Pegylated interferon alfa-2b treatment for patients with solid tumors: A phase I/II study
Pegylated interferon alfa-2b treatment for patients with solid tumors: A phase I/II study
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DOI：
10.1200/jco.2002.02.051
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发表时间：
2002-09-15
影响因子：
45.3
通讯作者：
Tendler, CL
中科院分区：
文献类型：
--
作者：
Bukowski, R;Ernstoff, MS;Tendler, CL
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 (IFNalpha-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 mug/kg/wk of pegylated IFNalpha-2b by subcutaneous injection for 12 weeks. An additional 35 previously untreated RCC patients received 6.0 and 7.5 mug/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 IFNalpha-2b at 12 weeks was 6.0 mug/kg/wk. One year of 6.0 mug/kg/wk was well tolerated with appropriate dose modification; no grade 3 or 4 fatigue occurred, and safety was comparable with that with nonpegylated IFNalpha-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, 4 previously untreated RCC patients, the objective response rate was 14%. Median survival for all RCC patients was 13.2 months.Conclusion: Pegylated IFNalpha-2b was active and well tolerated in patients with metastatic solid tumors, including RCC, at doses up to 6.0 mug/kg/wk. (C) 2002 by American Society of Clinical Oncology.
