitaxel had a 4.7 month survival versus 2.2 months in PS2 patients treated with paclitaxel alone. In 2013, Zukin and colleagues presented the results of a phase 3 comparison of single agent pemetrexed versus combination pemetrexed plus carboplatin chemotherapy in patients with performance status is 0- 2 and no prior chemotherapy (5). The response rates were 10.3% for single agent pemetrexed versus 23.8% for the combination of carboplatin and pemetrexed. In the attempt to treat population, the median PFS was 2.8 months for single agent pemetrexed and 5.8 months for the combination. Median overall survival was 5.3 months for pemetrexed and 9.3 months for the combination; one-year survival rates were 21.9% and 40.1 %, respectively. Toxicity was acceptable.

      Doublet therapy has also been compared in PS2 patients. ECOG 1599 was a phase 2 randomized trial for PS2 patients, in which patients were randomized to dose attenuated carboplatin plus paclitaxel or gemcitabine plus cisplatin. Disease control rates (RR and SD), time-to-progression (TTP), progression free survival (PFS) and survival results are similar for the two regimens. PCB yielded more grade 3–4 neutropenia, neuropathy and grade 1 arthralgia/myalgia. GC caused more grade 3 thrombocytopenia, fatigue, nausea and grade 1 nephropathy. (6)

      There is less data as to how these patients respond to immunotherapy, since they have been excluded in many clinical studies. However, several nivolumab studies have included patients with a performance status of 2. CheckMate 171 was a European, single arm, phase II study in previously treated patients with metastatic squamous cell carcinoma of the lung which included patients 70 years and older or with poor performance status. (7). A total of 809 patients were enrolled, 98 of whom had a performance status of 2. Baseline characteristics and prior therapy in the PS2 subgroup were consistent with those in the overall ambulation, with the exception that the PS2 subgroup had fewer complete or partial responses as best response to most recent therapy. The safety profile of nivolumab was also comparable between the overall patient population and those with a performance status of 2, including a rate of 6% grade 3 or 4 treatment related AE’s (TRAEs), and 5% TRAEs leading to discontinuation. Overall survival was low were in the PS2 patients (median 5.4 months compared to a median of 9.9 months in the total patient population.) 14 percent of all patients had a complete or partial response compared to 11 percent of PS2 patient.

      CheckMate 153 was a Phase ¾ study which evaluated the safety of nivolumab monotherapy in patients with previously treated metastatic non-small cell lung cancer in the US and Canada. 1375 patients were enrolled, 123 of whom had a performance status of 2. The frequency of grade 3 or four adverse events was 12% in patients with a performance status of zero or one compared to 10% in patients with a PS of 2. Grade 5 events were less than 1% in the PS 0-1 patients and was 2% in the PS 2 patients. Six-month and 1 year overall survival rates in the PS2 subgroup were lower than those in the PS 0-1 subgroup (10.5 months versus 3.9 months, respectively) and one year overall survival rates of 44 percent versus 17 percent. Significant improvements in symptoms burden were observed in the PS2 patients at most time points, with improvement in quality of life starting at week 6 onward. (8)

      CheckMate 169 was an expanded access program involving nivolumab in previously treated patients with advanced non-small lung cancer in 161 patients. Baseline characteristics were generally the same in the PS2 patient population as the overall patient population. The safety profile was also comparable, with rates of any grade or grade 3-4 TRAEs, and TRAEs leading to discontinuation were also similar. Median survival was 5.9 months in the PS2 patients and 9.1 months in the overall patient population. (9)

      Taken together, these studies show that patients with advanced non-small cell lung cancer and a poor performance status have a poor prognosis than those with a PS of 0 or 1. The data regarding TRAEs is more variable, with some studies suggesting they are comparable to those observed in PS 0 or 1 patients, while others report a higher incidence of TRAEs in PS 2 patients. Despite this, however, PS2 patients derive a benefit from chemotherapy when compared to no therapy, and doublet therapy vs single agent. Randomized trials with immunotherapy are lacking; however, retrospective data suggests that the toxicity data is comparable compared to patients with a better performance status.

      References

      1. Ruckedeschel J. C., et al. A randomized trial of the four most active regiments for NSCLC. Journal of Clinical Oncology 1986 4:1, 14-22

      2. Gridelli C., et al;, Annals of Oncology, Volume 15, Issue 3, 1 March 2004, Pages 419–426,

      3. Obasaju C.K., et al ASCO Article-Abstract A-7533.

      4. Reynolds C.; JCO.2009.27, 5808-5815.

      5. Zukin M., et al.. JCO 31, no. 23 2849-2853.

      6. Tester W.J., et al; ECOG 1599: JCO 22, no. 14_suppl 7055-7055.

      7. Popat S., et al;. Presented at the 17th World Conference on Lung Cancer; December 4-7; Vienna, Austria. 1303 PD.

      8. Spigel D., et al; Presented at the 17th World Conference on Lung Cancer; December 4-7; Vienna, Austria. P3.02c-026

      9. Juergens R., et al;. Presented at the 18th World Conference October 15-18, 2017; Yokohama, Japan. PO2.07-029

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    MTE10 - Emerging Technologies for Small and Smaller Lesions - Update on Ablation via Endoscopy vs Percutaneous (Ticketed Session) (ID 820)

    • Type: Meet the Expert Session
    • Track: Interventional Diagnostics/Pulmonology
    • Presentations: 1
    • Now Available
    • Moderators:
    • Coordinates: 9/24/2018, 07:00 - 08:00, Room 201 BD
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      MTE10.01 - Emerging Technologies for Small and Smaller Lesions - Update on Ablation via Endoscopy vs Percutaneous (Now Available) (ID 11563)

      07:00 - 08:00  |  Presenting Author(s): Felix JF Herth

      • Abstract
      • Presentation
      • Slides

      Abstract

      A solitary pulmonary nodule (SPN) is a round or oval opacity smaller than 3 cm in diameter that is completely surrounded by pulmonary parenchyma.

      Workup of these nodules is rather expensive and emotionally burdensome, especially when the patient has risk factors for bronchial carcinoma.

      SPNs are noted in up to 0.2% of chest radiograph, whereas 27.3% of patients undergoing the national lung screening trial (NLST) had at least one SPN with a diameter of more than 4mm on their CT examination.

      Numerous articles/papers have been published addressing the optimal strategy of evaluating individuals with lung nodules, including the published ACCP guideline for the diagnosis and management of lung cancer. Those strategies are generally based on the individuals’ risk of developing lung cancer, the pulmonary nodule characteristics and the capability of the current diagnostic and therapeutic approaches.

      Standard bronchoscopy has been limited in the evaluation of the peripheral pulmonary nodules, with diagnostic yields ranging from 19% to 68%. The addition of tools such as electromagnetic navigational bronchoscopy (ENB), radial endobronchial ultrasound (r-EBUS), and several other navigation technologies have been used and increased the diagnostic yield. Actual, The Transbronchial Parenchymal nodule access (TPNA) has shown the best results.

      Radiofrequency ablation (RFA) and Microwaves (MW) are promising alternative treatment method for early-stage lung cancer in non-surgical patients. They can also be used for oligometastasis from distant cancer or as a therapy for the local control

      of tumors.

      Compared to their percutaneous approach, in the lung, percutaneous ablation is associated with severe complications, including pneumothorax, hemothorax, bronchopleural fistulas, and pleural effusions.

      Therefore a bronchoscopic approach seems to be as effective with reduced complications.

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    PL01 - Patients First (ID 849)

    • Type: Plenary Session
    • Track:
    • Presentations: 6
    • Now Available
    • Moderators:
    • Coordinates: 9/24/2018, 08:15 - 09:45, Plenary Hall
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    MA01 - Early Stage Lung Cancer: Questions and Controversies (ID 894)

    • Type: Mini Oral Abstract Session
    • Track: Treatment of Early Stage/Localized Disease
    • Presentations: 12
    • Now Available
    • Moderators:
    • Coordinates: 9/24/2018, 10:30 - 12:00, Room 202 BD
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      MA01.01 - Proposal on Incorporating Lymphovascular Invasion as a T-Descriptor for Stage I Non-Small Cell Lung Cancer (Now Available) (ID 12754)

      10:30 - 10:35  |  Presenting Author(s): Shuyuan Wang  |  Author(s): Bo Zhang, Jianlin Xu, Rong Qiao, Baohui Han, Bo Yan, Yu Dong

      • Abstract
      • Presentation
      • Slides

      Background

      Lymphovascular invasion (LVI) and Visceral Pleural Invasion(VPI) have been reported to be risk factors for stage I Non-Small Cell Lung Cancer (NSCLC). However, only VPI was incorporated into the current 8th Tumor–Node–Metastasis(TNM) classification. This study aimed at exploring the prognostic impact of LVI on TNM staging in Pathological Stage I NSCLC.

      Method

      We retrospectively reviewed 2600 consecutive p-stage I NSCLC patients in the Shanghai Chest Hospital (2008-2012). By using the Kaplan–Meier method and Cox proportional hazard regression model, we identified the correlations between LVI, VPI and clinical outcomes in p-stage I NSCLC.

      Result

      Of all p-stage I NSCLC 2600 patients, 221 were pathologically diagnosed with LVI and 815 pathologically with VPI, respectively. It was observed that patients with LVI had an unfavorable lung cancer specific survival (LCSS) (hazard ratio [HR]: 1.883; 95% confidence interval [CI]: 1.351-2.625; P < 0.001) and recurrence-free survival (RFS) (HR: 2.025; 95% CI: 1.560-2.630; P < 0.001). The 5-year RFS rates of patients with LVI was significantly worse than those without LVI (61.2% VS 82.7%, P< 0.001). Patients with LVI exhibit similar prognosis (HR: 2.538; 95% CI: 1.570-4.098; P < 0.001) compared with that of VPI in pN0 non-small-cell lung cancer and a tumor diameter of 3cm or smaller. When tumor size was between 3-4cm, patients with LVI and VPI were associated with inferior prognosis than those with only LVI or VPI (P < 0.001).

      Conclusion

      The presence of LVI independently and significantly affects LCSS and RFS in patients with stage I NSCLC. Our results suggest that stage T1a-1c(IA) patients with LVI should be upstaged to T2a(IB), meanwhile, stage T2a(IB) patients coexist with LVI and VPI should be upstaged again in the TNM classification.

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      MA01.02 - Histologic Subtyping in Pathologic Stage I Lung Adenocarcinoma Provides Risk-Based Stratification for Surveillance (Now Available) (ID 13400)

      10:35 - 10:40  |  Presenting Author(s): Yusuke Takahashi  |  Author(s): Takashi Eguchi, Koji Kameda, Shaohua Lu, Raj G. Vaghjiani, Kay See Tan, David R. Jones, William D Travis, Prasad S. Adusumilli

      • Abstract
      • Presentation
      • Slides

      Background

      Current national practice guidelines (NCCN, ACCP, ESMO) recommend a uniform follow-up protocol with intensive surveillance within the first two years following lung resection for stage I NSCLC. We hypothesize that the recurrence hazard following lung resection for stage I lung adenocarcinoma (ADC) varies according to histologic subtype.

      Method

      A total of 1572 patients with resected pathologic stage I lung ADC were investigated. Two thoracic pathologists reviewed all tumor H&E slides (range 1-8, median 3) for histologic subtyping and percentage of each subtype. Recurrence hazard was estimated using the Kernel-Epanechnikov smoothing procedure. Association between recurrence hazard and high-grade histologic subtypes (micropapillary [MIP] and solid [SOL]) was assessed.

      Result

      Presence (≥5%) of these high-grade subtypes (MIP and/or SOL) was associated with significant increase of recurrence hazard compared to high-grade pattern negative (<5%) tumors (Figure): 1) patients with presence of either MIP or SOL had significant recurrence hazard peaks within two years after surgery; 2) SOL was associated with early hazard peak at the first year after surgery especially in distant recurrence hazard; 4) one-third of patients (515/1572, 33%) had no high-grade subtypes, in which the recurrence hazard was consistently very low (<2% risk each year) during the 10-year period after surgery without any hazard peak (red arrow).

      hazard fig 300.jpg

      Conclusion

      Our data suggest the utility of histologic subtyping for identifying patients with very low recurrence hazard, and provide foundation for establishing risk-based follow-up protocols. A potential option for low-risk patients may be omission of intensive follow-up during the first two years after surgery.

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      MA01.03 - An Externally Validated Nomogram for Predicting Distant Metastasis After SBRT for Early Stage Non-Small Cell Lung Cancer (Now Available) (ID 11182)

      10:40 - 10:45  |  Presenting Author(s): Aditya Juloori  |  Author(s): Alexander Zajichek, Michael Kattan, Daniel J. Mullen, Pamela Samson, Neil M Woody, Mike Roach, Jeffrey Bradley, Gregory M.M. Videtic, Cliff Robinson, Kevin L Stephans

      • Abstract
      • Presentation
      • Slides

      Background

      SBRT is a standard option for patients with early stage NSCLC who are medically inoperable. While SBRT is associated with excellent local control, distant metastases (DM) represent the primary pattern of failure. Adjuvant systemic therapy has not traditionally been used in this patient population due to medical comorbidities. With the advent of immunotherapy that may be better tolerated, there has been a renewed interest in identifying patients that may derive benefit. We developed and internally validated a nomogram to predict the likelihood of DM after SBRT for early stage NSCLC which was then externally validated.

      Method

      Our lung SBRT registry was queried for patients with early stage NSCLC treated with definitive intent from 2003-2017 and 1002 patients were identified for analysis to develop the model. A dataset from an external institution was used to similarly identify patients and 737 were used for the validation cohort. Random Survival Forest was used to assess importance, interactivity, and overall predictive ability with respect to DM for 14 variables. A Fine-Gray competing-risks regression model was formulated where apparent interactions were examined with likelihood-ratio tests. Backward variable selection was implemented to reduce to a parsimonious model. The concordance probability (C-index) of the model was internally validated with 10-fold cross validation.

      Result

      The median overall survival was 1.71 years internally and 1.92 years externally. Median follow-up was 18.3 months and 21.1 months. 1-year incidence of DM was 16% and 12.1% in the internal and external cohorts, respectively. Random Forest analysis suggested that tumor size and PET SUV are the most important predictors of distant failure. The 1-year cumulative incidence (CI) of DM was 18.5% for PET SUV ≥4.1 vs 8.4% for <4.1. 1-year CI for tumor size >3 cm was 26% vs 12.6% for ≤3 cm. The median time to DM was 0.86 years internally and 1.1 years externally. The final nomogram included tumor size, histology, PET SUV, age, KPS, and active smoking status, and had a cross-validated C-index of 0.62. The nomogram provides predictive value for probability of DM at 1-year between 10 and 70%.

      Conclusion

      This novel nomogram with external validation can be used to predict the 1-yr DM risk after SBRT for patients with early-stage NSCLC, accounting for the competing risk of death. This nomogram may help define patient subsets for stratification in future clinical trials to help identify who may benefit from adjuvant systemic therapy after SBRT to reduce the incidence of DM and disease-related death.

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      MA01.04 - Discussant - MA01.01, MA01.02, MA01.03 (Now Available) (ID 14572)

      10:45 - 11:00  |  Presenting Author(s): Deepali Jain

      • Abstract
      • Presentation
      • Slides

      Abstract not provided

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      MA01.05 - Opioids and Sleep Medication Use After Surgery for Early Stage Lung Cancer: A SEER-Medicare Analysis (Now Available) (ID 12961)

      11:00 - 11:05  |  Presenting Author(s): Stephanie Tuminello  |  Author(s): Juan Wisnivesky, Rebecca Schwartz, Bian Liu, Grace Mhango, Raja Flores, Emanuela Taioli

      • Abstract
      • Presentation
      • Slides

      Background

      More than 50% of patients undergoing surgery for early stage lung cancer experience persistent post-operative pain, which can prevent their returning to normal daily activities and cause disruptions in sleep. Whether Video-Assisted Thoracoscopic Surgery (VATS), a minimally invasive surgical technique, reduces long-term opioid and sleep medication use compared to traditional open surgery has not yet been established.

      Method

      The Surveillance, Epidemiology and End Results data linked to Medicare data (SEER-Medicare) database was queried to identify patients with stage I primary non-small cell lung cancer (NSCLC) who had VATS or open resection between 2007 to 2013, and had no record of opioid medication in the 30 days before surgery. Long-term opioid and sleep medication use were defined as having fulfilled one or more prescriptions in the first 90 days after surgery as well another prescription in the 90-180 days post-surgery. Logistic regression was used to investigate the associations between surgical type and long-term opioid and sleep medication use. Models were adjusted for relevant clinical and socioeconomic covariates.

      Result

      There were 3,900 NSCLC patients included in this analysis; 1,987 (51.0%) VATS and 1,913 (49.0%) open surgery patients; 15.5% of patients had a record of opioid use and 9.7% of sleep medication use long-term postoperatively.

      In the adjusted model, patients were less likely to use opioids long-term if they had VATS (ORadj 0.69, 95% CI: 0.57-0.84), were older (ORadj 0.96, 95% CI: 0.94-0.98), diagnosed in a later year (ORadj 0.86, 95% CI: 0.82-0.90), and had higher income (ORadj 0.77, 95% CI: 0.60-0.99). Long-term opioid use was more likely in those with a higher comorbidity score (ORadj 1.10 , 95% CI: 1.05-1.16), large cell histology (ORadj 1.88, 95% CI: 1.17-3.00), using sleep medication before surgery (ORadj 1.72, 95% CI: 1.28-2.32) and with a previous psychiatric condition (ORadj 1.64, 95% CI: 1.28-2.09).

      After adjustment, only those with a previous psychiatric condition (ORadj 1.95, 95% CI: 1.40-2.71) and previous sleep medication use (ORadj 37.36, 95% CI: 27.92-50.00) were more likely to use sleep medications long-term; no significant difference were observed with type of surgery (ORadj 1.01, 95% CI: 0.76-1.33).

      Conclusion

      Patients who were not previous opioid users became long-term opioid users after surgery. VATS might offer NSCLC patients a better quality of life than open surgery, and therefore minimize the risk of longer-term opioid use.

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      MA01.06 - Evaluation of Safety and Efficacy in Surgical Treatment for Octogenarian Lung Cancer Patients by Multicenter Prospective Study: JACS1303 (Now Available) (ID 13117)

      11:05 - 11:10  |  Presenting Author(s): Tomohiro Haruki  |  Author(s): Hisashi Saji, Takahiko Ueno, Morihito Okada, Hiroshige Nakamura, Masayuki Chida

      • Abstract
      • Presentation
      • Slides

      Background

      The percentage of octogenarian lung cancer patients have increased on the background of the aging of Japan’s demographics. Although some retrospective studies reported clinicopathological scoring systems for predicting postoperative complications and survival outcomes for elderly lung cancer patients, optimized scoring systems remain controversial. This study (JACS1303) aims to evaluate the clinical factors to develop a comprehensive operative risk scoring (RS) system for octogenarian patients with lung cancer.

      Method

      JACS conducted a nationwide multicenter prospective cohort and enrolled a total of 1,019 octogenarians with medically operable lung cancer. Details of the clinical factors, comorbidities, and comprehensive geriatric assessment were recorded for 895 patients to develop a comprehensive risk scoring (RS) system capable of predicting severe complications.

      Result

      Operative (30 days) and hospital mortality rates were 1.0% and 1.6%, respectively. Complications were observed in 308 (34%) patients, of whom 81 (8.4%) had grade 3–4 severe complications. Pneumonia was the most common severe complication, observed in 27 (3.0%) patients. The following five predictive factors: gender, comprehensive geriatric assessment (CGA)75: memory, Simplified Comorbidity Score (SCS): diabetes mellitus, Alb, and %VC were identified as independent predictive factors for severe postoperative complications (odds ratio = 2.73, 1.86, 1.54, 1.66, and 1.61, respectively) through univariate and multivariate analyses. A 5-fold cross validation was performed as an internal validation to reconfirm these five predictive factors (average AUC: 0.70). We developed a simplified RS system as follows: RS = 3 (Gender: male) + 2 (CGA75: memory: yes) + 2 (Alb: <3.8 ng/ml) + 1 (%VC: ≤90) + 1 (SCS: Diabetes mellitus: yes).

      Conclusion

      The current study shows that octogenarians can be successfully treated for lung cancer with surgical resection with an acceptable rate of severe complications and mortality. We propose a simplified RS system to predict severe complications in octogenarian patients with medically operative lung cancer.

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      MA01.07 - Validation of RTOG 0813 Normal Tissue Constraints for Pulmonary Toxicity in SBRT for Central Non-Small Cell Lung Cancer (Now Available) (ID 11318)

      11:10 - 11:15  |  Presenting Author(s): Kyle Verdecchia  |  Author(s): Bindu Manyam, Gregory M.M. Videtic, Tingliang Zhuang, Neil M Woody, Kevin L Stephans

      • Abstract
      • Presentation
      • Slides

      Background

      Stereotactic body radiation therapy (SBRT) yields excellent local control rates for medically inoperable early stage "central" non-small cell lung cancer. Normal tissue constraints provided in RTOG 0813, which tested safety and efficacy of lung SBRT for central tumors, were largely based on expert estimates, and clinical validation of constraints is limited. We sought to identify the sensitivity and specificity of the current RTOG constraints for predicting pulmonary toxicity in a large institutional data set.

      Method

      We identified 136 lesions within 2 cm of the proximal bronchial tree (PBT), treated from 2005 to 2014 from a prospective registry of 1,462 patients. Dose was 50 or 60 Gy given in 5 fractions. Pulmonary toxicity was categorized as pneumonitis or non-pneumonitis (fistula, bronchial stenosis or necrosis, atelectasis, hemoptysis, or clinically significant pleural effusion). A series of dose endpoints for the PBT was generated based on dose volume histograms, where dose levels ranged from 0 Gy to 80 Gy in increments of 0.1 Gy, and volumes ranged from 0.03 cc to 50 cc in increments of 0.03cc. A total of 1,333,600 dosimetric endpoints were analyzed. The sensitivity and specificity of these endpoints in predicting pulmonary toxicity was calculated. The optimal dosimetric endpoint was chosen by identifying the highest F-score.

      Result

      We observed nine Grade 2 pneumonitis and 10 Grade ≥ 2 non-pneumonitis toxicities, of which three were Grade 5 (broncho-pleural fistula, left mainstem bronchus necrosis, and bronchial stenosis). The optimal dosimetric endpoint to avoid Grade 2-5 non-pneumonitis toxicity was D0.03cc<50 Gy to the PBT, with 90% sensitivity and 77% specificity. The optimal point dose to avoid Grade 3-5 non-pneumonitis toxicity was D0.3cc<46.5 Gy, with 100% sensitivity and 85% specificity. Applying PBT RTOG constraints to our dataset achieved 18% sensitivity and 91% specificity for D4cc<18 Gy and 29% sensitivity and 93% specificity for D0.03cc<52.5 Gy.

      Conclusion

      Clinical results from this large institutional data set validate current RTOG constraints for PBT as predictive for pulmonary toxicity. The results also suggest that RTOG constraints D4cc<18 Gy and D0.03cc<52.5 Gy to PBT have moderate sensitivity but excellent specificity for pulmonary toxicity. We identified D0.03cc <50 Gy to PBT as having the largest sensitivity and specificity for toxicity prediction, and this value parallels current RTOG constraint of D0.03cc <52.5 Gy. This analysis suggests that an additional volume/dosimetric constraint of D0.3cc<46.5 Gy may be considered for avoidance of Grade 3-5 non-pneumonitis pulmonary toxicity.

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      MA01.08 - Discussant - MA01.05, MA01.06, MA01.07 (Now Available) (ID 14573)

      11:15 - 11:30  |  Presenting Author(s): Biniam Kidane

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      MA01.09 - Risk Factors of Radiation-Induced Lymphopenia (RIL) and Its Prognostic Significance in Small Lung Cancer Patients Treated with Stereotactic Body Radiation Therapy (Now Available) (ID 14426)

      11:30 - 11:35  |  Presenting Author(s): Xiaomei Gong  |  Author(s): Qianqian Zhao, Jian He

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      Background

      The decrease in peripheral blood lymphocytes induced by radiation lessens the antitumour effect of the immune response, which might cause immunosuppression. This reduction might be affected by fractionation scheme. The purpose of this study was to assess the effect of fractionation scheme (consecutive daily fractions or nonconsecutive fractions) of SBRT on clinical outcomes in early-stage peripheral non-small cell lung cancer (NSCLC). We also analyzed the different effect of these two fractionation schemes in reducing peripheral blood lymphocytes during SBRT treatment period.

      Method

      Data from a total of 61 early-stage peripheral NSCLC patients who had received SBRT were retrospectively analyzed. A total dose of 50 Gy in 5 fractions over 5-7 days was delivered for all patients. Peripheral blood lymphocytes were measured before and after SBRT. We used the Kaplan-Meier method, the log-rank test, and Cox proportional hazards regression to determine whether radiation treatment schedule associated with clinical outcomes.

      Result

      Figure 1 showed Kaplan–Meier estimates for progression free survival (PFS) (Figure A) and overall survival (OS) (Figure B) for entire cohort stratifying for fractionation regimen. Multivariate analysis showed that nonconsecutive fractionation was an independent predictor of a longer PFS (P = 0.002). OS trended toward improvement in the non-consecutive group, but this was not statistically significant (P = 0.181). Development of any grade 3 or higher toxicity was not significantly different between the two groups (P = 0.813). The average circulating lymphocyte counts of consecutive group patients significantly declined after RT (1977.27 versus 1368.18 cells/µl, P < 0.001) while the nonconsecutive group patients did not (1700.00 versus 1450.00 cells/µl, P = 0.155).
      figure 1.jpg

      Conclusion

      Five-fraction SBRT delivered over non-consecutive days achieved superior clinical outcomes and similar toxicity compared to consecutive fractionation. Consecutive daily fractions of SBRT might cause worse immunosuppression by the more severe damage of peripheral lymphocytes.

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      MA01.10 - Toxicity and Local Control in “Ultra-Central” Lung Tumors Treated With SBRT or High-Dose Hypofractionated RT (Now Available) (ID 13969)

      11:35 - 11:40  |  Presenting Author(s): Chunyu Wang  |  Author(s): Baho Sidiqi, Ellen Yorke, Dominique McKnight, Rosalind Dick-Godfrey, Danielle Torres, Daphna Gelblum, Andreas Rimner, Abraham J. Wu

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      Background

      Stereotactic body radiation therapy (SBRT) for central lung tumors has been associated with higher rates of severe toxicity. Data suggests that tumors with specific high-risk features, namely GTV abutting proximal bronchial tree (PBT), trachea or PTV intersecting esophagus (“ultra-central” tumors), are at risk of severe complications. We sought to evaluate toxicity and efficacy for high-risk lung tumors treated with SBRT in our institution.

      Method

      All patients treated with SBRT for central lung tumors during 2008 to 2017 were reviewed to identify ultra-central tumors. Patients who received more than 4 Gy per fraction and BED10≥84 were included in the analysis. The primary endpoint was grade 3+ adverse events potentially attributable to RT, based on CTCAE 4.0. Secondary endpoints were local control (LC) and overall survival (OS) for primary lung cancer patients, Kaplan-Meier analysis was used to estimate LC and OS.

      Result

      We identified 88 patients who met the inclusion criteria (76 with abutment of PBT, 8 with abutment of trachea, 22 with overlap of esophagus, and 17 with multiple structures at risk). The median follow-up was 21.5 (95%CI, 12.5 to 30.5) months. Forty-six patients had primary NSCLC, 7 had locally recurrent NSCLC and 35 had lung metastases. The prescription doses were 400cGy x 15 (n=21), 750cGy x 8 (n=13), 1000cGy x 5 (n=29) and 900cGy x 5 (n=25). Eight patients (9.1%), all abutting the PBT, experienced fatal complications potentially related to RT. Four patients developed fatal pulmonary hemorrhage. Maximum point doses to PBT were 54.9Gy, 51.4Gy, 49.4Gy (in 5 fractions) and 63.8Gy (8 fractions) and 2 of them had received bevacizumab in close proximity to RT. Four patients developed fatal pneumonia/radiation pneumonitis (all had pre-existing COPD). No Grade 4 toxicity was identified. Grade 3 overall toxicity rate was 12.5%. Only 3 of 22 (13.6%) patients whose PTV overlapped with esophagus had Grade 3 toxicity. The 1-year and 2-year LC for the whole cohort were 87.5% and 79.1%, respectively. The 1, 2-year OS for primary NSCLC patients were 77.8% and 62.6%, respectively.

      Conclusion

      To our knowledge, this is the largest reported series of patients who received SBRT for ultra-central tumors. RT achieves high rates of local control in these patients, but the rate of severe or fatal toxicity is substantial. Further studies are needed to establish the relationship between SBRT and toxicity in these patients.

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      MA01.11 - Salvage SBRT for Local Recurrence After Primary Surgical Resection of Early Stage Non-Small Cell Lung Cancer (Now Available) (ID 11284)

      11:40 - 11:45  |  Presenting Author(s): Sarah Sittenfeld  |  Author(s): Aditya Juloori, Chandana A. Reddy, Kevin L Stephans, Gregory M.M. Videtic

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      Background

      To report on the patient, tumor and treatment characteristics of patients treated with salvage lung SBRT (sSBRT) for non-metastatic NSCLC that has relapsed after previous surgical resection, and the resulting clinical outcomes.

      Method

      We surveyed our IRB-approved prospective lung SBRT registry for patients who received sSBRT for local recurrence after previous resection of an early stage NSCLC. Following sSBRT, outcomes of interest included local control (LC), overall survival (OS), and treatment-related toxicity graded per CTCAE version 4.0.

      Result

      For the interval 2004-2017, 50 (3.4%) pts, of a total of 1,461 lung SBRT cases, met criteria for analysis. Pre-sSBRT surgical approaches were: 23 (46%) wedge resection, 2 (4%) segmentectomy, 20 (40%) lobectomy, 2 (4%) bilobectomy, 1 (2%) pneumonectomy and 1 (2%) with unspecified surgery. At the time of resection, disease stage was: 34 (68%) stage I, 4 (8%) stage II, 5 (10%) stage III and for 3 (6%) pts, pre-operative stage was unknown. Median time to local recurrence after surgery was 27.45 months. At sSBRT, 38 (76%) pts had biopsy-proven recurrence while 12 (24%) had recurrence diagnosed only by radiographic findings. Forty seven (94%) pts could not have surgical salvage due to pulmonary (60%), cardiac (2%), technical unresectability (4%), poor KPS (2%), or multifactorial reasons (26%), with 3 (6%) refusing re-resection. Median age and KPS at salvage treatment was 74 years (range 50-89) and 80 (range 60-100) respectively. The most common sSBRT schedule was 50Gy in 5 fractions (68%), with all schedules having a BED of at least 100 Gy10. Median follow up after sSBRT was 22.2 months (3.8-108.8 months). Eight pts subsequently experienced local or lobar failure (16%), and 9 patients had nodal failure (18%). Median time to local failure after sSBRT was 12.5 months (2-66.1 months). At analysis, 11 (22%) pts remain alive and free from disease progression. At 24 months, LC and OS were 83.6% (95% CI 71.1-96) and 66.7% (95% CI 53.3-80.1). Median OS after sSBRT was 29.3 months. Twenty one (42%) pts failed distantly at a median time of 11.4 months and 12 (24%) pts received systemic therapy following distant failure. 74% of pts experienced no toxicity after sSBRT and three patients (6%) developed grade III toxicity (cough, atelectasis or soft tissue necrosis).

      Conclusion

      Similar to SBRT for primary early stage NSCLC, sSBRT for local relapse following initial surgical resection of NSCLC offers high rates of LC with limited toxicity. Distant failure remains the primary pattern of failure.

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      MA01.12 - Discussant - MA01.09, MA01.10, MA01.11 (Now Available) (ID 14574)

      11:45 - 12:00  |  Presenting Author(s): Drew Moghanaki

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      Abstract not provided

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