Virtual Library

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    MA18 - Modelling, Decision-Making and Population-Based Outcomes (ID 920)

    • Event: WCLC 2018
    • Type: Mini Oral Abstract Session
    • Track: Treatment in the Real World - Support, Survivorship, Systems Research
    • Presentations: 11
    • Now Available
    • Moderators:
    • Coordinates: 9/25/2018, 13:30 - 15:00, Room 201 F
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      MA18.01 - Non-Small Cell Lung Cancer Risk Assessment with Artificial Neural Networks (Now Available) (ID 13532)

      13:30 - 13:35  |  Presenting Author(s): Tafadzwa Lawrence Chaunzwa  |  Author(s): Yiwen Xu, David C Christiani, Andrea Shafer, Nancy Diao, Michael Lanuti, Raymond Mak, Hugo Aerts

      • Abstract
      • Presentation
      • Slides

      Background

      Lung cancer is a heterogeneous disease with many clinically important subtypes. Given the complexity of classification, there is room for innovative risk assessment tools to help ascertain prognosis and management. In this work we tested an Artificial Neural Network (ANN) to stratify patients into clinically significant low and high risk categories.

      a9ded1e5ce5d75814730bb4caaf49419 Method

      CT imaging, survival, and cancer staging data was extracted for a sample of 311 patients with Stage-I (n = 186) and Stage-II (n = 125) non-small cell lung cancer (NSCLC) from the comprehensive Boston Lung Cancer Survival (BLCS) cohort. Median follow-up from time of diagnosis was 3.5 years, with 86% 2-year survival. A deep convolutional neural network pretrained on ImageNet was used, with fine-tuning of the last convolutional layers, dense layers, and softmax for stratification. Inputs of this model were 50 x 50 mm2 image patches. Training was performed on 182 labeled CT scans (112 Stage-I and 70 Stage-II). 46 cases were used for initial cross-validation, with an independent test set of 83 cases. The median prediction probability from the ANN was used as a cutoff to divide patients into low and high risk groups.

      4c3880bb027f159e801041b1021e88e8 Result

      The model was able to perform classification of cancer stage on the heterogeneous test set (AUC = 0.73, p< 0.0005). The test set was split evenly into low risk (n = 42) and high risk (n= 41) groups based on model predictions. There was statistically significant separation in the Kaplan Meier-estimates for survivorship in the two stratified groups (p < 0.02).

      ialsc_figure.png

      8eea62084ca7e541d918e823422bd82e Conclusion

      ANNs can be effective tools for quantitative risk stratification in NSCLC. In addition to the potential for real-time clinical decision support, ANNs may also help create new paradigms in lung cancer risk assessment. The models have the capacity to perform suprahuman computations, which can help meet future demands of clinical practice, given expanding digital-imaging volumes.

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      MA18.03 - How in the Real World Are Lung Cancer Patients Treated? The Ontario, Canada Experience (Now Available) (ID 13772)

      13:35 - 13:40  |  Presenting Author(s): William Kenneth Evans  |  Author(s): William Flanagan, Cindy Gauvreau, Phongsack Manivong, Saima Memon, Natalie Fitzgerald, John R Goffin, Rochelle Garner, Edwin Khoo, Nicole Mittmann

      • Abstract
      • Presentation
      • Slides

      Background

      Clinical trials define treatment recommendations but how patients are actually treated in the real world is poorly understood. The Canadian Partnership Against Cancer has developed a model of lung cancer (LC) management (OncoSim-lung) based on clinical trials data and expert advice. To credibly project the future clinical and economic impacts of cancer control measures using OncoSim, the model has been refined using real-world data.

      a9ded1e5ce5d75814730bb4caaf49419 Method

      Treatment data by histology and stage were extracted from the Ontario Cancer Registry for LC cohorts diagnosed in 2010 and 2013. All incident cases that satisfied the IARC rule of a new primary were included. Missing or unknown stage cases were excluded. Clinical pathways were validated by oncologists from different disciplines across Canada.

      4c3880bb027f159e801041b1021e88e8 Result

      The 2013 cohort included 8,086 staged LC: NSCLC (n=7,143) Stage I 18.7%, II 8%, III/IIIa 11.4%, IIIb 4.9% IV 56.8%; SCLC (n= 943) limited 67.7%, extensive 32.3%. Of 1340 stage I NSCLC patients, 61% underwent surgery; 39% had no surgery and one third of these had no active treatment (NAT). 55% of those not receiving surgery underwent radical radiotherapy and 6% had palliative radiotherapy. Of 579 patients with stage II NSCLC, 60% underwent surgery and 47% of these received adjuvant chemotherapy; 40% had no surgery and 22% of these had NAT. Radical radiotherapy, radiotherapy plus chemotherapy or palliative radiotherapy were given in 33%, 19% and 18% of non-surgical cases, respectively. Of 813 stage III/IIIa patients, only 26% underwent surgery, 41% of whom received adjuvant chemotherapy or postoperative radical radiotherapy (16%); 13% received trimodality treatment. Of the 75% of Stage III not receiving surgery, 26% had NAT and 21% had palliative radiotherapy alone. Of those receiving active treatment, 20% received combined chemo +radiotherapy and 13% each had chemotherapy alone or radical radiotherapy alone. Of 356 stage IIIb patients, 17% had NAT, 28% received palliative radiotherapy and only 30% had chemo + radical radiotherapy. 18% had chemo alone. Of 4055 stage IV NSCLC, 47% had NAT, 24% received chemotherapy alone and 23% had palliative radiotherapy only. Of those who received first-line chemotherapy (n= 1059), 47% received second line chemotherapy and of those, 37% received third line therapy.

      8eea62084ca7e541d918e823422bd82e Conclusion

      Compared to prior expert opinion, there was a higher use of radiotherapy for early stage disease, a lower frequency of chemo-radiotherapy in Stage III disease and a higher frequency of NAT across all stages of disease.

      6f8b794f3246b0c1e1780bb4d4d5dc53

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      MA18.04 - Discussant - MA 18.01, MA 18.03 (Now Available) (ID 14651)

      13:40 - 13:55  |  Presenting Author(s): Shalini K Vinod

      • Abstract
      • Presentation
      • Slides

      Abstract not provided

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      MA18.05 - Characteristics and Long-Term OS of Non-Small Cell Lung Cancer Patients Receiving EGFR Tyrosine Kinase Inhibitor Treatment (Now Available) (ID 13197)

      13:55 - 14:00  |  Presenting Author(s): Michael Bergqvist  |  Author(s): Helene Nordahl Christensen, Fredrik Wiklund, Stefan Bergström

      • Abstract
      • Presentation
      • Slides

      Background

      Epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors (TKIs) are important therapeutic agents in treatment of EGFR mutation-positive non-small cell lung cancer (NSCLC) patients. However, long-term follow-up and knowledge of clinical factors and TKI treatment patterns, which may be associated with longer OS, remains unclear. Using nationwide registry data, the aim was to investigate survival, prognostic factors for OS, and first line TKI treatment pattern of stage IIIB/IV NSCLC patients in Sweden.

      a9ded1e5ce5d75814730bb4caaf49419 Method

      In this cohort study, data on all patients diagnosed with stage IIIB-IV NSCLC during 2010—2015 from the nationwide Cancer Registry of Sweden were linked with data on dispensed EGFR-TKI drugs, comorbidity, and mortality data from Swedish national health registries. OS was defined as the interval from date of diagnosis until date of death. Survival rates were estimated using the Kaplan-Meier method. Assessment of predictive factors for OS was performed in multivariable Cox regression.

      4c3880bb027f159e801041b1021e88e8 Result

      Of 9,992 stage IIIB/IV NSCLC patients (mean age 70 years, female 49%), 1419 (14%) received first-line TKI treatment. Overall, 59% of TKI treated patients (median age 68 years) were female, 44% had at least one comorbidity, 85% had adenocarcinoma, and 89% were stage IV. Median follow-up time was 15 months and median OS was 16 months; 1- and 3-years survival rates were 62% and 15%, respectively. Predictors of longer OS were younger age at diagnosis, adenocarcinoma, less advanced clinical stage, and less comorbid disease. Furthermore, patients included in the end of the period had a longer OS compared to earlier. TKI treatment switching/re-challenging, as well as prolonged TKI treatment, also predicted longer OS.

      8eea62084ca7e541d918e823422bd82e Conclusion

      This is the first nationwide study on NSCLC patients receiving first-line EGFR TKIs in routine clinical practice in Sweden. In addition to the reported prolonged TKI treatment length and TKI switching/re-challenging during the observation period, improvements and extension of EGFR testing targeting the appropriate NSCLC patient population may further have contributed to the observed relatively long overall survival.

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      MA18.06 - Patterns of Lung Cancer Care in the United States: Developments and Disparities (Now Available) (ID 11991)

      14:00 - 14:05  |  Presenting Author(s): Erik Ferdinand Blom  |  Author(s): Kevin ten Haaf, Douglas Arenberg, Harry J De Koning

      • Abstract
      • Presentation
      • Slides

      Background

      The level of adherence to lung cancer treatment guidelines is unclear. The aims of this current study were to provide an overview of current patterns of lung cancer care in the United States and to identify possible disparities in receiving standard of care.

      a9ded1e5ce5d75814730bb4caaf49419 Method

      Using the National Cancer Database, we evaluated the first course therapy of 468,422 lung cancer cases diagnosed between 2010-2014. We used a series of multivariate logistic regression models to identify relationships between patient, tumor, and health care provider characteristics and receiving predefined stage-specific standards of care.

      4c3880bb027f159e801041b1021e88e8 Result

      Most common treatments were surgery only (15.2%), radiotherapy only (12.8%), chemotherapy only (13.5%), and radiotherapy and chemotherapy (26.2%). 22.1% of subjects received no treatment. Between 2010-2014, the use of Video-Assisted Thoracoscopic Surgery among surgically treated cases increased from 24.6% to 42.3%, while the rate of conversions to open surgery decreased from 18.3% to 10.4%. Among stage IA non-small cell lung cancer patients treated with thoracic radiotherapy, the use of Stereotactic Body Radiotherapy increased from 53.4% to 73.0%. Overall, only 63.3% of subjects received standard of care. Receiving surgery for early-stage non-small cell lung cancer was less likely with increasing age (for those 80 and over: odds ratio [OR], 0.08; 95% confidence interval [95%CI], 0.07-0.09), for non-Hispanic Blacks (OR, 0.59; 95%CI, 0.57-0.62), and for squamous cell histology (OR, 0.46; 95%CI, 0.45-0.47). These disparities were also present in other stages.

      8eea62084ca7e541d918e823422bd82e Conclusion

      Particularly elderly lung cancer patients, non-Hispanic Blacks, and those with squamous cell histology are less likely to receive standard of care. These disparities may have consequences for lung cancer screening, as the effectiveness depends on adequate treatment of lung cancer.

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      • Abstract
      • Presentation
      • Slides

      Background

      Continued smoking after a LC diagnosis is associated with poorer cancer outcomes including increased risk of treatment-related side-effects, reduced treatment efficacy and poorer prognosis. Smoking cessation is an integral part of LC survivorship by improving both cancer and non-cancer outcomes. To enhance survivorship education, clinicians should understand patient awareness of the harms of continued smoking.

      a9ded1e5ce5d75814730bb4caaf49419 Method

      LC survivors from Princess Margaret Cancer Centre, Toronto (2014-2017) were surveyed with respect to self-awareness of the harms of continued smoking on cancer-related outcomes. Univariable and multivariable logistic regression models assessed factors associated with awareness and whether awareness was associated with cessation among current smokers at diagnosis.

      4c3880bb027f159e801041b1021e88e8 Result

      Of 553 patients, 181 were lifetime never-smokers. Among those smoking during the peri-diagnosis period (n=177), 65% quit after diagnosis. Among all, few patients were aware that smoking negatively impacts treatment-related outcomes [complications from cancer surgery (only 41% aware), radiation side-effects (30%), quality-of-life on chemotherapy (44%) and treatment efficacy (36%)]; half were aware that smoking negatively impacts cancer prognosis (51% aware) and risk of developing second primaries (50%). Compared to ex-smokers/never-smokers at diagnosis, current smokers at diagnosis were less aware of the impact of smoking on radiation side-effects (22% vs 31% aware, P=0.01), prognosis (44% vs 55%, P=0.02) and risk of second primaries (42% vs 55%, P=0.007). Among sociodemographic variables, only those speaking English at home were consistently found more likely unaware that smoking negatively impacts these outcomes (ORs=1.52-2.20, P<0.04). Patients with early stage disease were more likely unaware that smoking negative impacts radiation side-effects (OR=1.60, 95%CI[1.09-2.35], P=0.02); while patients on curative treatment (OR=1.53[1.08-2.17], P=0.02) and those exposed to second-hand smoke (SHS) were more likely unaware that smoking impacts quality-of-life on chemotherapy (OR=1.64[1.05-2.58], P=0.03). Exposure to SHS, treatment intent and stage were not associated with awareness of impact on prognosis or second primaries (P>0.11). Among smokers in the peri-diagnosis period, awareness of the impact of smoking on surgical complications (aOR=2.09 [0.96-4.54], P=0.06), quality-of-life while receiving chemotherapy (aOR=2.60[1.17-5.79], P=0.02) and on treatment efficacy (aOR =2.24[0.97-5.20], P=0.06) were each associated with subsequent quitting, adjusted for marital status, pack-years, self-rated health and SHS exposure.

      8eea62084ca7e541d918e823422bd82e Conclusion

      Many LC patients are unaware of the harms of continued smoking on cancer outcomes, particularly those smoking at diagnosis. Awareness of some of these outcomes was associated with subsequent tobacco cessation. Patient education on the health benefits of smoking cessation may increase quit rates and improve outcomes for LC patients.

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      MA18.08 - Discussant - MA 18.05, MA 18.06, MA 18.07 (Now Available) (ID 14652)

      14:10 - 14:25  |  Presenting Author(s): Vera Hirsh

      • Abstract
      • Presentation
      • Slides

      Abstract not provided

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      MA18.09 - Predictors of Health Utility Scores (HUS) in Advanced EGFR-Mutated NSCLC. (Now Available) (ID 13087)

      14:25 - 14:30  |  Presenting Author(s): Shirley Xue Jiang  |  Author(s): Manjusha Hurry, Katrina Hueniken, M Catherine Brown, Mindy Liang, Devalben Patel, Catherine Labbe, Lawson Eng, Hiten Naik, Penelope Bradbury, Natasha B Leighl, Frances A Shepherd, Wei Xu, Geoffrey Liu, Ryan N. Walton, Grainne M O'Kane

      • Abstract
      • Presentation
      • Slides

      Background

      Advanced NSCLC patients with EGFR mutations (EGFRm) are currently treated with first - to third-generation tyrosine kinase inhibitors (TKIs). In the advanced setting, quality of life is an important goal; we therefore evaluated determinants of HUS in this population.

      a9ded1e5ce5d75814730bb4caaf49419 Method

      In a prospective, observational study, patients with advanced EGFRm NSCLC completed EQ-5D surveys at outpatient visits generating HUS (range 0-1). Patients were allowed to enrol at any point in their disease course. Baseline clinical characteristics and outcome data were extracted from chart review. Patient imaging was reviewed and health states (stable/progressing) at each encounter recorded. Univariable analyses conducted using ANOVA and multivariable regression analyses with generalized estimating equations identified factors associated with HUS.

      4c3880bb027f159e801041b1021e88e8 Result

      From November 2014 to July 2017, 782 encounters (follow-up visits) were collected for 244 patients. Median age at first encounter was 64 years (range:29-96); 54% were female and 54% Asian. Median time from diagnosis of stage IV NSCLC to first encounter was 23 months (range:0-67). The median number of HUS collected per patient was 2 (range:1-14). For patients with multiple visits the median time between completed questionnaires was 1.8 months (1-18). 105 patients (43%) presented with or developed brain metastases during the study period. In a univariable analysis, regardless of treatment line, mean HUS (mHUS) on osimertinib was 0.85 (standard deviation (SD):0.15) (n=33 patients; 114 encounters) compared to mHUS=0.80 (SD:0.17) on gefitinib (n=147, 351 encounters); mHUS=0.72 (SD:0.16) on chemotherapy (n=32, 76 encounters); and mHUS=0.79 (SD=0.15) on other TKIs (n=49, 133 encounters); p<0.001. In a multivariable analysis, disease progression (p=0.04) and ECOG performance status >0 (p<0.001) were associated with lower HUS. In contrast, treatment with osimertinib (when compared to a reference group of first-generation TKIs, gefitinib/erlotinib) was associated with improved HUS (p=0.01), while line of therapy and number of metastatic sites of disease were not associated with HUS. In addition, brain metastases had no significant impact on HUS (p=0.33).

      8eea62084ca7e541d918e823422bd82e Conclusion

      Progressive disease and worse performance status associate with lower HUS in patients with EGFRm NSCLC. Patients treated with osimertinib had the highest HUS when compared with a reference group of first-generation EGFR TKIs regardless of line of therapy. These results may help in the choice of EGFR-TKI, especially in patients with a poor performance status.

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      MA18.10 - Evolving Immunotherapy Practice Patterns in Advanced NSCLC: Analysis of an Online Treatment Decision Tool (Now Available) (ID 13848)

      14:30 - 14:35  |  Presenting Author(s): David R. Gandara  |  Author(s): Timothy A Quill, Martin J. Edelman, Suresh S. Ramalingam, Heather A Wakelee, Howard West, Kevin L Obholz

      • Abstract
      • Presentation
      • Slides

      Background

      Checkpoint immunotherapy (IO) is revolutionizing NSCLC therapy. We have previously published results of an online decision support tool designed to provide clinicians with education and expert guidance (Chow et al: JTO 2015). Here we report an analysis of a recently updated version of this online tool, capturing the impact of emerging IO options.

      a9ded1e5ce5d75814730bb4caaf49419 Method

      From June 2016 to July 2017, the NSCLC decision tool was updated to incorporate new treatment options for 280 different case scenarios. Briefly, oncologists entered patient and disease characteristics and then their planned treatment into the tool. Afterwards recommendations from 5 lung cancer experts were provided for that specific patient scenario.

      4c3880bb027f159e801041b1021e88e8 Result

      This analysis includes 1481 individual cases entered by 863 practicing oncologists between June 2016 and April 2018 (USA 19%, Europe 33%, Rest of World 48%). During this time, treatment choices for EGFR and ALK cancers by oncologists closely resemble those of experts. After approval of 1st-line pembrolizumab for patients with high PD-L1 expression, oncologists recommended pembrolizumab less often than experts (67% vs 95%). In the 2nd-line setting following platinum chemotherapy, both tumor histology and PD-L1 expression level impacted treatment recommendations (see Table). For PD-L1 expression < 1%, recommendations between oncologists and experts differed substantially.

      Second-line setting after platinum chemotherapy
      Participants' Treatment Choice Experts' Treatment Choice
      2016 2017 2016 2017
      Nonsquamous
      PD-L1 (1%)

      54% IO

      34% CT

      (n = 35)

      79% IO

      15% CT

      (n = 47)

      100% IO

      85% IO

      15% CT

      PD-L1 (< 1%)

      28% IO

      65% CT

      (n = 104)

      49% IO

      41% CT

      (n = 63)

      40% IO

      55% CT

      75% IO

      25% CT

      Squamous
      PD-L1 (1%)

      62% IO

      25% CT

      (n = 24)

      74% IO

      4% CT

      (n = 23)

      100% IO

      100% IO

      PD-L1 (< 1%)

      28% IO

      65% CT

      (n = 74)

      38% IO

      40% CT

      (n = 45)

      85% IO

      15% CT

      80% IO

      20% CT

      8eea62084ca7e541d918e823422bd82e Conclusion

      This updated analysis of an online NSCLC decision-making tool integrates recent changes to the treatment landscape in 2017, capturing emerging patterns in IO therapy. Compared to earlier versions, practicing oncologist’s choice of 1st-line EGFR- and ALK- targeted therapy more closely tracked with experts during this period, while selection of IO differs from expert recommendations. A detailed analysis of expert versus online user data will be presented.

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      MA18.11 - Implementing a Comprehensive National Audit of Lung Cancer Surgery: The English Lung Cancer Clinical Outcomes Publication (LCCOP) Project (Now Available) (ID 12090)

      14:35 - 14:40  |  Presenting Author(s): Doug West  |  Author(s): Richard Page, Neal Navani, Susan V Harden, Aamir Khakwani, Richard Hubbard, Paul Beckett

      • Abstract
      • Presentation
      • Slides

      Background

      We report the establishment of a national audit of outcomes after lung cancer resection (LCCOP) in the English National Health Service (NHS), a government healthcare system providing the great majority of lung cancer surgery. LCCOP is a compulsory audit commissioned by NHS England.

      a9ded1e5ce5d75814730bb4caaf49419 Method

      Unusually, for a surgical audit, data is initially obtained from the cancer registry, and matched to national Hospital Episode Data (HES), before local validation by clinical teams. After case mix adjustment, unit level survival rates at 30, 60 and 90 days, and length-of-stay data are published online and in an annual report. The first annual report was released in 2014.

      Survival is adjusted for age, sex, performance status, stage, laterality, FEV1 percentage, comorbidity and socioeconomic status

      4c3880bb027f159e801041b1021e88e8 Result

      The number of resections rose by 21% between 2015-2017 (4892 to 5936). Median annual activity per surgeon rose from 30 to 49 cases between 2014-2017, a 63% increase. In 2015 survival at 30, 90 and 365 days was 98.1%, 96.3% and 87.9% respectively. Median length of stay was 6 days (IQR 4-9).

      In 2015, 43.9% of lobectomies were completed by VATS, 4.3% were started VATS and completed by open surgery and 0.7% completed by robotics.

      Adjusted 90 day survival by surgical unit: 2017 report (2015 data)

      90 day 2017(15).png

      8eea62084ca7e541d918e823422bd82e Conclusion

      Using routinely collected NHS activity data for surgical audit is feasible, and reduces the data collection burden for hospital teams. Clinical validation remains important to correct discrepancies. Surgical activity has risen significantly. Increases in individual surgeon case volume may reflect increasing subspecialisation. Significant inter-provider variation remains, particularly in length of stay.

      More lung cancer surgery is being done in the English NHS. Surgeons are increasingly subspecialising, with higher case volumes. Local variation remains, particularly around length of stay. A mixed model of routinely collected data with local validation appears acceptable to clinical units.

      6f8b794f3246b0c1e1780bb4d4d5dc53

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      MA18.12 - Discussant - MA 18.09, MA 18.10, MA 18.11 (Now Available) (ID 14653)

      14:40 - 14:55  |  Presenting Author(s): Martin R Stockler

      • Abstract
      • Presentation
      • Slides

      Abstract not provided

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    MS08 - Lung Cancer in the Real World (ID 787)

    • Event: WCLC 2018
    • Type: Mini Symposium
    • Track: Treatment in the Real World - Support, Survivorship, Systems Research
    • Presentations: 5
    • Now Available
    • Moderators:
    • Coordinates: 9/24/2018, 13:30 - 15:00, Room 201 F
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      MS08.01 - How Can Real World Data Improve Clinical Evidence Generation and Impact Regulatory Bodies - European Perspective (Now Available) (ID 11432)

      13:30 - 13:45  |  Presenting Author(s): Yolande Lievens

      • Abstract
      • Presentation
      • Slides

      Abstract

      Health technology assessment (HTA) evaluates the efficacy and effectiveness of new interventions, integrates these data with the costs to define efficiency and addresses future availability and distribution. As such, HTA focuses on accessibility, affordability and equity. Economic evaluations are central in this concept: weighing costs and effects, they support evidence-based decisions on reimbursement, thus endorsing the introduction of innovative healthcare interventions in daily practice.

      After more than 20 years of voluntary cooperation on HTA in Europe, more than 50 HTA bodies are currently operating in the European Union (EU), be it still fragmented with different systems, different procedures and different requirements regarding the type of clinical evidence. Efficacy, the outcome a new intervention provides in the well-defined circumstances of a randomised controlled trial (RCT) and typically the input used to derive cost-effectiveness evidence, may not provide the best insight into the impact of an intervention in daily clinical care. Moreover, in contrast to what is the case for pharmaceuticals, it is much more difficult to perform RCTs on radiotherapy or surgery, especially when it comes to evaluating the incremental evolution typical for new techniques and technologies, or the long-term benefits anticipated to follow more accurate treatment delivery. This has resulted in different regulatory systems for systemic and non-systemic treatment strategies, with attempts to come to a more homogenised HTA approach in the EU having so far failed.

      Real-world data are gradually expanding their role in the evidence generation of lung cancer radiotherapy. A first step moving away from RCTs is to adopt a more pragmatic approach to evidence generation, as is the case in the OligoCare project. This joint ESTRO-EORTC initiative is evaluating the outcome of oligometastatic patients, amongst others from primary lung cancer, treated with radical radiotherapy in a large prospective cohort study. Various patterns of care studies have generated clinical evidence on the uptake of new treatment techniques such as SBRT (Stereotactic Body Radiotherapy), on the value of multimodality treatments for locally-advanced non-small cell lung cancer (NSCLC) beyond the context of RCTs, or have allowed to develop prediction models to support shared decision-making. Furthermore, the wealth of data available in cancer registries and other nation-wide databases can be leveraged to learn more about the quality of care, actual access to different treatment strategies, geographical and institutional variations and their potential impact on lung cancer survival. Real-life data can also be used to generate the cost information necessary to perform cost-effectiveness evaluations. Besides the more frequent approach to derive this evidence from reimbursement data, actual resource costs can also be computed in daily practice. One such initiative was undertaken in Belgium, using Time-Driven Activity-Based Costing to compute real-life costs of radiotherapy, and more specifically of innovative radiotherapy techniques such as SBRT.

      Whereas all these examples provide interesting insight into the clinical and financial consequences of access to standard-of-care and innovative lung cancer radiotherapy, there is a dearth of information on how this evidence defines policy. One interesting approach to change practice is using coverage with evidence generation to provide early access to radiotherapy innovations, while stimulating the further generation of data. Such a programme of provisional financing has been set-up in Belgium to generate evidence from daily practice on SBRT for primary tumours, most typically early-stage NSCLC, and for oligometastatic disease. While this programme allowed radiation oncology centres to develop and provide SBRT without being financially penalised, it also generated the reassuring clinical evidence that will soon lead to the inclusion of SBRT in the formal national radiotherapy reimbursement system.

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      MS08.02 - How Can Real World Data Improve Clinical Evidence Generation and Impact Regulatory Bodies – US Perspective (Now Available) (ID 14624)

      13:45 - 14:00  |  Presenting Author(s): Gideon Blumenthal

      • Abstract
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      Abstract not provided

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      MS08.03 - Sources of Real World Data: Research Designs, Statistical Modelling and Quality Assurance Requirements (Now Available) (ID 11433)

      14:00 - 14:15  |  Presenting Author(s): Mary W. Redman

      • Abstract
      • Presentation
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      Abstract not provided

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      MS08.04 - The ASCO Perspective (Now Available) (ID 11434)

      14:15 - 14:30  |  Presenting Author(s): Bruce E Johnson

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      Abstract not provided

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      MS08.05 - The ESTRO Perspective (Now Available) (ID 11435)

      14:30 - 14:45  |  Presenting Author(s): Umberto Ricardi

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    MS13 - Novel Mediators of Lung Cancer Metastasis (ID 792)

    • Event: WCLC 2018
    • Type: Mini Symposium
    • Track: Biology
    • Presentations: 5
    • Now Available
    • Moderators:
    • Coordinates: 9/25/2018, 10:30 - 12:00, Room 201 F
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      MS13.01 - Liquid Biopsy-mediated Identification of Metastatic Variants (Now Available) (ID 11453)

      10:30 - 10:45  |  Presenting Author(s): Philip Christopher Mack

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      Abstract not provided

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      MS13.02 - Capicua Inactivation Drives Lung Cancer Metastasis (Now Available) (ID 11454)

      10:45 - 11:00  |  Presenting Author(s): Trever G Bivona

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      • Presentation
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      Abstract not provided

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      MS13.03 - Ubiquilin as a Novel Mediator of Lung Cancer Invasion and Metastasis (Now Available) (ID 11455)

      11:00 - 11:15  |  Presenting Author(s): Levi J. Beverly

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      • Presentation
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      Abstract

      Data from large, publicly available datasets indicate multiple somatic non-synonymous recurrent mutations in Ubiquilin (UBQLN) family genes or loss of either UBQLN1 or UBQLN2 loci in over 50% of human lung adenocarcinoma patient samples. The UBQLN family consists of 5 related proteins (UBQLN1-4 and UBQLNL) that all contain ubiquitin-like (UBL) and ubiquitin-associated (UBA) domains. Our work was the first to show that UBQLN proteins regulate processes involved in tumorigenesis. In fact, our work now conclusively demonstrates that Ubiquilin1 is a bona fide metastasis suppressors in human lung adenocarcinoma. Importantly, since the vast majority of patients that succumb to lung cancer, die from the metastatic disease and not from the primary tumor burden the combination of these data suggest that nearly 700,000 people die world-wide every year from lung cancers that have decreased or altered UBQLN function. The exact mechanism by which loss of UBQLN proteins leads to metastatic progression remains unclear, however metastatic cancer progression requires cells to acquire new aggressive properties, such as increased migration, invasion, survival and growth at the metastatic site. The identification of regulators of these properties will be crucial for our future success in decreasing metastatic progression and thus cancer mortality rates. The goal of our lab is to understand the detailed mechanisms by which disruption of UBQLN proteins contributes to the metastatic progression of hLAC. We demonstrate that (i.) loss of UBQLN1 or UBQLN2 increases proliferation, EMT, migration and invasion of hLAC cells, in vitro; (ii.) loss of UBQLN1 activates multiple signaling pathways known to regulate cell motility, such as IGF1R and Integrin/FAK; (iii.) inhibition of SRC kinase blocks migration, but not proliferation of cells lacking UBQLN1; (iv.) and finally, loss of UBQLN1 increases metastasis of hLAC cells in vivo. By understanding how UBQLN1 functions to protect cells from tumor progression and metastatic dissemination we may be able to use UBQLN1 status as a predictive biomarker for disease staging or as an indicator for which patients will respond to a given therapeutic. Further, by understanding how UBQLN1 alters signaling pathways that contribute metastatic progression, we may be able to target these downstream pathways specifically in tumors with altered UBQLN1 function to block metastasis, thus potentially affecting millions of lung cancer patients in the coming decades.

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      MS13.04 - Tracking the Evolution of Non-Small-Cell Lung Cancer (Now Available) (ID 11456)

      11:15 - 11:30  |  Presenting Author(s): Charles Swanton  |  Author(s):

      • Abstract
      • Presentation
      • Slides

      Abstract

      Increasing evidence supports complex subclonal relationships in solid tumours, manifested as intratumour heterogeneity. Parallel evolution of subclones, with distinct somatic events occurring in the same gene, signal transduction pathway or protein complex, suggests constraints to tumour evolution that might be therapeutically exploitable. Emerging data from TRACERx, a longitudinal lung cancer evolution study will be presented. Drivers of tumour heterogeneity change during the disease course and contribute to the temporally distinct origins of lung cancer driver events. APOBEC driven mutagenesis appears to be enriched in subclones in multiple tumour types. Oncogene, tumour suppressor gene and drug induced DNA replication stress are found to drive APOBEC mutagenesis. Evidence that intratumour heterogeneity and chromosomal instability is finely tuned will be presented, to create sufficient diversity for adaptation mitigating the risks of excessive genome instability resulting in cell autonomous lethality. On-going chromosomal instability, manifested as Mirrored Subclonal Allelic Imbalance (MSAI) is found to be a major driver of intratumour heterogeneity in non-small cell lung cancer, contributing to parallel evolution and selection. The finding of subclonal driver events, evidence of ongoing selection within subclones, combined with genome instability driving cell-to-cell variation is likely to limit the efficacy of targeted monotherapies, suggesting the need for new approaches to drug development and clinical trial design and integration of cancer immunotherapeutic approaches. The clonal neo-antigenic architecture may act as a tumour vulnerability, targeting multiple clonal neo-antigens present in each tumour to mitigate resistance and treatment failure. The role of cancer genome instability driving immune evasion and HLA/MHC loss and immune escape will be presented.

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      MS13.05 - Discussant (Now Available) (ID 11457)

      11:30 - 11:45  |  Presenting Author(s): David Beer

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      Abstract not provided

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

    • Event: WCLC 2018
    • 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
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      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
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      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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    MTE18 - Case-Based Management of Patients with Inadequate Tissue for Molecular Tests (Ticketed Session) (ID 828)

    • Event: WCLC 2018
    • Type: Meet the Expert Session
    • Track: Advanced NSCLC
    • Presentations: 1
    • Now Available
    • Moderators:
    • Coordinates: 9/25/2018, 07:00 - 08:00, Room 201 F
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      MTE18.01 - Case-Based Management of Patients with Inadequate Tissue for Molecular Tests (Now Available) (ID 11577)

      07:00 - 08:00  |  Presenting Author(s): Benjamin P Levy, Adrian Sacher

      • Abstract
      • Presentation
      • Slides

      Abstract

      Plasma genotyping has rapidly evolved from an investigational technology into a standard-of-care tool with the potential to direct therapy in metastatic non-small cell lung cancer (NSCLC). Tissue genotyping has historically been considered the gold standard for genotyping in NSCLC both at initial diagnosis and acquired resistance to therapy. However, plasma genotyping is increasingly useful as a rapid alternative to tissue genotyping in certain clinical contexts. This technology is particularly applicable in patients with insufficient tissue available for genotyping at initial diagnosis as well as at the development of acquired resistance. The optimal use and interpretation of plasma genotyping requires understanding of cell-free DNA (cfDNA) biology, assay characteristics and the application of testing in different clinical scenarios.

      In newly diagnosed metastatic NSCLC, plasma genotyping is useful for the detection of targetable genomic alterations or non-targetable driver alterations (eg, KRAS) that are mutually exclusive with targetable alterations. The potential utility of plasma genotyping in newly diagnosed patients is particularly pronounced in patients with insufficient tissue from their diagnostic biopsies for genotyping, those with inaccessible or difficult to biopsy lesions and patients in which rapid initiation of treatment is needed due to clinical deterioration. The high positive predictive value of most modern plasma genotyping platforms for the detection of targetable genomic alterations means that positive results can be used to rapidly guide initial targeted therapy in metastatic NSCLC patients. However, the modest sensitivity of these assays requires that negative results be confirmed by tissue genotyping with repeat biopsy, if necessary.

      In patients with acquired resistance to targeted therapy, plasma genotyping can be utilized to detect resistance mutations at the time of progression. Furthermore, plasma genotyping may detect resistance mutations missed by standard tissue genotyping in this context due to tumor heterogeneity. Plasma T790M testing in patients with acquired resistance to first- and second-generation EGFR kinase inhibitors has been utilized extensively for selecting patients for treatment with second-line osimertinib. However, the utility of this technology in acquired resistance to EGFR therapy is likely to decrease as more patients are treated with front-line osimertinib without a targeted therapy option at development of acquired resistance. The recent explosion of multiple treatments for ALK acquired resistance has opened a new opportunity to apply plasma genotyping technology for the selection of second-line targeted therapy in these patients.

      While cfDNA technology has aided in the detection of actionable mutations, there remain challenges at present related to modest assay sensitivity, standardization of both analytic and clinical validation across testing platforms and adapting this technology to the ever-changing treatment landscape of metastatic NSCLC. In addition, DNA captured in plasma may be from multiple sources other than tumor, including germline, fetal, post-organ transplantation and clonal hematopoiesis of indeterminate potential (CHiP). These mixed sources have been routinely detected in commercial-based assays and can affect the interpretability of assay results.

      Despite potential limitations, cfDNA platforms offer immense promise in serving as an accurate molecular proxy for tumor biology. There is considerable potential for plasma genotyping in the detection of early-stage disease and for patients at risk for disease recurrence post curative intent therapy. In addition, there may be future utility with these assays in the detection of tumor mutational burden (TMB) and other predictive biomarkers of immunotherapy. Future prospective efforts that mandate plasma interrogation both as a static and dynamic biomarker will enable a firmer understanding of how best to utilize this unique technology.

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    MTE28 - Lessons from the Past-What I Would Not Do Again in Diagnostic and Therapeutic IP (Ticketed Session) (ID 838)

    • Event: WCLC 2018
    • Type: Meet the Expert Session
    • Track: Interventional Diagnostics/Pulmonology
    • Presentations: 2
    • Now Available
    • Moderators:
    • Coordinates: 9/26/2018, 07:00 - 08:00, Room 201 F
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      MTE28.01 - Lessons from the Past-What I Would Not Do Again in Diagnostic and Therapeutic IP (Now Available) (ID 11595)

      07:00 - 07:30  |  Presenting Author(s): Navneet Singh  |  Author(s): Inderpaul S Sehgal

      • Abstract
      • Presentation
      • Slides

      Abstract

      Lung cancer and pulmonology are inseparable – as lung cancer patients are invariably first seen by pulmonologists, often undergo diagnostic and staging procedures performed by pulmonologists, get evaluated by pulmonologists for fitness for surgical resection (in early stage disease), are treated by pulmonologists at certain geographical regions of the world, undergo follow up with pulmonologists for treatment related complications and/or symptom palliation related to either the disease or associated pulmonary co-morbid conditions. The current focus of this abstract is the role of diagnostic and therapeutic interventional pulmonology (IP) in the context of lung cancer. The growing armamentarium of IP includes several procedures as listed in Table 1 below

      PROCEDURE ROLE
      1. Flexible bronchoscopy
      a) Endobronchial biopsy (EBBx) Diagnosis
      b) Transbronchial lung biopsy (TBLB) Diagnosis
      c) Conventional TBNA (c-TBNA) Diagnosis, Staging
      2. Endobronchial ultrasound (EBUS)
      a) Convex probe EBUS Staging, Diagnosis
      b) Radial probe EBUS Diagnosis
      3. Medical Thoracoscopy
      a) Flexi-rigid Diagnosis, Palliation
      b) Rigid Diagnosis, Palliation
      4. Rigid bronchoscopy
      a) Mechanical coring Palliation, Diagnosis
      b) Stent placement Palliation
      c) Argon plasma coagulation Palliation
      d) Electrocautery Palliation
      e) Laser Palliation
      f) Cryotherapy Palliation

      Endobronchial biopsy (EBBx):

      This is the most frequently performed bronchoscopic procedure for diagnosis of lung cancer. Its relatively safe with a high diagnostic yield (76%-97%). As airway bleeding is one of the commonly encountered problems, the learning points include:

      1)Hot (electrocautery enabled) biopsy from vascular lesions

      2)Avoid biopsy from cavity

      3)Avoid biopsy from an excavating ulcer with vascular supply

      4)Avoid biopsy from tracheal tumor or tumor at the tracheal carina

      Importantly, biopsy with electrocautery enabled forceps does not affect the tissue quality or the diagnostic yield.

      Transbronchial lung biopsy (TBLB):

      In certain situations TBLB is needed for diagnosing diffuse infiltrative lung disease in the setting of lung cancer including but not limited to lymphangitis, drug-induced interstitial lung disease, radiation pneumonitis and secondary infection.

      As pneumothorax, airway bleeding and crush artefacts are the commonly encountered problems, the important learning point is:

      1)Do not use cup forceps for doing TBLB. Alligator forceps is preferred. It is likely that the cup forceps cuts through the blood vessels, whereas the alligator forceps crushes the blood vessels, thus leading to higher bleeding with the former method. In addition, the cup forceps has a smaller diameter (4 mm) compared with the alligator forceps (7 mm) in the open position; thus,it possibly reaches the lung segments more distally compared with the alligator forceps, leading to more pneumothoraces.

      Bronchoscopic staging procedures:

      EBUS-TBNA is an accurate, safe and cost-effective tool for lung cancer staging. It has been shown to have a pooled sensitivity and specificity of 93% and 100% respectively. The subgroup of patients who were selected on the basis of CT or PET positive results had higher pooled sensitivity than those without any selection (94% vs. 76%; p<0.05). EBUS-TBNA and EUS-FNA have been shown to have similar yield but lower complication rates as compared to mediastinoscopy in the initial mediastinal staging of non-small cell lung cancer. These endosonographic procedures are also safe and highly specific (99%) for mediastinal restaging of lung cancer

      The important learning points are:

      1)Use of EBUS-TBNA results in significantly shorter time to treatment decision compared to conventional techniques

      2)Do not use conventional TBNA for staging of lung cancer. EBUS-TBNA is preferred for both diagnosis and staging

      3)Upfront mediastinoscopy for lung cancer staging in untreated patients and for restaging in patients after neoadjuvant chemotherapy (or neoadjuvant chemoradiation) is not needed as endoscopic procedures (EBUS-TBNA, EUS-FNA or their combination) are preferred for both of these

      Medical thoracoscopy:

      Medical thoracoscopy is a very useful procedure for both diagnosis of malignant pleural effusions as well as performing pleurodesis. Most patients present late at our center with extensive pleural adhesions and fibrosis. In such cases, flexi-rigid thoracoscopy has a lower yield in such cases (73% vs. 98%). The important learning point is:

      1)Do not use flexi-rigid thoracoscopy for diagnosis of malignant pleural effusions

      Rigid bronchoscopic procedures:

      These are often undertaken as part of intervention for airway obstruction/stenosis. The important learning points are:

      1)Avoid complex intervention procedures using flexible bronchoscope - prefer doing them using a rigid bronchoscope

      2)Avoid placing stents when the distal airways are involved

      3)When in doubt, place a silicon stent. Silicon stents are easy to extract, work even in malignant disorders, can always be replaced by metallic stents. Sometimes, what appears malignant may not be so and in tuberculosis endemic countries, endobronchial tuberculosis is a great mimicker of malignancy

      4)Never place uncovered metallic stent for malignant disorders

      5)Do not place metallic Y-stents using flexible bronchoscopy as this can be associated with criss-crossing of guidewires, loss of airway control (and immediate conversion to rigid bronchoscopy) and need for fluoroscopic guidance

      6)Do not place silicone stents using flexible bronchoscopy

      In summary, each bronchoscopic procedure has inherent risks and potential for unintended complications. Therefore, each procedure teaches us something. The crux of safety in the context of diagnostic and therapeutic IP in lung cancer is to avoid performing biopsy during flexible bronchoscopy in tracheal tumors associated with airway obstruction, to use EBUS-TBNA for diagnosing/staging lung cancer, performing all complex interventions with a rigid bronchoscope and avoiding stent placements in patients with distal airway involvement. The most important principle for IP and practice of medicine, in general, is Primum non nocere (first do no harm).

      Navneet Singh MD DM

      Email: navneetchd@hotmail.com; singh.navneet@pgimer.edu.in

      [The author is a thoracic medical oncologist-cum-pulmonologist currently working as an Additional Professor of Pulmonary Medicine at PGIMER, Chandigarh, India. He is a member of IASLC’s Staging & Prognostic Factors Committee and is IASLC’s Regent for Indian Subcontinent. Additionally, he is Chair of American Society of Clinical Oncology’s (ASCO) International Development and Education Award (IDEA) Working Group and member of its Thoracic-Cancer Guideline Advisory Group. His detailed profile is accessible at http://www.linkedin.com/in/navneet-singh-160012.]

      Acknowledgement: Dr. Inderpaul Singh Sehgal, Assistant Professor of Pulmonary Medicine, PGIMER, Chandigarh, India

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      MTE28.02 - Lessons from the Past-What I Would Not Do Again in Diagnostic and Therapeutic IP (Now Available) (ID 14696)

      07:30 - 08:00  |  Presenting Author(s): Jason S Agulnik

      • Abstract
      • Presentation
      • Slides

      Abstract

      Lung cancer is the leading cause of cancer death. The Canadian Cancer Society estimates that there were 28,600 new lung cancer cases diagnosed in 2017 in Canada. It is estimated that there were 21,100 deaths from lung cancer in Canada in 2017. Once a diagnosis of lung cancer is made, proper staging is imperitiive. The lung cancer staging system not only predicts the prognosis but also guides the treatment options. Proper staging requires both imaging tests and biopsies. The mediastinal lymph nodes often need to be sampled to differentiate an early stage lung cancer versus a locally advanced stage III NSCLC. ACCP guidelines for methods for staging NSCLC were last published in 2013 and recommend the following:
      4.4.4.1. In patients with discrete mediastinal lymph node enlargement (and no distant metastases) with or without PET uptake in mediastinal nodes, invasive staging of the mediastinum is recommended over staging by imaging alone (Grade 1C).
      4.4.4.2. In patients with PET activity in a mediastinal lymph node and normal appearing nodes by CT (and no distant metastases), invasive staging of the mediastinum is recommended over staging by imaging alone (Grade 1C).
      4.4.4.3. In patients with high suspicion of N2,3 involvement, either by discrete mediastinal lymph node enlargement or PET uptake (and no distant metastases), a needle technique (EBUS-NA, EUS-NA or combined EBUS/EUS-NA) is recommended over surgical staging as a best first test (Grade 1B).
      4.4.6.1. In patients with an intermediate suspicion of N2,3 involvement, ie, a radiographically normal mediastinum (by CT and PET) and a central tumor or N1 lymph node enlargement (and no distant metastases), invasive staging of the mediastinum is recommended over staging by imaging alone (Grade 1C).
      4.4.6.2. In patients with an intermediate suspicion of N2,3 involvement, ie, a radiographically normal mediastinum (by CT and PET) and a central tumor or N1 lymph node enlargement (and no distant metastases), a needle technique (EBUS-NA, EUS-NA or combined EBUS/EUS-NA) is suggested over surgical staging as a best first test (Grade 2B).
      Mediastinoscopy was a common modality for staging the mediastinum and is considered the gold standard for comparative studies. In 2002, a paper by Herth et al. described for the first time endobronchial ultrasound TBNA for lymph node staging. Non-invasive staging is now recommended as the first procedure to stage the mediastinum. Several papers have demonstrated similar results for EBUS TBNA compared to mediastinoscopy. EBUS TBNA is now commonly used as the first modality for mediastinal staging in lung cancer and is considered an essential tool for the interventional pulmonologist. Despite the advantages of EBUS TBNA, there are still occasions when mediastinoscopy is required. Several cases will be discussed that required mediastinoscopy after nondiagnositic EBUS or EUS biopsies.

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    OA04 - Improving Access and Outcomes in Lung Cancer Management (ID 898)

    • Event: WCLC 2018
    • Type: Oral Abstract Session
    • Track: Nursing and Allied Professionals
    • Presentations: 8
    • Now Available
    • Moderators:
    • Coordinates: 9/24/2018, 10:30 - 12:00, Room 201 F
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      OA04.01 - What is the Cost of a Strong Evidence for the Treatment of Advanced Non-Small Cell Lung Cancer? (Now Available) (ID 14410)

      10:30 - 10:40  |  Presenting Author(s): Pedro Aguiar Jr  |  Author(s): Barbara Gutierres, Barbara Dourado, Alanda Alves, Carmelia Maria Noia Barreto, Gilberto de Lima Lopes, Auro Del Giglio

      • Abstract
      • Presentation
      • Slides

      Background

      Evidence-based medicine was developed to guide medical decisions based upon the strongest scientific evidence available in the literature. However, large randomized clinical trials are expensive. In addition, new antineoplastic drugs development is also extremely expensive. Therefore, we hypothesized that the strongest evidence available nowadays comes from studies developed by the pharmaceutical industry.

      a9ded1e5ce5d75814730bb4caaf49419 Method

      We carried out a search on network databases for studies published between 2014 and 2017. We included only experimental studies that assessed the treatment for advanced or metastatic non-small cell lung cancer. All included studies were divided into two groups: studies funded by pharmaceutical industry and studies funded by other sources. The primary end point was to compare the evidence strength of each group. Secondary end points were to compare other aspects, such as the number of patients included by each group of studies and the number of innovative drugs studied by each group of studies.

      4c3880bb027f159e801041b1021e88e8 Result

      We found 1,502 studies and included 299 studies (154 sponsored by pharmaceutical industry and 145 funded by other sources). 52,988 patients were included in all studies (36,455 in studies sponsored by industry and 16,533 in studies with other funding sources; p < 0.001). The studies funded by pharmaceutical industry had the stronger evidence compared with studies with other sources of funding (p = 0.005). Moreover, studies sponsored by pharmaceutical industry studied more innovative therapies (72.4% versus 48.9%; p < 0.001) and had a higher proportion of open access manuscript (60.8% versus 43.9%; p = 0.004). Results are summarized in the table.

      Parameter Industry Sponsored P value

      Yes

      154 (100%)

      No

      145 (100%)
      Number of patients 36,455 16,533 <0.001
      Mean N of patients 236.7 115.6
      Line First 110 (71.4%) 94 (64.8%) 0.220
      Second or more 44 (28.6%) 51 (35.2%)
      Biomarker Yes 55 (35.9%) 55 (37.9%) 0.723
      No 98 (64.1%) 90 (62.1%)
      Innovative Tx Yes 110 (72.4%) 69 (48.9%) <0.001
      No 42 (27.6%) 71 (51.1%)
      Phase I 20 (13%) 25 (17.2%) 0.409
      II 101 (65.6%) 97 (66.9%)
      III 32 (20.8%) 21 (14.5%)
      IV 1 (0.6%) 2 (1.4%)
      Evidence Level 1 0 (0%) 1 (0.7%) 0.005
      2 76 (49.4%) 52 (35.9%)
      3 78 (50.6%) 87 (60%)
      4 0 (0%) 5 (3.4%)
      Experimental Yes 35 (47.3%) 26 (50%) 0.765
      Superiority No 39 (52.7%) 26 (50%)
      Open Access Yes 93 (60.8%) 61 (43.9%) 0.004
      Article No 60 (39.2%) 78 (56.1%)

      8eea62084ca7e541d918e823422bd82e Conclusion

      Studies funded by pharmaceutical industry had stronger evidence, tested more innovative therapies, and were more accessible to the readers compared with studies developed with other sources of funding. These findings may alert oncology cooperative groups to the need of more studies with more evidence strength.

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      OA04.02 - Demographic, Psychosocial, and Behavioral Associations with Cancer Screening Among a Homeless Population (Now Available) (ID 11252)

      10:40 - 10:50  |  Presenting Author(s): Lovoria B Williams  |  Author(s): Stephen W Looney, Thomas Joshua, Amber McCall, Martha S Tingen

      • Abstract
      • Presentation
      • Slides

      Background

      Although cancer incidence and mortality is declining, cancer remains among the leading causes of death worldwide. Research shows that cancer morbidity and mortality can be reduced by early detection. Yet, both cancer risks and screening behavior remain understudied in the United States homeless population. Lung cancer is the deadliest of cancers. Given the recent lung cancer screening guideline, it is especially important to assess population-based awareness of the screening recommendation among the homeless population, a population known to have higher cancer risk behaviors and lower cancer screening rates.

      a9ded1e5ce5d75814730bb4caaf49419 Method

      Researchers conducted a cross-sectional survey of homeless individuals (n =201) who attended a 1-day community event. Eligible study participants were English-speaking adults, aged 21 and above. Willing participants completed a 1-page 33 item paper survey. The analysis describes the demographic, psychosocial, and behavioral associations with cancer screenings and knowledge of the lung cancer screening recommendation.

      4c3880bb027f159e801041b1021e88e8 Result

      Participants’ mean age was 51.7 years (SD 13.6); the group was largely African American (77.3%) and male (67.9%). Despite higher cancer risk behaviors, knowledge of lung cancer screening and general participation rates for cancer screenings were below national benchmarks. Among women, the breast and cervical cancer screening rates were 46.5% and 85.1%. Among men, the prostate cancer screening rate was 34.2%. Among all participants, the colon cancer-screening rate was 44%. Cancer risk behaviors were higher than national rates and lung cancer screening knowledge was low (23.0%). Some cancer screening behaviors were associated with age, income, health status, obesity, tobacco use, and physical activity level.

      8eea62084ca7e541d918e823422bd82e Conclusion

      The associations of screening with modifiable risk factors such as smoking, physical activity and obesity suggests that relevant behavior change interventions are necessary among this high-risk population. Given the barriers to screening of poverty-stricken individuals, such as lack of transportation and access, nurses must not only educate patients on lung cancer screening, they must assist with identifying payment resources and care navigation. Moreover, nurses must be educated on the ambiguity and inconsistency among evidenced-based screening guidelines and be prepared to engage patients in shared decision-making that weighs the recommendations with the patient’s individual cancer risks. To improve cancer survival among disparate populations, sustained community outreach is necessary to increase awareness of screening recommendations, identify high-risk individuals, and navigate them to resources. It is imperative that resources are provided to support relevant behavior change interventions, such as tobacco cessation in this high-risk population.

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      OA04.03 - The Role of Comprehensive Genomic Profiling in the Community Setting  (Now Available) (ID 13559)

      10:50 - 11:00  |  Presenting Author(s): Kimberly Ann Rohan

      • Abstract
      • Presentation
      • Slides

      Background

      Comprehensive Genomic Profiling (CGP) is biomarker information to helo match patients to approved targeted therapies, immunotherapies, and clinical trials. This information can assist practitioners in caring for patients with solid tumors in decision making. Nurses play a key role in educating paitnets on how the testing is done, what information it will provide and how that information will be used in clinical practice.

      a9ded1e5ce5d75814730bb4caaf49419 Method

      A retrospective analysis was done on the results of Comprehensive Genomic Profiling (Foundation One) on paitents that were tested in our practice from 2014-2017. The Edward Cancer Center is a community hospital based cancer center in the western suburbs of Chicago. The practice has 7 oncologists and 4 Advanced Practice Nurses. The practice saw approximately 650 new cases of cancer last year. It is rare that a patient presents with Comprehensive Genomic Profining (CGP). Our center ordered CGP on 46 patients with a cancer diagnosis after discussion with their primary oncologist. Each case was reviewed for number of genomic alterations identified, treatment associated with potential for clinical trial benefit, therapies associated with lack of response and the clinical decisions that were made based on the findings.

      4c3880bb027f159e801041b1021e88e8 Result

      Of the 46 charts reviewed: 263 genomic alterations were identified, 172 therapies were associated with potential clinical benefit and 11 therapies associated with lack of response. Of these patients, 6 (13%) were referred to clinical trial and 12 (26%) resulted in change in therapy. Of the lung cancer patients, 2 (6%) were referred to clinical trial and 11 (34%) resulted in change in therapy.

      8eea62084ca7e541d918e823422bd82e Conclusion

      Comprehesive Genomic Profiling is a useful tool in identifying patients in the community setting for clinical trial enrollement. 6-13% exceeds the national clinical trial enrollment. The results also assist in directing patient care and in directing change of therapy to more targeted therapies or continuation of current therapy. There were 4 (8.5%) patients that opted to stop care and enroll in hospice care based on the CGP lresults.

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      OA04.04 - Discussant - OA 04.01, OA 04.02, OA 04.03 (Now Available) (ID 14552)

      11:00 - 11:15  |  Presenting Author(s): Jhanelle Elaine Gray

      • Abstract
      • Presentation
      • Slides

      Abstract not provided

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      OA04.05 - An Early Rehabilitation Intervention for Enhancing Oxygenation From Lung Cancer Surgery (Now Available) (ID 11990)

      11:15 - 11:25  |  Presenting Author(s): Wei Ling Hsiao

      • Abstract
      • Presentation
      • Slides

      Background

      The purpose of this study is to test the effects of an early rehabilitation intervention on oxygenation, postoperative complications, and recovery from lung cancer surgery.

      a9ded1e5ce5d75814730bb4caaf49419 Method

      The study uses an experimental design. Ninety patients scheduled for lung cancer surgeries was recruited from thoracic surgery units of a medical center in Taiwan. Patients were randomly assigned to the intervention or the control group. The intervention includes a 5-day postoperative in-hospital rehabilitation from post op day 1. The main components of the rehabilitation were aerobic and strength exercises as well as breathing training by using an incentive spirometry. Peripheral capillary oxygen saturation (SpO2) was measured in the morning of the preoperative day and of the 4 consecutive days from postoperative day one to four by using the Nellcor™ OxiMax N-65 Portable Pulse Oximeter. The SpO2/FiO2 (S/F) ratio was then calculated to assess patients’ oxygenation. Data on postoperative pulmonary compilations and durations of chest tube drainage were collected from the patients’ charts.

      4c3880bb027f159e801041b1021e88e8 Result

      The patients’ demographics and baseline measures were equivalent between groups. Results of GEE showed a significant group by time interaction effect on S/F ratio. As for the parameter estimates, from postoperative day 1 to day 4, the S/F ratio improvement in the intervention group was 74.49 (Wald X2 = 46.42, p<0.001) more than in the control group. Result of Chi-square test showed that the number of postoperative lung complications in the intervention group (n =1) was significantly less (X2 = 8.39, p = 0.004) than it in the control group (n =10). Result of t- test showed that the duration of chest tube drainage in the intervention group (2.00±1.00 days) was significantly shorter (t =-2.32, p = 0.022) than it in the control group (2.56±1.25 days).

      8eea62084ca7e541d918e823422bd82e Conclusion

      The study results support the effects of the early rehabilitation intervention on enhancing oxygenation, preventing complications, and promoting recovery from lung cancer surgery as indicated by shortened the duration of chest tube drainage. Surgery to remove the cancer is one of the primary treatment options for non-small cell lung cancer. However, lung cancer surgery may result in decreasing lung capacity and expansion; therefore, increase risks for postoperative pulmonary complications. Pulmonary rehabilitation designed to enhance lung expansion and ventilation may help to reduce postoperative lung complications and promote patients’ recovery from lung cancer surgery.

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      OA04.06 - Perceptions of Non-Participation in a Rehabilitation Intervention After Surgery for Non-Small Cell Lung Cancer (Now Available) (ID 12058)

      11:25 - 11:35  |  Presenting Author(s): Mai Nanna Schoenau  |  Author(s): Malene Missel

      • Abstract
      • Presentation
      • Slides

      Background

      Patients with non-small lung cancer (NSCLC) are difficult to engage in clinical trials. Few studies have examined in-depth why these patients refuse to participate. In a Danish randomized clinical trial; ’Postoperative rehabilitation in operable lung cancer patients (PROLUCA)’ only 32% of eligible participants consented to participate in the trial. The purpose of this qualitative study was therefore to explore perceptions, considerations and barriers of non-participation in PROLUCA.

      a9ded1e5ce5d75814730bb4caaf49419 Method

      This study was inspired by Reflective Life Research as developed by Dahlberg et al. as a descriptive and interpretive phenomenological research approach. Participants are patients who declined to participate in PROLUCA (non-participants). They were purposefully sampled and recruited from the group of patients who were found to be eligible for the exercise intervention but who declined to participate. Data were collected though telephone interviews. Openness, curiosity and sensitivity played an important role in carrying out the interviews. Analysis was performed according to Reflective Life Research.

      4c3880bb027f159e801041b1021e88e8 Result

      Fifteen non-participants consented to participate in qualitative interviews. Nine men and six women with a mean age of 68 years (range 48-84) were included. Mean time since surgery was 21 month (range 12-28). Five patients were working and ten were retired, eleven patients lived with a partner.

      The analysis revealed three essential themes referred to the patients’ experiences of being ‘Between healthy life and good life’, ‘Under the influence of society’ and their experiences of ‘Health and rehabilitation as a personal responsibility’. Perceptions of non-participation in rehabilitation after surgery for lung cancer are moderated between freedom and necessity. Patients experience ambivalence between a wish to participate in rehabilitation and not having the energy to participate. Patients refused to participate due to daily life priorities and lack of motivation which furthermore is related to social and interpersonal relationships. The patients exercise history is also essential in declining participation. Additionally the patients are under influence of norms and health perceptions from the society.

      8eea62084ca7e541d918e823422bd82e Conclusion

      Patients’ perception of "the good life" was fundamental for accepting or declining participation in a rehabilitation intervention study. Consideration and barriers of non-participation was influenced by norms from the society, motivation, priorities, exercise history, social and interpersonal relations.

      This study has contributed with a sensitive awareness of why patients following lung cancer surgery might refuse participating in rehabilitation. This knowledge can be taken into consideration in the planning of future clinical trials with lung cancer patients.

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      OA04.07 - Early Initiated Postoperative Rehabilitation Reduces Fatigue in Patients with Operable Lung Cancer: A Randomized Trial (Now Available) (ID 13733)

      11:35 - 11:45  |  Presenting Author(s): Morten Quist  |  Author(s): Maja Schick Sommer, Jette Vibe-Petersen, Maja Stærkind Bohlbro, Seppo W Langer, Klaus Richter Larsen, Karen Trier, Merete Christensen, Paul Frost Clementsen, Malene Missel, Carsten Henriksen, Kristina Poulsen, Henning Langberg, Jesper Holst Pedersen

      • Abstract
      • Presentation
      • Slides

      Background

      Surgical tolerability and perioperative risk of complications are correlated with high age, smoking history, comorbidities, low cardiorespiratory fitness (VO2peak) and low functional capacity, which paradoxically are characteristics describing the average patient with lung cancer. Little is known about the optimal amount and timing of exercise strain in concern of the operation wound and with regard improvement of physical function and quality of life (QOL). On this background, we decided to investigate the effect of early vs. late initiated postoperative rehabilitation in patients with operable lung cancer on exercise capacity, functional capacity, muscle strength, and QOL.

      a9ded1e5ce5d75814730bb4caaf49419 Method

      The study was designed as a two-armed randomized controlled trial with randomization to either early initiated postoperative rehabilitation (14 days after surgery (ERG)) or a control arm with late initiated postoperative rehabilitation (14 weeks after surgery (LRG)). The primary endpoint was a change in maximum oxygen consumption (VO2peak) from baseline to post intervention 26 weeks following lung resection. Fatigue was measured with EORTC QLQ C30 LC13.

      4c3880bb027f159e801041b1021e88e8 Result

      From April 2013 to June 2016, 582 patients with operable NSCLC were screened for eligibility. With 119 patients randomized in the early rehabilitation group (ERG) (68 females, 51 males; median age 65), and 116 randomized to late rehabilitation group (LRG) (62 females, 54 males; median age 65) the recruitment rate was 52.6%. There was a non-significant decrease in VO2peak in both ERG and LRG from baseline to 26 weeks and no significant difference between ERG and LRG (p=0.9269). There was a significant decrease from baseline to 14 weeks in both ERG (p=0.027) and LRG (p<0.001) and a significant difference between groups (p=0.0018). There was a non-significant increase from 14 weeks to 26 weeks in ERG (p=0.464) and a significant increase from 14 weeks to 26 weeks in LRG (p<0.001) and a significant difference between the two groups (p=0.0003). We found no significant differences in QOL but we found a significant difference between ERG and LRG from baseline to 14 weeks in fatigue level in favour of ERG.

      8eea62084ca7e541d918e823422bd82e Conclusion

      This is the first randomized controlled trial to investigate the effects of early vs. late initiated postoperative rehabilitation in patients with lung cancer. There is no difference in the commencement (early vs. late) of a postoperative exercise program for patients with lung cancer on exercise capacity. But to reduce fatigue patients should be recommended to initiate early exercise programs.

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      OA04.08 - Discussant - OA 04.05, OA 04.06, OA 04.07 (Now Available) (ID 14553)

      11:45 - 12:00  |  Presenting Author(s): Pippa Labuc

      • Abstract
      • Presentation
      • Slides

      Abstract not provided

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