Subgroup analyses of a randomized global phase II study of axitinib showed objective response rate of 66% and median progression-free survival of 27.6 months in treatment-naïve Japanese patients with metastatic renal cell carcinoma (RCC). This analysis evaluated overall survival (OS) and updated safety in 44 Japanese patients and compared with 169 non-Japanese patients. In addition, baseline characteristics for predictive factors that may influence OS in first-line metastatic RCC were explored using a Cox proportional hazard model in all patients. With median follow-up of 33 months, fewer than half (16 of 44) of Japanese patients had died and median OS was not reached (95% confidence interval [CI], 38.8 months-not estimable), whereas 107 of 169 (63%) non-Japanese patients had died and median OS was 33.9 months (95% CI, 28.9-42.7). Estimated 1-, 2-, and 3-year survival probability (95% CI) was 86.4% (76.2-96.5), 75.0% (62.2-87.8), and 68.2% (54.4-81.9), respectively, in Japanese patients, and was higher than that in non-Japanese patients (75.1% [68.4-81.8], 62.1% [54.5-69.7] and 47.2% [39.3-55.1], respectively). The updated safety analysis did not reveal any new adverse events of concern among Japanese or non-Japanese patients. The multivariate analysis identified that lower baseline Eastern Cooperative Oncology Group performance status, lower baseline tumor burden, and longer time from histological diagnosis to treatment were significant positive predictors of OS. The current analysis confirmed the clinical activity of axitinib in treatment-naïve Japanese patients with metastatic RCC, with an acceptable toxicity profile. This trial is registered at ClinicalTrials. gov, NCT00835978. This article is protected by copyright. All rights reserved.
Cancer science. 2017 Mar 07 [Epub ahead of print]
Mototsugu Oya, Yoshihiko Tomita, Satoshi Fukasawa, Nobuo Shinohara, Tomonori Habuchi, Brian I Rini, Yosuke Fujii, Yoichi Kamei, Yoshiko Umeyama, Angel H Bair, Hirotsugu Uemura
Department of Urology, Keio University School of Medicine, Tokyo, Japan., Department of Urology, Yamagata University Faculty of Medicine, Yamagata, Japan., Prostate Center and Division of Urology, Chiba Cancer Center, Chiba, Japan., Department of Urology, Hokkaido University Graduate School of Medicine, Hokkaido, Japan., Department of Urology, Akita University School of Medicine, Akita, Japan., Department of Solid Tumor Oncology, Cleveland Clinic Taussig Cancer Institute, Cleveland, OH, USA., Pfizer Japan Inc, Tokyo, Japan., Pfizer Oncology, San Diego, CA, USA., Department of Urology, Kindai University Faculty of Medicine, Osaka, Japan.