Kostinas J E, Leone L A, Cuttner J, Vinciguerra V, Green M, De Bellis R, Pajak T F
Cancer Treat Rep. 1979 Feb;63(2):197-200.
Patients with stage III and IV melanoma were randomly assigned to receive procarbazine (100 mg/m2, Days 1--10), vinblastine (5 mg/m2, Days 1 and 8), and actinomycin D (0.5 mg/m2, Days 1 and 8) with or without methanol-extracted residue (MER) of bacillus Calmette-Guerin (200 micrograms in five sites). In patients with measurable disease, 20% (eight of 40 patients) responded with only the combination chemotherapy while 15% (six of 39 patients) responded with the MER added. Toxicity was tolerable except for some instances of severe, gastrointestinal toxicity associated with procarbazine. MER as given in this study, failed to either increase the response rate or prolong survival.
III期和IV期黑色素瘤患者被随机分配接受丙卡巴肼(100mg/m²,第1 - 10天)、长春碱(5mg/m²,第1天和第8天)和放线菌素D(0.5mg/m²,第1天和第8天),同时在五个部位给予或不给予卡介苗甲醇提取物(MER,200微克)。在可测量疾病的患者中,仅联合化疗时20%(40例患者中的8例)有反应,添加MER时15%(39例患者中的6例)有反应。除了一些与丙卡巴肼相关的严重胃肠道毒性情况外,毒性是可耐受的。本研究中给予的MER未能提高反应率或延长生存期。