ADJUVANT TREATMENT IN COLON-CANCER - PROTOCOLS OF THE STUDY-GROUP GASTROINTESTINAL ONCOLOGY

Background: Adjuvant postoperative treatment with 5-fluorouracil (5-FU ) and levamisole in curatively resected stage III colon cancer signifi cantly reduces the risk of cancer recurrence. Biochemical modulation o f (5-FU) with leucovorin improves remission rates in metastatic colon cancer. Patients and Methods: Therefore, the effectiveness and toxicit y of 5-FU (400 mg/m(2) in the first chemotherapy course, then 450 mg/ m(2) x 5 d; 12 cycles, arm A) and leucovorin (100 mg/m(2)) were compar ed with 5-FU/levamisole (Moertel scheme; arm B) in patients with a cur ative resection of a stage III colon cancer in a prospective multicent ric trial. Randomization was stratified according to T, N and G stage, Results: 703 patients were entered into this study. The interval betw een surgery and start of therapy was 29 and 31 days (arm A and B, resp ectively). Adjuvant chemotherapy with 5-FU/levamisole as well as with 5-FU/leucovorin was generally well tolerated, Grade 3 or 4 toxic effec ts were documented in 3.5 to 8.3% of all chemotherapy cycles. Conclusi on: This interim analysis demonstrates that both chemotherapy schedule s can be used in the adjuvant setting because of a low percentage of m oderate to severe side effects. These interim results constitute the b asis for a new multicentric adjuvant trial evaluating the impact of ch emotherapy on tumor recurrence with high-dose 5-FU/leucovorin and of m onotherapy with high-dose 5-FU in comparison to 5-FU/leucovorin given for 5 days every 4 weeks.