A PHASE-II STUDY OF CONTINUOUS INFUSIONAL 5-FLUOROURACIL (5-FU) AND SUBCUTANEOUS INTERLEUKIN-2 (IL-2) IN METASTATIC RENAL-CANCER

In this study, the safety with efficacy of infusional 5-fluorouracil ( 5-FU) (200 mg/m(2)/day) combined with subcutaneous interleukin-2 (IL-2 ) (9-27 x 10(6)IU/day) was investigated in patients with metastatic an d renal cancer. In the 24 patients evaluated, the overall response rat e was 17% (1 CR, 3 PR). The major toxicity was the vascular leak syndr ome (VLS) which required inotrope support in 18% of treatment cycles. Other common systemic toxicities were vomiting, oedema and malaise (gr ades 1 and 2). There was no enhanced or novel toxicity from the combin ation of drugs. Based on this study, it will be feasible to use infusi onal chemotherapy with other cytokine combinations. (C) 1997 Elsevier Science Ltd.