Cited 377 times in
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
DC Field | Value | Language |
---|---|---|
dc.contributor.author | 김혜련 | - |
dc.date.accessioned | 2020-09-30T16:44:57Z | - |
dc.date.available | 2020-09-30T16:44:57Z | - |
dc.date.issued | 2020-07 | - |
dc.identifier.issn | 0732-183X | - |
dc.identifier.uri | https://ir.ymlib.yonsei.ac.kr/handle/22282913/179607 | - |
dc.description.abstract | Purpose: 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.statementOfResponsibility | restriction | - |
dc.language | English | - |
dc.publisher | American Society of Clinical Oncology | - |
dc.relation.isPartOf | JOURNAL OF CLINICAL ONCOLOGY | - |
dc.rights | CC BY-NC-ND 2.0 KR | - |
dc.title | 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 | - |
dc.type | Article | - |
dc.contributor.college | College of Medicine (의과대학) | - |
dc.contributor.department | Dept. of Internal Medicine (내과학교실) | - |
dc.contributor.googleauthor | Charles M Rudin | - |
dc.contributor.googleauthor | Mark M Awad | - |
dc.contributor.googleauthor | Alejandro Navarro | - |
dc.contributor.googleauthor | Maya Gottfried | - |
dc.contributor.googleauthor | Solange Peters | - |
dc.contributor.googleauthor | Tibor Csőszi | - |
dc.contributor.googleauthor | Parneet K Cheema | - |
dc.contributor.googleauthor | Delvys Rodriguez-Abreu | - |
dc.contributor.googleauthor | Mirjana Wollner | - |
dc.contributor.googleauthor | James Chih-Hsin Yang | - |
dc.contributor.googleauthor | Julien Mazieres | - |
dc.contributor.googleauthor | Francisco J Orlandi | - |
dc.contributor.googleauthor | Alexander Luft | - |
dc.contributor.googleauthor | Mahmut Gümüş | - |
dc.contributor.googleauthor | Terufumi Kato | - |
dc.contributor.googleauthor | Gregory P Kalemkerian | - |
dc.contributor.googleauthor | Yiwen Luo | - |
dc.contributor.googleauthor | Victoria Ebiana | - |
dc.contributor.googleauthor | M Catherine Pietanza | - |
dc.contributor.googleauthor | Hye Ryun Kim | - |
dc.contributor.googleauthor | KEYNOTE-604 Investigators | - |
dc.identifier.doi | 10.1200/JCO.20.00793 | - |
dc.contributor.localId | A01166 | - |
dc.relation.journalcode | J01331 | - |
dc.identifier.eissn | 1527-7755 | - |
dc.identifier.pmid | 32468956 | - |
dc.identifier.url | https://ascopubs.org/doi/10.1200/JCO.20.00793 | - |
dc.contributor.alternativeName | Kim, Hye Ryun | - |
dc.contributor.affiliatedAuthor | 김혜련 | - |
dc.citation.volume | 38 | - |
dc.citation.number | 21 | - |
dc.citation.startPage | 2369 | - |
dc.citation.endPage | 2379 | - |
dc.identifier.bibliographicCitation | JOURNAL OF CLINICAL ONCOLOGY, Vol.38(21) : 2369-2379, 2020-07 | - |
Items in DSpace are protected by copyright, with all rights reserved, unless otherwise indicated.