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

详细信息    查看全文

• 作者：Thomas E. Hutson¹ ; ^{Thomas.Hutson@USONCOLOGY.COM} ; Salman Al-Shukri² ; Viktor P. Stus³ ; Oleg N. Lipatov⁴ ; Yaroslav Shparyk⁵ ; Angel H. Bair⁶ ; Brad Rosbrook⁶ ; Glen I. Andrews⁶ ; Nicholas J. Vogelzang⁷
• 关键词：Eastern Cooperative Oncology Group performance status ; First-line treatment ; Randomized phase III trial ; Tyrosine kinase inhibitor ; VEGF receptor inhibitor
• 刊名：Clinical Genitourinary Cancer
• 出版年：2017
• 出版时间：February 2017
• 年：2017
• 卷：15
• 期：1
• 页码：72-76
• 全文大小：354 K
• 卷排序：15

文摘

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 MethodsPreviously 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).ResultsMedian 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.ConclusionOS was similar between axitinib and sorafenib in treatment-naive patients with metastatic RCC, and no new safety signals emerged.