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Exploratory analysis of brigatinib activity in patients with anaplastic lymphoma kinase-positive non-small-cell lung cancer and brain metastases in two clinical trials
DC Field | Value | Language |
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dc.contributor.author | Camidge, D. Ross | - |
dc.contributor.author | Kim, Dong-Wan | - |
dc.contributor.author | Tiseo, Marcello | - |
dc.contributor.author | Langer, Corey J. | - |
dc.contributor.author | Ahn, Myung-Ju | - |
dc.contributor.author | Shaw, Alice T. | - |
dc.contributor.author | Huber, Rudolf M. | - |
dc.contributor.author | Hochmair, Maximilian J. | - |
dc.contributor.author | Lee, Dae Ho | - |
dc.contributor.author | Bazhenova, Lyudmila A. | - |
dc.contributor.author | Gold, Kathryn A. | - |
dc.contributor.author | Ou, Sai-Hong Ignatius | - |
dc.contributor.author | West, Howard L. | - |
dc.contributor.author | Reichmann, William | - |
dc.contributor.author | Haney, Jeff | - |
dc.contributor.author | Clackson, Tim | - |
dc.contributor.author | Kerstein, David | - |
dc.contributor.author | Gettinger, Scott N. | - |
dc.date.accessioned | 2020-04-27T11:02:34Z | - |
dc.date.available | 2020-04-27T11:02:34Z | - |
dc.date.created | 2019-06-17 | - |
dc.date.issued | 2018-09 | - |
dc.identifier.citation | Journal of Clinical Oncology, Vol.36 No.26, pp.2693-2701 | - |
dc.identifier.issn | 0732-183X | - |
dc.identifier.other | 75763 | - |
dc.identifier.uri | https://hdl.handle.net/10371/165231 | - |
dc.description.abstract | PurposeIn patients with crizotinib-treated, anaplastic lymphoma kinase gene (ALK)-rearranged non-small-cell lung cancer (ALK-positive NSCLC), initial disease progression often occurs in the CNS. We evaluated brigatinib, a next-generation ALK inhibitor, in patients with ALK-positive NSCLC with brain metastases.Patients and MethodsPatients with ALK-positive NSCLC received brigatinib (90 to 240 mg total daily) in a phase I/II trial (phI/II; ClinicalTrials.gov identifier: NCT01449461) and in the subsequent randomized phase II trial ALTA (ALK in Lung Cancer Trial of AP26113; ClinicalTrials.gov identifier: NCT02094573; patients in arm A received 90 mg once daily; patients in arm B received 180 mg once daily with 7-day lead-in at 90 mg). Primary end points (systemic objective response rates [ORRs]) were previously reported. Independent review committees assessed intracranial efficacy in patients with baseline brain metastases.ResultsMost patients with ALK-positive NSCLC had baseline brain metastases (50 of 79 [63%], phI/II; 80 of 112 [71%] and 73 of 110 [66%] in ALTA arms A and B, respectively), many of whom had no prior brain radiotherapy (23 of 50 [46%], phI/II; 32 of 80 [40%], ALTA arm A; 30 of 73 [41%], arm B). All patients, except four in phI/II, had received crizotinib. Among patients with measurable ( 10 mm) brain metastases, confirmed intracranial ORR was 53% (eight of 15; 95% CI, 27% to 79%) in phI/II, 46% (12 of 26; 95% CI, 27% to 67%) in ALTA arm A, and 67% (12 of 18; 95% CI, 41% to 87%) in arm B. Intracranial ORRs were similar in subsets without prior radiation or progression postradiation. Among patients with any baseline brain metastases, median intracranial progression-free survival (iPFS) was 14.6 months (95% CI, 12.7 to 36.8 months), phI/II; 15.6 months (95% CI, 9.0 to 18.3 months), ALTA arm A; 18.4 months (95% CI, 12.8 months to not reached), ALTA arm B.ConclusionBrigatinib yielded substantial intracranial responses and durable iPFS in ALK-positive, crizotinib-treated NSCLC, with highest iPFS in patients receiving 180 mg once daily (with lead-in). | - |
dc.language | 영어 | - |
dc.publisher | American Society of Clinical Oncology | - |
dc.title | Exploratory analysis of brigatinib activity in patients with anaplastic lymphoma kinase-positive non-small-cell lung cancer and brain metastases in two clinical trials | - |
dc.type | Article | - |
dc.contributor.AlternativeAuthor | 김동완 | - |
dc.identifier.doi | 10.1200/JCO.2017.77.5841 | - |
dc.citation.journaltitle | Journal of Clinical Oncology | - |
dc.identifier.wosid | 000445669600005 | - |
dc.identifier.scopusid | 2-s2.0-85051109899 | - |
dc.citation.endpage | 2701 | - |
dc.citation.number | 26 | - |
dc.citation.startpage | 2693 | - |
dc.citation.volume | 36 | - |
dc.identifier.sci | 000445669600005 | - |
dc.description.isOpenAccess | N | - |
dc.contributor.affiliatedAuthor | Kim, Dong-Wan | - |
dc.type.docType | Article | - |
dc.description.journalClass | 1 | - |
dc.subject.keywordPlus | OPEN-LABEL | - |
dc.subject.keywordPlus | PHASE-1 TRIAL | - |
dc.subject.keywordPlus | SOLID TUMORS | - |
dc.subject.keywordPlus | SINGLE-ARM | - |
dc.subject.keywordPlus | WHOLE-BODY | - |
dc.subject.keywordPlus | ALK | - |
dc.subject.keywordPlus | CRIZOTINIB | - |
dc.subject.keywordPlus | CHEMOTHERAPY | - |
dc.subject.keywordPlus | CERITINIB | - |
dc.subject.keywordPlus | MULTICENTER | - |
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