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Outcomes with durvalumab by tumour PD-L1 expression in unresectable, stage III non-small-cell lung cancer in the PACIFIC trial

DC FieldValueLanguage
dc.contributor.author조병철-
dc.date.accessioned2020-09-29T01:08:56Z-
dc.date.available2020-09-29T01:08:56Z-
dc.date.issued2020-06-
dc.identifier.issn0923-7534-
dc.identifier.urihttps://ir.ymlib.yonsei.ac.kr/handle/22282913/179413-
dc.description.abstractBackground: In the PACIFIC trial, durvalumab significantly improved progression-free and overall survival (PFS/OS) versus placebo, with manageable safety, in unresectable, stage III non-small-cell lung cancer (NSCLC) patients without progression after chemoradiotherapy (CRT). We report exploratory analyses of outcomes by tumour cell (TC) programmed death-ligand 1 (PD-L1) expression. Patients and methods: Patients were randomly assigned (2:1) to intravenous durvalumab 10 mg/kg every 2 weeks or placebo ≤12 months, stratified by age, sex, and smoking history, but not PD-L1 status. Where available, pre-CRT samples were tested for PD-L1 expression (immunohistochemistry) and scored at pre-specified (25%) and post hoc (1%) TC cut-offs. Treatment-effect hazard ratios (HRs) were estimated from unstratified Cox proportional hazards models (Kaplan-Meier-estimated medians). Results: In total, 713 patients were randomly assigned, 709 of whom received at least 1 dose of study treatment durvalumab (n = 473) or placebo (n = 236). Some 451 (63%) were PD-L1-assessable: 35%, 65%, 67%, 33%, and 32% had TC ≥25%, <25%, ≥1%, <1%, and 1%-24%, respectively. As of 31 January 2019, median follow-up was 33.3 months. Durvalumab improved PFS versus placebo (primary-analysis data cut-off, 13 February 2017) across all subgroups [HR, 95% confidence interval (CI); medians]: TC ≥25% (0.41, 0.26-0.65; 17.8 versus 3.7 months), <25% (0.59, 0.43-0.82; 16.9 versus 6.9 months), ≥1% (0.46, 0.33-0.64; 17.8 versus 5.6 months), <1% (0.73, 0.48-1.11; 10.7 versus 5.6 months), 1%-24% [0.49, 0.30-0.80; not reached (NR) versus 9.0 months], and unknown (0.59, 0.42-0.83; 14.0 versus 6.4 months). Durvalumab improved OS across most subgroups (31 January 2019 data cut-off; HR, 95% CI; medians): TC ≥ 25% (0.50, 0.30-0.83; NR versus 21.1 months), <25% (0.89, 0.63-1.25; 39.7 versus 37.4 months), ≥1% (0.59, 0.41-0.83; NR versus 29.6 months), 1%-24% (0.67, 0.41-1.10; 43.3 versus 30.5 months), and unknown (0.60, 0.43-0.84; 44.2 versus 23.5 months), but not <1% (1.14, 0.71-1.84; 33.1 versus 45.6 months). Safety was similar across subgroups. Conclusions: PFS benefit with durvalumab was observed across all subgroups, and OS benefit across all but TC <1%, for which limitations and wide HR CI preclude robust conclusions.-
dc.description.statementOfResponsibilityrestriction-
dc.languageEnglish-
dc.publisherOxford University Press-
dc.relation.isPartOfANNALS OF ONCOLOGY-
dc.rightsCC BY-NC-ND 2.0 KR-
dc.titleOutcomes with durvalumab by tumour PD-L1 expression in unresectable, stage III non-small-cell lung cancer in the PACIFIC trial-
dc.typeArticle-
dc.contributor.collegeCollege of Medicine (의과대학)-
dc.contributor.departmentDept. of Internal Medicine (내과학교실)-
dc.contributor.googleauthorL Paz-Ares-
dc.contributor.googleauthorA Spira-
dc.contributor.googleauthorD Raben-
dc.contributor.googleauthorD Planchard-
dc.contributor.googleauthorB C Cho-
dc.contributor.googleauthorM Özgüroğlu-
dc.contributor.googleauthorD Daniel-
dc.contributor.googleauthorA Villegas-
dc.contributor.googleauthorD Vicente-
dc.contributor.googleauthorR Hui-
dc.contributor.googleauthorS Murakami-
dc.contributor.googleauthorD Spigel-
dc.contributor.googleauthorS Senan-
dc.contributor.googleauthorC J Langer-
dc.contributor.googleauthorB A Perez-
dc.contributor.googleauthorA-M Boothman-
dc.contributor.googleauthorH Broadhurst-
dc.contributor.googleauthorC Wadsworth-
dc.contributor.googleauthorP A Dennis-
dc.contributor.googleauthorS J Antonia-
dc.contributor.googleauthorC Faivre-Finn-
dc.identifier.doi10.1016/j.annonc.2020.03.287-
dc.contributor.localIdA03822-
dc.relation.journalcodeJ00171-
dc.identifier.eissn1569-8041-
dc.identifier.pmid32209338-
dc.identifier.urlhttps://www.sciencedirect.com/science/article/pii/S0923753420363742-
dc.subject.keywordPACIFIC-
dc.subject.keywordPD-L1 expression-
dc.subject.keyworddurvalumab-
dc.subject.keywordimmunotherapy-
dc.subject.keywordnon-small-cell lung cancer-
dc.subject.keywordstage III-
dc.contributor.alternativeNameCho, Byoung Chul-
dc.contributor.affiliatedAuthor조병철-
dc.citation.volume31-
dc.citation.number6-
dc.citation.startPage798-
dc.citation.endPage806-
dc.identifier.bibliographicCitationANNALS OF ONCOLOGY, Vol.31(6) : 798-806, 2020-06-
Appears in Collections:
1. College of Medicine (의과대학) > Dept. of Internal Medicine (내과학교실) > 1. Journal Papers

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