Weekly 24-h infusion of high-dose 5-Fluorouracil (5-FU) with folinic acid (FA) in adjuvant therapy of colon canter

After curative resection (R-0) of primary colon cancer or curative metastas es resection, the efficacy, toxicity and compliance of a weekly 24-h infusi on of high-dose 5-FU with folinic acid was examined in a prospective feasib ility trial. From June 1995 to June 1997, 19 patients were included, 11 pat ients with UICC stage III and 8 patients with UICC stage IV colon cancer. T he patients received weekly 500 mg/m(2) of calcium folinic acid (Rescuvolin (R)) as a 1-2h-infusion on an outpatient basis following a 24-h infusion of 2,000 mg/m(2) 5-FU via a pump system (Intermate LV5 Baxter(R)). The adjuva nt therapy was administered for 6 months. 90% of the patients received the planned 18 chemotherapy applications. The total 5-FU dose given to each pat ient amounted to 34.4 g/m(2) in 6 months, thus corresponding to 95% of the planned 5-FU total dose. The main toxicity was diarrhea CTC toxicity grade 3 in the case of 16% of the patients. After a median follow-up of 51 months (range: 37-59 months), 82% of the patients (9 out of 11) with stage III re mained free of recurrence. The 2 cases of recurrence belonged to the pN2 su bgroup. In stage IV only 12% of the patients (1 out of 8) remained free of recurrence. On an adjuvant basis, a weekly 24-h infusion of high-dose 5-FU with folinic acid is accompanied by a good complicance and a high-dose intensity of 5-F U. Now it is tested within randomized phase III trials of the "Arbeitsgemei nschaft Gastroenterologische Onkologie (ACO)" of the "Deutsche Gesellschaft fur Verdauungs- und Stoffwechselerkrankungen" for UICC stage III colon can cer. Concerning stage IV, adjuvant therapy was not effective, a fact that s eems to justify new drugs and new therapeutic strategies.