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Suresh S Ramalingam



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    MA06 - Challenges in the Treatment of Early Stage NSCLC (ID 124)

    • Event: WCLC 2019
    • Type: Mini Oral Session
    • Track: Treatment of Early Stage/Localized Disease
    • Presentations: 1
    • Now Available
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      MA06.07 - E1505: Adjuvant Chemotherapy +/- Bevacizumab for Early Stage NSCLC: Updated Chemotherapy Subset Analysis (Now Available) (ID 2885)

      13:30 - 15:00  |  Author(s): Suresh S Ramalingam

      • Abstract
      • Presentation
      • Slides

      Background

      Adjuvant chemotherapy (chemo) for resected early stage NSCLC provides modest survival benefit with limited comparison data between regimens. From this trial we previously reported that adding bevacizumab (B) to adjuvant chemo failed to improve either disease free survival (DFS) or overall survival (OS). Here we update outcomes by chemotherapy regimen with an additional 30 months of follow-up.

      Method

      Enrolled patients with resected early stage NSCLC, stratified by stage, histology, sex, and chemo option, were randomized 1:1 to chemo alone or with B (15 mg/kg every 3 weeks for up to 1 year). Chemo consisted of a planned 4 cycles of every 3 week cisplatin with either vinorelbine (V), docetaxel (D), gemcitabine (G) or pemetrexed (P).

      Result

      From July 2007 to September 2013, 1501 patients were enrolled with this distribution of chemo: V 25.0%, D 22.9%, G 18.9% and P 33.2%. P was added in 2009 and restricted to non-squamous (NSq) pts. Chemo regimen was chosen (not randomized). Arms were well balanced for known prognostic factors; 28% had Sq histology. Median f/up per chemo group is: V 83.5 months(m); D 89.9m; G 87.8m; P 71.9m. In pooled analysis DFS differed by histology ranging from 29.9m(G)-43.5m(V) for NSq and 59.4m(V)-77.3m(G) for Sq. OS also differed by histology ranging from 80m(D)-98.8m(P) for NSq and 98m(G)-119m(V) for Sq. A non-significant decline in both DFS and OS was seen when B was added to D or V regimens, regardless of histology. Conversely, the addition of B to P improved both DFS (HR 0.74, p= .00994) and OS (HR 0.65, p= .00368). We thus compared outcomes across non-B regimens and though numerical differences were seen in median DFS and OS, these failed to reach statistical significance. Toxicity details were presented previously.

      Conclusion

      B did not improve OS when added to adjuvant chemo for patients with surgically resected early stage NSCLC, though variable DFS and OS outcomes by chemotherapy regimen have emerged with longer-term follow-up. These include a significant positive improvement in DFS and OS with B combined with P and trends of worse outcomes when B was added to other regimens. Ongoing molecular analysis of samples will hopefully elucidate the etiology of these differences.

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    MA21 - Non EGFR/MET Targeted Therapies (ID 153)

    • Event: WCLC 2019
    • Type: Mini Oral Session
    • Track: Targeted Therapy
    • Presentations: 1
    • Now Available
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      MA21.03 - The International Association for the Study of Lung Cancer (IASLC) Global Survey on Molecular Testing in Lung Cancer (Now Available) (ID 1198)

      14:30 - 16:00  |  Author(s): Suresh S Ramalingam

      • Abstract
      • Presentation
      • Slides

      Background

      Evidence-based standards for molecular testing of lung cancer have been established, but the global frequency and practice of testing are not well understood. The IASLC conducted an international survey to evaluate current practice and barriers to molecular testing.

      Method

      Distributed to IASLC members and other healthcare professionals, content included: 7-question introduction, 32 questions for those requesting tests/treating patients, 45 questions on performing/interpreting assays, and 24 questions on tissue acquisition. All respondents were asked to provide 3-5 barriers to implementing/offering molecular testing.

      Respondents’ countries were grouped by geography or developing/developed using IASLC and World Bank criteria. Surveys were available in 7 languages. Regional comparisons used the Chi-squared test or ANOVA; free-text was analyzed with Nvivo.

      Result

      We obtained 2,537 responses from 102 countries. Respondents were 45% Medical Oncologists, 12% Pulmonologists, 12% Thoracic Surgeons, 9% Pathologists, and 22% scientists or other. 56% of responses were from developing countries, 44% developed. Regions included: 52% Asia, 19% Europe, 11% Latin America, 11% US/Canada, 7% Other.

      1683 (66%) chose the requesting/treating track (50% government, 42% academic, 8% other). 61% reported most patients in their country do not receive molecular testing, with the lowest rates in Latin America/Other (p<0.0001). 39% were not satisfied with the conditions of molecular testing in their country. Indications for requesting testing included: adenocarcinoma (89%), never-smoker (61%), female (57%), and young (54%) (variable by region, p<0.0001). 99% ordered EGFR, 95% ALK, 84% PDL1, 79% ROS1, all other tests <50%. 56% typically received results within 10 days. Only 67% were aware of CAP/IASLC/AMP guidelines, least frequently in Asia/Other (p=0.041). 37% have trouble understanding molecular testing result reports, most of whom cited a need for more technical and scientific knowledge. 75% had multidisciplinary tumor boards, but 23% met <1/month.

      The 316 (12%) testing track respondents were from laboratories that were 49% academic, 35% government, and 16% private/other. 94% of laboratories offered EGFR, 83% ALK, 69% KRAS, 68% BRAF, 64% ROS1, 56% HER2, and others <50%; 68% tested for PDL1. 57% offered Multiplex assays, less frequently in Latin America/Asia (p=0.0294). 69% tested blood-derived DNA, less frequently in US/Canada/Other (0.0013). 23% of respondents reported >10% of cases are rejected due to inadequate samples; however, 47% stated there is no policy or strategy to improve the quality of the tissue samples in their country. 52% reported patients/physicians are not satisfied with the state of molecular testing in their country. Respondents performing/interpreting assays (334, 14%) were typically informed of biopsy results (91%), and notified when the sample was inadequate (84%).

      The most frequent barrier to molecular testing in every region was cost, followed by quality/standards, turnaround-time, access, and awareness. After cost, time was the most common barrier in developed countries, while it was quality in developing countries. The second largest barrier was quality in Asia, access in Europe/Latin America/Other, and turn-around time in US/Canada.

      Conclusion

      These preliminary analyses show molecular testing usage varies across the globe. Barriers vary by region, and one-third of respondents were unaware of evidence-based guidelines. Global and regional strategies should be developed to address barriers.

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    OA02 - A New Vision of Targets and Strategies (ID 120)

    • Event: WCLC 2019
    • Type: Oral Session
    • Track: Targeted Therapy
    • Presentations: 1
    • Now Available
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      OA02.05 - First-In-Human Phase 1/2 Trial of Anti-AXL Antibody–Drug Conjugate (ADC) Enapotamab Vedotin (EnaV) in Advanced NSCLC (Now Available) (ID 343)

      10:30 - 12:00  |  Presenting Author(s): Suresh S Ramalingam

      • Abstract
      • Presentation
      • Slides

      Background

      AXL, a transmembrane receptor tyrosine kinase, is aberrantly expressed in various cancers, and associated with poor prognosis and treatment resistance. AXL overexpression is associated with resistance to PD-1 immune checkpoint inhibitors (Hugo et al. 2016). EnaV, a novel ADC of anti-AXL human IgG1 and monomethyl auristatin E, demonstrated potent anti-tumor activity in preclinical models, including NSCLC (Boshuizen et al. 2018). In a phase 1, dose escalation, multi-cohort trial (NCT02988817) in heavily pretreated patients with relapsed or refractory solid tumors, EnaV 2.2 mg/kg once every 3 weeks (1Q3W; recommended phase 2 dose) showed preliminary anti-tumor activity. Here we present initial results from patients with NSCLC in the phase 2a, expansion phase of this trial.

      Method

      We analyzed data from EnaV 2.2 mg/kg 1Q3W, in the cohort of pretreated patients with stage III/IV NSCLC without sensitizing EGFR mutations (EGFR WT) or ALK rearrangements (ALK-) who had failed ≤4 prior lines of therapy, including platinum-based chemotherapy and PD-1/PD-L1 inhibitor (either in combination or sequentially). Endpoints include safety, objective response rate (ORR; RECIST 1.1), and AXL expression in fresh tumor biopsies (immunohistochemistry).

      Result

      In the EGFR WT/ALK- cohort, 26 patients (median age 65.5 years, range 38–74; 57.7% male) with ECOG PS of 0 (11.5%) or 1 (88.5%) have been enrolled. Most patients (23/26) were treated with a checkpoint inhibitor. At a median follow-up of 18 weeks (range: 2–54), the most common (≥20%; any grade) treatment-emergent adverse events (TEAEs) were fatigue, constipation, nausea, decreased appetite, decreased weight, diarrhea, and vomiting. Two patients had a TEAE leading to dose reduction. Grade ≥3 TEAEs occurred in 12 patients, with the most common being gastrointestinal disorders in eight patients (constipation [n=1]; colitis, diarrhea, nausea, vomiting [n=2 each]; abdominal distension [n=1]. The confirmed ORR is 19% (95% CI: 8.5%, 37.9%). The disease control rate (CR+PR+SD) is 50% (13/26). Nine of 12 (75%) evaluable fresh biopsies were positive for AXL tumor cell staining.

      Conclusion

      In this high unmet need patient population, with advanced EGFR WT and ALK- NSCLC who are pretreated with PD-1/PD-L1 inhibitors and platimum-based therapies, EnaV monotherapy demonstrated a manageable safety profile and encouraging preliminary clinical activity. This cohort has expanded to allow up to 60 patients to gain further knowledge of AXL as a potential biomarker for responsiveness to EnaV and to gather additional data on safety and efficacy. Funding: Genmab A/S

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    OA04 - Immuno Combinations and the Role of TMB (ID 126)

    • Event: WCLC 2019
    • Type: Oral Session
    • Track: Immuno-oncology
    • Presentations: 1
    • Now Available
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      OA04.01 - A Phase III Randomized Study of Nivolumab/Ipilimumab vs Nivolumab for Previously Treated Stage IV Squamous Cell Lung Cancer (Now Available) (ID 872)

      15:15 - 16:45  |  Author(s): Suresh S Ramalingam

      • Abstract
      • Presentation
      • Slides

      Background

      Lung-MAP is a master protocol for patients (pts) with stage IV previously treated SqNSCLC. S1400I enrolled pts who were not eligible for a biomarker-matched sub-study. (Lung-MAP Sub-Study S1400I, NCT02785952)

      Method

      S1400I is phase III randomized trial for immunotherapy-naïve patients with ECOG 0-1 not selected by PD-L1 expression. Pts were assigned 1:1 to nivolumab and ipilimumab (N+I) vs nivolumab (N). N was given at 3 mg/kg q 2w, I was given at 1 mg/kg q 6w. The primary endpoint was overall survival (OS). Secondary endpoints: investigator-assessed progression-free survival (IA-PFS), response by RECIST 1.1, and toxicity.

      Result

      From December 18, 2015 to April 23, 2018, 275 pts enrolled and 252 determined eligible (125 N+I and 127 N). Median follow up for patients still alive was 17.4 months. The study was closed for futility at an interim analysis. Baseline characteristics were similar across arms. mOS was 10.0 m (8.0-12.8) and 11.0 m (8.2-13.5) for N+I and N. HR 0.97 (0.71-1.31), p 0.82. mPFS was 3.8 m (2.3-4.2) and 2.9 m (1.8-3.9) for N+I and N. HR 0.84 (0.64-1.09), p 0.19. The response rate was 18% (12-25) in N+I and 17 % (11, 24) in N. Outcomes were similar across TMB subgroups and PD-L1 expression levels. Most AE were low grade. There were 5 grade 5 AE in N+I arm and 1 in N arm. Grade ≥3 treatment-related AEs occurred in 48(39%) of pts on N+I vs 38(31%) on N. irAE reported in 39% of pts on N+I and 34% of patients on N. Drug-related AEs led to discontinuation in 25% of pts on N+I and 16% of pts on N.

      OS and PFS based on TMB and PD-L1

      N+I

      Median in months

      N

      Median in months
      HR p
      OS PD-L1 ≥5 14.1 (5.8-17.5) 12.0 (8.2-19.8) 1.06 (0.58-1.92) 0.86
      OS PD-L1 <5 8.3 (6.0-10.7) 10.3 (6.3-13.5) 1.01 (0.62-1.65) 0.97
      OS TMB ≥10 13.1 (9.3-17.0) 11.4 (8.2-16.1) 0.86 (0.56-1.32) 0.48
      OS TMB <10 7.6 (5.7-10.2) 10.0 (6.3-15.2) 1.08 (0.68-1.71) 0.74
      PFS PD-L1 ≥ 5 3.9 (1.7-7.1) 2.9 (1.8-4.7) 0.65 (0.38-1.08) 0.10
      PFS PD-L1 <5 4.4 (2.1-6.0) 1.6 (1.5-3.0) 0.64 (0.41-1.01) 0.06
      PFS TMB ≥ 10 4.2 (3.4-5.9) 3.4 (1.8-5.3) 0.75 (0.52-1.10) 0.15
      PFS TMB < 10 1.9 (1.5-4.1) 2.7 (1.6-3.3) 0.92 (0.62-1.39) 0.70

      Conclusion

      S1400I failed to show improvement in outcomes with N+I. Study was closed for futility at interim analysis. Toxicities were not different between two arms. Molecular correlates will be presented at the meeting.

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    OA07 - Precision Medicine Involves Biology and Patients (ID 132)

    • Event: WCLC 2019
    • Type: Oral Session
    • Track: Advanced NSCLC
    • Presentations: 1
    • Now Available
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      OA07.05 - High-Grade Chemotherapy-Induced Peripheral Neuropathy (CIPN):  An Analysis of ECOG-ACRIN Lung Cancer Clinical Trials (Now Available) (ID 1431)

      11:00 - 12:30  |  Author(s): Suresh S Ramalingam

      • Abstract
      • Presentation
      • Slides

      Background

      High-grade (CTCAE grade ≥3) CIPN implies severe symptoms and limitation of self-care activities of daily living (ADL). To date, studies characterizing the incidence of and factors associated with CIPN have been conducted almost exclusively in breast cancer populations. As such, they generally evaluate only women and lack assessment of platinum-based chemotherapy. We therefore examined the incidence and factors associated with high-grade CIPN among patients treated on ECOG-ACRIN advanced non-small cell lung cancer (NSCLC) clinical trials.

      Method

      We included two completed trials in the analysis: E1594 (comparison of 4 chemotherapy regimens: cisplatin-paclitaxel, cisplatin-gemcitabine, cisplatin-docetaxel, carboplatin-paclitaxel) and E4599 (carboplatin-paclitaxel ± bevacizumab). We identified patients who developed treatment-related grade ≥3 CIPN. Multivariable logistic regression modeling was performed to estimate adjusted odds ratios. For the treatment variable, the reference group ended up combining the cisplatin+paclitaxel and cisplatin+docetaxel arms since their results were not significantly different from one another. Body-mass index (BMI) was categorized by median value (25.2 kg/m2).

      Result

      Among 1,989 total patients, 167 (8.4%) developed grade ≥3 CIPN. Incidence was highest for the carboplatin-paclitaxel regimen (9.9%) and lowest for cisplatin-paclitaxel (4.5%) (P=0.006). Grade ≥3 CIPN was associated with BMI (9.9% for ≥25.2 kg/m2 vs 6.9% for <25.2 kg/m2; P=0.02) and sex (6.9% for men vs 10.4% for women; P=0.006). There was a non-significant trend toward association with age (10.4% for ≥70 years versus 7.8% for <70 years; P=0.08). In multivariate analysis, chemotherapy regimen, sex, and BMI remained independently associated with grade ≥3 CIPN.

      Conclusion

      Carboplatin-paclitaxel chemotherapy, female sex, and high BMI are associated with the development of high-grade CIPN. Given the clinical severity of this condition and the potential for long-term persistence, consideration of risk-based monitoring and treatment selection may be warranted.

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    P1.16 - Treatment in the Real World - Support, Survivorship, Systems Research (ID 186)

    • Event: WCLC 2019
    • Type: Poster Viewing in the Exhibit Hall
    • Track: Treatment in the Real World - Support, Survivorship, Systems Research
    • Presentations: 1
    • Moderators:
    • Coordinates: 9/08/2019, 09:45 - 18:00, Exhibit Hall
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      P1.16-08 - Integration of Durvalumab into the Treatment of Stage III Non-Small Cell Lung Cancer: Real-World Considerations (ID 1115)

      09:45 - 18:00  |  Author(s): Suresh S Ramalingam

      • Abstract

      Background

      Background: In 2017, the PACIFIC study demonstrated improvement in progression free survival, leading to FDA approval for the treatment of unresectable stage III non-small cell lung cancer (NSCLC) that has not progressed following concurrent platinum based chemoradiation (CRT). This study reports on practice patterns during the first year of adaptation of immunotherapy into the treatment paradigm for stage III NSCLC at a NCI designated Comprehensive Cancer Center.

      Method

      Methods: This retrospective study captured patients (pts) with unresectable NSCLC treated from 09/2017-10/2018 who referred to radiation oncology for definitive treatment. Clinical and treatment characteristics were extracted, including radiation dose parameters and information regarding durvalumab administration.

      Result

      Results: 48 pts with locally advanced NSCLC were referred for definitive radiation therapy. 17% were not eligible for concurrent CRT: of these, 6 received 60 Gy hypofractionated radiation alone, and 2 received 60-64 Gy with conventional fractionation. Forty (83%) received concurrent CRT (80% carboplatin/paclitaxel, 10% cisplatin/etoposide, 10% platinum/pemetrexed). Of the patients undergoing CRT, 32% did not go on to receive durvalumab due to the following factors: 25% due to unresolved grade 3 or higher toxicities, 25% due to relative contraindications to immunotherapy, 17% were lost to follow up, 8% due to disease progression, 8% due to active illicit drug use, 8% due to large tumor and potential risk for pneumonitis, and 8% received nivolumab. Twenty-seven (68% of pts receiving CRT, 56% of all referred pts) went on to receive durvalumab after completion of CRT. For these pts, the radiation dose parameters were as follows: median total dose of 60 Gy (range 60-66 Gy), median lung V20 of 22.7% (range 5.4-31.5%), median lung mean dose of 13.9 Gy (range 5.3-19.5 Gy), and median heart mean dose of 12.9 Gy (range .715 – 29.9 Gy). The median time from completion of radiation to start of durvalumab was 36 days (range 11-84). Restaging imaging with CT chest after completion of CRT was obtained at a median time point of 35 days. The median number of cycles of durvalumab was 5 (range 1-20). Of pts receiving durvalumab, 37% stopped before 1 year; 40% due to disease progression, 50% due to intolerable side effects, and 10% were lost to follow up.

      Conclusion

      Conclusions: Durvalumab was successfully integrated in a rapid fashion into the treatment paradigm for stage III NSCLC in this single institution experience, however only 56% of referred pts were ultimately able to receive durvalumab.

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    PL03 - Relevant Aspects of Lung Cancer Management (ID 90)

    • Event: WCLC 2019
    • Type: Plenary Session
    • Track: Advanced NSCLC
    • Presentations: 1
    • Now Available
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      PL03.03 - The Disparity of Lung Cancer Prevention, Diagnosis and Treatment Around the World…What Is the Role of IASLC (Now Available) (ID 3593)

      09:15 - 10:45  |  Presenting Author(s): Suresh S Ramalingam

      • Abstract
      • Presentation
      • Slides

      Abstract

      Lung cancer is a global health problem that results in over 1.8 million deaths globally each year. Diagnosis at an advanced stage, lack of effective treatment options and disabling co-morbid conditions, have all contributed to the poor outlook for patients with lung cancer. However, there is now new hope in the global fight against lung cancer. Improved understanding of the biology of the disease, early diagnosis and effective therapies have contributed to growing optimism. The International Association for the Study of Lung Cancer (IASLC) has been at the forefront of research and education by bringing together committed scientists, physicians, care providers, epidemiologists, nursing staff and patient communities to increase awareness, develop improved staging systems, fund research for early career researchers, promote development of novel therapies, and educate healthcare professionals at all levels.

      Tobacco smoking contributes to approximately 85-90% of all cases of lung cancer; while the prevalence of smoking has reduced in many developed countries, it appears to be on the upswing in developing nations. More recently, the introduction of electronic nicotine delivery systems (ENDS) has raised the possibility of creating a new generation of the population addicted to nicotine. Any efforts to reduce the burden of lung cancer has to start with educating the public about the health hazards related to smoking, tobacco cessation programs and reducing the access of teenagers and young adults to tobacco products.

      Early detection by adopting screening programs will be another important strategy to reduce the burden of lung cancer. In recent years, the reduction in mortality related to lung cancer by adopting low dose CT screening in high risk individuals has been proven beyond doubt. Despite this evidence, only a minority of eligible patients are being screened for lung cancer, even in developed nations. To increase adoption of screening, we have to collectively engage in educating the primary care physicians, subjects at risk and the entire health care community. Diagnosis of lung cancer at earlier stages will result in greater likelihood of cure due to the exciting advances that have taken place in the management of patients with stages I, II and III NSCLC.

      Even for patients diagnosed with advanced stage lung cancer, long term survival is possible; precision therapies directed to oncogenic molecular events, immune checkpoint inhibitors and multi-modality treatment approaches have all contributed to the recent progress. For patients with mutations in the epidermal growth factor receptor and aberrations in the anaplastic lymphoma kinase gene, the median survival for stage 4 disease is now measured in years with the use of specific targeted treatment approaches. There are at least five genomic targets in lung adenocarcinoma that can be treated with specific tyrosine kinase inhibitors. It is likely that more genomic mutations will join the list of treatable aberrations, thanks to the rapid pace of drug development. Molecular testing remains critical to the ability to personalize therapies for patients with lung cancer. A recent survey conducted by the IASLC across the world noted several barriers to routine adoption of molecular testing.

      Finally, access to cutting-edge therapies is a major challenge in several parts of the world. Rising costs of healthcare and medicines have resulted in the inability for patients to receive optimal care.

      Our efforts to improve lung cancer outcomes and reduce the burden of this disease will have to address every one of these issues. The IASLC is launching an ambitious program to double the 5-year survival rate for patients with lung cancer later this year. This will be accomplished by a multi-pronged approach to promote early detection, optimal staging and diagnostic testing and by addressing survivorship issues. A new staging system seeks to integrate molecular knowledge to traditional clinical staging in order to provide precise prognostic information. Investments in improving the sensitivity of CT screening, promoting universal standards for CT imaging and partnering with other societies to increase awareness regarding early detection will all be important components of this strategy.

      The IASLC has made major contributions to diagnosis of lung cancer by developing a new pathology classification system for lung cancer; it has also conducted original research to improve biomarker testing and promote education on molecular diagnosis. In the upcoming years, the IASLC will seek to study the correlation between major pathological response with neo-adjuvant therapy and overall survival. This will allow for earlier utilization of exciting novel agents to be used as part of curative therapies for early stage NSCLC.

      The IASLC will also promote research on issues specific to survivorship; as long-term outcomes for lung cancer patients becomes a reality, it is important to learn about coping with physical and emotional challenges that can be related to their journey. Very little work has been conducted to date on this topic.

      In conclusion, the time is ripe for us to launch a collective campaign to reduce the burden of lung cancer globally. The IASLC will partner with like-minded organizations, and engage its membership to aggressively pursue innovative approaches that will ultimately result in lower number of patients diagnosed with lung cancer, and improved survival and quality of life for patients afflicted with lung cancer.

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