Phase IV clinical trial of sorafenib in combination with interferon-alpha as the first-line treatment in patients with advanced renal cell carcinoma:interim analysis of efficacy and safety

Abstract

：Objective To evaluatethe efficacy and safety of sorafenib in combination with interferon-alpha(IFN-α)as the first-line treatment in patients with advanced renal cellcarcinoma.Methods Since Dec 2007 to Jun 2008,137 legal patients with advanced renal cellcarcinoma (RCC)were enrolled in the trail from 22 hospitals in China.All the patientscontinuously received the treatment of sorafenib plus IFN-α untill disease progressed or patients were unable to tolerate.The primary endpoints were objective response,disease control rate and adverse effects rate.Results Thisinterim analysis was based on the data collected from the study initiation date to2009/3/20.The overall response rate(ORR),including complete response (CR) and partialresponse(PR),was 32.8%(45/137).The median follow-up time was 11.9 months,only 25 patientsprogressed at the cut off time.The most common adverse events were hand-foot skinreaction(48.2%),alopecia(23.4%),rash (20.4%),diarrhea(19.70A),fever(16.8%),lassitude(10.2%),etc.The incidence of 3 or 4 grade hand-foot skinreaction was 8.8%.Conclusions Sorafenib in combination with IFN-α as the firstline treatment in patient with advanced RCC could beeffective and safe.