Prolongation of postoperative disease-free interval and survival in human colorectal cancer by B.C.G. or B.C.G. plus 5-fluorouracil.
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.
D000284:Administration, Oral; D001500:BCG Vaccine / Q000008:administration & dosage / Q000627:therapeutic use*; D003110:Colonic Neoplasms / Q000401:mortality / Q000628:therapy*; D005069:Evaluation Studies as Topic; D005472:Fluorouracil / Q000008:administration & dosage / Q000627:therapeutic use*; D005500:Follow-Up Studies; D006801:Humans; D008207:Lymphatic Metastasis; D008643:Mesentery; D009364:Neoplasm Recurrence, Local / Q000453:epidemiology; D011182:Postoperative Care; D011379:Prognosis; D012004:Rectal Neoplasms / Q000401:mortality / Q000628:therapy*; D013997:Time Factors
D001500:BCG Vaccine; D005472:Fluorouracil