134 O - The S.M.A.C. study: large scale collaborative trial of adjuvant therapy in colon cancer

The efficacy of adjuvant therapy in stage B2 - C colon cancer patients has been proven for 5FU-Levamisol and 5FU-Folinic acid combinations. A pooled analysis of intraporial 5FU demonstrated a significant reduction in mortality. Therefore, the combination of intraportal and systemic therapy might reduce mortality achieved with each single regimen. On April 1992 a multicentric randomized trial of adjuvant chemotherapy in completely resected colon cancer patients was launched in Italy, comparing the efficacy of: 1) systemic 5FU (370 mg/m 2 on days 1, 2, 3, 4, 5) + Folinic acid (100 mg/m 2 on days 1, 2, 3, 4, 5) (FUFA); cycles were repeated every 28 days for 6 months; 2) continuous intraportal vein infusion of 5FU (500 mg/m 2 /day) + heparine (5000 Ul/day/c 7 days) (IP); 3) combinetion of the two. Treatment is allocated by central randomization during surgery. As at October 1995, a total of 1001 patients have been enrolled by 62 general hospitals, with an average accrual of 300 patients/year. Post surgical complications were 9%, equatly distributed among the three arms. Complications at anasthomosis affacted 19 (2.1%) patients and 2 patients experienced liver toxicity. Overall, 7 patients died for surgical complications. Systemic therapy has been completed in 74% of patients, while 82% of patients completed IP. Intraportal therapy was interrupted lor surgical complications (5,4%), problem related to catheter inserction/dislocation (12,5%) and toxicity (3,3%), Treatments were well tolerated. Diarrhoea was the most important problem, occurring in 3.1% of patients. AI a median follow-up time of 23 months 69 relapses (30 of the liver) and 49 deaths (28 correlated to disease progression) have been reported. No deaths related to toxicily were rsported.