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| 题名: | Olmutinib in T790M-positive non-small cell lung cancer after failure of first-line epidermal growth factor receptor-tyrosine kinase inhibitor therapy: A global, phase 2 study |
| 作者: | Park, K;Janne, PA;Kim, DW;Han, JY;Wu, MF;Lee, JS;Kang, JH;Lee, DH;Cho, BC;Yu, CJ;Pang, YK;Felip, E;Kim, H;Baek, E;Noh, YS |
| 关键词: | epidermal growth factor receptor;non-small cell lung cancer;olmutinib;T790M;tyrosine kinase inhibitor |
| 日期: | 2021 |
| 上传时间: | 2022-08-05T09:41:21Z (UTC)
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| 出版者: | WILEY |
| ISSN: | 0008-543X |
| 摘要: | BACKGROUND: In this open-label, international phase 2 study, the authors assessed the efficacy and safety of olmutinib in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who had a confirmed T790M mutation and disease progression on previous epidermal growth factor receptor-tyrosine kinase inhibitor therapy. METHODS: Patients aged >= 20 years received once-daily oral olmutinib 800 mg continuously in 21-day cycles. The primary endpoint was the objective response rate (patients who had a confirmed best overall response of a complete or partial response), assessed by central review. Secondary endpoints included the disease control rate, the duration of objective response, progression-free survival, and overall survival. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (version 4.03). RESULTS: Overall, 162 patients (median age, 63 years; women, >60%) were enrolled from 68 sites in 9 countries. At the time of database cutoff, 23.5% of enrolled patients remained on treatment. The median treatment duration was 6.5 months (range, 0.03-21.68 months). Overall, 46.3% of patients (95% CI, 38.4%-54.3%) had a confirmed objective response (all partial responses). The best overall response (the objective response rate regardless of confirmation) was 51.9% (84 patients; 95% CI, 43.9%-59.8%). The confirmed disease control rate for all patients was 86.4% ( 95% CI, 80.2%-91.3%). The median duration of objective response was 12.7 months (95% CI, 8.3-15.4 months). Estimated median progression-free survival was 9.4 months (95% CI, 6.9-12.3 months), and estimated median overall survival was 19.7 months (95% CI, 15.1 months to not reached). All patients experienced treatment-emergent adverse events, and 71.6% of patients had grade >= 3 treatment-emergent adverse events. CONCLUSIONS: Olmutinib has meaningful clinical activity and a manageable safety profile in patients with T790M-positive non-small cell lung cancer who received previous epidermal growth factor receptor-tyrosine kinase inhibitor therapy. Cancer 2020;0:1-10. (c) 2020 The Authors. Cancer published by Wiley Periodicals LLC on behalf of American Cancer Society. This is an open access article under the terms of the Creative Commons Attribution-NonCommercial-NoDerivs License, which permits use and distribution in any medium, provided the original work is properly cited, the use is non-commercial and no modifications or adaptations are made. |
| URI: | http://dx.doi.org/10.1002/cncr.33385
https://www.webofscience.com/wos/woscc/full-record/WOS:000606964500001
https://ir.csmu.edu.tw:8080/handle/310902500/23692 |
| 關聯: | CANCER ,2021,v127,issue 9, P1407-1416 |
| 显示于类别: | [中山醫學大學研究成果] 期刊論文
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