两种国产多西紫杉醇治疗晚期乳腺癌的随机对照临床研究

背景与目的:两种国产多西紫杉醇化学结构相同,临床前研究显示,它们具有相同的药理作用和毒性。试验用多西紫杉醇经SDA审查后批准作为Ⅳ类新药进行临床研究,本实验旨在评价两种国产多西紫杉醇治疗晚期乳腺癌的疗效和耐受性。方法:采用多中心随机对照研究,患者在接受地塞米松预处理后给予其中一种国产多西紫杉醇75mg/m2,1h静脉输注,每3周为一个疗程,至少接受2个疗程化疗。治疗后评价疗效。结果:共67例患者入组,试验组33例,对照组34例。试验组可评价疗效31例,其中完全缓解(completeremission,CR)1例,部分缓解(partialremission,PR)9例,疾病稳定(stabledisease,SD)11例,疾病进展(progressivedisease,PD)10例,经确认后的总有效率为22.2%。对照组可评价疗效34例,其中CR1例,PR5例,SD19例,PD9例,经确认后的总有效率为15.15%。两组疗效差异无显著性(P=0.662)。两组随访时间8～28个月,中位随访时间16.5个月。治疗组无进展生存(progression-freelysurvival,FPS)时间2～12个月,中位FPS时间为6.2个月;1年生存率68.5%,2年生存率40.1%。对照组FPS时间为2.3～11个月,中位FPS时间为7.1个月;1年生存率65.2%,2年生存率39.7%。两组FPS和1年、2年生存率均无显著性差异(P值分别为0.102,0.096,0.089)。主要不良反应是骨髓抑制、一过性转氨酶升高、脱发,试验组1例发生严重过敏反应,对照组1例发生全身水肿。结论:试验用多西紫杉醇与国内已上市的同类产品疗效、不良反应相当。

Randomized controlled trial of two kinds of home-produced docetaxel in China for advanced breast cancer

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/m2 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.