2/11/2024 0 Comments Checkmate 577 nejmNivolumab doubled the median disease-free survival from 11.0 to 22. In this trial, after neoadjuvant chemoradiotherapy and resection, patients with residual disease were randomly assigned to receive nivolumab or placebo. (Funded by Bristol Myers Squibb and Ono Pharmaceutical CheckMate 577 number, NCT02743494.)Īdjuvant chemotherapy has not improved disease-free survival among patients with resected esophageal or gastroesophageal junction cancer. The trial regimen was discontinued because of adverse events related to the active drug or placebo in 9% of the patients in the nivolumab group and 3% of those in the placebo group.ĬonclusionsAmong patients with resected esophageal or gastroesophageal junction cancer who had received neoadjuvant chemoradiotherapy, disease-free survival was significantly longer among those who received nivolumab adjuvant therapy than among those who received placebo. Grade 3 or 4 adverse events that were considered by the investigators to be related to the active drug or placebo occurred in 71 of 532 patients (13%) in the nivolumab group and 15 of 260 patients (6%) in the placebo group. Disease-free survival favored nivolumab across multiple prespecified subgroups. Among the 532 patients who received nivolumab, the median disease-free survival was 22.4 months (95% confidence interval, 16.6 to 34.0), as compared with 11.0 months (95% CI, 8.3 to 14.3) among the 262 patients who received placebo (hazard ratio for disease recurrence or death, 0.69 96.4% CI, 0.56 to 0.86 P<0.001). ResultsThe median follow-up was 24.4 months. The primary end point was disease-free survival. The maximum duration of the trial intervention period was 1 year. A serious adverse reaction reported in 2. In Checkmate 577, serious adverse reactions occurred in 33 of patients receiving OPDIVO (n532). Adults with resected (R0) stage II or III esophageal or gastroesophageal junction cancer who had received neoadjuvant chemoradiotherapy and had residual pathological disease were randomly assigned in a 2:1 ratio to receive nivolumab (at a dose of 240 mg every 2 weeks for 16 weeks, followed by nivolumab at a dose of 480 mg every 4 weeks) or matching placebo. CheckMate -901 is the first and only Phase 3 trial with an immunotherapy-based combination to demonstrate a survival benefit compared to standard-of-care cisplatin-based combinations in the. MethodsWe conducted CheckMate 577, a global, randomized, double-blind, placebo-controlled phase 3 trial to evaluate a checkpoint inhibitor as adjuvant therapy in patients with esophageal or gastroesophageal junction cancer. Department of Internal Medicine and PediatricsĪbstract BackgroundNo adjuvant treatment has been established for patients who remain at high risk for recurrence after neoadjuvant chemoradiotherapy and surgery for esophageal or gastroesophageal junction cancer.Ko, Kynan Feeney, Michael Schenker, Piotr Kocon, Jenny Zhang, Lili Zhu, Ming Lei, Prianka Singh, Kaoru Kondo, James M. , Syed Zafar, Stephanie Snow, Andrew H. Ajani, Jaroslaw Kuzdzal, Thomas Zander, Eric Van Cutsem, Guillaume Piessen, Guillermo Mendez, Josephine Feliciano, Satoru Motoyama, Astrid Lievre, Hope Uronis, Elena Elimova, Cecile Grootscholten ,
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