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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
DC Field | Value | Language |
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dc.contributor.author | Kim, Dong-Wan | - |
dc.contributor.author | Tiseo, Marcello | - |
dc.contributor.author | Ahn, Myung-Ju | - |
dc.contributor.author | Reckamp, Karen L. | - |
dc.contributor.author | Hansen, Karin Holmskov | - |
dc.contributor.author | Kim, Sang-We | - |
dc.contributor.author | Huber, Rudolf M. | - |
dc.contributor.author | West, Howard L. | - |
dc.contributor.author | Groen, Harry J. M. | - |
dc.contributor.author | Hochmair, Maximilian J. | - |
dc.contributor.author | Leighl, Natasha B. | - |
dc.contributor.author | Gettinger, Scott N. | - |
dc.contributor.author | Langer, Corey J. | - |
dc.contributor.author | Rodriguez, Luis G. Paz-Ares | - |
dc.contributor.author | Smit, Egbert F. | - |
dc.contributor.author | Kim, Edward S. | - |
dc.contributor.author | Reichmann, William | - |
dc.contributor.author | Haluska, Frank G. | - |
dc.contributor.author | Kerstein, David | - |
dc.contributor.author | Camidge, D. Ross | - |
dc.date.accessioned | 2020-04-27T11:07:58Z | - |
dc.date.available | 2020-04-27T11:07:58Z | - |
dc.date.created | 2018-09-13 | - |
dc.date.issued | 2017-08 | - |
dc.identifier.citation | Journal of Clinical Oncology, Vol.35 No.22, pp.2490-2498 | - |
dc.identifier.issn | 0732-183X | - |
dc.identifier.other | 53593 | - |
dc.identifier.uri | https://hdl.handle.net/10371/165256 | - |
dc.description.abstract | Purpose 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.language | 영어 | - |
dc.publisher | American Society of Clinical Oncology | - |
dc.title | Brigatinib in Patients With Crizotinib-Refractory Anaplastic Lymphoma Kinase-Positive Non-Small-Cell Lung Cancer: A Randomized, Multicenter Phase II Trial | - |
dc.type | Article | - |
dc.contributor.AlternativeAuthor | 김동완 | - |
dc.identifier.doi | 10.1200/JCO.2016.71.5904 | - |
dc.citation.journaltitle | Journal of Clinical Oncology | - |
dc.identifier.wosid | 000406473900009 | - |
dc.identifier.scopusid | 2-s2.0-85020586637 | - |
dc.citation.endpage | 2498 | - |
dc.citation.number | 22 | - |
dc.citation.startpage | 2490 | - |
dc.citation.volume | 35 | - |
dc.identifier.sci | 000406473900009 | - |
dc.description.isOpenAccess | Y | - |
dc.contributor.affiliatedAuthor | Kim, Dong-Wan | - |
dc.type.docType | Article | - |
dc.description.journalClass | 1 | - |
dc.subject.keywordPlus | BRAIN METASTASES | - |
dc.subject.keywordPlus | ALK INHIBITORS | - |
dc.subject.keywordPlus | OPEN-LABEL | - |
dc.subject.keywordPlus | SAFETY | - |
dc.subject.keywordPlus | RESISTANCE | - |
dc.subject.keywordPlus | CHEMOTHERAPY | - |
dc.subject.keywordPlus | PROGRESSION | - |
dc.subject.keywordPlus | CERITINIB | - |
dc.subject.keywordPlus | AP26113 | - |
dc.subject.keywordPlus | POTENT | - |
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