- Published
- 2021-03-31
- Venue
- New England Journal of Medicine, vol. 384, no. 13, pp. 1191-1203
- Cited by
- 1,840
- Open access
- Yes, bronze
- DOI
- 10.1056/nejmoa2032125
- PubMed
- 33789008
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<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.).
Cite this paper
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- APA 7
Kelly, R. J., Ajani, J. A., Kużdżał, J., Zander, T., Cutsem, E. V., Piessen, G., Mendez, G. A., Feliciano, J. L., Motoyama, S., Lièvre, A., Uronis, H. E., Elimova, E. C., Grootscholten, C., Geboes, K. P., Zafar, S., Snow, S. L., Ko, A. H., Feeney, K., Schenker, M., … Moehler, M. H. (2021). Adjuvant Nivolumab in Resected Esophageal or Gastroesophageal Junction Cancer. New England Journal of Medicine, 384(13), 1191–1203. https://doi.org/10.1056/nejmoa2032125
- MLA 9
Kelly, Ronan Joseph, et al. "Adjuvant Nivolumab in Resected Esophageal or Gastroesophageal Junction Cancer." New England Journal of Medicine, vol. 384, no. 13, 2021, pp. 1191–1203, https://doi.org/10.1056/nejmoa2032125.
- Chicago
Kelly, Ronan Joseph, Jaffer A. Ajani, Jarosław Kużdżał, Thomas Zander, Eric Van Cutsem, Guillaume Piessen, Guillermo Ariel Mendez, et al. "Adjuvant Nivolumab in Resected Esophageal or Gastroesophageal Junction Cancer." New England Journal of Medicine 384, no. 13 (2021): 1191–1203. https://doi.org/10.1056/nejmoa2032125.
- GOST
Kelly R. J., Ajani J. A., Kużdżał J. [и др.] Adjuvant Nivolumab in Resected Esophageal or Gastroesophageal Junction Cancer // New England Journal of Medicine. — 2021. — Vol. 384, № 13. — P. 1191–1203. — URL: https://doi.org/10.1056/nejmoa2032125
- BibTeX
@article{kelly2021adjuvant, title = {{Adjuvant Nivolumab in Resected Esophageal or Gastroesophageal Junction Cancer}}, author = {Ronan Joseph Kelly and Jaffer A. Ajani and Jarosław Kużdżał and Thomas Zander and Eric Van Cutsem and Guillaume Piessen and Guillermo Ariel Mendez and Josephine Louella Feliciano and Satoru Motoyama and Astrid Lièvre and Hope Elizabeth Uronis and Elena C. Elimova and Cecile Grootscholten and Karen Paula Geboes and Syed Zafar and Stephanie Leann Snow and Andrew H. Ko and Kynan Feeney and Michael Schenker and Piotr Kocoń and Jenny Zhang and Lili Zhu and Ming Lei and Prianka Singh and Kaoru Kondo and James M. Cleary and Markus Hermann Moehler}, journal = {New England Journal of Medicine}, year = {2021}, volume = {384}, number = {13}, pages = {1191--1203}, doi = {10.1056/nejmoa2032125}, url = {https://doi.org/10.1056/nejmoa2032125} }- RIS
TY - JOUR AU - Kelly, Ronan Joseph AU - Ajani, Jaffer A. AU - Kużdżał, Jarosław AU - Zander, Thomas AU - Cutsem, Eric Van AU - Piessen, Guillaume AU - Mendez, Guillermo Ariel AU - Feliciano, Josephine Louella AU - Motoyama, Satoru AU - Lièvre, Astrid AU - Uronis, Hope Elizabeth AU - Elimova, Elena C. AU - Grootscholten, Cecile AU - Geboes, Karen Paula AU - Zafar, Syed AU - Snow, Stephanie Leann AU - Ko, Andrew H. AU - Feeney, Kynan AU - Schenker, Michael AU - Kocoń, Piotr AU - Zhang, Jenny AU - Zhu, Lili AU - Lei, Ming AU - Singh, Prianka AU - Kondo, Kaoru AU - Cleary, James M. AU - Moehler, Markus Hermann TI - Adjuvant Nivolumab in Resected Esophageal or Gastroesophageal Junction Cancer JO - New England Journal of Medicine VL - 384 IS - 13 SP - 1191 EP - 1203 PY - 2021 DA - 2021/03/31 DO - 10.1056/nejmoa2032125 UR - https://doi.org/10.1056/nejmoa2032125 ER -
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