CLINICAL-TRIAL OF CONTINUOUS-INFUSION OF 5-FLUOROURACIL USING AN AMBULATORY PUMP FOR METASTATIC COLORECTAL-CANCER

A clinical trial was conducted in order to evaluate the anti-tumor eff ect and toxicity of a continuous ifusion of 5-fluorouracil (5-FU) for metastati colorectal cancer. Two-hundred and fifty mg/m(2)/day 5-FU wa s administered as a continuous infusion through an indwelling central venous catheter with ambulatory pump. Twenty patients with metastatic colorectal cancer which could be measured or evaluated were enrolled i n the trial. The objective response rate was 35% (95% confidence inter val, 14-56%). The response rates by site were 33% in liver, 17% in lun g, 60% in lymph nodes, 50% in adrenal gland and 50% in primary lesion. The major toxicity was stomatitis (50%; grades 2 and 3 on Eastern Coo perative Oncology Group (ECOG) criteria) and hand-foot syndrome (40%; grades 2 and 3 on ECOG criteria). The sequence of toxicity was stomati tis first, followed by hand-foot syndrome. The median cumulative dose of 5-FU from the initiation of therapy to the onset of toxicity was 71 25 mg in stomatitis and 17,875 mg in handfoot syndrome. These toxiciti es were mild and reversible after a short interruption to the 5-FU inf usion. Neither hematological toxicity nor serious catheter-related com plications were observed. We concluded that continuous infusion of 5-F U was a feasible treatment for the patient with metastatic colorectal cancer, and manageable on an out-patient basis.