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J Clin Oncol. 2018 May 10;36(14):1405-1411. doi: 10.1200/JCO.2017.75.5587. Epub 2018 Mar 29.

Phase II Study of Crizotinib in East Asian Patients With ROS1-Positive Advanced Non-Small-Cell Lung Cancer.

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Yi-Long Wu and Jin-Ji Yang, Guangdong General Hospital and Guangdong Academy of Medical Sciences, Guangzhou; Shun Lu, Jiao Tong University, Shanghai; Jianying Zhou, First Affiliated Hospital of Zhejiang University, Hangzhou, People's Republic of China; James Chih-Hsin Yang, National Taiwan University Hospital and National Taiwan University Cancer Center, Taipei, Republic of China; Dong-Wan Kim, Seoul National University Hospital; Myung-Ju Ahn, Samsung Medical Center, Seoul, South Korea; Takashi Seto, National Kyushu Cancer Center, Fukuoka; Noboru Yamamoto, National Cancer Center Hospital, Tokyo; Toshiaki Takahashi, Shizuoka Cancer Center, Shizuoka; Takeharu Yamanaka, Yokohama City University School of Medicine, Yokohama; Koichi Goto, National Cancer Center Hospital East, Kashiwa, Japan; Allison Kemner and Debasish Roychowdhury, OxOnc Development, Princeton, NJ; Nirvan Consultants, Lexington, MA; Jolanda Paolini and Tiziana Usari, Pfizer, Milan, Italy; and Keith D. Wilner, Pfizer, La Jolla, CA.


Purpose Approximately 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 Methods This 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. Results In 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. Conclusion This 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.


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