Adjuvant Therapy

A global, randomized, double-blind, placebo-controlled, phase III trial evaluated a checkpoint inhibitor as adjuvant therapy in 794 patients with esophageal or gastroesophageal junction cancer. Adults with a performance status of 0 or 1 and R0 stage II or III disease who had received neoadjuvant chemoradiation therapy and had residual pathological disease were included. Patients were randomly assigned in a 2:1 ratio to receive either nivolumab (240 mg every 2 weeks for 16 weeks) followed by nivolumab (480 mg every 4 weeks) (532 patients) or matching placebo (262 patients). Patients were enrolled regardless of programmed death-ligand 1 (PD-L1) expression. The maximum duration of the trial intervention period was 1 year. The primary end point was DFS. The median follow-up was 24.4 months.[42][Level of evidence B1]

A global, randomized, double-blind, placebo-controlled, phase III trial evaluated a checkpoint inhibitor as adjuvant therapy in 794 patients with esophageal or gastroesophageal junction cancer. Adults with a performance status of 0 or 1 and R0 stage II or III disease who had received neoadjuvant chemoradiation therapy and had residual pathological disease were included. Patients were randomly assigned in a 2:1 ratio to receive either nivolumab (240 mg every 2 weeks for 16 weeks) followed by nivolumab (480 mg every 4 weeks) (532 patients) or matching placebo (262 patients). Patients were enrolled regardless of programmed death-ligand 1 (PD-L1) expression. The maximum duration of the trial intervention period was 1 year. The primary end point was DFS. The median follow-up was 24.4 months.[42][Level of evidence B1]

The median DFS was 22.4 months (95% CI, 16.6–34.0) among patients who received nivolumab, compared with 11.0 months (95% CI, 8.3–14.3) among patients who received placebo. The HRdisease recurrence or death was 0.69 (96.4% CI, 0.56–0.86; P < .001).

A global, randomized, double-blind, placebo-controlled, phase III trial evaluated a checkpoint inhibitor as adjuvant therapy in 794 patients with esophageal or gastroesophageal junction cancer. Adults with a performance status of 0 or 1 and R0 stage II or III disease who had received neoadjuvant chemoradiation therapy and had residual pathological disease were included. Patients were randomly assigned in a 2:1 ratio to receive either nivolumab (240 mg every 2 weeks for 16 weeks) followed by nivolumab (480 mg every 4 weeks) (532 patients) or matching placebo (262 patients). Patients were enrolled regardless of programmed death-ligand 1 (PD-L1) expression. The maximum duration of the trial intervention period was 1 year. The primary end point was DFS. The median follow-up was 24.4 months.[42][Level of evidence B1]

Median DFS was evaluated across a prespecified subgroup according to histological type. Among patients with adenocarcinoma, the median DFS was 19.4 months in the 376 patients who received nivolumab (95% CI, 15.9–29.4), compared with 11.1 months in the 187 patients who received the placebo (95% CI, 8.3–16.8); the HRdisease recurrence or death was 0.75 (95% CI, 0.59–0.96). Among patients with squamous cell carcinoma, the median DFS was 29.7 months (95% CI, 14.4 to not estimable) in the 155 patients who received nivolumab, compared with 11 months (95% CI, 7.6–17.8) in the 75 patients who received the placebo; the HRdisease recurrence or death was 0.61 (95% CI, 0.42–0.88).

A global, randomized, double-blind, placebo-controlled, phase III trial evaluated a checkpoint inhibitor as adjuvant therapy in 794 patients with esophageal or gastroesophageal junction cancer. Adults with a performance status of 0 or 1 and R0 stage II or III disease who had received neoadjuvant chemoradiation therapy and had residual pathological disease were included. Patients were randomly assigned in a 2:1 ratio to receive either nivolumab (240 mg every 2 weeks for 16 weeks) followed by nivolumab (480 mg every 4 weeks) (532 patients) or matching placebo (262 patients). Patients were enrolled regardless of programmed death-ligand 1 (PD-L1) expression. The maximum duration of the trial intervention period was 1 year. The primary end point was DFS. The median follow-up was 24.4 months.[42][Level of evidence B1]

HRs for disease recurrence or death were remarkably close between the 570 patients whose tumors expressed less than 1% of PD-L1 (HR, 0.73; 95% CI, 0.57–0.92) and the 129 patients whose tumors expressed 1% or more of PD-L1 (HR, 0.75; 95% CI, 0.45–1.24).

A global, randomized, double-blind, placebo-controlled, phase III trial evaluated a checkpoint inhibitor as adjuvant therapy in 794 patients with esophageal or gastroesophageal junction cancer. Adults with a performance status of 0 or 1 and R0 stage II or III disease who had received neoadjuvant chemoradiation therapy and had residual pathological disease were included. Patients were randomly assigned in a 2:1 ratio to receive either nivolumab (240 mg every 2 weeks for 16 weeks) followed by nivolumab (480 mg every 4 weeks) (532 patients) or matching placebo (262 patients). Patients were enrolled regardless of programmed death-ligand 1 (PD-L1) expression. The maximum duration of the trial intervention period was 1 year. The primary end point was DFS. The median follow-up was 24.4 months.[42][Level of evidence B1]

Grade 3 or 4 adverse events of any cause occurred in 183 of 532 patients (34%) in the nivolumab group and 84 of 260 patients (32%) in the placebo group, and serious adverse events of any grade occurred in 30% of the patients in each group (nivolumab: 158 of 532; placebo: 78 of 260). Adverse events that were considered by the investigators to be related to the trial regimen were more common with nivolumab than with placebo, including grade 3 or 4 events (nivolumab: 71 of 532 patients [13%]; placebo: 15 of 260 patients [6%]) and events leading to discontinuation of therapy (nivolumab: 48 of 532 patients [9%]; placebo: 8 of 260 patients [3%]).

A global, randomized, double-blind, placebo-controlled, phase III trial evaluated a checkpoint inhibitor as adjuvant therapy in 794 patients with esophageal or gastroesophageal junction cancer. Adults with a performance status of 0 or 1 and R0 stage II or III disease who had received neoadjuvant chemoradiation therapy and had residual pathological disease were included. Patients were randomly assigned in a 2:1 ratio to receive either nivolumab (240 mg every 2 weeks for 16 weeks) followed by nivolumab (480 mg every 4 weeks) (532 patients) or matching placebo (262 patients). Patients were enrolled regardless of programmed death-ligand 1 (PD-L1) expression. The maximum duration of the trial intervention period was 1 year. The primary end point was DFS. The median follow-up was 24.4 months.[42][Level of evidence B1]

OS data have not been reported for this study.