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.

Reference

  1. 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.