Thomas E Hutson1, Salman Al-Shukri2, Viktor P Stus3, Oleg N Lipatov4, Yaroslav Shparyk5, Angel H Bair6, Brad Rosbrook6, Glen I Andrews6, Nicholas J Vogelzang7. 1. Charles A. Sammons Cancer Center, Dallas, and US Oncology Research, Houston, TX. Electronic address: Thomas.Hutson@USONCOLOGY.COM. 2. Urological Department, First Saint-Petersburg State Pavlov Medical University, Saint Petersburg, Russian Federation. 3. Urology Department #2, Municipal Institution "Dnipropetrovsk Regional Clinical Hospital n.a. I.I. Mechnikov", Dnipropetrovsk, Ukraine. 4. Department of Oncology, Republican Clinical Oncology Dispensary, Ufa, Russian Federation. 5. Lviv State Oncologic Regional Treatment and Diagnostic Center, Chemotherapy Department, Lviv, Ukraine. 6. Pfizer Oncology, San Diego, CA. 7. Comprehensive Cancer Centers of Nevada, Las Vegas, NV.
Abstract
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.
RCT Entities:
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.
Authors: Brian I Rini; Victor Gruenwald; Eric Jonasch; Mayer N Fishman; Yoshihiko Tomita; M Dror Michaelson; Jamal Tarazi; Laura Cisar; Subramanian Hariharan; Angel H Bair; Brad Rosbrook; Thomas E Hutson Journal: Target Oncol Date: 2017-06 Impact factor: 4.493
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