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Eldsamira Mascarenhas

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    MS04 - New Systemic Adjuvant/Neo-Adjuvant Strategies in Early Stage Lung Cancer: Targeted Therapy and I/O (ID 67)

    • Event: WCLC 2019
    • Type: Mini Symposium
    • Track: Treatment of Early Stage/Localized Disease
    • Presentations: 5
    • Now Available
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      MS04.01 - EGFR TKIs for Resected EGFRmut NSCLC (Now Available) (ID 3455)

      15:15 - 16:45  |  Presenting Author(s): Yi-Long Wu

      • Abstract
      • Presentation
      • Slides

      Abstract

      Adjuvant chemotherapy became the standard treatment for resected stage 2-3 non-small cell lung cancer (NSCLC). It increased overall survival (OS) by 5% at 5 years, and resected NSCLC was considered "curable disease." Stage II to IIIA resected NSCLC is heterogeneous. The 5-year survival was only 40% -50%. There is a huge medical need to improve the long-term survival for these patients whose cancers are destined to recur after surgery.

      BR.19, the first trial to evaluate an EGFR TKI (gefinitib) in the adjuvant setting, and the subsequent RADIANT trial, which compared erlotinib to placebo, were not designed specifically for patients with EGFR mutations. Thus, these two adjuvant TKIs failed to show meaningful benefits.1,2 The ADJUVANT trial, first randomized phase 3 trial compared gefitinib with doublet chemotherapy for stage 2 and 3 (N1N2) resected EGFR mutant NSCLC. The results showed that adjuvant gefitinib significant improved disease-free survival (DFS). HR for recurrence was 0.60 with 28.7 months in gefitinib vs 18.0 months in chemotherapy3. Subsequently the EVAN -- another Chinese phase 2 trial confirmed that adjuvant erlotinib was superior to chemotherapy in DFS4. SELLECT trial from American once again confirmed that adjuvant EGFR TKI improved DFS5. The both Chinese adjuvant trials targeted the patients with the highest risk of recurrence and are more likely to respond to EGFR TKIs in patients harboring an EGFR mutation. Unlike BR.31 and RADIAN EGFR TKIs were used following adjuvant chemotherapy. the ADJUVANT trial was a direct comparison of adjuvant TKIs with Vinorelbine plus cisplatin instead of comparing TKIs with placebo after chemotherapy, as evaluated in the BR.19 and RADIANT trials. Compliance with adjuvant TKIs (95.5%) was better than that with chemotherapy (78.4%) in ADJUVANT trial. This means that patients receiving adjuvant TKIs were more likely to complete treatment than patients receiving standard chemotherapy. The design of ADJUVANT is different from RADIANT, and the hypothesis of the two trials designs is different. The ADJUVANT study was created to test whether an EGFR TKI might be a viable treatment alternative to chemotherapy in the adjuvant setting, specifically in EGFR mutant (+) NSCLC. In this situation, using DFS as the primary endpoint was rational. The U.S. Food and Drug Administration has stated that a prolonged delay in the development of metastatic disease is an objective and a clinically relevant outcome and that agents can be approved based on metastasis-free survival (MFS) if substantial effects on this endpoint are demonstrated and the safety profile is acceptable.6 In addition, after adjuvant gefitinib or erlotinib, patients with disease recurrence still have the opportunity to be re-challenged with TKIs. And the median duration of treatment approximates the DFS in a de novo advanced EGFR-mutant population.7

      Recently Zhong et al reported a phase 2 trial on neo-adjuvant setting for EGFR mutant stage 3A resectable NSCLC. Of 386 patients screened, 72 were randomized to treatment. The ORR for neoadjuvant erlotinib versus GC chemotherapy was 54·1% versus 34·3% (p=0·092). pCR was 10·7% vs 0. Median DFS was significantly longer with erlotinib (21·5 months) versus GC chemotherapy (11·9 months; HR 0·42; 95% CI, 0·23–0·76; p=0·003)8. The results of neo-adjuvant EGFR TKI treatment in CTONG 1103 was similar to adjuvant EGFR TKI in CTONG 1104. The difference of DFS comparing with chemotherapy in both trials are 10 months. Definitely EGFR TKIs could be safely and effectively used in early resected NSCLC.

      The treatment paradigm for early resectable NSCLC is evolving. Similar to advanced NSCLC early stage NSCLC should be divided to driver mutation or wild type NSCLC. For wild NSCLC check point blockade should be tested in peri-operation. For driver mutation NSCLC TKIs including EGFRi or ALKi even other rare mutation should be tested.

      Some issues should be evaluated. One issue is how to select populations more precisely for adjuvant or neo-adjuvant treatment. Whether circulating tumor DNA (ctDNA) could serve as biomarker of minimal residual disease (MRD) and how to monitor it9? Second issue is what is the primary endpoint for neo-adjuvant or adjuvant treatment in NSCLC? Apparent OS is rational but the trial will last a long time even beyond 10 years. The third issue is how to choose neo-adjuvant or adjuvant treatment for recectable NSCLC either clinical trial or clinical practice. For personalized adjuvant treatment in the future, we need to identify patients precisely and match the appropriate treatment with appropriate patient.

      References:

      1. Goss GD, O'Callaghan C, Lorimer I, et al. Gefitinib versus placebo in completely resected non-small-cell lung cancer: results of the NCIC CTG BR19 study. J Clin Oncol. 2013;31(27):3320-3326.

      2. Kelly K, Altorki NK, Eberhardt WE, et al. Adjuvant Erlotinib Versus Placebo in Patients With Stage IB-IIIA Non-Small-Cell Lung Cancer (RADIANT): A Randomized, Double-Blind, Phase III Trial. J Clin Oncol. 2015;33(34):4007-4014.

      3. Zhong W-Z, Wang Q, Mao W-M, et al. Gefitinib versus vinorelbine plus cisplatin as adjuvant treatment for stage II–IIIA (N1–N2) EGFR -mutant NSCLC (ADJUVANT/CTONG1104): a randomised, open-label, phase 3 study. Lancet Oncol. 2018;19(1):139-148

      4. Yue D, Xu SD, Wang Q, et al. Erlotinib verse vinorebine plus cisplatin as adjuvant therapy in Chinese patitents with stage 3A EGFR mutantion-positive non-small-cell lung cancer (EVAN): a randomised, open-lable. phase 2 trial. Lancet Res Med 2018; 6(11):863-873

      5. Pennell NA, Neal JW, Chaft JE, et al. SELECT: A Phase II Trial of Adjuvant Erlotinib in Patients With Resected Epidermal Growth Factor Receptor-Mutant Non-Small-Cell Lung Cancer. J Clin Oncol. 2019;37(2):97-104.

      6. Mauguen A, Pignon JP, Burdett S, et al. Surrogate endpoints for overall survival in chemotherapy and radiotherapy trials in operable and locally advanced lung cancer: a re-analysis of meta-analyses of individual patients' data. Lancet Oncol. 2013;14(7):619-626.

      7. Oxnard GR, Janjigian YY, Arcila ME, et al. Maintained sensitivity to EGFR tyrosine kinase inhibitors in EGFR-mutant lung cancer recurring after adjuvant erlotinib or gefitinib. Clin Cancer Res. 2011;17(19):6322-6328

      8. Zhong WZ, Chen KN, Chen C, et al. Erlotinib verse gemcitabine plus cisplatin as neoadjuvant treatment for stage IIIA-N2 EGFR-mutant NSCLC (EMERGING-CTONG 1103): a randomized phase II study, J Clin Oncol 2019 in press.

      9. Ng TL, Camidge DR. Lung cancer's real adjuvant EGFR targeted therapy questions. Lancet Oncol. 2018;19(1):15-17.

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      MS04.02 - Neo-Adjuvant PD-(L)1 Checkpoint Inhibitors (Now Available) (ID 3456)

      15:15 - 16:45  |  Presenting Author(s): Luis Raez

      • Abstract
      • Presentation
      • Slides

      Abstract

      Neoadjuvant chemotherapy never made to become standard of care for non-small cell lung cancer (NSCLC) and until today it is being used in special circumstances. However neoadjuvant immunotherapy as single agent or in combination with chemotherapy has become a very promissory intervention. In 2018 we had the publication from Forde et al in the NEJM showing that using nivolumab as neoadjuvant approach did not delay surgery in any of the treated patients (pts) and there were no unexpected safety signals were seen. Very interesting 45% of resected tumors demonstrated a major pathologic response (MPR) that correlated with mutational burden. MPR was defined as less than 10% viable tumor in the resected specimen [1]. Following these results there were also several presentations at ASCO 2018: The LCMC study Rusch et al [2] (treats pts with atezolizumab for 2 cycles follow by surgery then standard of care chemotherapy follow by immunotherapy for 1 year) showed 4/19 (21%) pts had MPR after 2 doses of atezolizumab. Shu et al (Abstract 8532) showed that 4 cycles carboplatin/nab-paclitaxel/atezolizumab had 7/14 (50%) pts with MPR and 3/14 (21%) had pCR. [3]

      Later at the 2018 World lung Cancer Conference in Toronto in September, we have had the Spanish Lung Cancer Group presenting the study NADIM by Provencio-Pulla that was briefly presented before at ASCO 2018 [4,5]. They had a phase II open label study for patients with stage IIIA NSCLC that received carboplatin/paclitaxel/nivolumab for 3 cycles follow by surgery and adjuvant immunotherapy for 1 year. The CR was 10%, PR 60% and SD 30% for a DCR of 100%. MPR was 80% and complete response 75%. The toxicity profile was tolerable and not unexpected. During the same meeting Rusch [6] did an updated of the LCMC study this time with 45 pts: the ORR was 10% and the DCR 100%. 22% of the pts had MPR. There was no observable correlation between pathologic and radiographic responses. Neoadjuvant atezolizumab did not cause major delays to surgery or interfere with surgical resection, and there were no unexpected safety findings.

      There was also a poster presentation of the CheckMate 816 [7]: Phase 3 Neoadjuvant Trial of Chemotherapy with and without nivolumab for stage I-IIIA NSCLC presented by Enriqueta Felip with 21 pts in the nivolumab arm that have 10% CR and 45% MPR.

      Following this success from 2018 at this year in ASCO 2019 there will be 2 important presentations Neoadjuvant nivolumab (N) or nivolumab plus ipilimumab (NI) for resectable non-small cell lung cancer (NSCLC): the NEOSTAR study for pts with stage I-IIIA [8] and another updated of the LCMC study that is expected to showed data with larger number of pts [9]. There are also several studies with targeted agents for NSCLC that will be presented at 2019 World Lung Cancer Conference where we will have the opportunity to review the updates of some of the studies mentioned before and new ones.

      References:

      1) Forde PM1, Chaft JE1, Smith KN1, et al. 1. Neoadjuvant PD-1 Blockade in Resectable Lung Cancer.N Engl J Med. 2018 May 24; 378(21):1976-1986. doi: 10.1056/NEJMoa1716078. Epub 2018 Apr 16.

      2) Rusch, Valerie et al. Neoadjuvant atezolizumab in resectable non-small cell lung cancer (NSCLC): Initial results from a multicenter study (LCMC3) J Clin Oncol 36, 2018 (suppl; abstr 8541)

      3) Catherine A. Shu, Claud Grigg, Codruta Chiuzan, Neoadjuvant atezolizumab + chemotherapy in resectable non-small cell lung cancer (NSCLC). J Clin Oncol 36, 2018 (suppl; abstr 8532)

      4) Provencio-pulla et al. Neoadjuvant chemo/immunotherapy for the treatment of stages IIIA resectable non-small cell lung cancer (NSCLC): A phase II multicenter exploratory study—NADIM study-SLCG. J Clin Oncol 36, 2018 (suppl; abstr 8521)

      5) M. Provencio, E. Nadal, A. Insa, R. et al. OA01.05 Phase II Study of Neo-adjuvant hemo/Immunotherapy for Resectable Stages IIIA Non-Small Cell Lung Cancer- Nadim Study-SLCG Journal of Thoracic Oncology, Vol. 13, Issue 10, S320

      6) V. Rusch, J. Chaft, B. Johnson, et al. MA04.09 Neoadjuvant Atezolizumab in Resectable Non-Small Cell Lung Cancer (NSCLC): Updated Results from a Multicenter Study (LCMC3) Journal of Thoracic Oncology, Vol. 13, Issue 10, S369

      7) E. Felip, J. Brahmer, S. Broderick, et al. P2.16-03 CheckMate 816: A Phase 3 Trial of Neoadjuvant Nivolumab Plus Ipilimumab or Chemotherapy vs Chemotherapy in Early-Stage NSCLC

      8) Tina Cascone et al., Neoadjuvant nivolumab (N) or nivolumab plus ipilimumab (NI) for resectable non-small cell lung cancer (NSCLC): Clinical and correlative results from the NEOSTAR study.J Clin Oncol 37, 2019 (suppl; abstr 8504)8)

      9) Rusch V et al. Neoadjuvant atezolizumab in resectable non-small cell lung cancer (NSCLC): Interim analysis and biomarker data from a multicenter study (LCMC3). J Clin Oncol 37, 2019 (suppl; abstr 8503)

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      MS04.03 - Adjuvant PD-(L)1 Checkpoint Inhibitors (Now Available) (ID 3457)

      15:15 - 16:45  |  Presenting Author(s): Heather A Wakelee  |  Author(s): Jessica Hellyer

      • Abstract
      • Presentation
      • Slides

      Abstract

      Advances in adjuvant therapy for early stage, resectable, non-small cell lung cancer (NSCLC) have been slow for many years. Four cycles of post-operative platinum-based chemotherapy remains the standard of care in most of the world, yet this confers a survival benefit of only ~5% at 5 years.1 Early efforts to stimulate adaptive immunity to prevent tumor recurrence via several immunologic interventions including antigen specific cancer vaccines, Bacillus Calmette-Guerin (BCG), adoptive cell transfer and tumor-infiltrating lymphocytes failed to show a benefit in overall survival in a meta analysis of the early trials2,3 In 2018 though positive results from the PACIFIC trial ushered in a new era of immunotherapy with PD-L1 checkpoint blockade in non-operable, stage III non-small cell lung cancer (NSCLC) and established consolidation durvalumab following chemoradiation as the new standard of care.4 These data provided further enthusiasm for ongoing trials of checkpoint inhibitors in early stage, surgically resectable disease.

      Promising preliminary data has been presented from ongoing neoadjuvant PD-(L)1 checkpoint inhibitor trials, many of which contain an adjuvant component. The most exciting results to date have come from the NADIM trial of neoadjuvant carboplatin/paclitaxel/nivolumab followed by adjuvant nivolumab for one year after surgical resection. Analysis of the first 41 patients following surgical resection showed 35 (86%) of patients with a major pathologic response (MPR) (defined as <10% viable tumor cells present) and of those, 25 (71%) had a complete pathologic response (CR).5 The NEOSTAR study of induction nivolumab or nivolumab/ipilumumab and the LCMC trial with neoadjuvant followed by adjuvant atezolizumab in resectable NSCLC patients were both updated at ASCO 2019 with reported MPR in 17%, 33%, and 19% (with 5% CR) of the nivolumab and nivolumab/ipilumumab and atezolizumab intent to treat populations, respectively.6,7 However, immune toxicity was reported in all of these trials and there were some patients who were not able to complete definitive surgery. We also do not know how MPR with immune therapy correlates with disease free survival (DFS) and overall survival (OS).

      Thus there is still a lot of enthusiasm for the post-operative (adjuvant) use of checkpoint inhibitors. There are multiple adjuvant immunotherapy trials currently underway although there are no results reported to date. A branch of the US coopertive network (NCTN) ALCHEMIST trial, ANVIL, is currently enrolling patients with stage IB (>4cm)-IIIA NSCLC who test negative for EGFR and ALK mutations. After completion of surgical resection and standard of care adjuvant therapy (chemotherapy or radiation therapy if indicated), patients are randomized to up to a year of adjuvant nivolumab or observation. These patients are further stratified by stage, histology, adjuvant treatment received and PD-L1 status (≥1% or <1%). Co-primary endpoints are disease free and overall survival.8 IMpower 010 is a randomized, phase III trial of adjuvant atezolizumab vs supportive care in stage IB (>4cm) - IIIA NSCLC patients following surgical resection and cisplatin-based adjuvant chemotherapy with enrollment of 1280 patients. This study does not allow for radiation therapy and mandates that the adjuvant chemotherapy contain cisplatin plus vinorelbine, gemcitabine, docetaxel or pemetrexed. Following completion of 4 cycles of adjuvant chemotherapy, patients are randomized 1:1 to a year of atezolizumab or observation. Primary outcome is disease free survival.9 In KEYNOTE-091 patients with IB/II-IIIA surgically resected NSCLC who have completed standard of care adjuvant therapy will be randomized to one year of pembrolizumab vs supportive care. The target enrollment is 1080 patients. Primary endpoint is disease free survival. Finally, adjuvant durvalumab is being examined in a randomized, phase III prospective, triple-blind, placebo controlled trial of patients with stage IB (>4cm)-IIIA resected NSCLC being lead by the Canadian Cancer Trials Group. Standard adjuvant chemotherapy is permitted, but post-operative radiation is only allowed for N2 disease. Primary endpoint is disease free survival in PD-L1 positive patients and in all randomized patients. The study stratifies across PD-L1 subgroups (≤1%, 1-49% and ≥50%). Target enrollment is 1360 patients.10

      Checkpoint inhibitor therapy has been established as the new standard of care in unresectable and metastatic NSCLC. Many trials are underway with adjuvant and neoadjuvant immunotherapy for early stage lung cancer and preliminary data from the neoadjuvant trials are promising. In a setting where patients have only modestly benefited from chemotherapy, we eagerly await the results of the ongoing adjuvant immunotherapy studies with the hopes of improving outcomes for surgically resectable NSCLC.

      References

      1. Pignon JP, et al. Lung adjuvant cisplatin evaluation: a pooled analysis by the LACE Collaborative Group. J Clin Oncol. 2008;26(21):3552-3559.

      2. Somasundaram A, Burns TF. Pembrolizumab in the treatment of metastatic non-small-cell lung cancer: patient selection and perspectives. Lung Cancer (Auckl). 2017;8:1-11.

      3. Zhu J, et al. Immunotherapy (excluding checkpoint inhibitors) for stage I to III non-small cell lung cancer treated with surgery or radiotherapy with curative intent. Cochrane Database Syst Rev. 2017;12:CD011300.

      4. Antonia SJ, et al. Overall Survival with Durvalumab after Chemoradiotherapy in Stage III NSCLC. N Engl J Med. 2018.

      5. Provencio-Pulla M, , et al. Neoadjuvant chemo/immunotherapy for the treatment of stages IIIA resectable non-small cell lung cancer (NSCLC): A phase II multicenter exploratory study—NADIM study-SLCG. Journal of Clinical Oncology. 2018;36(15_suppl):8521-8521.

      6. Cascone T, et al. Neoadjuvant nivolumab (N) or nivolumab plus ipilimumab (NI) for resectable non-small cell lung cancer (NSCLC): Clinical and correlative results from the NEOSTAR study. ASCO 2019.

      7. Kwiatkowski DJ, et al. Neoadjuvant Atezolizumab in Resectable Non-Small Cell Lung Cancer (NSCLC): Interim Analysis and Biomarker Data From a Multicenter Study (LCMC3). ASCO 2019

      8. Chaft JE, et al. EA5142 adjuvant nivolumab in resected lung cancers (ANVIL). Journal of Clinical Oncology. 2018.

      9. Wakelee HA, et al. A phase III trial to compare atezolizumab (atezo) vs best supportive care (BSC) following adjuvant chemotherapy in patients (pts) with completely resected NSCLC: IMpower010. Journal of Clinical Oncology. 2017;35(15_suppl):TPS8576-TPS8576

      10. O'Brien MER, et al. EORTC-ETOP randomized, phase 3 trial with anti-PD-1 monoclonal antibody pembrolizumab versus placebo for patients with early stage non-small cell lung cancer (NSCLC) after resection and standard adjuvant chemotherapy: PEARLS (NCT02504372). Journal of Clinical Oncology. 2016;34(15_suppl):TPS8571-TPS8571.

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      MS04.04 - Optimal Clinical Trial Design for Adjuvant Systemic Therapy (Now Available) (ID 3458)

      15:15 - 16:45  |  Presenting Author(s): Janet Edwards

      • Abstract
      • Presentation
      • Slides

      Abstract

      Surgery is the gold standard local therapy for medically operable patients with stage I or II NSCLC. Adjuvant chemotherapy is indicated for high risk patients with stage IB disease as well as those with stage II disease. While cytotoxic chemotherapy remains the standard of care in the adjuvant setting, the modest benefits offered leave much room to advance therapy and improve survival in patients with early stage NSCLC (1). One particular area of enthusiasm surrounds the potential role of novel agents such as immunotherapies in the treatment of early NSCLC, given the benefits seen in the advanced NSCLC setting (2). Select ongoing studies addressing novel adjuvant therapeutic regimens in NSCLC are summarized in Table 1. This presentation examines issues surrounding advancement of knowledge in systemic therapy in the adjuvant setting. First, clinical trials must identify and address questions of relevance to both care providers and patients. These include optimal biomarker testing, the use of biomarkers as predictive and prognostic factors, the role of targeted and immunotherapies, novel and combination regimens, optimal duration of therapy and the role of maintenance therapy. Second, outcomes with clinical relevance which are also of interest to cancer patients should be prioritized such as prolongation of survival and improvement in quality of life. Third, studies should be designed in a robust manner focusing on improved efficiency and generalizability. Novel trial designs such as platform studies employing umbrella and basket protocols, driven by biomarkers with flexible objectives should be considered to accelerate clinical development and generate enthusiasm in the community of practitioners treating NSCLC. In platform studies, a single master protocol is employed in which multiple treatments are evaluated simultaneously. Platform designs can be implemented in an adaptive fashion, allowing treatments to be added as they become available, dropped for futility, or declared superior during the course of a trial (3). Inclusion and exclusion criteria, which are often quite restrictive in explanatory trial designs such as conventional randomized controlled trials, limit generalizability and are often not reflective of the real world setting. Consideration of a more pragmatic approach with broadened inclusion criteria may increase both enrollment and applicability in the broader clinical context. Other novel study designs focused on precision medicine such as co-clinical trials provide an attractive alternative to traditional early phase clinical trials. The Adjuvant Lung Cancer Enrichment Marker Identification and Sequencing Trials (ALCHEMIST) trial is reviewed as an example of a biomarker driven platform study with the potential to provide actionable molecular targets, guide personalized approaches to the care of patients with early NSCLC, and establish standard of practice in those without defined genetic targets (4). Finally, in this post surgical setting, involvement of surgeons in the design and implementation of trials should be encouraged. This could serve to maximize identification and enrollment of patients. Also the integration of surgical questions with those of medical therapy will allow further advancement in the personalized care of patients. In conclusion, the ongoing challenge will be to efficiently and robustly answer questions that matter to researchers, clinicians and patients in a rapidly changing treatment landscape, keeping in mind the ultimate goals of improved survival and quality of life. References (1) Lung adjuvant cisplatin evaluation: a pooled analysis by the LACE Collaborative Group. Pignon et al. 2008 Jul 20;26(21):3552-9. (2) Antonia et al. Overall Survival with Durvalumab after Chemoradiotherapy in Stage III NSCLC. 2018 Dec 13;379(24):2342-2350 (3) Saville and Berry. Efficiencies of platform clinical trials: A vision of the future. Clin Trials. 2016 Jun;13(3):358-66. (4) The ALCHEMIST Lung Cancer Trials [website]. National Cancer Institute. Updated July 24, 2017. https://www.cancer.gov/types/lung/research/alchemist. Accessed July 27, 2017. 3. Cancer Research Institute [website]. Clinical trials. 2017.

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      MS04.05 - Preoperative Optimization: Reducing surgical complications through tobacco cessation (Now Available) (ID 3459)

      15:15 - 16:45  |  Presenting Author(s): Matthew Allen Steliga

      • Abstract
      • Presentation
      • Slides

      Abstract

      In Process

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Author of

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    EP1.16 - Treatment in the Real World - Support, Survivorship, Systems Research (ID 206)

    • Event: WCLC 2019
    • Type: E-Poster Viewing in the Exhibit Hall
    • Track: Treatment in the Real World - Support, Survivorship, Systems Research
    • Presentations: 1
    • Now Available
    • Moderators:
    • Coordinates: 9/08/2019, 08:00 - 18:00, Exhibit Hall
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      EP1.16-39 - Prospective Epidemiological Study of Metastatic Non-Small Cell Lung Cancer (NSCLC) in Latin America – LATINO Lung (LACOG 0116) (Now Available) (ID 1405)

      08:00 - 18:00  |  Author(s): Eldsamira Mascarenhas

      • Abstract
      • Slides

      Background

      Non-small cell lung carcinoma (NSCLC) is the main cause of cancer-related death in Latin America. Nonetheless, there is insufficient information regarding its epidemiology, treatment and outcomes in the region. The goals of this study are to describe disease characteristics, treatment patterns and survival for advanced NSCLC in Latin America.

      Method

      LACOG 0116 LATINO Lung is a prospective cohort study aiming to include approximately 800 patients with advanced stage NSCLC (stage III/IV at diagnosis or distant relapse of early-stage disease) from 24 sites in Brazil, Argentina, Mexico, Colombia and Chile. All consecutive newly diagnosed patients seen at each site will be invited to participate. Data on socioeconomic and demographic characteristics, medical/oncologic history and clinical-pathological characteristics will be collected at baseline. Thereafter, patients will be followed every 6 months for 3 years in order to gather information regarding treatment patterns and sequencing, reasons for treatment discontinuation, response to treatment, disease progression and overall survival. Data will be collected during medical visits or telephone calls and by medical charts review. Primary endpoint is to estimate the overall survival. Descriptive analysis of treatments and outcomes are planned. Multivariable regression methods will be applied to assess possible independent prognostic or predictive factors.

      Result

      As of April 3rd, 2019, 107 patients have been included, all of them within 16 sites in Brazil. Currently, there are 2 sites from Argentina, 2 from Mexico, 3 from Colombia and 1 from Chile awaiting regulatory approval to begin enrollment. Recruitment is planned to last until December 2019, when the estimated sample size will be achieved.figure1.png

      Conclusion

      LACOG 0116 LATINO Lung is the first Latin American lung cancer prospective cohort study that will generate real-world data on NSCLC. The study may identify gaps and inequities in a diverse population of NSCLC in Latin America and consequently raise the need for improvement and individualized approach of lung cancer care in the region.

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    P1.09 - Pathology (ID 173)

    • Event: WCLC 2019
    • Type: Poster Viewing in the Exhibit Hall
    • Track: Pathology
    • Presentations: 1
    • Now Available
    • Moderators:
    • Coordinates: 9/08/2019, 09:45 - 18:00, Exhibit Hall
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      P1.09-02 - Comprehensive Genomic Profiling of Non-Small Cell Lung Cancer in Brazil (GBOT 0118/LACOG 0418) (Now Available) (ID 2048)

      09:45 - 18:00  |  Presenting Author(s): Eldsamira Mascarenhas

      • Abstract
      • Slides

      Background

      Lung cancer is the leading cause of cancer-related morbidity and mortality worldwide. Cancer driver mutations have been examined extensively and are the basis for modern precision therapy. The access of genomic tests in Brazil and, therefore, the prevalence of driver mutations of NSCLC in the country is not well described. The objective of this study is to carry out an epidemiological analysis of the somatic genetic profile of Brazilian NSCLC samples tested with FoundationOne®.

      Method

      GBOT 0118/LACOG 0418 is a retrospective cross-sectional study with patients diagnosed with NSCLC in Brazil and who performed comprehensive genomic profiling (CGP) using FoundationOne® or FoundationACT®. Raw data containing anonymous clinical-pathological characteristics and the results of CGP was analyzed. We described the molecular profile of patients using descriptive statistics. Categorical variables are presented as frequency and compared using the Chi-square test.

      Result

      We obtained a total of 513 CGP results, 457 (89.0%) from Foundation One® and 56 (10.9%) from FoundationACT®. Adenocarcinoma was the most common histological subtype (83.8%) followed by NSCLC NOS (16.1%). Median age at testing date was 64 years, and 51.27% were male. EGFR activating mutations were detected in 23.39% patients, ALK rearrangements in 5.65%, ROS1 rearrangements in 2.34%, RET alterations in 2.53%, BRAF mutations in 5.46%, KRAS mutations in 25,15% and NTRK fusions in 0,58% . Tumor mutational burden (TMB) analysis was available for 80.51% of samples tested and was measured in mutation per megabase. TMB were divided into three groups based on the Foundation Medicine reports: low (1-5 mutations/mb), intermediate (6-19 mutations/mb) and high (≥ 20 mutations/mb). The of tumors had low (42.69%) or intermediate (32.36%) TMB, and only 5.46% had high TMB.

      Table 1. Frequency of somatic genetic alterations in tumors tested with FoundationOne® and availability of targeted therapies in Brazil.

      GENE

      Frequency in NSCLC (%)

      Availability in Brazil

      EGFR

      23.39

      Approved

      ALK

      5.65

      Approved

      ROS1

      2.43

      Approved

      BRAF

      5.46

      Approved

      KRAS

      25.15

      No drugs available

      RET

      2,53

      Drugs available but not approved

      NTRK

      0,58

      Drugs available but not approved

      Conclusion

      This is the most comprehensive study describing CGP of NSCLC in Brazil using FoundationOne® or ACT. Our study shows rates of EGFR mutations and ALK rearrangements similar to those previously described. The knowledge of the molecular patterns of NSCLC in Brazil may help to improve health policies and access to targeted agents in the country.

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