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

• Published in: Clinical genitourinary cancer 2017-02, Vol.15 (1), p.72-76
• Main Authors: Hutson, Thomas E, Al-Shukri, Salman, Stus, Viktor P, Lipatov, Oleg N, Shparyk, Yaroslav, Bair, Angel H, Rosbrook, Brad, Andrews, Glen I, Vogelzang, Nicholas J
• Format: Article
• Language: English
• Subjects: Carcinoma, Renal Cell - drug therapy; Disease-Free Survival; Eastern Cooperative Oncology Group performance status; Female; First-line treatment; Hematology, Oncology and Palliative Medicine; Humans; Imidazoles - administration & dosage; Imidazoles - therapeutic use; Indazoles - administration & dosage; Indazoles - therapeutic use; Kidney Neoplasms - drug therapy; Male; Niacinamide - administration & dosage; Niacinamide - analogs & derivatives; Niacinamide - therapeutic use; Phenylurea Compounds - administration & dosage; Phenylurea Compounds - therapeutic use; Protein Kinase Inhibitors - administration & dosage; Protein Kinase Inhibitors - therapeutic use; Randomized phase III trial; Survival Analysis; Treatment Outcome; Tyrosine kinase inhibitor; Urology; VEGF receptor inhibitor
• ISSN: 1558-7673; 1938-0682
• DOI: 10.1016/j.clgc.2016.05.008

Abstract Background In a randomized phase III trial in treatment-naïve patients with metastatic renal cell carcinoma, axitinib versus sorafenib yielded numerically longer progression-free survival (median, 10.1 vs. 6.5 months; hazard ratio [HR], 0.77; 1-sided P = 0.038) and significantly higher objective response (32% vs. 15%, 1-sided P = 0.0006). Here, we report overall survival (OS) and updated safety results. Methods Previously untreated patients with metastatic RCC (N = 288), stratified by Eastern Cooperative Oncology Group performance status (0 vs. 1), were randomized 2:1 to receive axitinib 5 mg bid (n = 192) or sorafenib 400 mg bid (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; one-sided P = 0.4883). Among patients with Eastern Cooperative Oncology Group performance status (ECOG PS) 0, median OS was numerically longer with axitinib than with sorafenib (41.2 vs. 31.9 months; HR, 0.811, 1-sided P = 0.1748), 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 = 0.7973). Incidence and severity of common adverse events were consistent with previous reports. Conclusion OS was similar between axitinib and sorafenib in treatment-naïve patients with metastatic RCC, and no new safety signals emerged.