Efficacy and Safety of Axitinib Versus Sorafenib in Metastatic Renal Cell Carcinoma: Subgroup Analysis of Japanese Patients from the Global Randomized Phase 3 AXIS Trial
Efficacy and Safety of Axitinib Versus Sorafenib in Metastatic Renal Cell Carcinoma: Subgroup Analysis of Japanese Patients from the Global Randomized Phase 3 AXIS Trial
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DOI：
10.1093/jjco/hyt054
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发表时间：
2013-06-01
影响因子：
2.4
通讯作者：
Akaza, Hideyuki
中科院分区：
文献类型：
--
作者：
Ueda, Takeshi;Uemura, Hirotsugu;Akaza, Hideyuki
阿西替尼是一种有效的选择性血管内皮生长因子受体1、2和3的第二代抑制剂。评价了阿西替尼在日本转移性肾细胞癌患者中的疗效和安全性。在转移性肾细胞癌的一次全身治疗失败后，参加阿西替尼与索拉非尼随机III期试验的日本患者进行了一项亚组分析。分别随机分配到阿西替尼组和索拉非尼组的25名（361名）和29名（362名）患者来自日本，并纳入了本分析。在日本患者中，阿西替尼的中位无进展生存期为12.1个月（95可信区间8.6至不可估计），索拉非尼的中位无进展生存期为4.9个月（95可信区间2.86.6）（风险比0.390；95可信区间0.1301.173；分层单侧P 0.0401）。客观缓解率阿西替尼为52.0，索拉非尼为3.4 （P = 0.0001）。在日本患者中，常见的全因果不良事件（所有级别）为阿西替尼的发音困难（68）、高血压（64）、手足综合征（64）和腹泻（56），索拉非尼的手足综合征（86）、高血压（62）和腹泻（52）。阿西替尼和索拉非尼在日本患者中的安全性与在总体人群中观察到的情况大致相似，除了高血压、语音障碍、手足综合征、甲状腺功能减退和口炎的发生率较高。阿西替尼在日本既往治疗的转移性肾细胞癌患者中有效且耐受性良好，与总体人群的结果一致，为这些日本患者提供了一种新的靶向治疗方法。
Axitinib is a potent and selective second-generation inhibitor of vascular endothelial growth factor receptors 1, 2 and 3. The efficacy and safety of axitinib in Japanese patients with metastatic renal cell carcinoma were evaluated.A subgroup analysis was conducted in Japanese patients enrolled in the randomized Phase III trial of axitinib versus sorafenib after failure of one prior systemic therapy for metastatic renal cell carcinoma.Twenty-five (of 361) and 29 (of 362) patients randomized to the axitinib and sorafenib arms, respectively, were Japanese and included in this analysis. Median progression-free survival in Japanese patients was 12.1 months (95 confidence interval 8.6 to not estimable) for axitinib and 4.9 months (95 confidence interval 2.86.6) for sorafenib (hazard ratio 0.390; 95 confidence interval 0.1301.173; stratified one-sided P 0.0401). The objective response rate was 52.0 for axitinib and 3.4 for sorafenib (P 0.0001). The common all-causality adverse events (all grades) in Japanese patients were dysphonia (68), hypertension (64), handfoot syndrome (64) and diarrhea (56) for axitinib, and handfoot syndrome (86), hypertension (62) and diarrhea (52) for sorafenib. The safety profiles of axitinib and sorafenib in Japanese patients were generally similar to those observed in the overall population, with the exceptions of higher incidences of hypertension, dysphonia, handfoot syndrome, hypothyroidism and stomatitis.Axitinib is efficacious and well tolerated in Japanese patients with previously treated metastatic renal cell carcinoma, consistent with the results in the overall population, providing a new targeted therapy for these Japanese patients.