1. Adjuvant nivolumab significantly improved disease-free survival compared to placebo among patients with resected esophageal or gastroesophageal junction cancer.
2. Adverse events were more common in the nivolumab group compared to the placebo group.
Evidence Rating Level: 1 (Excellent)
Study Rundown: Neoadjuvant chemotherapy followed by surgery and surveillance is the current standard of care treatment for resectable, locally advanced esophageal or gastroesophageal junction cancer. There remains a high level of recurrence of disease post-treatment, suggesting the need for adjuvant therapy. Nivolumab, a monoclonal anti-programmed death 1 (PD-1) antibody, has been shown to improve survival in this patient population in previous trials. This study evaluated the use of nivolumab as adjuvant treatment in patients with esophageal or gastroesophageal junction cancer who received neoadjuvant chemotherapy and surgery. Treatment with nivolumab, compared to placebo, led to improved disease-free survival. In addition to a disease-free survival benefit, nivolumab treatment resulted in improved distant metastasis-free survival; however, adverse events were more common in the nivolumab group compared to the placebo group. Study limitations include relatively small sample size, underrepresentation of racial minority patients, and lack of reporting on long-term outcomes. Nonetheless, this study’s results are significant in using nivolumab as effective adjuvant therapy in patients with resectable, locally advanced esophageal or gastroesophageal junction cancer.
Click to read the study in NEJM
In-Depth [randomized controlled trial]: This randomized control trial enrolled 794 patients across 170 sites and 29 countries. Patients 18 years or older who had resected esophageal or gastroesophageal junction cancer and received neoadjuvant chemoradiation therapy were included in the study. Patients diagnosed with stage I esophageal or gastroesophageal junction cancer were excluded from the study. The patients were randomized in a 2:1 ratio to receive nivolumab or placebo, respectively. The primary endpoint was disease-free survival defined as the time from randomization to the first date of disease recurrence or death. Median disease-free survival was 22.4 months (95% confidence interval [CI], 16.6 to 34.0) in the nivolumab group compared to 11.0 months (95% CI, 8.3 to 14.3) in the placebo group (hazard ratio for disease recurrence or death, 0.69; 96.4% CI, 0.56 to 0.86; P<0.001). Furthermore, the risk of distant recurrence or death was 26% lower when treated with nivolumab compared to placebo (hazard ratio 0.74; 95% CI, 0.60 to 0.92). Adverse events were more common with nivolumab than placebo, including grade 3 or 4 events (nivolumab group, 13%; placebo group, 6%). Altogether, this trial showed in patients with resectable, locally advanced esophageal or gastroesophageal junction cancer, nivolumab therapy led to improved disease-free survival compared to placebo.
Image: PD
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