After the matching procedure, the median disease-free survival was 17.2 months and median overall survival was 28.2 months.ĭisease-free survival in our population-based study was considerably longer than the placebo population of CheckMate-577 (19.7 versus 11.0 months). Median disease-free survival was 19.7 months and median overall survival was 32.2 months. Sixty percent of patients were diagnosed with recurrence or were deceased at the end of follow-up. In addition, to adjust for differences in characteristics between CheckMate 577 and our population-based cohort, a matching-adjusted indirect comparison was performed for pathological lymph node status and pathological tumor status. Disease-free and overall survival were assessed from 12 weeks after resection using Kaplan-Meier methods. Patients with cervical esophageal cancer, irradical resection, or complete pathological response were excluded. Resected patients with stage II/III esophageal or gastroesophageal junction cancer (2015–2016) treated with neoadjuvant chemoradiotherapy were selected from the Netherlands Cancer Registry. The aim of our study was to investigate disease-free and overall survival in a nationwide population aligned with the inclusion criteria of CheckMate 577. Population-based data can provide insights in outcomes from clinical practice. The researchers conclude that adjuvant nivolumab administration demonstrated clinically significant efficacy, a manageable safety profile, and maintained quality of life, providing additional support for its use as the new standard of care for patients with resected stage II or III esophageal or gastroesophageal junction cancer who had residual pathologic disease after treatment with neoadjuvant chemoradiotherapy.Results of CheckMate 577 show an improved disease-free survival for patients with resected esophageal or gastroesophageal junction cancer treated with adjuvant nivolumab compared with placebo (22.4 versus 11.0 months). There were similar trends for improvement in the baseline quality of life for nivolumab and placebo during treatment, with maintenance of the post-treatment benefit The most common treatment-related adverse events (TRAEs) reported for nivolumab were cutaneous (24%), endocrinological (17%), gastrointestinal (17%), hepatic (9%), pulmonary (4%) and renal (1%) events.

Median progression-free survival 2 (i.e., time from randomization to progression after subsequent systemic therapy, initiation of the second systemic therapy, or death ) was not achieved with nivolumab versus 32.1 months with placebo (HR 0.77 CI 95% 0.60–0.99). In total, 794 patients were randomized (nivolumab: 532 placebo: 262). Distant recurrence was reported in 29% versus 39% and locoregional recurrence in 12% versus 17% of patients in the nivolumab versus placebo groups.

The primary endpoint was disease-free survival. Patients were randomized in a 2:1 ratio to receive nivolumab 240mg every two weeks for 16 weeks, followed by maintenance nivolumab at a dose of 480mg every four weeks for one year or a corresponding placebo. The phase III, randomized, global, double-blind, placebo-controlled trial evaluated nivolumab as adjuvant therapy in patients with resected (R0) stage II or III esophageal or gastroesophageal junction cancer who had residual pathologic disease after treatment with neoadjuvant chemoradiotherapy. Nivolumab is known to demonstrate significant improvement in disease-free survival versus placebo in patients with resected stage II/III esophageal cancer with residual pathologic disease after neoadjuvant chemoradiotherapy, according to a recent publication in NEJMĪdditional data on the efficacy, safety, and quality of life from CheckMate 577 (NCT02743494) were presented during ASCO World Congress 2021.

Checkmate 577