HealthDay News — The duration of disease-free survival is increased with sunitinib treatment for patients with locoregional, high-risk clear-cell renal-cell carcinoma, according to a study published online October 10 in the New England Journal of Medicine. The research was published to coincide with the annual European Society of Medical Oncology Congress, held from October 7 to 11 in Copenhagen, Denmark.

Alain Ravaud, MD, PhD, from the Hôpital Saint André in Bordeaux, France, and colleagues conducted a randomized trial involving 615 patients with locoregional, high-risk clear-cell renal-cell carcinoma to receive sunitinib or placebo on a four-weeks on, two-weeks off schedule.

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The researchers found that the median duration of disease-free survival was 6.8 and 5.6 years in the sunitinib and placebo groups, respectively (hazard ratio, 0.76). At the time of data cut-off, overall survival data were not mature. The sunitinib group had more frequent dose reductions because of adverse events (34.3 versus 2.0%), as well as dose interruptions (46.4 versus 13.2%) and discontinuations (28.1 versus 5.6%). The sunitinib group more frequently had grade 3 or 4 adverse events than the placebo group (48.4 and 12.1 versus 15.8 and 3.6%). The incidence of serious adverse events was similar between the groups (21.9 and 17.1%, repectively).

“Among patients with locoregional clear-cell renal-cell carcinoma at high risk for tumor recurrence after nephrectomy, the median duration of disease-free survival was significantly longer in the sunitinib group than in the placebo group, at a cost of a higher rate of toxic events,” the authors write.

The study was funded by Pfizer, the manufacturer of sunitinib.

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