In this phase 3 trial, we randomly assigned, in a 1:1 ratio, patients with confirmed metastatic clear-cell renal-cell carcinoma at presentation who were suitable candidates for nephrectomy to undergo nephrectomy and then receive sunitinib (standard therapy) or to receive sunitinib alone. Randomization was stratified according to prognostic risk (intermediate or poor) in the Memorial Sloan Kettering Cancer Center prognostic model. Patients received sunitinib at a dose of 50 mg daily in cycles of 28 days on and 14 days off every 6 weeks. The primary endpoint was overall survival.
A total of 450 patients were enrolled from September 2009 to September 2017. At this planned interim analysis, the median follow-up was 50.9 months, with 326 deaths observed. The results in the sunitinib-alone group were non-inferior to those in the nephrectomy–sunitinib group with regard to overall survival (stratified hazard ratio for death, 0.89; 95% confidence interval, 0.71 to 1.10; upper boundary of the 95% confidence interval for noninferiority, ≤1.20). The median overall survival was 18.4 months in the sunitinib-alone group and 13.9 months in the nephrectomy–sunitinib group. No significant differences in response rate or progression-free survival were observed. Adverse events were as anticipated in each group.
Sunitinib alone was not inferior to nephrectomy followed by sunitinib in patients with metastatic renal-cell carcinoma who were classified as having an intermediate risk or poor-risk disease. (Funded by Assistance Publique–Hôpitaux de Paris and others; CARMENA ClinicalTrials.gov number, NCT00930033.)
Arnaud Méjean, M.D., Ph.D., Alain Ravaud, M.D., Ph.D., Simon Thezenas, Ph.D., Sandra Colas, M.D., Jean-Baptiste Beauval, M.D., Karim Bensalah, M.D., Ph.D., Lionnel Geoffrois, M.D., Antoine Thiery-Vuillemin, M.D., Ph.D., Luc Cormier, M.D., Ph.D., Hervé Lang, M.D., Ph.D., Laurent Guy, M.D., Ph.D., Gwenaelle Gravis, M.D., Frederic Rolland, M.D., Claude Linassier, M.D., Ph.D., Eric Lechevallier, M.D., Ph.D., Christian Beisland, M.D., Ph.D., Michael Aitchison, M.D., Stephane Oudard, M.D., Ph.D., Jean-Jacques Patard, M.D., Ph.D., Christine Theodore, M.D., Christine Chevreau, M.D., Brigitte Laguerre, M.D., Jacques Hubert, M.D., Marine Gross-Goupil, M.D., Ph.D., Jean-Christophe Bernhard, M.D., Ph.D., Laurence Albiges, M.D., Ph.D., Marc-Olivier Timsit, M.D., Ph.D., Thierry Lebret, M.D., Ph.D., and Bernard Escudier, M.D.
DOI: 10.1056/NEJMoa1803675 Copyright © 2018 Massachusetts Medical Society.
Read the 2018 ASCO Presentation and a Discussion: Arnaud Mejean, MD, Ph.D., Daniel George, MD Sunitinib Alone Shows Non-inferiority Versus Standard of Care in mRCC - The CARMENA Study