中国两种国产多西他赛治疗晚期乳腺癌的随机对照试验
[Randomized controlled trial of two kinds of home-produced docetaxel in China for advanced breast cancer].
作者信息
Liu Dong-Geng, Peng Rou-Jun, Feng Feng-Yi, Hu Xiao-Hua, Tang Gui-Di, Xiong Jian-Ping, Zhao Hong-Yun, Guo Ying, Guan Zhong-Zhen
机构信息
State Key Laboratory of Oncology in South China, Guangzhou, Guangdong, 510060, P. R. China.
出版信息
Ai Zheng. 2006 Dec;25(12):1557-60.
BACKGROUND & OBJECTIVE: Two kinds of home-produced docetaxel in China, injection Yiyoutasai and injection Aisu, have the same structure. Data from preclinical study had shown that injection Yiyoutasai has the same pharmacokinetics and toxicity as injection Aisu. This study was to evaluate the efficacy and toxicity of injection Yiyoutasai in treating advanced breast cancer.
METHODS
Eligible breast cancer patients were enrolled and randomly assigned to study group and control group, and received injection of 75 mg/m(2) Yiyoutasai or Aisu, respectively. The injections were repeated every 3 weeks. All patients received at least 2 cycles. The efficacy of Yiyoutasai and Aisu were evaluated after treatment.
RESULTS
A total of 67 patients were enrolled: 33 in study group, and 34 in control group. Of the 31 evaluable cases in study group, 1 achieved complete remission (CR), 9 achieved partial remission (PR), 11 had stable disease (SD), and 10 had progressive disease (PD); the total response rate was 22.22%. There were 1 CR, 5 PR, 19 SD, and 9 PD in control group; the total response rate was 15.15%. There was no significant difference between the 2 groups (P=0.662). The median follow-up was 16.5 months (8-28 months). In study group, the median progression-free survival time was 6.2 months (2-12 months), the 1-year survival rate was 68.51%, and the 2-year survival rate was 40.12%; in control group, the median progression-free survival time was 7.1 months (2.3-11 months), the 1-year survival rate was 65.23%, and the 2-year survival rate was 39.71%. There was no significant difference between the 2 groups (P=0.102, 0.098, 0.089, respectively). Common adverse events were myelosuppression, transient transaminase elevation, and alopecia. One patient in study group suffered from severe allergic reaction after infusion, 1 in control group suffered from whole body edema.
CONCLUSION
Yiyoutasai and Aisu have similar efficacy on and toxicity to advanced breast cancer patients.
背景与目的
国内两种国产多西他赛，益优他赛注射液和艾素注射液，结构相同。临床前研究数据表明，益优他赛注射液与艾素注射液具有相同的药代动力学和毒性。本研究旨在评价益优他赛注射液治疗晚期乳腺癌的疗效和毒性。
方法
入选符合条件的乳腺癌患者，随机分为研究组和对照组，分别接受75mg/m²益优他赛或艾素注射液注射。每3周重复注射。所有患者至少接受2个周期治疗。治疗后评估益优他赛和艾素的疗效。
结果
共纳入67例患者：研究组33例，对照组34例。研究组31例可评估病例中，1例完全缓解（CR），9例部分缓解（PR），11例病情稳定（SD），10例病情进展（PD）；总缓解率为22.22%。对照组有1例CR，5例PR，19例SD，9例PD；总缓解率为15.15%。两组间差异无统计学意义（P=0.662）。中位随访时间为16.5个月（8-28个月）。研究组中位无进展生存期为6.2个月（2-12个月），1年生存率为68.51%，2年生存率为40.12%；对照组中位无进展生存期为7.1个月（2.3-11个月），1年生存率为65.23%，2年生存率为39.71%。两组间差异无统计学意义（分别为P=0.102、0.098、0.089）。常见不良事件为骨髓抑制、一过性转氨酶升高和脱发。研究组1例患者输液后发生严重过敏反应，对照组1例患者出现全身水肿。
结论
益优他赛和艾素对晚期乳腺癌患者的疗效和毒性相似。
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