ESMO 2016: Longer Disease-Free Survival in Phase III Trial of Sunitinib as Adjuvant Treatment for Kidney Cancer
A phase III trial of sunitinib (Sutent) has met its primary endpoint of disease-free survival for adjuvant treatment of high-risk renal cell carcinoma after nephrectomy, reported Ravaud et al at the European Society for Medical Oncology (ESMO) 2016 Congress in Copenhagen (Abstract LBA11_PR).
“The recurrence rate of kidney cancer after nephrectomy…is up to 50% in some subgroups of patients,” said lead author Alain Ravaud, MD, PhD, Head of Medical Oncology at University Hospital of Bordeaux, France. “This distinguishes it from other tumors such as breast cancer, where, in general, there is a low chance of the cancer coming back.”
“We have good drugs to control disease in patients with metastatic kidney cancer, but there are no standard adjuvant treatments,” he added.
S-TRAC Trial
The phase III S-TRAC trial tested the ability of adjuvant treatment with sunitinib, a receptor tyrosine kinase inhibitor, to improve disease-free survival in clear cell renal carcinoma. The study included 615 postnephrectomy patients at high risk of recurrence.
Patients were randomized to placebo or sunitinib for 1 year. Sunitinib was administered at 50 mg/d in a 4-weeks-on/2-weeks-off schedule, and 1 dose reduction to 37.5 mg per day was allowed. Patients with suspected metastases in an independent central review were excluded from the study.
The primary endpoint was disease-free survival, which was assessed by an independent central review committee of radiologists who examined computed topography (CT) scans and ruled whether an event had occurred or not. Events included recurrence in the remaining kidney or in local lymph nodes; metastases; or a second malignancy. In cases of disagreement between the independent central review and the study investigators, a decision was reached by obtaining a biopsy or surgery sample of the tumor—if it contained cancer this was ruled as a recurrence.
Study Findings
The primary endpoint of the trial was met with a significantly longer disease-free survival of 6.8 years with sunitinib compared to 5.6 years with placebo (hazard ratio = 0.761, P = .03). Adverse events of grade 3 or higher were more frequent with sunitinib (62.1%) compared to placebo (21.1%). There were no deaths due to treatment toxicity.
Dr. Ravaud said, “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. The results of this trial could change practice because there is currently no standard treatment in this setting.”
He concluded, “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. In other words, in patients with predominant clear cell renal cell carcinoma without metastases and at high risk of recurrence, at a starting dose of 50 mg and a minimum dose of 37.5 mg per day and with the same dosing schedule. This is particularly important, since sunitinib was not beneficial in another trial using a different methodology.”
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