Overall survival of 1st-line axitinib in metastatic renal cell carcinoma: Japanese subgroup analysis from phase II study (original) (raw)

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 pati...