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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

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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.authorLee, Ki Hyeong-
dc.contributor.authorDelmonte, Angelo-
dc.contributor.authorGarcia Campelo, Maria Rosario-
dc.contributor.authorKim, Dong-Wan-
dc.contributor.authorGriesinger, Frank-
dc.contributor.authorFelip, Enriqueta-
dc.contributor.authorCalifano, Raffaele-
dc.contributor.authorSpira, Alexander-
dc.contributor.authorGettinger, Scott N.-
dc.contributor.authorTiseo, Marcello-
dc.contributor.authorLin, Huamao M.-
dc.contributor.authorGupta, Neeraj-
dc.contributor.authorHanley, Michael J.-
dc.contributor.authorNi, Quanhong-
dc.contributor.authorZhang, Pingkuan-
dc.contributor.authorPopat, Sanjay-
dc.date.accessioned2021-01-31T08:06:32Z-
dc.date.available2021-01-31T08:06:32Z-
dc.date.created2020-11-30-
dc.date.created2020-11-30-
dc.date.created2020-11-30-
dc.date.issued2020-11-01-
dc.identifier.citationJournal of Clinical Oncology, Vol.38 No.31, pp.3592-3603-
dc.identifier.issn0732-183X-
dc.identifier.other117863-
dc.identifier.urihttps://hdl.handle.net/10371/171809-
dc.description.abstractPURPOSEBrigatinib, 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).METHODSPatients 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.RESULTSTwo 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).CONCLUSIONBrigatinib 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.language영어-
dc.publisherAmerican Society of Clinical Oncology-
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.typeArticle-
dc.contributor.AlternativeAuthor김동완-
dc.identifier.doi10.1200/JCO.20.00505-
dc.citation.journaltitleJournal of Clinical Oncology-
dc.identifier.wosid000588411100004-
dc.identifier.scopusid2-s2.0-85094933151-
dc.citation.endpage3603-
dc.citation.number31-
dc.citation.startpage3592-
dc.citation.volume38-
dc.identifier.sci000588411100004-
dc.description.isOpenAccessY-
dc.contributor.affiliatedAuthorKim, Dong-Wan-
dc.type.docTypeArticle-
dc.description.journalClass1-
dc.subject.keywordPlusQUALITY-OF-LIFE-
dc.subject.keywordPlusEML4-ALK FUSION GENE-
dc.subject.keywordPlusKINASE INHIBITOR-
dc.subject.keywordPlusCHEMOTHERAPY-
dc.subject.keywordPlusALECTINIB-
dc.subject.keywordPlusEFFICACY-
dc.subject.keywordPlusOUTCOMES-
dc.subject.keywordPlusQLQ-C30-
dc.subject.keywordPlusSAFETY-
dc.subject.keywordPlusEGFR-
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