A phase II study of continuous infusional 5-fluorouracil (5-FU) and subcutaneous interleukin-2 (IL-2) in metastatic renal cancer

Abstract In this study, the safety with efficacy of infusional 5-fluorouracil (5-FU) (200 mg/m 2 /day) combined with subcutaneous mterleukin-2 (IL-2) (9–27 × 10 6 IU/day) was investigated in patients with metastatic and renal cancer. In the 24 patients evaluated, the overall response rate was 17% (1 CR, 3 PR). The major toxicity was the vascular leak syndrome (VLS) which required inotrope support in 18% of treatment cycles. Other common systemic toxicities were vomiting, oedema and malaise (grades 1 and 2). There was no enhanced or novel toxicity from the combination of drugs. Based on this study, it will be feasible to use infusional chemotherapy with other cytokine combinations.