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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
DC Field | Value | Language |
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dc.contributor.author | Camidge, D. Ross | - |
dc.contributor.author | Kim, Hye Ryun | - |
dc.contributor.author | Ahn, Myung-Ju | - |
dc.contributor.author | Yang, James C. H. | - |
dc.contributor.author | Han, Ji-Youn | - |
dc.contributor.author | Hochmair, Maximilian J. | - |
dc.contributor.author | Lee, Ki Hyeong | - |
dc.contributor.author | Delmonte, Angelo | - |
dc.contributor.author | Garcia Campelo, Maria Rosario | - |
dc.contributor.author | Kim, Dong-Wan | - |
dc.contributor.author | Griesinger, Frank | - |
dc.contributor.author | Felip, Enriqueta | - |
dc.contributor.author | Califano, Raffaele | - |
dc.contributor.author | Spira, Alexander | - |
dc.contributor.author | Gettinger, Scott N. | - |
dc.contributor.author | Tiseo, Marcello | - |
dc.contributor.author | Lin, Huamao M. | - |
dc.contributor.author | Gupta, Neeraj | - |
dc.contributor.author | Hanley, Michael J. | - |
dc.contributor.author | Ni, Quanhong | - |
dc.contributor.author | Zhang, Pingkuan | - |
dc.contributor.author | Popat, Sanjay | - |
dc.date.accessioned | 2021-01-31T08:06:32Z | - |
dc.date.available | 2021-01-31T08:06:32Z | - |
dc.date.created | 2020-11-30 | - |
dc.date.created | 2020-11-30 | - |
dc.date.created | 2020-11-30 | - |
dc.date.issued | 2020-11-01 | - |
dc.identifier.citation | Journal of Clinical Oncology, Vol.38 No.31, pp.3592-3603 | - |
dc.identifier.issn | 0732-183X | - |
dc.identifier.other | 117863 | - |
dc.identifier.uri | https://hdl.handle.net/10371/171809 | - |
dc.description.abstract | PURPOSEBrigatinib, 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.language | 영어 | - |
dc.publisher | American Society of Clinical Oncology | - |
dc.title | 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 | - |
dc.type | Article | - |
dc.contributor.AlternativeAuthor | 김동완 | - |
dc.identifier.doi | 10.1200/JCO.20.00505 | - |
dc.citation.journaltitle | Journal of Clinical Oncology | - |
dc.identifier.wosid | 000588411100004 | - |
dc.identifier.scopusid | 2-s2.0-85094933151 | - |
dc.citation.endpage | 3603 | - |
dc.citation.number | 31 | - |
dc.citation.startpage | 3592 | - |
dc.citation.volume | 38 | - |
dc.identifier.sci | 000588411100004 | - |
dc.description.isOpenAccess | Y | - |
dc.contributor.affiliatedAuthor | Kim, Dong-Wan | - |
dc.type.docType | Article | - |
dc.description.journalClass | 1 | - |
dc.subject.keywordPlus | QUALITY-OF-LIFE | - |
dc.subject.keywordPlus | EML4-ALK FUSION GENE | - |
dc.subject.keywordPlus | KINASE INHIBITOR | - |
dc.subject.keywordPlus | CHEMOTHERAPY | - |
dc.subject.keywordPlus | ALECTINIB | - |
dc.subject.keywordPlus | EFFICACY | - |
dc.subject.keywordPlus | OUTCOMES | - |
dc.subject.keywordPlus | QLQ-C30 | - |
dc.subject.keywordPlus | SAFETY | - |
dc.subject.keywordPlus | EGFR | - |
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