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dc.contributorVall d'Hebron Barcelona Hospital Campus
dc.contributor.authorCamidge, D. Ross
dc.contributor.authorKim, Hye Ryun
dc.contributor.authorAhn, Myung-Ju
dc.contributor.authorYang, James C. H.
dc.contributor.authorHan, Ji-Youn
dc.contributor.authorHochmair, Maximilian J.
dc.contributor.authorFelip Font, Enriqueta
dc.date.accessioned2021-09-23T11:08:10Z
dc.date.available2021-09-23T11:08:10Z
dc.date.issued2020-11-01
dc.identifier.citationCamidge DR, Kim HR, Ahn MJ, Yang JCH, Han JY, Hochmair MJ, et al. Brigatinib Versus Crizotinib in Advanced ALK Inhibitor–Naive ALK-Positive Non–Small Cell Lung Cancer: Second Interim Analysis of the Phase III ALTA-1L Trial. J Clin Oncol. 2020 Nov 1;38(31):3592–603.
dc.identifier.issn1527-7755
dc.identifier.urihttp://hdl.handle.net/11351/6346
dc.descriptionLung cancer; Brigatinib; ALTA-1L study
dc.description.abstractPURPOSE Brigatinib, a next-generation anaplastic lymphoma kinase (ALK) inhibitor, demonstrated superior progression-free survival (PFS) and improved health-related quality of life (QoL) versus crizotinib in advanced ALK inhibitor–naive ALK-positive non–small cell lung cancer (NSCLC) at first interim analysis (99 events; median brigatinib follow-up, 11.0 months) in the open-label, phase III ALTA-1L trial (ClinicalTrials.gov identifier: NCT02737501). We report results of the second prespecified interim analysis (150 events). METHODS Patients with ALK inhibitor–naive advanced ALK-positive NSCLC were randomly assigned 1:1 to brigatinib 180 mg once daily (7-day lead-in at 90 mg once daily) or crizotinib 250 mg twice daily. The primary end point was PFS as assessed by blinded independent review committee (BIRC). Investigator-assessed efficacy, blood samples for pharmacokinetic assessments, and patient-reported outcomes were also collected. RESULTS Two hundred seventy-five patients were randomly assigned (brigatinib, n = 137; crizotinib, n = 138). With median follow-up of 24.9 months for brigatinib (150 PFS events), brigatinib showed consistent superiority in BIRC-assessed PFS versus crizotinib (hazard ratio [HR], 0.49 [95% CI, 0.35 to 0.68]; log-rank P < .0001; median, 24.0 v 11.0 months). Investigator-assessed PFS HR was 0.43 (95% CI, 0.31 to 0.61; median, 29.4 v 9.2 months). No new safety concerns emerged. Brigatinib delayed median time to worsening of global health status/QoL scores compared with crizotinib (HR, 0.70 [95% CI, 0.49 to 1.00]; log-rank P = .049). Brigatinib daily area under the plasma concentration–time curve was not a predictor of PFS (HR, 1.005 [95% CI, 0.98 to 1.031]; P = .69). CONCLUSION Brigatinib represents a once-daily ALK inhibitor with superior efficacy, tolerability, and QoL over crizotinib, making it a promising first-line treatment of ALK-positive NSCLC.
dc.language.isoeng
dc.publisherAmerican Society of Clinical Oncology
dc.relation.ispartofseriesJournal of Clinical Oncology;38(31)
dc.rightsAttribution-NonCommercial-NoDerivatives 4.0 International
dc.rights.urihttp://creativecommons.org/licenses/by-nc-nd/4.0/
dc.sourceScientia
dc.subjectPulmons - Càncer - Tractament
dc.subjectMedicaments antineoplàstics - Ús terapèutic - Eficàcia
dc.subject.meshCarcinoma, Non-Small-Cell Lung
dc.subject.mesh/drug therapy
dc.subject.meshProgression-Free Survival
dc.titleBrigatinib Versus Crizotinib in Advanced ALK Inhibitor–Naive ALK-Positive Non–Small Cell Lung Cancer: Second Interim Analysis of the Phase III ALTA-1L Trial
dc.typeinfo:eu-repo/semantics/article
dc.identifier.doi10.1200/JCO.20.00505
dc.subject.decscarcinoma de pulmón de células no pequeñas
dc.subject.decs/farmacoterapia
dc.subject.decssupervivencia libre de progresión
dc.relation.publishversionhttps://doi.org/10.1200/JCO.20.00505
dc.type.versioninfo:eu-repo/semantics/publishedVersion
dc.audienceProfessionals
dc.contributor.organismesInstitut Català de la Salut
dc.contributor.authoraffiliation[Camidge DR] University of Colorado Cancer Center, Aurora, CO. [Kim HR] Division of Medical Oncology, Department of Internal Medicine, Yonsei Cancer Center, Yonsei University College of Medicine, Seoul, South Korea. [Ahn MJ] Samsung Medical Center, Seoul, South Korea. [Yang JCH] National Taiwan University Hospital, Taipei, Taiwan. [Han JY] National Cancer Center, Goyang, South Korea. [Hochmair MJ] Department of Respiratory and Critical Care Medicine, Krankenhaus Nord–Klinik Floridsdorf, Vienna, Austria. [Felip E] Vall d’Hebron Hospital Universitari, Barcelona, Spain
dc.identifier.pmid32780660
dc.identifier.wos000588411100004
dc.rights.accessrightsinfo:eu-repo/semantics/openAccess


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