Efficacy and safety analysis of trastuzumab and paclitaxel based regimen plus carboplatin or epirubicin as neoadjuvant therapy for clinical stage II-III, HER2-positive breast cancer patients: a phase 2, open-label, multicenter, randomized trial.
机构：[1]Department of Breast Surgery, Fudan University Shanghai Cancer Center/Cancer Institute, Shanghai, China[2]Department of Oncology, Shanghai Medical College, Fudan University, Shanghai, China[3]Department of Pathology, Cancer Center/Cancer Institute, Shanghai, China[4]Department of Medical Oncology, Cancer Institute and Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China[5]Department of Breast and Thyroid Surgery, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China华中科技大学同济医学院附属协和医院[6]Department of Breast Tumor Surgery, Zhejiang Cancer Hospital, Hangzhou, Zhejiang, China浙江省肿瘤医院[7]Department of Head and Neck and Mammary Oncology, Cancer Center and State Key Laboratory of Biotherapy, Laboratory of Molecular Diagnosis of Cancer, West China Hospital, Sichuan University, Chengdu, China四川大学华西医院[8]Breast Cancer Center, Shandong Cancer Hospital and Institute, Jinan, China[9]Breast Tumor Center, Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University, Guangzhou, China中山大学附属第二医院[10]3rd Department of Breast Cancer, Tianjin Medical University Cancer Institute and Hospital, Tianjin, China[11]Henan Breast Cancer Center, Henan Cancer Hospital, Zhengzhou, China河南省肿瘤医院[12]Department of Breast Surgery, The Third Affiliated Hospital of Harbin Medical University, Harbin, China[13]Department of Breast Surgery, Xiangya Hospital, Central South University, Changsha, China[14]Department of Breast Surgery, Peking University Third Hospital, Beijing, China[15]Department of Breast Cancer Center, The Fourth Hospital of Hebei Medical University, Shijiazhuang, China临床科室外一科河北医科大学第四医院
This trial was designed to compare the efficacy and safety between epirubicin (E) and carboplatin (C) in combination with paclitaxel (P) and trastuzumab (H) in neoadjuvant setting. In 13 Chinese cancer centers, 100 patients with HER2-positive, locally advanced breast cancer were 1:1 randomized to receive medication as follows: trastuzumab and paclitaxel weekly combined with carboplatin weekly for PCH group, or epirubicin every 3 weeks for PEH group. Patients were given 4 to 6 cycles of chemotherapy. The primary endpoint was pathologic complete response (pCR) rate, which was no significant difference in PCH and PEH regimen (39.1% vs. 48.8%; p=0.365). However, PEH regimen achieved higher pCR in luminal-B (HER2-poitive) subgroup (55.0% vs. 24.0%; p = 0.033), but not in ERBB2+ subgroup (42.9% vs. 57.1%; p = 0.355). PEH regimen showed a favorable efficacy in PIK3CA mutated subgroup (69.2% vs.23.5%, p=0.012). No significant difference was observed in the subgroup analysis of TP53 mutation status, PTEN expression, FCGR2A SNP and FCGR3A SNP. Both regimens as neoadjuvant chemotherapy achieve similar efficacy and safety. PEH might improve pCR rate, especially in the luminal-B subtype and PIK3CA mutation subtype. PEH is feasible and less likely to increase the incidence of acute cardiac events compared to PCH.
基金：
This study was supported by Shanghai Roche Pharmaceuticals Limited and China Breast Cancer Clinical Study Group.
第一作者机构：[1]Department of Breast Surgery, Fudan University Shanghai Cancer Center/Cancer Institute, Shanghai, China[2]Department of Oncology, Shanghai Medical College, Fudan University, Shanghai, China
共同第一作者：
通讯作者：
通讯机构：[1]Department of Breast Surgery, Fudan University Shanghai Cancer Center/Cancer Institute, Shanghai, China[2]Department of Oncology, Shanghai Medical College, Fudan University, Shanghai, China
推荐引用方式(GB/T 7714)：
Liang Huang,Sheng Chen,Wentao Yang,et al.Efficacy and safety analysis of trastuzumab and paclitaxel based regimen plus carboplatin or epirubicin as neoadjuvant therapy for clinical stage II-III, HER2-positive breast cancer patients: a phase 2, open-label, multicenter, randomized trial.[J].ONCOTARGET.2015,6(21):18683-18692.doi:10.18632/oncotarget.4337.
APA：
Liang Huang,Sheng Chen,Wentao Yang,Binghe Xu,Tao Huang...&Zhiming Shao.(2015).Efficacy and safety analysis of trastuzumab and paclitaxel based regimen plus carboplatin or epirubicin as neoadjuvant therapy for clinical stage II-III, HER2-positive breast cancer patients: a phase 2, open-label, multicenter, randomized trial..ONCOTARGET,6,(21)
MLA：
Liang Huang,et al."Efficacy and safety analysis of trastuzumab and paclitaxel based regimen plus carboplatin or epirubicin as neoadjuvant therapy for clinical stage II-III, HER2-positive breast cancer patients: a phase 2, open-label, multicenter, randomized trial.".ONCOTARGET 6..21(2015):18683-18692
医学