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Pembrolizumab or Placebo Plus Etoposide and Platinum as First-Line Therapy for Extensive-Stage Small-Cell Lung Cancer: Randomized, Double-Blind, Phase III KEYNOTE-604 Study

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dc.contributor.author김혜련-
dc.date.accessioned2020-09-30T16:44:57Z-
dc.date.available2020-09-30T16:44:57Z-
dc.date.issued2020-07-
dc.identifier.issn0732-183X-
dc.identifier.urihttps://ir.ymlib.yonsei.ac.kr/handle/22282913/179607-
dc.description.abstractPurpose: Pembrolizumab monotherapy has shown antitumor activity in patients with small-cell lung cancer (SCLC). The randomized, double-blind, phase III KEYNOTE-604 study compared pembrolizumab plus etoposide and platinum (EP) with placebo plus EP for patients with previously untreated extensive-stage (ES) SCLC. Methods: Eligible patients were randomly assigned 1:1 to pembrolizumab 200 mg once every 3 weeks or saline placebo for up to 35 cycles plus 4 cycles of EP. Primary end points were progression-free survival (PFS; RECIST version 1.1, blinded central review) and overall survival (OS) in the intention-to-treat population. Objective response rate (ORR) and duration of response were secondary end points. Prespecified efficacy boundaries were one-sided P = .0048 for PFS and .0128 for OS. Results: Of the 453 participants, 228 were randomly assigned to pembrolizumab plus EP and 225 to placebo plus EP. Pembrolizumab plus EP significantly improved PFS (hazard ratio [HR], 0.75; 95% CI, 0.61 to 0.91; P = .0023). Twelve-month PFS estimates were 13.6% with pembrolizumab plus EP and 3.1% with placebo plus EP. Although pembrolizumab plus EP prolonged OS, the significance threshold was not met (HR, 0.80; 95% CI, 0.64 to 0.98; P = .0164). Twenty-four-month OS estimates were 22.5% and 11.2%, respectively. ORR was 70.6% in the pembrolizumab plus EP group and 61.8% in the placebo plus EP group; the estimated proportion of responders remaining in response at 12 months was 19.3% and 3.3%, respectively. In the pembrolizumab plus EP and placebo plus EP groups, respectively, any-cause adverse events were grade 3-4 in 76.7% and 74.9%, grade 5 in 6.3% and 5.4%, and led to discontinuation of any drug in 14.8% and 6.3%. Conclusion: Pembrolizumab plus EP significantly improved PFS compared with placebo plus EP as first-line therapy for patients with ES-SCLC. No unexpected toxicities were seen with pembrolizumab plus EP. These data support the benefit of pembrolizumab in ES-SCLC.-
dc.description.statementOfResponsibilityrestriction-
dc.languageEnglish-
dc.publisherAmerican Society of Clinical Oncology-
dc.relation.isPartOfJOURNAL OF CLINICAL ONCOLOGY-
dc.rightsCC BY-NC-ND 2.0 KR-
dc.titlePembrolizumab or Placebo Plus Etoposide and Platinum as First-Line Therapy for Extensive-Stage Small-Cell Lung Cancer: Randomized, Double-Blind, Phase III KEYNOTE-604 Study-
dc.typeArticle-
dc.contributor.collegeCollege of Medicine (의과대학)-
dc.contributor.departmentDept. of Internal Medicine (내과학교실)-
dc.contributor.googleauthorCharles M Rudin-
dc.contributor.googleauthorMark M Awad-
dc.contributor.googleauthorAlejandro Navarro-
dc.contributor.googleauthorMaya Gottfried-
dc.contributor.googleauthorSolange Peters-
dc.contributor.googleauthorTibor Csőszi-
dc.contributor.googleauthorParneet K Cheema-
dc.contributor.googleauthorDelvys Rodriguez-Abreu-
dc.contributor.googleauthorMirjana Wollner-
dc.contributor.googleauthorJames Chih-Hsin Yang-
dc.contributor.googleauthorJulien Mazieres-
dc.contributor.googleauthorFrancisco J Orlandi-
dc.contributor.googleauthorAlexander Luft-
dc.contributor.googleauthorMahmut Gümüş-
dc.contributor.googleauthorTerufumi Kato-
dc.contributor.googleauthorGregory P Kalemkerian-
dc.contributor.googleauthorYiwen Luo-
dc.contributor.googleauthorVictoria Ebiana-
dc.contributor.googleauthorM Catherine Pietanza-
dc.contributor.googleauthorHye Ryun Kim-
dc.contributor.googleauthorKEYNOTE-604 Investigators-
dc.identifier.doi10.1200/JCO.20.00793-
dc.contributor.localIdA01166-
dc.relation.journalcodeJ01331-
dc.identifier.eissn1527-7755-
dc.identifier.pmid32468956-
dc.identifier.urlhttps://ascopubs.org/doi/10.1200/JCO.20.00793-
dc.contributor.alternativeNameKim, Hye Ryun-
dc.contributor.affiliatedAuthor김혜련-
dc.citation.volume38-
dc.citation.number21-
dc.citation.startPage2369-
dc.citation.endPage2379-
dc.identifier.bibliographicCitationJOURNAL OF CLINICAL ONCOLOGY, Vol.38(21) : 2369-2379, 2020-07-
Appears in Collections:
1. College of Medicine (의과대학) > Dept. of Internal Medicine (내과학교실) > 1. Journal Papers

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