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

TitleOutcomes with durvalumab by tumour PD-L1 expression in unresectable, stage III non-small-cell lung cancer in the PACIFIC trial
Authors
Keywordsdurvalumab
immunotherapy
non-small-cell lung cancer
PACIFIC
PD-L1 expression
stage III
Issue Date2020
Citation
Annals of Oncology, 2020, v. 31, n. 6, p. 798-806 How to Cite?
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.
Persistent Identifierhttp://hdl.handle.net/10722/326496
ISSN
2023 Impact Factor: 56.7
2023 SCImago Journal Rankings: 13.942
ISI Accession Number ID

 

DC FieldValueLanguage
dc.contributor.authorPaz-Ares, L.-
dc.contributor.authorSpira, A.-
dc.contributor.authorRaben, D.-
dc.contributor.authorPlanchard, D.-
dc.contributor.authorCho, B. C.-
dc.contributor.authorÖzgüroğlu, M.-
dc.contributor.authorDaniel, D.-
dc.contributor.authorVillegas, A.-
dc.contributor.authorVicente, D.-
dc.contributor.authorHui, R.-
dc.contributor.authorMurakami, S.-
dc.contributor.authorSpigel, D.-
dc.contributor.authorSenan, S.-
dc.contributor.authorLanger, C. J.-
dc.contributor.authorPerez, B. A.-
dc.contributor.authorBoothman, A. M.-
dc.contributor.authorBroadhurst, H.-
dc.contributor.authorWadsworth, C.-
dc.contributor.authorDennis, P. A.-
dc.contributor.authorAntonia, S. J.-
dc.contributor.authorFaivre-Finn, C.-
dc.date.accessioned2023-03-10T02:19:42Z-
dc.date.available2023-03-10T02:19:42Z-
dc.date.issued2020-
dc.identifier.citationAnnals of Oncology, 2020, v. 31, n. 6, p. 798-806-
dc.identifier.issn0923-7534-
dc.identifier.urihttp://hdl.handle.net/10722/326496-
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.languageeng-
dc.relation.ispartofAnnals of Oncology-
dc.subjectdurvalumab-
dc.subjectimmunotherapy-
dc.subjectnon-small-cell lung cancer-
dc.subjectPACIFIC-
dc.subjectPD-L1 expression-
dc.subjectstage III-
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.description.naturelink_to_subscribed_fulltext-
dc.identifier.doi10.1016/j.annonc.2020.03.287-
dc.identifier.pmid32209338-
dc.identifier.scopuseid_2-s2.0-85084203905-
dc.identifier.volume31-
dc.identifier.issue6-
dc.identifier.spage798-
dc.identifier.epage806-
dc.identifier.eissn1569-8041-
dc.identifier.isiWOS:000535705600013-

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