Britell J C, Ahmann D L, Bisel H F, Frytak S, Ingle J N, Rubin J, O'Fallon J R
Cancer Clin Trials. 1979 Winter;2(4):345-50.
The value of immunotherapy as an adjuvant to chemotherapy for advanced breast cancer is an unsettled question. To clarify this issue, 71 women with measurable or evaluable metastatic breast cancer were randomized to receive cyclophosphamide, 5-fluorouracil, and prednisone (CFP) with or without methanol-extracted residue of Bacillus Calmette-Guerin (MER). The total regression rates were 52% (CFP) and 39% (CFP + MER), including complete regression rates of 13% (CFP) and 65% (CFP + MER). The median duration of regressions for CFP-treated patients was 257-261 days and for CFP + MER-treated patients was 385 days. The median time to progression was 248-261 days in the CFP group and 159 days in the CFP-MER group. Projected median survival for both treatment groups is 20 months. Immunotherapy (MER) as used in this study does not appear to augment regression rates or vurvival for patients with advanced breast cancer receiving CFP.
免疫疗法作为晚期乳腺癌化疗辅助治疗手段的价值仍是一个未解决的问题。为了阐明这一问题，71名患有可测量或可评估转移性乳腺癌的女性被随机分组，分别接受环磷酰胺、5-氟尿嘧啶和泼尼松（CFP）治疗，其中一组同时加用卡介苗甲醇提取物（MER）。总缓解率分别为52%（CFP组）和39%（CFP+MER组），其中完全缓解率分别为13%（CFP组）和65%（CFP+MER组）。CFP治疗患者的缓解持续时间中位数为257-261天，CFP+MER治疗患者为385天。CFP组的疾病进展时间中位数为248-261天，CFP-MER组为159天。两个治疗组预计的中位生存期均为20个月。本研究中使用的免疫疗法（MER）似乎并未提高接受CFP治疗的晚期乳腺癌患者的缓解率或生存率。
