Katsumata N, Watanabe T, Minami H, Aogi K, Tabei T, Sano M, Masuda N, Andoh J, Ikeda T, Shibata T, Takashima S
Department of Medical Oncology, National Cancer Center Hospital, Tokyo, Japan.
Ann Oncol. 2009 Jul;20(7):1210-5. doi: 10.1093/annonc/mdn781. Epub 2009 Mar 2.
This randomized, multicenter, phase III trial compared doxorubicin plus cyclophosphamide (AC), single-agent docetaxel (D), and an alternating regimen of AC and docetaxel (AC-D) as first-line chemotherapy in metastatic breast cancer (MBC).
Patients with MBC resistant to endocrine therapy were entered in a randomized study to receive either six cycles of AC (doxorubicin 40 mg/m2 plus cyclophosphamide 500 mg/m2), D (60 mg/m2), or alternating treatment with AC-D (i.e. three cycles of AC and three cycles of D). Treatment was administered every 3 weeks.
A total of 441 patients were entered in a randomized study. Response rates were 30% for AC, 41% for D, and 35% for AC-D. The median times to treatment failure (TTFs) were 6.4, 6.4, and 6.7 months (one-sided log-rank test, P = 0.13 for AC versus D, P = 0.14 for AC versus AC-D) and median overall survival (OS) was 22.6, 25.7, and 25.0 months (P = 0.09 for AC versus D, P = 0.13 for AC versus AC-D) in the AC, D, and AC-D, respectively.
There was no difference in the TTF among the three arms. However, there was a trend toward a better response and better OS in the D than in the AC.
这项随机、多中心、III期试验比较了阿霉素联合环磷酰胺（AC）、单药多西他赛（D）以及阿霉素联合环磷酰胺与多西他赛交替方案（AC-D）作为转移性乳腺癌（MBC）一线化疗方案的疗效。
对内分泌治疗耐药的MBC患者进入一项随机研究，接受六个周期的AC（阿霉素40mg/m²加环磷酰胺500mg/m²）、D（60mg/m²）或AC-D交替治疗（即三个周期的AC和三个周期的D）。每3周进行一次治疗。
共有441例患者进入随机研究。AC组的缓解率为30%，D组为41%，AC-D组为35%。AC组治疗失败时间（TTF）的中位数为6.4个月，D组为6.4个月，AC-D组为6.7个月（单侧对数秩检验，AC与D相比P = 0.13，AC与AC-D相比P = 0.14）；AC组、D组和AC-D组的总生存（OS）中位数分别为22.6个月、25.7个月和25.0个月（AC与D相比P = 0.09，AC与AC-D相比P = 0.13）。
三组的TTF无差异。然而，D组的缓解和OS有优于AC组的趋势。
