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Clinical Trial
. 1976 Apr 24;1(7965):871-6.
doi: 10.1016/s0140-6736(76)92093-6.

Prolongation of Postoperative Disease-Free Interval and Survival in Human Colorectal Cancer by B.C.G. Or B.C.G. Plus 5-fluorouracil

Clinical Trial

Prolongation of Postoperative Disease-Free Interval and Survival in Human Colorectal Cancer by B.C.G. Or B.C.G. Plus 5-fluorouracil

G M Mavligit et al. Lancet. .

Abstract

83 patients with colorectal carcinoma of the Dukes' C class were randomised to receive postoperative adjuvant therapy with B.C.G. alone or in combination with oral doses of 5-fluorouracil (5-F.U.), and have been followed for up to thirty months. Results were compared with carefully selected historical controls who were treated by surgery alone. A statistically significant prolongation of both disease-free interval and overall survival was observed in 50 patients receiving the combination of B.C.G. and 5-F.U. (P=0.03, P=0.01 respectively) as well as in 33 patients receiving B.C.G. alone (P=0.03, P=0.05 respectively). The efficacy of B.C.G.+5-F.U. was independent of the number of tumour-involved lymph-nodes in the surgical specimen. In contrast, B.C.G. given alone appears to be highly effective among 10 patients with 6 or more positive lymph-nodes (P less than 0.04) and ineffective (as yet) among 23 patients with 5 or less positive lymph-nodes. These results suggest that adjuvant immunotherapy, with or without chemotherapy, can improve the prognosis of surgically treated patients with colorectal carcinoma of the Dukes' C class.

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