title: Axitinib Versus Sorafenib in First-Line Metastatic Renal Cell Carcinoma: Overall Survival From a Randomized Phase III Trial.
abstract: 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.
  
  
  
  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).
  
  
  
  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.
  
  
  
  OS was similar between axitinib and sorafenib in treatment-naive patients with metastatic RCC, and no new safety signals emerged.
authors: Charles A. Sammons Cancer Center, Dallas, and US Oncology Research, Houston, TX. Electronic address: Thomas.Hutson@USONCOLOGY.COM.
authors: Thomas E
authors: TE
authors: Hutson
authors: Urological Department, First Saint-Petersburg State Pavlov Medical University, Saint Petersburg, Russian Federation.
authors: Salman
authors: S
authors: Al-Shukri
authors: Urology Department #2, Municipal Institution "Dnipropetrovsk Regional Clinical Hospital n.a. I.I. Mechnikov", Dnipropetrovsk, Ukraine.
authors: Viktor P
authors: VP
authors: Stus
authors: Department of Oncology, Republican Clinical Oncology Dispensary, Ufa, Russian Federation.
authors: Oleg N
authors: ON
authors: Lipatov
authors: Lviv State Oncologic Regional Treatment and Diagnostic Center, Chemotherapy Department, Lviv, Ukraine.
authors: Yaroslav
authors: Y
authors: Shparyk
authors: Pfizer Oncology, San Diego, CA.
authors: Angel H
authors: AH
authors: Bair
authors: Pfizer Oncology, San Diego, CA.
authors: Brad
authors: B
authors: Rosbrook
authors: Pfizer Oncology, San Diego, CA.
authors: Glen I
authors: GI
authors: Andrews
authors: Comprehensive Cancer Centers of Nevada, Las Vegas, NV.
authors: Nicholas J
authors: NJ
authors: Vogelzang
mesh_terms: D000077784:Axitinib; D002292:Carcinoma, Renal Cell / Q000188:drug therapy*; D018572:Disease-Free Survival; D005260:Female; D006801:Humans; D007093:Imidazoles / Q000008:administration & dosage* / Q000627:therapeutic use; D007191:Indazoles / Q000008:administration & dosage* / Q000627:therapeutic use; D007680:Kidney Neoplasms / Q000188:drug therapy*; D008297:Male; D009536:Niacinamide / Q000008:administration & dosage / Q000031:analogs & derivatives* / Q000627:therapeutic use; D010671:Phenylurea Compounds / Q000008:administration & dosage* / Q000627:therapeutic use; D047428:Protein Kinase Inhibitors / Q000008:administration & dosage* / Q000627:therapeutic use; D000077157:Sorafenib; D016019:Survival Analysis; D016896:Treatment Outcome
chemical_list: D007093:Imidazoles; D007191:Indazoles; D010671:Phenylurea Compounds; D047428:Protein Kinase Inhibitors; D009536:Niacinamide; D000077157:Sorafenib; D000077784:Axitinib
keywords: Eastern Cooperative Oncology Group performance status; First-line treatment; Randomized phase III trial; Tyrosine kinase inhibitor; VEGF receptor inhibitor