Dieras V, Marty M, Tubiana N, Corette L, Morvan F, Serin D, Mignot L, Chazard M, Garet F, Onetto N
Institut Curie, Paris, France.
Semin Oncol. 1995 Aug;22(4 Suppl 8):33-9.
Paclitaxel (Taxol; Bristol-Myers Squibb Company, Princeton, NJ) has been shown to be an effective agent in the treatment of metastatic breast carcinoma. This multicenter randomized study compared paclitaxel 175 mg/m2 given as a 3-hour infusion every 3 weeks with mitomycin 12 mg/m2 given as an intravenous infusion every 6 weeks. Eighty-one patients have been randomized, and preliminary results of a planned analysis of the first 36 evaluable patients per arm are reported. Pretreatment characteristics were well balanced between the two groups. All patients previously have received chemotherapy for metastatic disease, and half had both adjuvant therapy and chemotherapy for metastatic disease. All but one patient previously had received anthracyclines. Of the first 81 randomized patients, 72 were evaluable for response and toxicity (four never treated, five concomitant hormonotherapy). Partial responses were seen in 17% of patients in the paclitaxel arm and 6% in the mitomycin arm (P = .14). Crossover to paclitaxel therapy following progression on mitomycin achieved an objective response rate of 24% (five of 21 patients). Responses to paclitaxel therapy lasted for a median duration of 9.1 months (range, 6.2 to 12+ months). Median time to progression was significantly longer in the paclitaxel arm (3.5 months v 1.6 months; P = .026). The quality-of-life-adjusted analysis confirmed the advantage of paclitaxel therapy, even when the delay of disease progression was adjusted for important adverse events. Adverse events, most importantly neutropenia and neuropathy, were more frequently observed in the paclitaxel arm. However, patients remained on paclitaxel therapy for many more courses than did those treated in the mitomycin arm. In conclusion, paclitaxel 175 mg/m2 given as a 3-hour intravenous infusion has been demonstrated to be an active agent in the treatment of chemotherapy-refractory advanced breast cancer, even after therapy with mitomycin has failed.
紫杉醇（泰素；百时美施贵宝公司，新泽西州普林斯顿）已被证明是治疗转移性乳腺癌的一种有效药物。这项多中心随机研究将每3周静脉滴注3小时给予175mg/m²紫杉醇与每6周静脉滴注给予12mg/m²丝裂霉素进行了比较。81例患者已被随机分组，现报告每组前36例可评估患者的计划分析初步结果。两组的预处理特征均衡良好。所有患者此前均接受过转移性疾病化疗，半数患者曾接受辅助治疗和转移性疾病化疗。除1例患者外，所有患者此前均接受过蒽环类药物治疗。在最初随机分组的81例患者中，72例可评估疗效和毒性（4例未接受治疗，5例接受同步激素治疗）。紫杉醇组17%的患者出现部分缓解，丝裂霉素组为6%（P=0.14）。丝裂霉素治疗进展后交叉接受紫杉醇治疗的患者客观缓解率为24%（21例患者中的5例）。紫杉醇治疗的缓解持续时间中位数为9.1个月（范围6.2至12+个月）。紫杉醇组至疾病进展的中位时间显著更长（3.5个月对1.6个月；P=0.026）。生活质量调整分析证实了紫杉醇治疗的优势，即使在针对重要不良事件对疾病进展延迟进行调整后亦是如此。不良事件，最重要的是中性粒细胞减少和神经病变，在紫杉醇组更频繁观察到。然而，与丝裂霉素组治疗的患者相比，紫杉醇组患者接受的疗程更多。总之，每3小时静脉滴注给予175mg/m²紫杉醇已被证明是治疗化疗难治性晚期乳腺癌的一种有效药物，即使在丝裂霉素治疗失败后亦是如此。
