By ecancer reporter Jo Armstrong

Randomised, double-blind phase III study of pazopanib in patients with advanced/metastatic renal cell carcinoma (MRCC): final overall survival (OS) results - CN Sternberg et al.

Final overall survival (OS) results and a safety update for pazopanib in patients with clear cell mRCC were presented as a late breaker at ESMO 2010. A median OS of 22.9 versus 20.5 months in the pazopanib and placebo arms, respectively (p=0.224) were reported. It was found that the OS analysis had been confounded by the early, high rate and prolonged duration of crossover from placebo to pazopanib. More placebo than pazopanib patients received subsequent treatment (66% versus 30%, respectively) with 54% of placebo patients crossing to pazopanib, some as early as week 6. Additionally, placebo patients who crossed over to open-label pazopanib remained on pazopanib longer than patients originally randomised to the blinded pazopanib arm; 9.7 versus 7.4 months, respectively. The IPCW analysis demonstrated a 50% reduction in the risk of death with pazopanib vs. placebo (p=0.002). The RPSFT analysis is still on-going. With a 30% increase in cumulative exposure in the pazopanib arm, no important changes to the type, frequency and severity of the adverse events were identified compared to data previously reported. This latest analysis demonstrates suggests an OS benefit with pazopanib versus placebo.