Virtual Library

Start Your Search

Gilberto de Castro Jr



Author of

  • +

    ESMO-IASLC Best Abstracts (ID 62)

    • Event: ELCC 2019
    • Type: Proffered Paper session
    • Track:
    • Presentations: 1
    • Moderators:
    • Coordinates: 4/11/2019, 14:45 - 16:15, Room B
    • +

      102O - Final analysis of the phase III KEYNOTE-042 study: Pembrolizumab (Pembro) versus platinum-based chemotherapy (Chemo) as first-line therapy for patients (Pts) with PD-L1–positive locally advanced/metastatic NSCLC (ID 542)

      14:45 - 16:15  |  Author(s): Gilberto de Castro Jr

      • Abstract
      • Presentation
      • Slides

      Background

      Pembro significantly improved OS vs chemo as first-line therapy in pts with PD-L1–positive locally advanced/metastatic NSCLC without EGFR/ALK alterations after median follow-up of 12.8 mo based on interim analysis of KEYNOTE-042 (NCT02220894). We present the final protocol-specified analysis with an additional 6 mo of follow-up.

      a9ded1e5ce5d75814730bb4caaf49419 Methods

      Pts were randomized 1:1 to 35 cycles of pembro 200 mg Q3W or chemo (6 cycles of paclitaxel/pemetrexed [pem] + carboplatin with optional pem maintenance [nonsquamous only]), stratified by region (east Asia/non-east Asia), ECOG PS (0/1), histology (squamous/nonsquamous), and PD-L1 tumor proportion score (TPS; ≥50%/1%–49%). No α was allocated to OS in this analysis as the primary hypotheses for OS were met at the interim analysis. PFS differences (secondary endpoints) were assessed sequentially in pts with TPS ≥50%, ≥20%, and ≥1% using the stratified log-rank test (one-sided P = 0.01977, 0.02022, and 0.02065, respectively). Other secondary endpoints were ORR and safety. Duration of response (DOR) was an exploratory endpoint.

      20c51b5f4e9aeb5334c90ff072e6f928 Results

      1274 pts were randomized, 637 per arm. As of September 4, 2018 (median follow-up, 14 mo), 6% were receiving pembro and 3% were receiving pem maintenance. OS benefit with pembro vs chemo was maintained with longer follow-up (Table). PFS was not significantly improved with pembro vs chemo in pts with TPS ≥50%, therefore secondary efficacy hypotheses were not formally tested beyond TPS ≥50%. DOR was longer with pembro vs chemo (Table). Grade 3–5 treatment-related AEs were less frequent with pembro (18%) vs chemo (41%).

      fd69c5cf902969e6fb71d043085ddee6 Conclusions

      With an additional 6 mo follow-up, pembro demonstrated continued OS benefit vs chemo as first-line therapy in pts with locally advanced/metastatic PD-L1–positive NSCLC without EGFR/ALK alterations.

      b651e8a99c4375feb982b7c2cad376e9 Clinical trial identification

      NCT02220894.

      7a6a3ffa2dadc03a6151ee2c4d6fa383 Editorial acknowledgement

      Medical writing and editorial assistance was provided by Rozena Varghese, PharmD, of C4 MedSolutions, LLC (Yardley, PA), a CHC Group company. This assistance was funded by Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.

      934ce5ff971f1ab29e840a35e3ca96e9 Legal entity responsible for the study

      Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.

      213f68309caaa4ccc14d5f99789640ad Funding

      Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.

      682889d0a1d3b50267a69346a750433d Disclosure

      T.S.K. Mok: Grants or research support: AstraZeneca, Bristol-Myers Squibb, Clovis Oncology, Merck Sharp & Dohme, Novartis, Pfizer, Roche, SFJ Pharmaceuticals, XCovery; Speakers’ fees: AstraZeneca, Roche/Genentech, Pfizer, Eli Lilly, Boehringer Ingelheim, Merck Sharp & Dohme, Novartis, Bristol-Myers Squibb, Taiho, Takeda Oncology; Honoraria: AstraZeneca, Roche/Genentech, Pfizer, Eli Lilly, Boehringer Ingelheim, Merck Serono, Merck Sharp & Dohme, Novartis, SFJ Pharmaceuticals, ACEA Biosciences, Inc., Vertex Pharmaceuticals, Bristol-Myers Squibb, OncoGenex Pharmaceuticals, Inc., Celgene, Ignyta, Inc., Fishawack Facilitate Ltd, Takeda Oncology, Janssen; Major stockholder: Sanomics Ltd.; Advisory board member: AstraZeneca, Roche/Genentech, Pfizer, Eli Lilly, Boehringer Ingelheim, Clovis Oncology, Merck Serono, Merck Sharp & Dohme, Novartis, SFJ Pharmaceuticals, ACEA Biosciences, Inc., Vertex Pharmaceuticals, Bristol-Myers Squibb, geneDecode Co., Ltd., OncoGenex Technologies Inc., Celgene, Ignyta, Inc., Cirina, Fishawack Facilitate Ltd., Janssen, Takeda, ChiMed. Y-L. Wu: Honoraria: AstraZeneca, Eli Lilly, Roche, Pierre Fabre, Pfizer, Sanofi; Consulting, advisory role: AstraZeneca, Roche, Merck, Boehringer Ingelheim; Research funding to institution: Boehringer Ingelheim, Roche. B.C. Cho: Honoraria: AstraZeneca, Roche, Boehringer Ingelheim; Consultant/advisor: AstraZeneca, Roche, Boehringer Ingelheim; Speakers’ bureau: AstraZeneca, BMS, Merck Sharp & Dohme, Novartis; Research funding: Bayer, AstraZeneca, Yuhan, Novartis. G. de Castro Jr: Consulting, advisory role: AstraZeneca, MSD, BMS, Roche, Novartis, Boehringer Ingelheim; Speakers’ bureau: MSD, BMS, Novartis, AstraZeneca; Travel, accommodation, expenses: MSD, BMS, Roche, Bayer, Novartis, Boehringer Ingelheim, AstraZeneca. K. Kubota: Research funding: Boehringer Ingelheim, Taiho, Ono; Speakers’ fees: Chugai, Taiho, MSD, Boehringer Ingelheim, AstraZeneca, BMS, Eli-Lilly, Daiichi Sankyo, Novartis, Ono, Dainippon-Sumitomo, Kyowa-Kirin, Eisai; Advisory role: Taiho. C. Caglevic: Consultant/advisor: BMS, MSD, Bayer, AZ; Speakers’ bureau: BMS, MSD, Bayer, Lilly, Roche; Research funding: MSD, Boehringer Ingelheim, GSK, Bayer, AZ, Medivation, Astellas Pharma, BMS; Travel, accommodation expenses: Boehringer Ingelheim, MSD. T. Dang, L. Yin, J. Penrod: Employee: Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA. G. Lopes: Research funding to institution: Merck & Co., Inc., EMD Serono, AstraZeneca. All other authors have declared no conflicts of interest.

      cffcb1a185b2d7d5c44e9dc785b6bb25

      Only Members that have purchased this event or have registered via an access code will be able to view this content. To view this presentation, please login, select "Add to Cart" and proceed to checkout. If you would like to become a member of IASLC, please click here.

      Only Active Members that have purchased this event or have registered via an access code will be able to view this content. To view this presentation, please login or select "Add to Cart" and proceed to checkout.

  • +

    Lunch & Poster Display session (ID 58)

    • Event: ELCC 2019
    • Type: Poster Display session
    • Track:
    • Presentations: 1
    • Moderators:
    • Coordinates: 4/11/2019, 12:30 - 13:00, Hall 1
    • +

      99P - Efficacy and safety of adjuvant chemotherapy in lung cancer: Real-world evidence (ID 387)

      12:30 - 13:00  |  Author(s): Gilberto de Castro Jr

      • Abstract
      • Slides

      Background

      Platinum-based adjuvant chemotherapy (CT) improves survival in surgically resected non-small-cell lung cancer (NSCLC) patients (pts). However, cisplatin and vinorelbine (PV), the most studied regimen, is often associated with increased rates of grade 3-4 toxicities. We aimed to study the efficacy and safety of adjuvant CT in NSCLC pts in a real-world scenario.

      a9ded1e5ce5d75814730bb4caaf49419 Methods

      We performed a retrospective analysis of NSCLC pts treated with surgery with curative intent between 2009 and 2018 in an academic cancer center. After surgery, pts were accessed to receive adjuvant CT, based on physicians’ discretion. Electronic records were reviewed and data were collected for pts and tumor characteristics, treatments, outcomes (overall survival [OS] and disease-free survival [DFS]), and toxicities. OS and DFS were estimated by the Kaplan-Meier method, and curves were compared by log-rank. Prognostic factors were evaluated using Cox regression.

      20c51b5f4e9aeb5334c90ff072e6f928 Results

      250 consecutive pts were studied: 80 adjuvant CT and 170 observation; 55/80 received PV. Median age 65 years, 62% adenocarcinoma and 28% squamous cell carcinoma. The observation group differed from the adjuvant CT group in terms of type of surgery (lobectomy, 88% vs 76%; p = .020), 7th ed TNM staging (I, 50% vs 2%; II, 29% vs 45%; III, 20% vs 42%; p < .001), and lymph node status (N0, 71% vs 31%; p < .001). After a median follow-up of 24 months (mo), median DFS was 56.0 vs 39.3 mo in CT and observation groups, and median OS was 61.4 vs 58.5 mo, respectively. In an adjusted analysis, adjuvant CT was associated with improved DFS (HR 0.36, IC 95% 0.23-0.58; p < .001) and OS (HR 0.47, IC 95% 0.28-0.78; p .004). Toxicities were high in the PV group: 49% of the pts required hospitalization, 45% discontinued treatment, and 89% presented grade 3-4 toxicities, including 29% of febrile neutropenia. Five pts (9%) had treatment-related deaths.

      fd69c5cf902969e6fb71d043085ddee6 Conclusions

      Our study supports both the OS and DFS benefits of NSCLC adjuvant CT in the real world scenario. However, PV was associated with alarming rates of treatment-related toxicities and deaths, suggesting that new adjuvant avenues are warranted.

      b651e8a99c4375feb982b7c2cad376e9 Legal entity responsible for the study

      The authors.

      213f68309caaa4ccc14d5f99789640ad Funding

      Has not received any funding.

      682889d0a1d3b50267a69346a750433d Disclosure

      All authors have declared no conflicts of interest.

      cffcb1a185b2d7d5c44e9dc785b6bb25

      Only Active Members that have purchased this event or have registered via an access code will be able to view this content. To view this presentation, please login or select "Add to Cart" and proceed to checkout.