![]() ![]() The majority of treatment-related adverse events (TRAEs) were grade 1 or 2. At a pre-specified interim analysis, adjuvant nivolumab showed a statistically significant improvement in DFS vs placebo (HR 0.69 P = 0.0003) median DFS was doubled (22.4 vs 11.0 mo, respectively Table). Approximately 70% of patients had adenocarcinoma and almost 60% had a pathologic lymph node status ≥ypN1 in both groups. Resultsħ94 patients were randomized (nivolumab, 532 placebo, 262). The primary endpoint was disease-free survival (DFS). MethodsĪdults with resected (R0) stage II/III EC/GEJC who received neoadjuvant CRT and had residual pathologic disease were randomized 2:1 to nivolumab 240 mg or placebo Q2W for 16 weeks, followed by nivolumab 480 mg or placebo Q4W. CheckMate 577 is the first global, randomized, double-blind, phase 3 study to report the efficacy and safety of a checkpoint inhibitor in the adjuvant setting after trimodality therapy for EC/GEJC. The risk of recurrence after neoadjuvant CRT followed by surgery (trimodality therapy) remains high in EC/GEJC and there is no established adjuvant treatment. 20 Gastroenterology / Endosonography, Johannes-Gutenberg University Clinic, 55131 - Mainz/DE.19 Medical Oncology, Dana Farber Cancer Institute, 02215 - Boston/US.18 Immuno-oncology, Bristol-Myers Squibb Company, 08540 - Princeton/US.17 Clinical Pharmacology, Bristol-Myers Squibb Company, 08540 - Princeton/US.16 Oncology Biostatistics, Bristol-Myers Squibb Company, 08540 - Princeton/US.15 Clinical Research, Bristol-Myers Squibb Company, 08540 - Princeton/US.14 Gastroenterology, UZ Gent, 9000 - Gent/BE.13 Gastrointestinal Oncology, Netherlands Cancer Institute-Antoni van Leeuwenhoek Hospital, 1066 CX - Amsterdam/NL.12 Medical Oncology, Princess Margaret Cancer Centre, M5G 2M9 - Toronto/CA.11 Medical Oncology, Duke Cancer Institute, 27710 - Durham/US.10 Service Des Maladies De L’appareil Digestif, CHU Pontchaillou, 35000 - Rennes/FR.9 Esophageal Surgery, Akita University Hospital, 010-8543 - Akita/JP.8 Medical Oncology, Johns Hopkins Sidney Kimmel Comprehensive Cancer Center, 21224 - Baltimore/US.7 Clinical Oncology, Fundacion Favaloro, 1093 - Bueno Aires/AR.Lille, Claude Huriez University Hospital, 59037 - Lille/FR 6 Digestive And Oncological Surgery, Univ.5 Gastroenterology / Digestive Oncology, University Hospitals Gasthuisberg, Leuven and KULeuven, 3000 - Leuven/BE.4 Internal Medicine, University Hospital Of Cologne, 50937 - Cologne/DE.3 Thoracic Surgery, Jagiellonian University, John Paul II Hospital, 31-202 - Krakow/PL.2 Gastrointestinal Medical Oncology, Division Of Cancer Medicine, The University of Texas MD Anderson Cancer Center, 77030 - Houston/US. ![]() Sammons Cancer Center at Baylor University Medical Center, 75246 - Dallas/US ![]()
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