Axitinib Versus Sorafenib in First-Line Metastatic Renal Cell Carcinoma: Overall Survival From a Randomized Phase III Trial

In a randomized phase III trial, axitinib did not significantly improve progression-free survival over sorafenib in treatment-naive patients with metastatic renal cell carcinoma. This updated analysis confirmed clinical activity of axitinib with an acceptable safety profile after long-term treatment. Although axitinib did not prolong survival over sorafenib, axitinib might provide an acceptable first-line treatment option in patients with good performance status. Background: In a randomized phase III trial in treatment-naive patients with metastatic renal cell carcinoma (RCC), axitinib versus sorafenib yielded numerically longer progression-free survival (median, 10.1 vs. 6.5 months; hazard ratio [HR], 0.77; 1-sided P = .038) and significantly higher objective response rate (32% vs. 15%; 1-sided P = .0006). In this article, we report overall survival (OS) and updated safety results. Patients and Methods: Previously untreated patients with metastatic RCC (n = 288), stratified according to Eastern Cooperative Oncology Group performance status (ECOG PS; 0 vs. 1), were randomized 2:1 to receive axitinib 5 mg twice per day (b.i.d.; n = 192) or sorafenib 400 mg b.i.d. (n = 96). Results: Median OS (95% confidence interval [CI]) was 21.7 months (18.0-31.7) with axitinib versus 23.3 months (18.1-33.2) with sorafenib (stratified HR, 0.995; 95% CI, 0.731-1.356; 1-sided P = .4883). Among patients with ECOG PS of 0, median OS was numerically longer with axitinib than with sorafenib (41.2 vs. 31.9 months; HR, 0.811, 1-sided P = .1748), whereas among patients with ECOG PS 1, median OS was shorter with axitinib than with sorafenib (14.2 vs. 19.8 months; HR, 1.203; 1-sided; P =.7973). Incidence and severity of common adverse events were consistent with previous reports. Conclusion: OS was similar between axitinib and sorafenib in treatment-naive patients with metastatic RCC, and no new safety signals emerged. (C) 2016 Elsevier Inc. All rights reserved.