(ChemotherapyAdvisor) – No benefit in efficacy or safety for continuous daily dosing of sunitinib in the first-line treatment of patients with metastatic renal cell carcinoma (RCC) was found when compared with the standard intermittent schedule, results of a multicenter randomized Phase 2 trial in the Journal of Clinical Oncology published online March 19 has found.
Motzer et al. randomly assigned patients with treatment-naive, clear-cell advanced RCC to receive sunitinib 50mg/day for four weeks followed by two weeks off treatment (n=146) or 37.5mg/day as a continuous daily dose (n=146); both schedules were administered for up to two years.
Median time to tumor progression, the primary end point, was 9.9 months for the intermittent schedule and 7.1 months for the continuous daily dosing schedule (HR, 0.77; P=0.090). The investigators found no significant difference in overall survival (23.1 vs. 23.5 months; P=0.615), commonly reported adverse events, or patient-reported symptoms of RCC. The intermittent schedule was also statistically superior to continuous daily dosing in time to deterioration, a composite end point of death, progression, and disease-related symptoms (P=0.034).
Given the numerically longer time to tumor progression with the approved 50mg/day dose on the intermittent schedule, “adherence to this dose and schedule remains the treatment goal for patients with advanced RCC,” they concluded.