LEVAMISOLE ADDS GRANULOCYTE TOXICITY TO 5FU-BASED CHEMOTHERAPIES IN ADJUVANT TREATMENT OF DUKES B-C COLORECTAL-CANCER - A PRELIMINARY-REPORT

41 patients (pilot study-I) and 50 patients (multicenter study II) was randomized to receive as systemic chemotherapy for 6 courses with 5 F U alone (A) [440 (I)-450 (II) mg/m(2) IV bolus, 5/21 days] or folinic acid followed by 5 FU(B) (respectively 200 and 370 mg/m(2) IV bolus, 5 /21 days). In the multicenter trial, oral levamisole at the dose of 15 0 mg/day (3/14 days) was added to chemotherapy for one year. Ten patie nts in study I and 19 patients in study II also received a post-operat ive course of inh a-portal chemotherapy. Toxicity was evaluated respec tively on 232 (I) and 276 (11) courses. Clinical limiting toxicities w ere stomatitis and diarrhea. In protocol II, a significant enhancement of grades 3-4 granulocyte toxicity was seen (17.3% of courses in II v s only 3.4% in I; p < 0.001). This was especially recorded in the grou p treated with 5-FU alone (26% of courses in A vs 11% in B; p < 0.001) . Levamisole was therefore stopped in 12 cases (10 cases in A; 2 cases in B).