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 / 中华泌尿外科杂志

ABSTRACT

Objective To evaluate the efficacy and safety of sorafenib in combination with interferon-alpha(IFN-α)as the first-line treatment in patients with advanced renal cell carcinoma.Methods Since Dec 2007 to Jun 2008,137 legal patients with advanced renal cell carcinoma (RCC)were enrolled in the trail from 22 hospitals in China.All the patients continuously received the treatment of sorafenib plus IFN-α untill disease progressed or patients were unable to tolerate.The primary end points were objective response,disease control rate and adverse effects rate.Results This interim analysis was based on the data collected from the study initiation date to 2009/3/20.The overall response rate(ORR),including complete response (CR) and partial response(PR),was 32.8%(45/137).The median follow-up time was 11.9 months,only 25 patients progressed at the cut off time.The most common adverse events were hand-foot skin reaction(48.2%),alopecia(23.4%),rash (20.4%),diarrhea(19.7 0A),fever(16.8%),lassitude(10.2%),etc.The incidence of 3 or 4 grade hand-foot skin reaction was 8.8%.Conclusions Sorafenib in combination with IFN-α as the firstline treatment in patient with advanced RCC could be effective and safe.