Hoover H C, Surdyke M G, Dangel R B, Peters L C, Hanna M G
Cancer. 1985 Mar 15;55(6):1236-43. doi: 10.1002/1097-0142(19850315)55:6<1236::aid-cncr2820550616>3.0.co;2-#.
Over the last four years a guinea pig model of active-specific immunotherapy (ASI) with a syngeneic tumor cell:bacillus calmette-Guerin (BCG) vaccine was translated into a prospectively randomized, controlled clinical trial in patients with colorectal cancer. Primary tumors from patients undergoing standard surgical resection were dissociated enzymatically and cryopreserved by techniques that maintain cell viability. Patients with transmural extension of tumor or nodal metastases were randomized into groups treated by resection alone (control) or resection plus ASI. With a mean follow-up of 28 months (range, 14-24), only 3 of 20 treatment patients had recurrences and none have died, whereas 9 of 20 control patients had recurrences and 4 died. These differences are statistically significant and are sufficiently encouraging to warrant expansion of these studies into other research centers.
在过去四年中，一种使用同基因肿瘤细胞：卡介苗（BCG）疫苗进行主动特异性免疫治疗（ASI）的豚鼠模型被转化为一项针对结直肠癌患者的前瞻性随机对照临床试验。接受标准手术切除的患者的原发性肿瘤通过酶解分离，并采用维持细胞活力的技术进行冷冻保存。肿瘤穿透壁层或有淋巴结转移的患者被随机分为单纯手术切除治疗组（对照组）或手术切除加ASI治疗组。平均随访28个月（范围14 - 24个月），20例治疗患者中只有3例复发，无死亡病例，而20例对照患者中有9例复发，4例死亡。这些差异具有统计学意义，足以令人鼓舞，值得将这些研究扩展到其他研究中心。
