132 O - Oral adjuvant chemotherapy in stage II (B2-3) and III (C) colon cancer

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From March 89 to March 92, 164 patients (p) with stage II and III colon cancer were included in a adjuvant trial using an orel schedule of UFT (tegafur+uracil) 400mg/24h continuous plus Levamisole 150mg/24h × 3days/15days. The purpose was to demonstrate the benefit in the disease free interval and survival of a non-toxic and comfortable treatment. Patients aged from 18 to 75years undergoing curative surgery were included after the informed consent was obtained. For stage II we compared 12months (m) of chemotherapy vs control. For stage III, as the benefit of adjuvant chemotherapy was proved by preliminary results of MOF end FU+levamisole, we compared 6 vs 12m treatment without control group. The study was stopped prematurely due to several reasons. We present the results of 164 p with a median follow-up of 52m (minimum 42, maximum 78). For stage II 96 p were included, 42 control (C) and 54 treatment (CT). No differences in prognostic factors were observed between the groups. The results show no statistical difference in disease free survival (DFS)(19% C relapses vs 18.5% CT relapses) and 78months survival (S), but S was 10.5% superior for CT group (78.5% C vs 89% CT). For stage 111 68 p were included 35 in 6m treatment (6CT) and 33 in 12m treatment (12CT) without differences in prognostic factors. No differences in DFS (34% 6CT relapses vs 33% 12CT relapses) and S (74.2% 6CT VB 69.7% 12CT). The toxicity was mild. 4% grade 3-4 gastrointestinal toxicity and 0 grade 3-4 hematologic toxicity. The small number of cases do not permit to achieve statistical conclusions but our results reproduce with an oral and non-toxic treatment those obtained by Mayo Clinic and intergroup (ECOG; NCCTG:SWOG) using a intravenous schedule (N Engl J Med 1990). It is also remarkable that in stage III the survival is 69–74% at 6 1/2years without difference between 6 and 12months of CT. These results suggest the UFT plus Levamisole oral combination is a schedule to have in mind in future trials in adjuvant colon cancer treatment.