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

Abstract

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/m2 on days 1, 2, 3, 4, 5) + Folinic acid (100 mg/m2 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/m2/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. 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/m2 on days 1, 2, 3, 4, 5) + Folinic acid (100 mg/m2 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/m2/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.