Mavligit G M, Gutterman J U, Burgess M A, Khankhanian N, Seibert G B, Speer J F, Jubert A V, Martin R C, McBride C M, Copeland E M, Gehan E A, Hersh E M
Lancet. 1976 Apr 24;1(7965):871-6. doi: 10.1016/s0140-6736(76)92093-6.
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.
83例Dukes' C期结直肠癌患者被随机分组，分别接受单独使用卡介苗（B.C.G.）或卡介苗联合口服5-氟尿嘧啶（5-F.U.）的术后辅助治疗，并已随访长达30个月。将结果与精心挑选的仅接受手术治疗的历史对照患者进行比较。在50例接受卡介苗和5-氟尿嘧啶联合治疗的患者中观察到无病生存期和总生存期均有统计学意义的延长（分别为P = 0.03，P = 0.01），以及在33例仅接受卡介苗治疗的患者中也观察到同样情况（分别为P = 0.03，P = 0.05）。卡介苗+5-氟尿嘧啶的疗效与手术标本中受累肿瘤淋巴结的数量无关。相比之下，单独使用卡介苗在10例有6个或更多阳性淋巴结的患者中似乎非常有效（P小于0.04），而在23例有5个或更少阳性淋巴结的患者中目前尚无效果。这些结果表明，无论是否联合化疗，辅助免疫治疗均可改善接受手术治疗的Dukes' C期结直肠癌患者的预后。
