【摘要】 背景与目的:常规新辅助化疗方案在治疗Luminal A型乳腺癌患者中达病理完全缓解(pathologic complete remission,pCR)率小于10%,寻求新型的新辅助化疗方案以提高pCR率从而进一步改善患者的预后具有重要的临床意义。我们对卡培他滨联合多西他赛(XT方案)加或不加戈舍瑞林去势在中国人群绝经前Luminal A型乳腺癌新辅助化疗的疗效及安全性方面进行了初步评价。方法:纳入研究的36例患者被随机分配至XT组或XT+去势组。两组患者术前均接受4周期XT方案新辅助化疗,XT+去势组同时接受新辅助戈舍瑞林去势治疗。主要终点为pCR率,次要终点为总体反应(overall response,OR)率。并按CTCAE v3.0对不良反应事件进行分级。采用四格表检验比较组间的pCR率与OR率的差异。结果:总共纳入36例符合入组标准的患者,按1:1随机至XT组与XT+去势组,两组患者平均年龄分别为40.6岁(27～48岁)与42.8岁(27～48岁)。所有患者均按计划完成术前4个周期新辅助治疗。XT组pCR率为16.7%,OR率为94.4%。XT+去势组pCR率为16.7%,OR率为100%。两组的pCR率与OR率均无显著差异。两组患者在新辅助化疗过程期间均未发现需要调整剂量的严重不良反应事件。结论:新辅助XT±戈舍瑞林去势在中国人群绝经前Luminal A型乳腺癌中有较高的pCR率及OR率,同时具有较高的安全性。更多还原

【Abstract】 Background and purpose:Conventional neoadjuvant chemotherapy regimens have less than 10% pCR rate in Luminal A subtype breast cancer,so the pursuit of novel regimens with higher pCR rate is very important.In this study,we preliminary investigated the efficacy and safety of neoadjuvant Capecitabine combined with Docetaxel with or without Goserelin ablation in premenopausal Luminal A type breast cancer patients.Methods:Thirty-six patients were randomized to either XT group or XT+Goserelin group.Both groups underwent 4 cycles of neoadjuvant XT chemotherapy or XT+Goserelin ablation at the same time.The primary end point was pathologic complete remission(pCR) rate and the secondary end point was overall response(OR).Safety assessment was performed according to CTCAE v3.0.Results:Thirty-six eligible patients were enrolled and randomized to either XT group or XT+Goserelin group according to 1:1 ratio.The average age was 40.6 years(27 to 48 years) and 42.8 years(27 to 48 years),respectively.All patients completed 4 cycles of preoperative chemotherapy.In XT group,pCR rate was 16.7% and OR rate was 94.4%,respectively.In XT+ Goserelin group,pCR rate was 16.7% and OR rate was 100%,respectively.There were no significant statistical differences in pCR rate or OR rate between these two groups.Conclusion:Neoadjuvant XT±Goserelin ablation in Chinese premenopausal Luminal A type breast cancer patients has high pCR rate and OR rate with good tolerability and safety.更多还原