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Adjuvant Pembrolizumab after Nephrectomy in Renal-Cell Carcinoma

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Abstract
Abstract
Background: Patients with renal-cell carcinoma who undergo nephrectomy have no options for adjuvant therapy to reduce the risk of recurrence that have high levels of supporting evidence.

Methods: In a double-blind, phase 3 trial, we randomly assigned, in a 1:1 ratio, patients with clear-cell renal-cell carcinoma who were at high risk for recurrence after nephrectomy, with or without metastasectomy, to receive either adjuvant pembrolizumab (at a dose of 200 mg) or placebo intravenously once every 3 weeks for up to 17 cycles (approximately 1 year). The primary end point was disease-free survival according to the investigator's assessment. Overall survival was a key secondary end point. Safety was a secondary end point.

Results: A total of 496 patients were randomly assigned to receive pembrolizumab, and 498 to receive placebo. At the prespecified interim analysis, the median time from randomization to the data-cutoff date was 24.1 months. Pembrolizumab therapy was associated with significantly longer disease-free survival than placebo (disease-free survival at 24 months, 77.3% vs. 68.1%; hazard ratio for recurrence or death, 0.68; 95% confidence interval [CI], 0.53 to 0.87; P = 0.002 [two-sided]). The estimated percentage of patients who remained alive at 24 months was 96.6% in the pembrolizumab group and 93.5% in the placebo group (hazard ratio for death, 0.54; 95% CI, 0.30 to 0.96). Grade 3 or higher adverse events of any cause occurred in 32.4% of the patients who received pembrolizumab and in 17.7% of those who received placebo. No deaths related to pembrolizumab therapy occurred.

Conclusions: Pembrolizumab treatment led to a significant improvement in disease-free survival as compared with placebo after surgery among patients with kidney cancer who were at high risk for recurrence. (Funded by Merck Sharp and Dohme, a subsidiary of Merck; KEYNOTE-564 ClinicalTrials.gov number, NCT03142334.).
Issued Date
2021
Type
Article
Keyword
Abridged Index MedicusAdverse eventsCancerCarcinomaRenal cellCare and treatmentHematologyManuscriptsMetastasisNephrectomyNephrologyNephrology GeneralOncologyPatient outcomesPatientsPembrolizumabPlacebosSurgeryTreatments in Oncology
DOI
10.1056/NEJMoa2106391
URI
https://oak.ulsan.ac.kr/handle/2021.oak/8458
https://ulsan-primo.hosted.exlibrisgroup.com/primo-explore/fulldisplay?docid=TN_cdi_proquest_miscellaneous_2562831831&context=PC&vid=ULSAN&lang=ko_KR&search_scope=default_scope&adaptor=primo_central_multiple_fe&tab=default_tab&query=any,contains,Adjuvant%20Pembrolizumab%20after%20Nephrectomy%20in%20Renal-Cell%20Carcinoma&offset=0&pcAvailability=true
Publisher
NEW ENGLAND JOURNAL OF MEDICINE
Location
미국
Language
영어
ISSN
0028-4793
Citation Volume
385
Citation Number
8
Citation Start Page
683
Citation End Page
694
Appears in Collections:
Medicine > Medicine
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