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Phase II study of crizotinib in east asian patients with ROS1-positive advanced non–small-cell lung cancer
DC Field | Value | Language |
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dc.contributor.author | Wu, Yi-Long | - |
dc.contributor.author | Yang, James Chih-Hsin | - |
dc.contributor.author | Kim, Dong-Wan | - |
dc.contributor.author | Lu, Shun | - |
dc.contributor.author | Zhou, Jianying | - |
dc.contributor.author | Seto, Takashi | - |
dc.contributor.author | Yang, Jin-Ji | - |
dc.contributor.author | Yamamoto, Noboru | - |
dc.contributor.author | Ahn, Myung-Ju | - |
dc.contributor.author | Takahashi, Toshiaki | - |
dc.contributor.author | Yamanaka, Takeharu | - |
dc.contributor.author | Kemner, Allison | - |
dc.contributor.author | Roychowdhury, Debasish | - |
dc.contributor.author | Paolini, Jolanda | - |
dc.contributor.author | Usari, Tiziana | - |
dc.contributor.author | Wilner, Keith D. | - |
dc.contributor.author | Goto, Koichi | - |
dc.date.accessioned | 2020-04-27T11:01:50Z | - |
dc.date.available | 2020-04-27T11:01:50Z | - |
dc.date.created | 2019-06-17 | - |
dc.date.issued | 2018-05 | - |
dc.identifier.citation | Journal of Clinical Oncology, Vol.36 No.14, pp.1405-1411 | - |
dc.identifier.issn | 0732-183X | - |
dc.identifier.other | 75737 | - |
dc.identifier.uri | https://hdl.handle.net/10371/165228 | - |
dc.description.abstract | PurposeApproximately 1% to 2% of non-small-cell lung cancers (NSCLCs) harbor a c-ros oncogene 1 (ROS1) rearrangement. Crizotinib, an inhibitor of anaplastic lymphoma kinase (ALK), ROS1, and MET, has shown marked antitumor activity in a small expansion cohort of patients with ROS1-positive advanced NSCLC from an ongoing phase I study. We assessed the efficacy and safety of crizotinib in the largest cohort of patients with ROS1-positive advanced NSCLC.Patients and MethodsThis phase II, open-label, single-arm trial enrolled East Asian patients with ROS1-positive (assessed through validated AmoyDx assay [Amoy Diagnostics, Xiamen, China] at three regional laboratories) advanced NSCLC who had received three or fewer lines of prior systemic therapies. Patients were to receive oral crizotinib at a starting dose of 250 mg twice daily and continued treatment until Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1-defined progression (by independent radiology review [IRR]), unacceptable toxicity, or withdrawal of consent. The primary end point was objective response rate (ORR) by IRR.ResultsIn the efficacy and safety analyses, 127 patients were included, with 49.6% still receiving treatment at data cutoff. ORR by IRR was 71.7% (95% CI, 63.0% to 79.3%), with 17 complete responses and 74 partial responses. ORRs were similar irrespective of the number of prior lines of therapy, and responses were durable (median duration of response, 19.7 months; 95% CI, 14.1 months to not reached). Median progression-free survival by IRR was 15.9 months (95% CI, 12.9 to 24.0 months). No new safety signals associated with crizotinib were reported.ConclusionThis study demonstrated clinically meaningful benefit and durable responses with crizotinib in East Asian patients with ROS1-positive advanced NSCLC. Crizotinib was generally well tolerated, with a safety profile consistent with previous reports. | - |
dc.language | 영어 | - |
dc.publisher | American Society of Clinical Oncology | - |
dc.title | Phase II study of crizotinib in east asian patients with ROS1-positive advanced non–small-cell lung cancer | - |
dc.type | Article | - |
dc.contributor.AlternativeAuthor | 김동완 | - |
dc.identifier.doi | 10.1200/JCO.2017.75.5587 | - |
dc.citation.journaltitle | Journal of Clinical Oncology | - |
dc.identifier.wosid | 000432174200005 | - |
dc.identifier.scopusid | 2-s2.0-85047118567 | - |
dc.citation.endpage | 1411 | - |
dc.citation.number | 14 | - |
dc.citation.startpage | 1405 | - |
dc.citation.volume | 36 | - |
dc.identifier.sci | 000432174200005 | - |
dc.description.isOpenAccess | N | - |
dc.contributor.affiliatedAuthor | Kim, Dong-Wan | - |
dc.type.docType | Article | - |
dc.description.journalClass | 1 | - |
dc.subject.keywordPlus | ROS1 REARRANGEMENT | - |
dc.subject.keywordPlus | ADENOCARCINOMA | - |
dc.subject.keywordPlus | KINASE | - |
dc.subject.keywordPlus | FUSIONS | - |
dc.subject.keywordPlus | RESISTANCE | - |
dc.subject.keywordPlus | INHIBITOR | - |
dc.subject.keywordPlus | CHEMOTHERAPY | - |
dc.subject.keywordPlus | MUTATIONS | - |
dc.subject.keywordPlus | THERAPY | - |
dc.subject.keywordPlus | RET | - |
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