Academic Journal
FOLFIRI Plus Durvalumab With or Without Tremelimumab in Second-Line Treatment of Advanced Gastric or Gastroesophageal Junction Adenocarcinoma ; The PRODIGE 59-FFCD 1707-DURIGAST Randomized Clinical Trial
| العنوان: | FOLFIRI Plus Durvalumab With or Without Tremelimumab in Second-Line Treatment of Advanced Gastric or Gastroesophageal Junction Adenocarcinoma ; The PRODIGE 59-FFCD 1707-DURIGAST Randomized Clinical Trial |
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| المؤلفون: | Tougeron, David, Dahan, Laetitia, Evesque, Ludovic, Le Malicot, Karine, El Hajbi, Farid, Aparicio, Thomas, Bouché, Olivier, Bonichon Lamichhane, Nathalie, Chibaudel, Benoist, Angelergues, Antoine, Bodere, Anaïs, Phelip, Jean-Marc, Mabro, May, Kaluzinski, Laure, Petorin, Caroline, Breysacher, Gilles, Rinaldi, Yves, Zaanan, Aziz, Smith, Denis, Gouttebel, Marie-Claude, Perret, Clément, Etchepare, Nicolas, Emile, Jean-François, Sanfourche, Ivan, Di Fiore, Frédéric, Lepage, Côme, Artru, Pascal, Louvet, Christophe, HAUTEFEUILLE, Vincent, THIROT-BIDAULT, Anne, BOUSTANY-GRENIER, Rania, FAURE, Marjorie, DEBELLEIX, Christophe, TAVAN, David, EL WESHI, Amr, LAM, You-Heng, PEZET, Denis, BOLLIET, Marion, DARUT-JOUVE, Ariane, PAITEL, Jean-François, CARNOT, Aurélien, PANNIER, Diane, LE BRUN LY, Valérie, DESRAME, Jérôme, GIGOUT, Julie, DOMINICI, Philippe, DULUC, Muriel, NORGUET MONNEREAU, Emmanuelle, LOCHER, Christophe, ANDRE, Morgan |
| المصدر: | JAMA Oncology ; volume 10, issue 6, page 709 ; ISSN 2374-2437 |
| بيانات النشر: | American Medical Association (AMA) |
| سنة النشر: | 2024 |
| الوصف: | Importance Efficacy of second-line chemotherapy in advanced gastric or gastrooesphageal junction (GEJ) adenocarcinoma remains limited. Ojectives To determine the efficacy of 1 or 2 immune checkpoint inhibitors combined with FOLFIRI (leucovorin [folinic acid], fluorouracil, and irinotecan) in the treatment of advanced gastric/GEJ adenocarcinoma. Design, Setting, and Participants The PRODIGE 59-FFCD 1707-DURIGAST trial is a randomized, multicenter, noncomparative, phase 2 trial, conducted from August 27, 2020, and June 4, 2021, at 37 centers in France that included patients with advanced gastric/GEJ adenocarcinoma who had disease progression after platinum-based first-line chemotherapy. Intervention Patients were randomized to receive FOLFIRI plus durvalumab (anti–programmed cell death 1 [PD-L1]) (FD arm) or FOLFIRI plus durvalumab and tremelimumab (anti–cytotoxic T-lymphocyte associated protein 4 [CTLA-4]) (FDT arm). The efficacy analyses used a clinical cutoff date of January 9, 2023. Main outcome and Measures The primary end point was progression-free survival (PFS) at 4 months according to RECIST 1.1 criteria evaluated by investigators. Results Overall, between August 27, 2020, and June 4, 2021, 96 patients were randomized (48 in each arm). The median age was 59.7 years, 28 patients (30.4%) were women and 49 (53.3%) had GEJ tumors. Four month PFS was 44.7% (90% CI, 32.3-57.7) and 55.6% (90% CI, 42.3-68.3) in the FD and FDT arms, respectively. The primary end point was not met. Median PFS was 3.8 and 5.4 months, objective response rates were 34.7% and 37.7%, and median overall survival was 13.2 and 9.5 months in the FD and FDT arms, respectively. Disease control beyond 1 year was 14.9% in the FD arm and 24.4% in the FDT arm. Grade 3 to 4 treatment-related adverse events were observed in 22 (47.8%) patients in each arm. A combined positive score (CPS) PD-L1 of 5 or higher was observed in 18 tumors (34.0%) and a tumor proportion score (TPS) PD-L1 of 1% or higher in 13 tumors (24.5%). Median PFS according to CPS ... |
| نوع الوثيقة: | article in journal/newspaper |
| اللغة: | English |
| DOI: | 10.1001/jamaoncol.2024.0207 |
| الاتاحة: | http://dx.doi.org/10.1001/jamaoncol.2024.0207 https://jamanetwork.com/journals/jamaoncology/articlepdf/2817120/jamaoncology_tougeron_2024_oi_240003_1718739243.62222.pdf |
| رقم الانضمام: | edsbas.7A1EFAC8 |
| قاعدة البيانات: | BASE |
| DOI: | 10.1001/jamaoncol.2024.0207 |
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