Kelly, Ronan J., Ajani, Jaffer A., Kuzdzal, Jaroslaw, Zander, Thomas, Van Cutsem, Eric, Piessen, Guillaume, Mendez, Guillermo, Feliciano, Josephine, Motoyama, Satoru, Lievre, Astrid, Uronis, Hope, Elimova, Elena, Grootscholten, Cecile, Geboes, Karen, Zafar, Syed, Snow, Stephanie ORCID: 0000-0003-3847-0289, Ko, Andrew H., Feeney, Kynan, Schenker, Michael ORCID: 0000-0003-2645-6391, Kocon, Piotr, Zhang, Jenny, Zhu, Lili, Lei, Ming, Singh, Prianka, Kondo, Kaoru, Cleary, James M. and Moehler, Markus (2021). Adjuvant Nivolumab in Resected Esophageal or Gastroesophageal Junction Cancer. N. Engl. J. Med., 384 (13). S. 1191 - 1204. WALTHAM: MASSACHUSETTS MEDICAL SOC. ISSN 1533-4406

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Abstract

BackgroundNo 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. MethodsWe 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. ResultsThe 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. ConclusionsAmong 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.) Adjuvant chemotherapy has not improved disease-free survival among patients with resected esophageal or gastroesophageal junction cancer. In this trial, after neoadjuvant chemoradiotherapy and resection, patients with residual disease were randomly assigned to receive nivolumab or placebo. Nivolumab doubled the median disease-free survival from 11.0 to 22.4 months.

Item Type: Journal Article
Creators:
CreatorsEmailORCIDORCID Put Code
Kelly, Ronan J.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Ajani, Jaffer A.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Kuzdzal, JaroslawUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Zander, ThomasUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Van Cutsem, EricUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Piessen, GuillaumeUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Mendez, GuillermoUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Feliciano, JosephineUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Motoyama, SatoruUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Lievre, AstridUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Uronis, HopeUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Elimova, ElenaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Grootscholten, CecileUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Geboes, KarenUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Zafar, SyedUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Snow, StephanieUNSPECIFIEDorcid.org/0000-0003-3847-0289UNSPECIFIED
Ko, Andrew H.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Feeney, KynanUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Schenker, MichaelUNSPECIFIEDorcid.org/0000-0003-2645-6391UNSPECIFIED
Kocon, PiotrUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Zhang, JennyUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Zhu, LiliUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Lei, MingUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Singh, PriankaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Kondo, KaoruUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Cleary, James M.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Moehler, MarkusUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
URN: urn:nbn:de:hbz:38-606751
DOI: 10.1056/NEJMoa2032125
Journal or Publication Title: N. Engl. J. Med.
Volume: 384
Number: 13
Page Range: S. 1191 - 1204
Date: 2021
Publisher: MASSACHUSETTS MEDICAL SOC
Place of Publication: WALTHAM
ISSN: 1533-4406
Language: English
Faculty: Unspecified
Divisions: Unspecified
Subjects: no entry
Uncontrolled Keywords:
KeywordsLanguage
IPILIMUMAB; DISEASEMultiple languages
Medicine, General & InternalMultiple languages
URI: http://kups.ub.uni-koeln.de/id/eprint/60675

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