Adjuvant chemoimmuno- and immunotherapy in Dukes' stage B2 and C colorectal carcinoma: A 7-year follow-up analysis

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Abstract
A prospectively randomised controlled clinical trial of adjuvant therapy was undertaken, at a single‐centre, population‐based cancer institute, in patients with Dukes' stages B2 and C colorectal carcinoma after curative surgery. Between 1976 and 1983, 253 patients were randomised to either control (no further therapy after surgery), immunotherapy (oral bacille Calmette‐Guérin [BCG] 120 mg once a month) for 5 years or chemoimmunotherapy (oral BCG as above with methyl‐cyclohexyl‐chloroethyl nitrosourea [meCCNU] 130 mg/m2 on day 1 and 5‐fluorouracil [5‐FU] 325 mg/m2/day on days 1–5 and 375 mg/m2/day on days 36–40) repeated every 10 weeks for 8 cycles. The median follow‐up of patients is now 6.95 years. Of the control, immunotherapy, and chemoimmunotherapy groups 22.35%, 39.28%, and 28.57%, respectively, have relapsed. The log‐rank analysis of results shows no disease‐free or overall survival advantage for patients receiving adjuvant therapy compared with the control group. Patients receiving adjuvant immunotherapy for stage B2 appear to have a significantly inferior disease‐free survival compared with other groups, but their overall survival is similar. There are no significant differences in disease‐free or overall survival in the three groups of patients with stage C tumour. Of 82 patients dying, 78.05% died of progressive colorectal carcinoma, 13 patients developed a second malignancy; the remainder died of seemingly unrelated causes.