紫杉醇脂质体与传统紫杉醇治疗乳腺癌和非小细胞肺癌的随机对照研究

Multi-center prospective randomized trial on paclitaxel liposome and traditional taxol in the treatment of breast cancer and non-small-cell lung cancer

目的 比较注射用紫杉醇脂质体与传统紫杉醇注射液 (紫烷素 )治疗乳腺癌和非小细胞肺癌疗效及不良反应的差别。方法 采用多中心、随机对照的方法进行研究 ,分为试验组和对照组。试验组给紫杉醇脂质体每次剂量 135mg/m2 ;对照组给紫烷素每次剂量 135mg/m2 。两组均联合阿霉素或顺铂治疗 ,每 3周重复 1次 ,为 1周期 ,共 2周期。结果 入组 12 9例患者中 ,有 12 8例可供评价不良反应 ,12 6例可供评价疗效。试验组 6 3例 ,完全缓解率 1.6 % ,部分缓解率 33.3% ,总有效率34.9% ;对照组 6 3例 ,完全缓解率 6 .3% ,部分缓解率 2 2 .2 % ,总有效率 2 8.6 %。两组疗效差异无显著性。在血液学毒性方面 ,两组发生率差异无显著性。在聚氧乙基代蓖麻油与无水乙醇的混合溶媒所产生的相关毒性方面 ,试验组发生率明显低于对照组 ,差异有显著性。结论 紫杉醇脂质体联合阿霉素或顺铂治疗晚期乳腺癌和晚期非小细胞肺癌效果良好 ,与紫烷素疗效相当 ,但过敏反应发生率明显低于紫烷素。

Objective To analyze the effects and side effects of paclitaxel liposome formula on breast cancer and non small cell lung cancer, compared with traditional taxol. Methods 129 patients from multicenters were prospectively randomzed into a test group, given paclitaxel liposome at 135 mg/m 2 each session, and a control group, given traditional taxol at 135 mg/m 2 each session. Both groups received these regimens combined with ADM or DDP for two cycles (3 weeks per cycle). Results Of 129 cases, 128 were eligible for the analysis of side effects and 126 for the overall response rate. The complete remission rate, partial remission rate and overall response rate were 1.6%, 33.3%, 34.9% in the test group and 6.3%, 22.2%, 28.6% in the control group. There was no significant difference between the two groups. Though there was no significant difference in hematological toxicity between the two groups, the toxicity from the mixed solvent of polyethoxylated castor oil and ethanol was significantly lower in the test group than that in the control group. Conclusion Paclitaxel liposome combined with ADM or DDP in the treatment of advanced breast cancer and non small cell lung cancer, being similarily effective as taxol, can significantly lower the incidence of serious hypersensitive reactions.