Nathanson L, Schoenfeld D, Regelson W, Colsky J, Mittelman A
Cancer. 1979 May;43(5):1630-5. doi: 10.1002/1097-0142(197905)43:5<1630::aid-cncr2820430511>3.0.co;2-z.
Fifty-nine patients with metastatic melanoma predominantly localized in the skin were randomly assigned to treatment with BCG given either intralesionally (IL-BCG) or by multiple puncture vaccination at a nontumor bearing site in the skin (MPV-BCG). Half the patients with IL-BCG experienced moderate fever, chills and malaise, suggesting systemic exposure to this live organism. However, only three of these patients required systemic antituberculous chemotherapy and all responded to it. MPV-BCG treated patients experienced significantly less systemic toxicity. Among fully evaluable patients 45% objective response rate was seen in the IL-BCG group and a 9% response rate in the MPV-BCG group, a significant difference. The only complete responses were seen in the IL-BCG group. Among fully evaluable patients, median survival was 21.1 months in the IL-BCG group and 13.3 months in the MPV-BCG groups (NSD). No patients with pretreatment anergy to all skin tests utilized, experienced objective response to BCG.
59例主要局限于皮肤的转移性黑色素瘤患者被随机分配接受卡介苗治疗，治疗方式为病灶内注射（IL-BCG）或在皮肤上无肿瘤部位进行多点穿刺接种（MPV-BCG）。接受IL-BCG治疗的患者中有一半出现中度发热、寒战和不适，提示全身接触了这种活病原体。然而，这些患者中只有3例需要全身抗结核化疗，且所有患者对化疗均有反应。接受MPV-BCG治疗的患者全身毒性明显较小。在可全面评估的患者中，IL-BCG组的客观缓解率为45%，MPV-BCG组为9%，差异显著。仅在IL-BCG组观察到完全缓解。在可全面评估的患者中，IL-BCG组的中位生存期为21.1个月，MPV-BCG组为13.3个月（无显著差异）。对所有使用的皮肤试验预处理无反应的患者，均未对卡介苗产生客观反应。
