Adjuvant nivolumab is the first therapy to provide a statistically significant and clinically meaningful improvement in disease-free survival in patients with resected esophageal and gastroesophageal junction cancer, according to research presented by Guillaume Piessen, MD, PhD, and colleagues at the Society of Surgical Oncology 2021 International Conference on Surgical Cancer Care (Abstract 94).
“The risk of recurrence after neoadjuvant chemoradiation therapy followed by surgery (trimodality therapy) remains high in [patients with] esophageal or gastroesophageal junction cancer and there is no established adjuvant treatment,” said Dr. Piessen, of University of Lille, Claude Huriez University Hospital in Lille, France.
Guillaume Piessen, MD, PhD
CheckMate 577 Details
A network of researchers developed CheckMate 577, the first global, randomized, double-blind, phase III study on the efficacy and safety of a checkpoint inhibitor in the adjuvant setting after trimodality therapy for esophageal or gastroesophageal junction cancer.
The researchers enrolled 794 adults with resected (R0) stage II/III esophageal or gastroesophageal junction cancer who received neoadjuvant chemoradiation therapy and had residual pathologic disease. Patients were randomly assigned 2:1 to receive either nivolumab at 240 mg (n = 532) or placebo (n = 262) every 2 weeks for 16 weeks, followed by nivolumab at 480 mg or placebo every 4 weeks. Maximum treatment duration was 1 year. The primary endpoint was disease-free survival.
Approximately 70% of patients had adenocarcinoma and almost 60% had a pathologic lymph node status ≥ ypN1 in both groups.
Disease-Free Survival
At a prespecified interim analysis, adjuvant nivolumab showed a statistically significant improvement in disease-free survival vs placebo (hazard ratio = 0.69, 96.4% confidence interval = 0.56–0.86, P = .0003). Median disease-free survival was doubled with nivolumab vs placebo: 22.4 vs 11.0 months. Most treatment-related adverse events were grade 1 or 2. The frequency of serious adverse reactions leading to discontinuation was ≤ 9% with nivolumab and 3% with placebo.
The study authors concluded, “Adjuvant nivolumab is the first therapeutic to provide a statistically significant and clinically meaningful improvement in disease-free survival vs placebo and a well-tolerated safety profile in patients with resected esophageal or gastroesophageal junction cancer, who have received neoadjuvant chemoradiotherapy. These results represent the first treatment advance in many years for these patients, potentially establishing adjuvant nivolumab as a new standard of care.”
