Sorafenib in combination with interferon-α-2b for the treatment of metastatic renal cell carcinoma: pre-liminary results

Abstract

Objective To explore the efficacy and tolerability of sorafenib in combination with interferon-α-2b for Chinese patients with metastatic renal cell carcinoma. Methods Seventeen pa-tients with unreseetable metastatic renal cell carcinoma were enrolled and received sorafenib in combi-nation with interferon-α-2b. Sorafenib was continuously given at the dose of 400 mg twice per day, in-terferon-α-2b 300 MIU subscutaneously once per day for 5 d each week, until disease progression or intolerable toxieities occurred. Tumor responses were evaluated every two months by response evalua-tion criteria in solid tumor. Results The median treatment duration was 120(51-442)d. All 17 pa-tients were evaluable for efficacy and safety. Five patients achieved partial responses (PR), 1 uncon-firmed PR,9 stable diseases. Two patients had progressed diseases. The overall response rate was 29%(5/17)with the disease control rate of 88%(15/17). Due to short-time follow up, the median progression free and overall survival time were not yet available. The common side effects included: fever 82%(14/17), diarrhea 82%(14/17), hand-foot syndrome 71%(12/17), asthenia 65%(11/17), rash 53%(9/17), alopecia 41% (7/17), mucosities 41% (7/17), hypertension 29% (5/17), anorexia 24% (4/17), hoarseness 24% (4/17), myalgia 24 % (4/17), nausea/vomiting 12 % (2/17) and headach/ dizzle 12%(2/17). Eleven (65%) out of 17 patients developed neutropenia, 5(29%) thrombocytope-nia and 5 (29%)anemia. Four(24%) out of 17 patients had abnormally elevated ALT/AST. Conclu-sion Sorafenib in combination with interferon-α-2b for metastatic renal cell carcinoma improves re-sponse rate with manageable toxicity. Key words: Carcinoma, renal cell; Interferon; Neoplasm metastasis; Sorafenib