摘要
目的评价多西他赛联合表阿霉素（TE方案）与多西他赛联合顺铂（TP方案）一线治疗局部晚期或转移性乳腺癌患者的疗效和安全性。方法88例患者按2：1随机进入TE组和，TP组。TE组患者药物剂量为多西他赛75mg／m^2，表阿霉素60mg／m^2；TP组患者药物剂量为多西他赛75mg／m^2，顺铂75mg／m^2。21d为1个周期，2个周期末评价近期疗效及安全性。结果TE组可评价近期疗效者55例，其中CR3例，PR26例，SD22例，PD4例。TP组可评价近期疗效者27例，其中CR1例，PR16例，SD9例，PD1例。TE组和，TP组近期有效率分别为48．3％和60．7％（P=0．2788），临床受益率分别为85．0％和92．9％（P=0．4899），中位肿瘤进展时间（TTP）分别为10个月和8个月（P=0．7119）。Ⅲ、Ⅳ度不良反应主要为中性粒细胞减少，TE组和TP组发生率分别为66．7％和53．6％（P=0．2373）；其次为脱发，TE和TP组分别为30．0％和10．7％（P=0．0508）。结论TE方案与TP方案一线治疗局部晚期或转移性乳腺癌的疗效和安全性相当。
Objective To evaluate the efficacy and safety of combination of docetaxel plus epirubicin （TE） versus docetaxel plus cisplatin （rip） as first-line chemotherapy for locally advanced or metastatic breast cancer. Methods Eighty-eight patients were randomized into two groups with a ratio of 2：1 , either to receive TE or TP regimen. The patients received docetaxel 75 mg/m2 plus epirubicin 60 mg/m2 （ TE group） or docetaxel 75 mg/m2 plus cisplatin 75 mg/m2 （ TP group） administrated intravenously. Both regimens were once repeated 3 weeks later. The efficacy, time to progression and safety were evaluated at the end of the second cycle. Results Complete response was achieved in 5% of TE group and 3.6% of TP. Overall （complete plus partial） response rates in TE and TP group were 48.3% and 60.7% , respectively （P=0.2788）. Disease control rates （CR ＋ PR ＋ SD） for TE and TP groups were 83.6% and 80%, respectively （P = 0. 4899 ）. The median time to progression （TYP） was 10 months for TE versus 8 months for TP groups （P =0.7119）. The major grade Ⅲ or Ⅳ toxicities were neutropenia （66.7% in TE; 53.6% in TP, P=0.2373） ; and alopecia （30.0% in TE; 10.7% in TP, P=0.0508）. Condusion Both TE and TP regimens as first-line chemotherapy were similarly effective, safe and tolerable in the treatment for locally advanced or metastatic breast cancer.
出处
《中华肿瘤杂志》
CAS
CSCD
北大核心
2008年第7期541-544,共4页
Chinese Journal of Oncology
