THURSDAY, April 1, 2021 (HealthDay News) — Among patients with resected esophageal or gastroesophageal junction cancer who have received neoadjuvant chemoradiotherapy, disease-free survival is significantly longer with nivolumab adjuvant therapy versus placebo, according to a study published in the April 1 issue of the New England Journal of Medicine.
Ronan J. Kelly, M.B., B.Ch., from the Charles A. Sammons Cancer Center at Baylor University Medical Center in Dallas, and colleagues conducted a phase 3 trial to assess a checkpoint inhibitor as adjuvant therapy in adults with resected stage II or III esophageal or gastroesophageal junction cancer. Participants who had received neoadjuvant chemoradiotherapy and had residual pathological disease were randomly assigned in a 2:1 ratio to receive either nivolumab or matching placebo (532 and 262 patients, respectively). The trial intervention period had a maximum duration of one year; the median follow-up was 24.4 months.
The researchers found that the median disease-free survival was 22.4 and 11.0 months among those who received nivolumab and placebo, respectively (hazard ratio for disease recurrence or death, 0.69). Across multiple prespecified subgroups, disease-free survival favored nivolumab. Grade 3 or 4 adverse events that were considered to be related to the active drug or placebo occurred in 13 and 6 percent of patients in the nivolumab and placebo groups, respectively. Due to adverse events related to the active drug or placebo, in 9 and 3 percent of patients in the nivolumab and placebo groups, respectively, the trial regimen was discontinued.
“Nivolumab adjuvant therapy showed superior efficacy over placebo in the primary end point of disease-free survival,” the authors write.
Several authors disclosed financial ties to pharmaceutical companies, including Bristol Myers Squibb, which manufactures nivolumab and, along with Ono Pharmaceutical, funded the study.
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