Key predictive factors for efficacy of axitinib in first-line metastatic renal cell carcinoma: subgroup analysis in Japanese patients from a randomized, double-blind phase II study.

It should be noted that in a randomized Phase III study of axitinib in treatment-naïve patients with mRCC (one-quarter of whom were Asian), the difference in the primary endpoint of PFS between axitinib and sorafenib did not reach statistical significance in the overall population (median PFS: 10.1 vs. 6.5 months; hazard ratio 0.77 [95% CI: 0.56–1.05]; one-sided P = 0.038), but median PFS was significantly longer with axitinib than sorafenib in patients with ECOG PS 0 (13.7 vs. 6.6 months; hazard ratio 0.64 [95% CI: 0.42–0.99]; one-sided P = 0.022) ( 21 ).

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