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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。
BACKGROUND & OBJECTIVE: Two domestic docetaxel chemical structures are identical. Preclinical studies have shown that they have the same pharmacological effects and toxicity. The docetaxel used in the trial was approved by SDA as a class IV new drug for clinical research. This experiment was designed to evaluate the efficacy and tolerability of two domestically produced docetaxel in the treatment of advanced breast cancer. METHODS: A multicenter, randomized controlled trial was conducted in which patients were given docetaxel 75 mg/m2 domestically for 1 h after dexamethasone pretreatment. Each week was a course of treatment and at least 2 courses of chemotherapy were given. Efficacy was evaluated after treatment. Results: A total of 67 patients were enrolled in the study, 33 in the experimental group and 34 in the control group. The experimental group can evaluate 31 cases of curative effect, including complete remission (CR) in 1 case, partial remission (PR) in 9 cases, stable disease (SD) in 11 cases, and progressive disease (PD) in 10 cases. The total effective rate after confirmation is 22.2%. The control group can evaluate 34 cases of curative effect, including 1 case of CR, 5 cases of PR, 19 cases of SD, and 9 cases of PD. The total effective rate after confirmation is 15.15%. There was no significant difference between the two groups (P=0.662). The follow-up time was 8 to 28 months in both groups with a median follow-up of 16.5 months. The progression-free survival (FPS) time of the treatment group was 2 to 12 months, the median FPS time was 6.2 months, the 1-year survival rate was 68.5%, and the 2-year survival rate was 40.1%. The FPS time in the control group was 2.3 to 11 months, the median FPS time was 7.1 months, the 1-year survival rate was 65.2%, and the 2-year survival rate was 39.7%. There was no significant difference in FPS and 1-year and 2-year survival rates between the two groups (P values were 0.102, 0.096, and 0.089, respectively). The main adverse reactions were myelosuppression, transient transaminase elevation, and hair loss. Severe allergic reactions occurred in 1 patient in the experimental group and 1 patient in the control group developed systemic edema. Conclusion: The efficacy and adverse reactions of docetaxel used in the trials are similar to those of similar products that have been marketed in China.