Universität zu Köln

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:	Creators Email ORCID ORCID Put Code Kelly, Ronan J. UNSPECIFIED UNSPECIFIED UNSPECIFIED Ajani, Jaffer A. UNSPECIFIED UNSPECIFIED UNSPECIFIED Kuzdzal, Jaroslaw UNSPECIFIED UNSPECIFIED UNSPECIFIED Zander, Thomas UNSPECIFIED UNSPECIFIED UNSPECIFIED Van Cutsem, Eric UNSPECIFIED UNSPECIFIED UNSPECIFIED Piessen, Guillaume UNSPECIFIED UNSPECIFIED UNSPECIFIED Mendez, Guillermo UNSPECIFIED UNSPECIFIED UNSPECIFIED Feliciano, Josephine UNSPECIFIED UNSPECIFIED UNSPECIFIED Motoyama, Satoru UNSPECIFIED UNSPECIFIED UNSPECIFIED Lievre, Astrid UNSPECIFIED UNSPECIFIED UNSPECIFIED Uronis, Hope UNSPECIFIED UNSPECIFIED UNSPECIFIED Elimova, Elena UNSPECIFIED UNSPECIFIED UNSPECIFIED Grootscholten, Cecile UNSPECIFIED UNSPECIFIED UNSPECIFIED Geboes, Karen UNSPECIFIED UNSPECIFIED UNSPECIFIED Zafar, Syed UNSPECIFIED UNSPECIFIED UNSPECIFIED Snow, Stephanie UNSPECIFIED orcid.org/0000-0003-3847-0289 UNSPECIFIED Ko, Andrew H. UNSPECIFIED UNSPECIFIED UNSPECIFIED Feeney, Kynan UNSPECIFIED UNSPECIFIED UNSPECIFIED Schenker, Michael UNSPECIFIED orcid.org/0000-0003-2645-6391 UNSPECIFIED Kocon, Piotr UNSPECIFIED UNSPECIFIED UNSPECIFIED Zhang, Jenny UNSPECIFIED UNSPECIFIED UNSPECIFIED Zhu, Lili UNSPECIFIED UNSPECIFIED UNSPECIFIED Lei, Ming UNSPECIFIED UNSPECIFIED UNSPECIFIED Singh, Prianka UNSPECIFIED UNSPECIFIED UNSPECIFIED Kondo, Kaoru UNSPECIFIED UNSPECIFIED UNSPECIFIED Cleary, James M. UNSPECIFIED UNSPECIFIED UNSPECIFIED Moehler, Markus UNSPECIFIED UNSPECIFIED UNSPECIFIED
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:	Keywords Language IPILIMUMAB; DISEASE Multiple languages Medicine, General & Internal Multiple languages
URI:	http://kups.ub.uni-koeln.de/id/eprint/60675