Nabholtz J M, Thuerlimann B, Bezwoda W R, Melnychuk D, Deschênes L, Douma J, Vandenberg T A, Rapoport B, Rosso R, Trillet-Lenoir V, Drbal J, Aapro M S, Alaki M, Murawsky M, Riva A
Cross Cancer Institute, Edmonton, Alberta, Canada.
Oncology (Williston Park). 1997 Aug;11(8 Suppl 8):25-30.
This nonblinded, multicenter, randomized phase III study compares the median time to progression (primary endpoint), response rate, and quality of life, safety, and survival of docetaxel (Taxotere) vs mitomycin (Mutamycin) plus vinblastine (Velban) in patients with metastatic breast cancer in whom previous anthracycline-containing chemotherapy has failed. Patients were randomized to receive an intravenous infusion of either 100 mg/m2 of docetaxel for 1 hour every 3 weeks, or 12 mg/m2 of mitomycin every 6 weeks plus 6 mg/m2 of vinblastine every 3 weeks. This preliminary analysis presents data on 200 patients among 392 patients recruited. Median time to progression was longer in the group treated with docetaxel compared with the mitomycin/vinblastine group (17 vs 9 weeks). The overall response rates were higher with docetaxel (28% vs 13%, respectively), and fewer patients in the docetaxel group had progressive disease as their best overall response (29% vs 48%). As expected, thrombocytopenia was more common in the mitomycin/vinblastine group, and neutropenia occurred more frequently in the docetaxel group. Severe fluid retention in the docetaxel group (8.7%) resulted in treatment discontinuation in 5 patients (5%). Severe thrombocytopenia (12%) and constipation (6%) led to treatment discontinuation in 7 and 3 patients, respectively, in the mitomycin/vinblastine group. Based on this preliminary analysis, docetaxel appears to be equally as safe as and more active than mitomycin/ vinblastine in patients with metastatic breast cancer in whom previous anthracycline-containing chemotherapy has failed. These results are subject to cautious interpretation because this analysis was conducted on the first 200 patients who finished the study treatments, and these preliminary results may underestimate response and overstate treatment discontinuation rates. Thus, the final analysis on the entire patient population is necessary to confirm these preliminary findings.
这项非盲法、多中心、随机III期研究比较了多西他赛（泰索帝）与丝裂霉素（丝裂霉素）加长春碱（长春花碱）在先前含蒽环类化疗失败的转移性乳腺癌患者中的中位进展时间（主要终点）、缓解率、生活质量、安全性和生存率。患者被随机分为两组，一组每3周静脉输注100mg/m²多西他赛1小时，另一组每6周静脉输注12mg/m²丝裂霉素加每3周静脉输注6mg/m²长春碱。这项初步分析呈现了392例入组患者中200例患者的数据。与丝裂霉素/长春碱组相比，多西他赛治疗组的中位进展时间更长（17周对9周）。多西他赛的总体缓解率更高（分别为28%对13%），多西他赛组中以疾病进展作为最佳总体缓解的患者更少（29%对48%）。正如预期的那样，血小板减少症在丝裂霉素/长春碱组更常见，中性粒细胞减少症在多西他赛组更频繁发生。多西他赛组严重液体潴留（8.7%）导致5例患者（5%）停止治疗。丝裂霉素/长春碱组严重血小板减少症（12%）和便秘（6%）分别导致7例和3例患者停止治疗。基于这项初步分析，在先前含蒽环类化疗失败的转移性乳腺癌患者中，多西他赛似乎与丝裂霉素/长春碱一样安全且活性更高。这些结果需谨慎解读，因为该分析是针对完成研究治疗的前200例患者进行的，这些初步结果可能低估了缓解率并高估了治疗中断率。因此，有必要对全体患者进行最终分析以证实这些初步发现。
