Adjuvant Nivolumab in Resected Esophageal or Gastroesophageal Junction Cancer.
Publication/Presentation Date
4-1-2021
Abstract
BACKGROUND: No adjuvant treatment has been established for patients who remain at high risk for recurrence after neoadjuvant chemoradiotherapy and surgery for esophageal or gastroesophageal junction cancer.
METHODS: We conducted CheckMate 577, a global, randomized, double-blind, placebo-controlled phase 3 trial to evaluate a checkpoint inhibitor as adjuvant therapy in patients with esophageal or gastroesophageal junction cancer. Adults with resected (R0) stage II or III esophageal or gastroesophageal junction cancer who had received neoadjuvant chemoradiotherapy and had residual pathological disease were randomly assigned in a 2:1 ratio to receive nivolumab (at a dose of 240 mg every 2 weeks for 16 weeks, followed by nivolumab at a dose of 480 mg every 4 weeks) or matching placebo. The maximum duration of the trial intervention period was 1 year. The primary end point was disease-free survival.
RESULTS: The median follow-up was 24.4 months. Among the 532 patients who received nivolumab, the median disease-free survival was 22.4 months (95% confidence interval [CI], 16.6 to 34.0), as compared with 11.0 months (95% CI, 8.3 to 14.3) among the 262 patients who received placebo (hazard ratio for disease recurrence or death, 0.69; 96.4% CI, 0.56 to 0.86; P
CONCLUSIONS: Among patients with resected esophageal or gastroesophageal junction cancer who had received neoadjuvant chemoradiotherapy, disease-free survival was significantly longer among those who received nivolumab adjuvant therapy than among those who received placebo. (Funded by Bristol Myers Squibb and Ono Pharmaceutical; CheckMate 577 ClinicalTrials.gov number, NCT02743494.).
Volume
384
Issue
13
First Page
1191
Last Page
1203
ISSN
1533-4406
Published In/Presented At
Kelly, R. J., Ajani, J. A., Kuzdzal, J., Zander, T., Van Cutsem, E., Piessen, G., Mendez, G., Feliciano, J., Motoyama, S., Lièvre, A., Uronis, H., Elimova, E., Grootscholten, C., Geboes, K., Zafar, S., Snow, S., Ko, A. H., Feeney, K., Schenker, M., Kocon, P., … CheckMate 577 Investigators (2021). Adjuvant Nivolumab in Resected Esophageal or Gastroesophageal Junction Cancer. The New England journal of medicine, 384(13), 1191–1203. https://doi.org/10.1056/NEJMoa2032125
Disciplines
Medicine and Health Sciences
PubMedID
33789008
Department(s)
Department of Medicine
Document Type
Article