拉帕替尼对比曲妥珠单抗在HER-2阳性乳腺癌新辅助治疗中的疗效荟萃分析

Efficacy of lapatinib versus trastuzumab in neoadjuvant therapy of HER-2 positive breast cancer： a meta-analysis

目的 比较拉帕替尼或拉帕替尼联合曲妥珠单抗与曲妥珠单抗在人表皮生长因子受体2（HER-2）阳性乳腺癌新辅助治疗中的有效性.方法 检索MEDLINE数据库、美国临床肿瘤学会（ASCO）、圣安东尼奥乳腺癌研讨会（SABCS）、欧洲临床肿瘤协会年会（ESMO）会议论文以及中国生物医学文献数据库中关于曲妥珠单抗或拉帕替尼用于乳腺癌新辅助治疗的文献,没有时间和语言限制.对符合人选标准的文献进行质量评价与荟萃分析.结果 共有5项临床研究纳入分析,包括1 794例患者,其中拉帕替尼联合新辅助化疗719例,曲妥珠单抗联合新辅助化疗714例,两药同时联合新辅助化疗361例.拉帕替尼组病理完全缓解（pCR）率为28.2％,低于曲妥珠单抗组的35.4％,差异有统计学意义（P=0.004）.拉帕替尼、曲妥珠单抗两药联合治疗组pCR率为53.2％,显著高于曲妥珠单抗组的38.1％ （P ＜0.001）.结论 拉帕替尼不能取代曲妥珠单抗作为HER-2阳性乳腺癌新辅助治疗的首选,同时联合曲妥珠单抗可取得优于曲妥珠单抗的pCR率,不考虑经济负担可作为HER-2阳性乳腺癌患者新辅助治疗的首选.

Objective To compare the efficacy of lapatinib or lapatinib plus trastuzumab versus trastuzumab in the neoadjuvant therapy of human epidermal growth factor receptor 2 （HER-2） positive breast cancer.Methods MEDLINE database,American Society of Clinical Oncology （ASCO）,San Antonio Breast Cancer Symposium （SABCS）,European Society for Medical Oncology （ESMO） proceedings and China Biomedical Database were searched for literatures of trastuzumab or lapatinib in neoadjuvant therapy for breast cancer.There was no limit of language or time.A meta-analysis was performed for retrieved literatures meeting the inclusion criteria.Results A total of 1 794 breast cancer patients from 5 clinical trials were included.And the regimens were lapatinib plus neoadjuvant chemotherapy （n =719）,trastuzumab plus neoadjuvant chemotherapy （n =714） and both drugs plus neoadjuvant chemotherapy （n =361）.The rate of pathological complete remission （pCR） was lower in lapatinib group than that in trastuzumab group （28.2％ vs 35.4％）.And the difference was statistically significant （P =0.004）.The pCR rate was significantly higher in lapatinib plus trastuzumab therapy group than that in trastuzumab group （53.2％ vs 38.1％,P ＜ 0.001）.Conclusions Lapatinib can not replace trastuzumab as a first-choice agent in neoadjuvant therapy of HER-2 positive breast cancer.Lapatinib plus trastuzumab achieves better pCR than trastuzumab so that it and may become a first-choice of neoadjuvant therapy for HER-2 positive breast cancer regardless of economic affordability for patients.