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. Jpn J Clin Oncol

Objective: Axitinib is a potent and selective second-generation inhibitor of vascular endothe-lial growth factor receptors 1, 2 and 3. The efficacy and safety of axitinib in Japanese patients with metastatic renal cell carcinoma were evaluated. Methods: A subgroup analysis was conducted in Japanese patients enrolled in the rando-mized Phase III trial of axitinib versus sorafenib after failure of one prior systemic therapy for metastatic renal cell carcinoma. Results: Twenty-five (of 361) and 29 (of 362) patients randomized to the axitinib and soraf-enib 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 2.8–6.6) for sorafenib (hazard ratio 0.390; 95 % confidence interval 0.130–1.173; stratified one-sided P 0.0401). The objective response rate was 52.0 % for axitinib and 3.4 % for sorafenib (P 0.0001). Th