A PHASE-III STUDY OF RECOMBINANT INTERLEUKIN-2 AND 5-FLUOROURACIL CHEMOTHERAPY IN PATIENTS WITH METASTATIC COLORECTAL-CANCER

Sixteen patients with metastatic colorectal cancer have been treated w ith a regimen involving an 120 h continuous infusion of rIL-2. 18 x 10 (6) iu m-2 day followed by three,injections of 5FU 600 Mg M-2 at weekl y intervals. Entry criteria included no previous chemotherapy, ambulat ory performance status, and a measurable lesion. In most cases side ef fects were easily manageable and only one patient required transfer to an intensive care unit with the capillary leak syndrome. In three pat ients persistent hypotension was found to be unrelated to treatment wi th rIL-2, being caused respectively by a line infection, pulmonary emb olus, and bowel perforation. This last proved a fatal complication. Fi ve patients (33%; [95% confidence limits, 11.8% 61.6%]) achieved a par tial response, and two non-responders later achieved a partial respons e when treated with weekly 5FU. This regimen is currently being evalua ted in a phase-Ill randomised controlled trial.