Back to Search
Start Over
Axitinib Versus Sorafenib in First-Line Metastatic Renal Cell Carcinoma: Overall Survival From a Randomized Phase III Trial
- Source :
- Clinical genitourinary cancer. 15(1)
- Publication Year :
- 2016
-
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.
- Subjects :
- 0301 basic medicine
Sorafenib
Male
Niacinamide
medicine.medical_specialty
Indazoles
Axitinib
medicine.drug_class
Urology
Gastroenterology
Tyrosine-kinase inhibitor
Disease-Free Survival
03 medical and health sciences
0302 clinical medicine
Renal cell carcinoma
Internal medicine
Medicine
Humans
Adverse effect
neoplasms
Carcinoma, Renal Cell
Protein Kinase Inhibitors
business.industry
Incidence (epidemiology)
Phenylurea Compounds
Hazard ratio
Imidazoles
medicine.disease
Survival Analysis
Confidence interval
Kidney Neoplasms
Surgery
030104 developmental biology
Treatment Outcome
Oncology
030220 oncology & carcinogenesis
Female
business
medicine.drug
Subjects
Details
- ISSN :
- 19380682
- Volume :
- 15
- Issue :
- 1
- Database :
- OpenAIRE
- Journal :
- Clinical genitourinary cancer
- Accession number :
- edsair.doi.dedup.....b3927d47e887b92d848b304a0c36fa73