A Phase II trial of intravenous gemcitabine and 5-fluorouracil with subcutaneous interleukin-2 and interferon-? in patients with metastatic renal cell carcinoma

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Abstract
BACKGROUND The objective of this study was to determine the response rate and toxicity of gemcitabine and continuous‐infusion 5‐fluorouracil (5‐FU) in combination with subcutaneous interleukin‐2 (IL2) and interferon‐α (IFNA) in patients with metastatic renal cell carcinoma. METHODS Forty‐one patients were treated with gemcitabine 600 mg/m2 on Days 1, 8, and 15 and continuous‐infusion 5‐FU on Days 1–21. The dose of 5‐FU was 200 mg/m2 per day for the initial 8 patients but was reduced to 150 mg/m2 per day for all remaining patients due to toxicity. Starting on Day 15, IL2 and IFNA were administered for 4 weeks. IL2 was administered at a dose of 11 × 106 IU subcutaneously (sc) 4 days per week and IFNA was administered at a dose of 10.0 × 106 IU sc 2 days per week. RESULTS Of 41 patients enrolled in the study, there was 1 complete response (CR), and there were 5 partial responses (PR), for an overall response rate of 14.6% (90% confidence interval [90%CI], 6.6–26.9%). The median time to disease progression was 6.6 months (90%CI, 3.9–7.5 months), and the median overall survival was 20.6 months (90%CI, 9.6–23.3 months). Toxicity was moderate to severe, with fatigue, fever, anorexia, or nausea experienced by 75–90% of patients. Mucositis and neutropenia, likely due to the gemcitabine and 5‐FU, were experienced by a majority of patients. CONCLUSIONS The addition of gemcitabine and 5‐FU to subcutaneous IL2 and IFNA results in a similar response rate to what was observed in previous studies of IL2‐based therapy. The toxicity of this four‐drug combination is significant, and the regimen is not recommended for further development. Cancer 2002;94:2602–9. © 2002 American Cancer Society. DOI 10.1002/cncr.10528

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