EVALUATION OF LOW-DOSE CONTINUOUS-INFUSION 5-FLUOROURACIL IN PATIENTSWITH ADVANCED AND RECURRENT RENAL-CELL CARCINOMA - A SOUTHWEST-ONCOLOGY-GROUP STUDY

Background. The response rate of metastatic renal cell cancer to cytot oxic therapy over the last 10 years has been 5.6%. Low dose continuous 5-fluorouracil (5-FU) has demonstrated efficacy in other cytotoxic re fractory tumors, such as pancreas, colorectal, and recurrent breast. T he Southwest Oncology Group undertook a Phase II trial of low dose, co ntinuous 5-FU in metastatic renal cell cancer. Methods. Sixty-one pati ents were entered in the study to receive 300 mg 5-FU/m(2)/day for 7 d ays via a central venous catheter and external programmable pump. The pump was refilled every 7 days. Pyridoxine (50 mg, orally) was adminis tered prophylactically three times a day. Results. A response of 5.2% (one complete response [CR] and two partial responses [PRs]) was achie ved. The overall survival was 12 months. The duration of the CR is mor e than 30 months. Both PRs lasted 6 months. No survival advantage was noted with either prior nephrectomy or biologic therapy. The majority of toxicities were Grade 2: anemia, anorexia, diarrhea, nausea/vomitin g, and stomatitis. No toxic deaths occurred. Conclusion. Low dose, con tinuous 5-FU demonstrated minimal activity in metastatic renal cancer.