Overall survival and final efficacy and safety results from a Japanese phase II study of axitinib in cytokine-refractory metastatic renal cell carcinoma.
Overall survival and final efficacy and safety results from a Japanese phase II study of axitinib in cytokine-refractory metastatic renal cell carcinoma.
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DOI：
10.1111/cas.12546
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发表时间：
2014-12
期刊：
影响因子：
5.7
通讯作者：
Japan Axitinib Phase II Study Group
中科院分区：
文献类型：
--
作者：
Eto M;Uemura H;Tomita Y;Kanayama H;Shinohara N;Kamei Y;Fujii Y;Umeyama Y;Ozono S;Naito S;Akaza H;Japan Axitinib Phase II Study Group
在一项对日本细胞因子难治性转移性肾癌患者进行的开放式、多中心II期研究中，Axitinib显示出显著的抗肿瘤活性，安全性可接受。在这里，我们报告了总体存活率和最新的疗效和安全性结果。64名日本转移性肾癌患者在接受细胞因子治疗后接受了阿西替尼的治疗，起始剂量为5 mg，每天2次。中位疗程14.2个月后，中位总生存期为37.3个月(95%可信区间28.6~49.9)。研究的主要终点--客观有效率为51.6%(95%可信区间，38.7-64.2)；中位缓解持续时间为11.1个月(95%可信区间，8.2-13.7)；中位无进展生存期为11.0个月(95%可信区间，9.2-12.0)。常见的与治疗相关的所有级别的不良反应是高血压(88%)、手足综合征(75%)、腹泻(66%)、蛋白尿(63%)、疲劳(55%)和发音困难(53%)。在一项探索性分析中，研究发现，在第一个治疗周期中，血浆中可溶性血管内皮生长因子受体-2水平下降较大的患者的中位总生存期显著延长。总而言之，目前的研究表明，在这些日本患者中，Axitinib是有效的，长期治疗的毒性通常是可以通过调整剂量和/或标准药物来控制的。一些经常报告的不良事件需要密切监测和管理。血浆中可溶性血管内皮生长因子受体-2水平的变化可作为阿西替尼治疗后转移性肾癌患者总体生存的预后因素。这项研究已在http://ClinicalTrial.gov注册(编号：NCT00569946)。
In an open-label, multicenter phase II study of Japanese patients with cytokine-refractory metastatic renal cell carcinoma, axitinib showed substantial antitumor activity with an acceptable safety profile. Here, we report overall survival and updated efficacy and safety results. Sixty-four Japanese patients with metastatic renal cell carcinoma following prior therapy with cytokines were treated with axitinib at a starting dose of 5 mg b.i.d. Following median treatment duration of 14.2 months, median overall survival was 37.3 months (95% CI, 28.6–49.9). The objective response rate, the primary endpoint of the study, was 51.6% (95% CI, 38.7–64.2); the median duration of response, 11.1 months (95% CI, 8.2–13.7); and the median progression-free survival was 11.0 months (95% CI, 9.2–12.0), assessed by the independent review committee. Common treatment-related all-grade adverse events were hypertension (88%), hand-foot syndrome (75%), diarrhea (66%), proteinuria (63%), fatigue (55%) and dysphonia (53%). In an exploratory analysis, median overall survival was found to be significantly longer in patients who had greater decreases in plasma levels of soluble vascular endothelial growth factor receptor-2 during the first cycle of treatment. In conclusion, the present study showed axitinib to be effective, and toxicities with long-term treatment were generally controllable with axitinib dose modification and/or standard medications in these Japanese patients. Some frequently reported adverse events warrant close monitoring and management. Changes in the plasma levels of soluble vascular endothelial growth factor receptor-2 may be used as a prognostic factor for overall survival in metastatic renal cell carcinoma following axitinib treatment. This study is registered at http://ClinicalTrial.gov (identifier NCT00569946).
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