Paterson A H, Willans D, Jerry L M, McPherson T A
Recent Results Cancer Res. 1978;68:387-92. doi: 10.1007/978-3-642-81332-0_58.
A prospectively controlled randomized clinical trial of adjuvant BCG immunotherapy in patients with stage 1B malignant melanoma (Clark's level 3--5) is described. The combination of intradermal and oral BCG allows approximation of the bacilli to any microscopic foci of residual disease. The trial was activated in May 1975 and to date 107 patients have been admitted to the trial, 49 patients being randomil entered patients, there have been five relapses of 49 patients in the treatment group and ten relapses of 58 patients in the control group. This encouraging trend is not yet statsitically significant at the 5% level (P = 0.17). If evaluable patients with Clark's level 3 and 4 lesions are assessed separately, there is a significant trend in favour of the immunotherapy group (P less than 0.05) with three relapses in the treatment group and ten relapses in the control group.
本文描述了一项针对1B期恶性黑色素瘤（克拉克分级3 - 5级）患者的辅助性卡介苗免疫疗法的前瞻性对照随机临床试验。皮内注射和口服卡介苗的联合使用能使杆菌接近残留疾病的任何微观病灶。该试验于1975年5月启动，迄今为止，已有107名患者进入试验，其中49名患者是随机入组的。治疗组49名患者中有5例复发，对照组58名患者中有10例复发。这一令人鼓舞的趋势在5%的水平上尚未具有统计学意义（P = 0.17）。如果将克拉克分级3级和4级病变的可评估患者分别进行评估，免疫治疗组有显著优势（P < 0.05），治疗组有3例复发，对照组有10例复发。
