Adjuvant treatment with sunitinib prolonged disease-free survival, and was associated with a manageable safety profile compared with placebo, among patients with high-risk locoregional renal cell carcinoma (RCC), according to a study presented at the European Society for Medical Oncology (ESMO) 2016 Congress.1
Sunitinib is an effective treatment strategy for metastatic RCC; researchers therefore determined the efficacy and safety of sunitinib among patients with locoregional RCC at high risk for disease recurrence following nephrectomy.
For the double-blind, phase 3 S-TRAC study (ClinicalTrials.gov Identifier: NCT00375674), researchers enrolled 615 treatment-naive patients with locoregional RCC who underwent nephrectomy. Participants were randomly assigned to receive sunitinib or placebo for 4 weeks on, 2 weeks off for 1 year until disease recurrence, occurrence of a secondary malignancy, or unacceptable toxicity.
Median disease-free survival was 6.8 years (95% CI, 5.8-not reached) with sunitinib compared with 5.6 years (95% CI, 3.8-6.6) with placebo (hazard ratio [HR], 0.761; 95% CI, 0.594-0.975; P = .030) per central review.
Among those at high risk of tumor recurrence, median disease-free survival was 6.2 years (95% CI, 4.9-not reached) and 4.0 years (95% CI, 2.6-6.0) for sunitinib and placebo, respectively (HR, 0.737; 95% CI, 0.548-0.993; P = .044).
Median overall survival data were not yet mature and will be presented after a future analysis.
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Grade 3 or worse adverse events were more common with sunitinib (62.1%) versus placebo (21.1%), though the incidence of serious adverse events was similar between treatment arms, and no deaths due to treatment were observed.
Given the significant improvement in disease-free survival and a manageable toxicity profile with adjuvant sunitinib, the findings suggest that sunitinib is a potential new treatment strategy in this setting.
- Ravaud A, Motzer RJ, Pandha HS, et al. Phase III trial of sunitinib (SU) vs placebo (PBO) as adjuvant treatment for high-risk renal cell carcinoma (RCC) after nephrectomy (S-TRAC). Paper presented at: European Society for Medical Oncology (ESMO) 2016 Congress; October 7-11, 2016; Copenhagen, Denmark.