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Adjuvant Nivolumab in Resected Esophageal or Gastroesophageal Junction Cancer.

Publication ,  Journal Article
Kelly, RJ; Ajani, JA; Kuzdzal, J; Zander, T; Van Cutsem, E; Piessen, G; Mendez, G; Feliciano, J; Motoyama, S; Lièvre, A; Uronis, H; Elimova, E ...
Published in: N Engl J Med
April 1, 2021

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<0.001). Disease-free survival favored nivolumab across multiple prespecified subgroups. Grade 3 or 4 adverse events that were considered by the investigators to be related to the active drug or placebo occurred in 71 of 532 patients (13%) in the nivolumab group and 15 of 260 patients (6%) in the placebo group. The trial regimen was discontinued because of adverse events related to the active drug or placebo in 9% of the patients in the nivolumab group and 3% of those in the placebo group. 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.).

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Published In

N Engl J Med

DOI

EISSN

1533-4406

Publication Date

April 1, 2021

Volume

384

Issue

13

Start / End Page

1191 / 1203

Location

United States

Related Subject Headings

  • Stomach Neoplasms
  • Nivolumab
  • Neoadjuvant Therapy
  • Middle Aged
  • Male
  • Kaplan-Meier Estimate
  • Intention to Treat Analysis
  • Immune Checkpoint Inhibitors
  • Humans
  • General & Internal Medicine
 

Citation

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Kelly, R. J., Ajani, J. A., Kuzdzal, J., Zander, T., Van Cutsem, E., Piessen, G., … CheckMate 577 Investigators. (2021). Adjuvant Nivolumab in Resected Esophageal or Gastroesophageal Junction Cancer. N Engl J Med, 384(13), 1191–1203. https://doi.org/10.1056/NEJMoa2032125
Kelly, Ronan J., Jaffer A. Ajani, Jaroslaw Kuzdzal, Thomas Zander, Eric Van Cutsem, Guillaume Piessen, Guillermo Mendez, et al. “Adjuvant Nivolumab in Resected Esophageal or Gastroesophageal Junction Cancer.N Engl J Med 384, no. 13 (April 1, 2021): 1191–1203. https://doi.org/10.1056/NEJMoa2032125.
Kelly RJ, Ajani JA, Kuzdzal J, Zander T, Van Cutsem E, Piessen G, et al. Adjuvant Nivolumab in Resected Esophageal or Gastroesophageal Junction Cancer. N Engl J Med. 2021 Apr 1;384(13):1191–203.
Kelly, Ronan J., et al. “Adjuvant Nivolumab in Resected Esophageal or Gastroesophageal Junction Cancer.N Engl J Med, vol. 384, no. 13, Apr. 2021, pp. 1191–203. Pubmed, doi:10.1056/NEJMoa2032125.
Kelly RJ, Ajani JA, 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 AH, Feeney K, Schenker M, Kocon P, Zhang J, Zhu L, Lei M, Singh P, Kondo K, Cleary JM, Moehler M, CheckMate 577 Investigators. Adjuvant Nivolumab in Resected Esophageal or Gastroesophageal Junction Cancer. N Engl J Med. 2021 Apr 1;384(13):1191–1203.

Published In

N Engl J Med

DOI

EISSN

1533-4406

Publication Date

April 1, 2021

Volume

384

Issue

13

Start / End Page

1191 / 1203

Location

United States

Related Subject Headings

  • Stomach Neoplasms
  • Nivolumab
  • Neoadjuvant Therapy
  • Middle Aged
  • Male
  • Kaplan-Meier Estimate
  • Intention to Treat Analysis
  • Immune Checkpoint Inhibitors
  • Humans
  • General & Internal Medicine