Pilot trial of infusional 5-fluorouracil, interleukin-2, and subcutaneous interferon-α for advanced renal cell carcinoma

The authors developed an outpatient, three-drug combination regimen for advanced renal cell carcinoma. Treatment was administered for 5 days each week for 4 weeks, followed by 2-week rests. Each weekly treatment consisted of fluorouracil 1,750 mg/m(2) continuous intravenous infusion for 24 hours followed by interleukin-2 6 mIU/m(2) per day continuous intravenous infusion for 4 days, and interferon;alpha 2b 6 mU/m(2) subcutaneously on days 1, 2, and 5. This trial was undertaken to assess tolerability to this regimen and obtain a preliminary assessment of its effectiveness. Most patients required some dose adjustments (especially of cytokines), treatment interruptions, or both. Toxicities were as would be expected from individual drug profiles with only mild to moderate hematologic toxicities. Among 16 patients with renal cell carcinoma treated, four had major (clinical partial response) responses, one of which was demonstrated to be a pathologic clinical response after surgical resection of a residual mass. Estimated median survival time of all patients was 93 weeks. Response and survival were correlated with known clinical risk factors. Responding patients were noted to be significantly older in age ((X) over bar = 61.75 years) than nonresponders ((X) over bar = 48.92 years). There was no correlation between age and other clinical risk factors, treatment tolerance, of survival. The authors conclude that this three-drug regimen is a practical, tolerable, and promising regimen for further study in renal cell carcinoma.