Clinical study of sorafenib for patients with advanced renal cell carcinoma

Abstract

Objective To evaluate the safety and efficacy of sorafenib for patients with advanced stage renal cell carcinoma.Methods The clinical data of 85 patients with advanced renal cell carcinoma were reviewed.These patients were treated by sorafenib 400 mg Bid,dose escalation of sorafenib(400 mg Bid 1-4 weeks;600 mg Bid 5-8 weeks;800 mg Bid since then) or sorafenib 400 mg Bid+NF-α,respectively,until intolerance or disease progression occurred.The primary end points were objective response,disease control rate and adverse effects rate.Results The data of 80 patients can be evaluated.The median follow-up duration was 72 weeks (4-108 weeks).One patient (1.2%) reached complete remission(CR),17 cases(21.2%) reached partial remission(PR),50 cases (62.5%) maintained stable disease (SD),and 12 cases (15%) progressed.The objective response (CR+PR) was 22.5%,disease control rate (CR+PR-SD)was 85.0%.By May 2009,only 18 patients died,progression free survival and overall survival were not available.The common side effects included hand-foot skin reaction (55.0%),mucosa hemorrhage (52.5%),diarrhea(40.0%),lassitude (35.0%),anorexia(22.5%),mucosa ulcer(20.0%),hypertension(15.0%) and baldness(15.0%)etc.Most of these side effects could be released by symptomatic treatment.Conclusion Sorafenib has good short term effect for patients with advanced renal cell carcinoma and is well tolerated. Key words: Carcinoma,renal cell; Neoplasm metastasis; Sorafenib