紫杉醇脂质体与紫杉醇联合表阿霉素在乳腺癌新辅助化疗中的对照研究

A controlled trial of neoadjuvant chemotherapy to patients with breast cancer treated with liposomal paclitaxel plus epirubicin and paclitaxel plus epirubicin

目的比较紫杉醇脂质体与普通紫杉醇联合表阿霉素两种方案在乳腺癌新辅助化疗中的临床疗效和安全性。方法本试验采用开放式、随机、对照的方法进行研究。56例需新辅助化疗的女性乳腺癌患者随机分为紫杉醇脂质体联合表阿霉素组(A组)和普通紫杉醇联合表阿霉素组(B组)。A组每周期予以紫杉醇脂质体175mg/m2,B组每周期予以紫杉醇175mg/m2,每周期两组表阿霉素均为75mg/m2。21天为1周期,每周期评价毒性反应,2周期化疗后评价疗效。结果入组病例中A组完成28例,B组完成27例。A组和B组的总有效率(CR+PR)分别为53.6%和48.1%(P>0.05)。两组毒副反应中皮疹、皮肤潮红发生率具有明显差异,以A组较低(P<0.05);其他如血液学毒性、呕吐、腹泻及发热等基本一致(P>0.05)。结论紫杉醇脂质体与普通紫杉醇联合表阿霉素方案在乳腺癌新辅助化疗中的疗效相当,但紫杉醇脂质体过敏反应发生率明显低于紫杉醇。

Objective To analyze the efficacy and safety of neoadjuvant chemotherapy to patients with breast cancer treated with liposomal paclitaxel plus epirubicin and paclitaxel plus epirubicin.Methods A open,randomized,controlled trial was performed in this study.A total of fifty-six female patients with breast cancer received neoadjuvant chemotherapy were randomly divided into group A and B.Patients in group A were treated with combination of liposomal paclitaxel（175mg/m^2,d1） and epirubicin（75mg/m^2,d1）;patients in group B were treated with paclitaxel（175mg/m^2,d1） and epirubicin（75mg/m^2,d1）.All patients received neoadjuvant chemotherapy every 3 weeks for two cycles.Side effects were investigated in each cycle,and efficacy was evaluated after two cycles.Results All patients in group A（28/28 cases） and group B（27/28 cases） completed the study and were evaluable for efficacy.The objective response rate（CR＋PR） was 53.6% in group A compared to 48.1% in group B,but there was no significant difference between the two groups（P〉0.05）.Significant differences were found between group A and group B in the incidences of adverse events included erythra and skin flushing（P〈0.05）.There was no significant difference between the two groups in other adverse events such as hematological toxicity,vomiting,diarrhea,fever,etc.（P〉0.05）.Conclusion The results demonstrated that both treatments of liposomal paclitaxel plus epirubicin and paclitaxel plus epirubicin had similar efficacy to patients with breast cancer receiving neoadjuvant chemotherapy.Liposomal paclitaxel could significantly lower the incidence of hypersensitive reactions compared to paclitaxel.