Patients with renal cell carcinoma at high risk for recurrence had prolonged disease-free survival when treated with sunitinib compared with placebo.
Patients with renal cell carcinoma at high risk for recurrence had prolonged disease-free survival when treated with sunitinib compared with placebo, according to the results of a phase III trial (abstract LBA11_PR) presented at the European Society for Medical Oncology (ESMO) 2016 Congress, held October 7–11 in Copenhagen, Denmark.
“Sunitinib is a potential new option for adjuvant therapy in renal cell carcinoma, given the increase in disease-free survival and the manageable safety profile,” said lead author Alain Ravaud, MD, PhD, head of medical oncology, University Hospital of Bordeaux, France, in a press release. “The results of this trial could change practice because there is currently no standard treatment in this setting.”
The trial included 615 patients with previously untreated locoregional renal cell carcinoma. All patients had undergone nephrectomy and were randomly assigned to 50 mg/d sunitinib or placebo in a 4 weeks on 2 weeks off schedule for 1 year. One dose reduction to 37.5 mg per day was allowed in the protocol. The primary endpoint was disease-free survival assessed by central review.
At follow-up, fewer disease-free events occurred in the sunitinib arm compared with placebo (113 vs 144). Sunitinib significantly prolonged disease-free survival by central review compared with placebo (hazard ratio [HR], 0.761; P = .030). The median disease-free survival was 6.8 years for sunitinib compared with 5.6 years for placebo. Similar prolongation of disease-free survival was seen in higher-risk patients as well (HR, 0.737; P = .044).
Patients assigned to sunitinib experienced more grade 3 or worse adverse events (62.1%) compared with placebo (21.1%); however, the rate of serious adverse events was similar between the two arms and no deaths occurred due to treatment toxicity.
“We hope sunitinib will be approved by regulators for adjuvant therapy in renal cell carcinoma. Clinicians should then use the drug according to the trial,” Ravaud said. “This is particularly important since sunitinib was not beneficial in another trial using a different methodology.”
Patients who showed benefit had clear cell renal cell carcinoma, no metastases, and were at high risk of recurrence.
“Disease-free survival is a useful surrogate endpoint, but the results from different studies have been contradictory. It does not necessarily translate to overall survival, which is the gold standard,” said Thomas Powles, MBBS, MD, professor of urology cancer at the Barts Cancer Institute, London, commenting on the study. “Without a consistently positive disease-free survival signal it would be premature for me to recommend sunitinib as adjuvant therapy for my patients, particularly when one considers the toxicity.”