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Pegylated Interferon Alfa-2b Treatment for Patients With Solid Tumors: A Phase I/II Study

From the Cleveland Clinic Cancer Center, Cleveland, OH; the Dartmouth Hitchcock Medical Center, Norris Cotton Cancer Center, Lebanon, NH; the Royal Marsden Hospital, London, England; the Dallas Research Center, Dallas, and Baylor College of Medicine, Texas Medical Center, Houston, TX; and Schering-Plough Research Institute, Kenilworth, NJ.

Address reprint requests to Ronald M. Bukowski, MD, Director, Experimental Therapeutics Program, Cleveland Clinic Cancer Center/T40, 9500 Euclid Ave, Cleveland, OH 44195-5237; email: bukowsr{at}cc.ccf.org

PURPOSE: The efficacy of interferon alfa has been established in treating advanced melanoma and renal cell carcinoma (RCC) patients. We conducted a phase I/II study to determine the maximum-tolerated dose (MTD), the safety and tolerability, and the preliminary efficacy of once-weekly pegylated interferon alfa-2b (IFN-2b) in patients with advanced solid tumors (primarily RCC).

PATIENTS AND METHODS: To determine the MTD, 35 patients with a variety of advanced solid tumors received 0.75 to 7.5 µg/kg/wk of pegylated IFN-2b by subcutaneous injection for 12 weeks. An additional 35 previously untreated RCC patients received 6.0 and 7.5 µg/kg/wk for up to 12 weeks. Patients with a response or stable disease after 12 weeks were eligible for the extension protocol and were treated for up to 1 year or until disease progression.

RESULTS: The MTD for pegylated IFN-2b at 12 weeks was 6.0 µg/kg/wk. One year of 6.0 µg/kg/wk was well tolerated with appropriate dose modification; no grade 3 or 4 fatigue occurred, and safety was comparable with that with nonpegylated IFN-2b. The most common nonhematologic adverse events included mild to moderate nausea, anorexia, and fatigue. Six patients had grade 3 or 4 hematologic toxicity. Twenty-nine patients continued on the extension protocol. Four patients had a complete response, and five patients had a partial response. Among 44 previously untreated RCC patients, the objective response rate was 14%. Median survival for all RCC patients was 13.2 months.

CONCLUSION: Pegylated IFN-2b was active and well tolerated in patients with metastatic solid tumors, including RCC, at doses up to 6.0 µg/kg/wk.

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