A PHASE-II STUDY OF CONTINUOUS-INFUSION 5-FLUOROURACIL IN ADVANCED HORMONE-REFRACTORY PROSTATE-CANCER - AN ILLINOIS CANCER CENTER STUDY

Background. 5-Fluorouracil (5-FU) has been previously associated with therapeutic benefit in hormone refractory prostate cancer. However, no previous study has administered 5-FU as a prolonged continuous infusi on, which may be the optimal schedule for this cell-cycle specific age nt. Methods. Therefore, 25 patients were treated with 5-FU administere d as a continuous intravenous infusion at a dose of 1000 mg/m2/day for 5 days every 28 days. Eligibility required disease defined by bidimen sionally measurable lesions or evaluable lesions on bone scan or radio graph with elevated serum levels of prostate-specific antigen (PSA), n o severe cytopenias, and an Eastern Cooperative Oncology Group perform ance status less than 3. Prior chemotherapy was not allowed. Dose modi fications were specified for mucositis and hematologic toxicity. Resul ts. Eighteen of 22 patients were evaluable for response and toxicity, whereas 4 were evaluable for toxicity alone. Toxicity was significant using this dose and schedule and included episodes of sudden death (on e patient), paroxysmal supraventricular tachycardia (one patient), and congestive heart failure (one patient). Other Grade 3 toxicities incl uded stomatitis (two patients) and diarrhea (one patient). Significant myelosuppression did not occur. Objective responses were not observed , but 12 patients experienced stable disease with a median duration of 4 months. Conclusions. Infusional 5-FU can not be recommended for the treatment of advanced hormone refractory prostate cancer.