Cancer. 1989 May 1;63(9):1676-80.
Fifty-one patients with advanced malignant melanoma (M. D. Anderson Stage IV) were treated with a four-drug regimen known as the BOLD protocol. In brief, the 5-day treatment consisted of bleomycin, 7.5 U subcutaneously (SC) on the first course and 15 U on days 1 and 4; vincristine, 1 mg/m2 intravenously (IV) on days 1 and 5; CCNU, 80 mg/m2 orally on day 1; and DTIC, 200 mg/m2 IV on days 1 through 5. The entire cycle was repeated every 4 to 6 weeks. Sixteen patients had been previously treated for localized disease with surgery and bacillus Calmette-Guerin (BCG) immunotherapy before relapsing with advanced disease. The BCG therapy was continued in these patients during the between-cycle periods. There were only two short-lived partial responses (4%). The median survival time for all patients was 17.0 weeks and for those who completed at least two chemotherapy cycles (44 patients) was 17.3 weeks. Four candidate prognostic factors were analyzed with respect to the overall survival of all patients: age, sex, site of metastatic spread, and use of concurrent BCG therapy. None played a significant explanatory role either in univariate or multivariate analyses. These unfavorable results preclude the recommendation of this multiagent therapy as a substitute for single-drug (DTIC) regimens aimed at the palliation of advanced, disseminated malignant melanoma.
51例晚期恶性黑色素瘤患者（MD安德森IV期）接受了一种名为BOLD方案的四联药物治疗。简而言之，为期5天的治疗包括：博来霉素，第一个疗程皮下注射7.5单位，第1天和第4天注射15单位；长春新碱，第1天和第5天静脉注射1mg/m²；洛莫司汀，第1天口服80mg/m²；达卡巴嗪，第1天至第5天静脉注射200mg/m²。整个周期每4至6周重复一次。16例患者先前曾接受过局部疾病的手术治疗及卡介苗（BCG）免疫治疗，之后复发为晚期疾病。在这些患者的周期间隙期继续进行BCG治疗。仅出现了2例短期部分缓解（4%）。所有患者的中位生存时间为17.0周，至少完成两个化疗周期的患者（44例）的中位生存时间为17.3周。分析了四个候选预后因素对所有患者总生存的影响：年龄、性别、转移扩散部位以及是否同时使用BCG治疗。在单因素和多因素分析中，这些因素均未发挥显著的解释作用。这些不理想的结果使得无法推荐这种多药联合治疗方案替代旨在缓解晚期播散性恶性黑色素瘤的单药（达卡巴嗪）治疗方案。
