MONDAY, June 4, 2018 (HealthDay News) -- For patients with metastatic renal cell carcinoma classified as having intermediate or poor prognostic risk, sunitinib alone is noninferior to nephrectomy and sunitinib, according to a study published online June 3 in the New England Journal of Medicine. The research was published to coincide with the annual meeting of the American Society of Clinical Oncology, held from June 1 to 5 in Chicago.
Arnaud Méjean, M.D., Ph.D., from the Hôpital Européen Georges-Pompidou in Paris, and colleagues randomized 450 patients with confirmed metastatic clear-cell renal-cell carcinoma at presentation who were suitable candidates for nephrectomy to either undergo nephrectomy and then receive sunitinib or receive sunitinib alone.
The researchers observed 326 deaths at planned interim analysis, with a median follow-up of 50.9 months. With respect to overall survival, the results in the sunitinib-alone group were noninferior to those in the nephrectomy-sunitinib group (stratified hazard ratio for death, 0.89; 95 percent confidence interval, 0.71 to 1.10; upper boundary of the 95 percent confidence interval for noninferiority, ≥1.20). The median overall survival was 18.4 and 13.9 months in the sunitinib-alone and nephrectomy-sunitinib groups, respectively. There were no significant between-group differences in response rate or progression-free survival.
"Our study is the first to question the need for surgery in the era of targeted therapies and clearly shows that surgery for certain people with kidney cancer should no longer be the standard of care," Méjean said in a statement.
The study was partially funded by Pfizer, the manufacturer of sunitinib.