Adjuvant systemic treatment after resection of colorectal carcinoma utilizing 5-fluorouracil versus 5-fluorouracil plus levamisole

ABSTRACT

The study included 90 patients with resected stages B2-C colorectal carcinoma. All patients received localized postoperative radiotherapy to a dose of 5000-5500 cGy. Patients were divided into three treatment groups. Group A receiving no adjuvant systemic treatment [Controls], group B receiving 5-fluorouracil [5FU] alone [450 mg/m[2] IV bolus for 5 consecutive days] repeated every 28 days; and group C receiving 5FU as in group B/ and levamizole [Lev] [50 mg, 3 times daily for 3 days and repeated every 2 weeks]. Adjuvant treatment in groups B and C was given for one year. The follow up ranged between 25-62 months [median 3.5 years]. Patients of 5FU/Lev group showed significantly lower recurrence rates than controls [P<0.025], but no difference in rate of recurrence between 5FU group and controls. The advantage of 5FU /Lev group over controls in reduction of recurrences was significant only in patients with stage C disease [P<0.01]. Also patients treated by 5FU/Lev combination showed significantly better overall survival compared to controls [P<0.05]. Toxicity of 5FU/Lev combination was mild and consistent with what might be expected with 5FU alone. 5FU /Lev is tolerable adjuvant therapy to patients with colorectal carcinoma with significant reduction of recurrence rate and significant improvement of overall survival