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Article: Five-Year Survival Outcomes From the PACIFIC Trial: Durvalumab After Chemoradiotherapy in Stage III Non-Small-Cell Lung Cancer

TitleFive-Year Survival Outcomes From the PACIFIC Trial: Durvalumab After Chemoradiotherapy in Stage III Non-Small-Cell Lung Cancer
Authors
Issue Date2022
Citation
Journal of Clinical Oncology, 2022, v. 40, n. 12, p. 1301-1311 How to Cite?
AbstractPURPOSEThe phase III PACIFIC trial compared durvalumab with placebo in patients with unresectable, stage III non-small-cell lung cancer and no disease progression after concurrent chemoradiotherapy. Consolidation durvalumab was associated with significant improvements in the primary end points of overall survival (OS; stratified hazard ratio [HR], 0.68; 95% CI, 0.53 to 0.87; P =.00251) and progression-free survival (PFS [blinded independent central review; RECIST v1.1]; stratified HR, 0.52; 95% CI, 0.42 to 0.65; P <.0001), with manageable safety. We report updated, exploratory analyses of survival, approximately 5 years after the last patient was randomly assigned.METHODSPatients with WHO performance status 0 or 1 (any tumor programmed cell death-ligand 1 status) were randomly assigned (2:1) to durvalumab (10 mg/kg intravenously; administered once every 2 weeks for 12 months) or placebo, stratified by age, sex, and smoking history. Time-to-event end point analyses were performed using stratified log-rank tests. Medians and landmark survival rates were estimated using the Kaplan-Meier method.RESULTSSeven hundred and nine of 713 randomly assigned patients received durvalumab (473 of 476) or placebo (236 of 237). As of January 11, 2021 (median follow-up, 34.2 months [all patients]; 61.6 months [censored patients]), updated OS (stratified HR, 0.72; 95% CI, 0.59 to 0.89; median, 47.5 v 29.1 months) and PFS (stratified HR, 0.55; 95% CI, 0.45 to 0.68; median, 16.9 v 5.6 months) remained consistent with the primary analyses. Estimated 5-year rates (95% CI) for durvalumab and placebo were 42.9% (38.2 to 47.4) versus 33.4% (27.3 to 39.6) for OS and 33.1% (28.0 to 38.2) versus 19.0% (13.6 to 25.2) for PFS.CONCLUSIONThese updated analyses demonstrate robust and sustained OS and durable PFS benefit with durvalumab after chemoradiotherapy. An estimated 42.9% of patients randomly assigned to durvalumab remain alive at 5 years and 33.1% of patients randomly assigned to durvalumab remain alive and free of disease progression, establishing a new benchmark for standard of care in this setting.
Persistent Identifierhttp://hdl.handle.net/10722/326433
ISSN
2023 Impact Factor: 42.1
2023 SCImago Journal Rankings: 10.639
ISI Accession Number ID

 

DC FieldValueLanguage
dc.contributor.authorSpigel, David R.-
dc.contributor.authorFaivre-Finn, Corinne-
dc.contributor.authorGray, Jhanelle E.-
dc.contributor.authorVicente, David-
dc.contributor.authorPlanchard, David-
dc.contributor.authorPaz-Ares, Luis-
dc.contributor.authorVansteenkiste, Johan F.-
dc.contributor.authorGarassino, Marina C.-
dc.contributor.authorHui, Rina-
dc.contributor.authorQuantin, Xavier-
dc.contributor.authorRimner, Andreas-
dc.contributor.authorWu, Yi Long-
dc.contributor.authorÖzgüroǧlu, Mustafa-
dc.contributor.authorLee, Ki H.-
dc.contributor.authorKato, Terufumi-
dc.contributor.authorDe Wit, Maike-
dc.contributor.authorKurata, Takayasu-
dc.contributor.authorReck, Martin-
dc.contributor.authorCho, Byoung C.-
dc.contributor.authorSenan, Suresh-
dc.contributor.authorNaidoo, Jarushka-
dc.contributor.authorMann, Helen-
dc.contributor.authorNewton, Michael-
dc.contributor.authorThiyagarajah, Piruntha-
dc.contributor.authorAntonia, Scott J.-
dc.date.accessioned2023-03-10T02:19:15Z-
dc.date.available2023-03-10T02:19:15Z-
dc.date.issued2022-
dc.identifier.citationJournal of Clinical Oncology, 2022, v. 40, n. 12, p. 1301-1311-
dc.identifier.issn0732-183X-
dc.identifier.urihttp://hdl.handle.net/10722/326433-
dc.description.abstractPURPOSEThe phase III PACIFIC trial compared durvalumab with placebo in patients with unresectable, stage III non-small-cell lung cancer and no disease progression after concurrent chemoradiotherapy. Consolidation durvalumab was associated with significant improvements in the primary end points of overall survival (OS; stratified hazard ratio [HR], 0.68; 95% CI, 0.53 to 0.87; P =.00251) and progression-free survival (PFS [blinded independent central review; RECIST v1.1]; stratified HR, 0.52; 95% CI, 0.42 to 0.65; P <.0001), with manageable safety. We report updated, exploratory analyses of survival, approximately 5 years after the last patient was randomly assigned.METHODSPatients with WHO performance status 0 or 1 (any tumor programmed cell death-ligand 1 status) were randomly assigned (2:1) to durvalumab (10 mg/kg intravenously; administered once every 2 weeks for 12 months) or placebo, stratified by age, sex, and smoking history. Time-to-event end point analyses were performed using stratified log-rank tests. Medians and landmark survival rates were estimated using the Kaplan-Meier method.RESULTSSeven hundred and nine of 713 randomly assigned patients received durvalumab (473 of 476) or placebo (236 of 237). As of January 11, 2021 (median follow-up, 34.2 months [all patients]; 61.6 months [censored patients]), updated OS (stratified HR, 0.72; 95% CI, 0.59 to 0.89; median, 47.5 v 29.1 months) and PFS (stratified HR, 0.55; 95% CI, 0.45 to 0.68; median, 16.9 v 5.6 months) remained consistent with the primary analyses. Estimated 5-year rates (95% CI) for durvalumab and placebo were 42.9% (38.2 to 47.4) versus 33.4% (27.3 to 39.6) for OS and 33.1% (28.0 to 38.2) versus 19.0% (13.6 to 25.2) for PFS.CONCLUSIONThese updated analyses demonstrate robust and sustained OS and durable PFS benefit with durvalumab after chemoradiotherapy. An estimated 42.9% of patients randomly assigned to durvalumab remain alive at 5 years and 33.1% of patients randomly assigned to durvalumab remain alive and free of disease progression, establishing a new benchmark for standard of care in this setting.-
dc.languageeng-
dc.relation.ispartofJournal of Clinical Oncology-
dc.titleFive-Year Survival Outcomes From the PACIFIC Trial: Durvalumab After Chemoradiotherapy in Stage III Non-Small-Cell Lung Cancer-
dc.typeArticle-
dc.description.naturelink_to_subscribed_fulltext-
dc.identifier.doi10.1200/JCO.21.01308-
dc.identifier.pmid35108059-
dc.identifier.scopuseid_2-s2.0-85125441729-
dc.identifier.volume40-
dc.identifier.issue12-
dc.identifier.spage1301-
dc.identifier.epage1311-
dc.identifier.eissn1527-7755-
dc.identifier.isiWOS:000799692000006-

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