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Brigatinib in Patients With Crizotinib-Refractory Anaplastic Lymphoma Kinase-Positive Non-Small-Cell Lung Cancer: A Randomized, Multicenter Phase II Trial

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dc.contributor.authorKim, Dong-Wan-
dc.contributor.authorTiseo, Marcello-
dc.contributor.authorAhn, Myung-Ju-
dc.contributor.authorReckamp, Karen L.-
dc.contributor.authorHansen, Karin Holmskov-
dc.contributor.authorKim, Sang-We-
dc.contributor.authorHuber, Rudolf M.-
dc.contributor.authorWest, Howard L.-
dc.contributor.authorGroen, Harry J. M.-
dc.contributor.authorHochmair, Maximilian J.-
dc.contributor.authorLeighl, Natasha B.-
dc.contributor.authorGettinger, Scott N.-
dc.contributor.authorLanger, Corey J.-
dc.contributor.authorRodriguez, Luis G. Paz-Ares-
dc.contributor.authorSmit, Egbert F.-
dc.contributor.authorKim, Edward S.-
dc.contributor.authorReichmann, William-
dc.contributor.authorHaluska, Frank G.-
dc.contributor.authorKerstein, David-
dc.contributor.authorCamidge, D. Ross-
dc.date.accessioned2020-04-27T11:07:58Z-
dc.date.available2020-04-27T11:07:58Z-
dc.date.created2018-09-13-
dc.date.issued2017-08-
dc.identifier.citationJournal of Clinical Oncology, Vol.35 No.22, pp.2490-2498-
dc.identifier.issn0732-183X-
dc.identifier.other53593-
dc.identifier.urihttps://hdl.handle.net/10371/165256-
dc.description.abstractPurpose Most crizotinib-treated patients with anaplastic lymphoma kinase gene (ALK)-rearranged non-smallcell lung cancer (ALK-positive NSCLC) eventually experience disease progression. We evaluated two regimens of brigatinib, an investigational next-generation ALK inhibitor, in crizotinib-refractory ALK-positive NSCLC. Patients and Methods Patients were stratified by brain metastases and best response to crizotinib. They were randomly assigned (1: 1) to oral brigatinib 90 mg once daily (arm A) or 180 mg once daily with a 7-day lead-in at 90 mg (180 mg once daily [with lead-in]; arm B). Investigator-assessed confirmed objective response rate (ORR) was the primary end point. Results Of 222 patients enrolled (arm A: n = 112, 109 treated; arm B: n = 110, 110 treated), 154 (69%) had baseline brain metastases and 164 of 222 (74%) had received prior chemotherapy. With 8.0-month median follow-up, investigator-assessed confirmed ORR was 45% (97.5% CI, 34% to 56%) in arm A and 54% (97.5% CI, 43% to 65%) in arm B. Investigator-assessed median progression-free survival was 9.2 months (95% CI, 7.4 to 15.6) and 12.9 months (95% CI, 11.1 to not reached) in arms A and B, respectively. Independent review committee-assessed intracranial ORR in patients with measurable brain metastases at baseline was 42% (11 of 26 patients) in arm A and 67% (12 of 18 patients) in arm B. Common treatment-emergent adverse events were nausea (arm A/B, 33%/ 40%), diarrhea (arm A/B, 19%/38%), headache (arm A/B, 28%/27%), and cough (arm A/B, 18%/ 34%), and were mainly grades 1 to 2. A subset of pulmonary adverse events with early onset (median onset: day 2) occurred in 14 of 219 treated patients (all grades, 6%; grade >= 3, 3%); none occurred after escalation to 180 mg in arm B. Seven of 14 patients were successfully retreated with brigatinib. Conclusion Brigatinib yielded substantial whole-body and intracranial responses as well as robust progressionfree survival; 180 mg (with lead-in) showed consistently better efficacy than 90 mg, with acceptable safety. (C) 2017 by American Society of Clinical Oncology-
dc.language영어-
dc.publisherAmerican Society of Clinical Oncology-
dc.titleBrigatinib in Patients With Crizotinib-Refractory Anaplastic Lymphoma Kinase-Positive Non-Small-Cell Lung Cancer: A Randomized, Multicenter Phase II Trial-
dc.typeArticle-
dc.contributor.AlternativeAuthor김동완-
dc.identifier.doi10.1200/JCO.2016.71.5904-
dc.citation.journaltitleJournal of Clinical Oncology-
dc.identifier.wosid000406473900009-
dc.identifier.scopusid2-s2.0-85020586637-
dc.citation.endpage2498-
dc.citation.number22-
dc.citation.startpage2490-
dc.citation.volume35-
dc.identifier.sci000406473900009-
dc.description.isOpenAccessY-
dc.contributor.affiliatedAuthorKim, Dong-Wan-
dc.type.docTypeArticle-
dc.description.journalClass1-
dc.subject.keywordPlusBRAIN METASTASES-
dc.subject.keywordPlusALK INHIBITORS-
dc.subject.keywordPlusOPEN-LABEL-
dc.subject.keywordPlusSAFETY-
dc.subject.keywordPlusRESISTANCE-
dc.subject.keywordPlusCHEMOTHERAPY-
dc.subject.keywordPlusPROGRESSION-
dc.subject.keywordPlusCERITINIB-
dc.subject.keywordPlusAP26113-
dc.subject.keywordPlusPOTENT-
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College of Medicine/School of Medicine (의과대학/대학원)Dept. of Medicine (의학과)Journal Papers (저널논문_의학과)
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