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

Clin Genitourin Cancer. 2017 Feb;15(1):72-76. doi: 10.1016/j.clgc.2016.05.008. Epub 2016 May 27.

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.

Trial registration: ClinicalTrials.gov NCT00920816.

Keywords: Eastern Cooperative Oncology Group performance status; First-line treatment; Randomized phase III trial; Tyrosine kinase inhibitor; VEGF receptor inhibitor.

Publication types

  • Clinical Trial, Phase III
  • Comparative Study
  • Randomized Controlled Trial

MeSH terms

  • Axitinib
  • Carcinoma, Renal Cell / drug therapy*
  • Disease-Free Survival
  • Female
  • 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
  • Sorafenib
  • Survival Analysis
  • Treatment Outcome

Substances

  • Imidazoles
  • Indazoles
  • Phenylurea Compounds
  • Protein Kinase Inhibitors
  • Niacinamide
  • Sorafenib
  • Axitinib

Associated data

  • ClinicalTrials.gov/NCT00920816