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学科主题: 临床医学
题名:
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
作者: Huang, Liang1,2; Chen, Sheng1,2; Yang, Wentao2,3; Xu, Binghe4,5,6; Huang, Tao7; Yang, Hongjian8; Zheng, Hong9,10; Wang, Yongsheng11; Song, Erwei12; Zhang, Jin13; Cui, Shude14; Pang, Da15; Tang, Lili16; Lei, Yutao17; Geng, Cuizhi18; Shao, Zhiming1,2
关键词: neoadjuvant chemotherapy ; trastuzumab ; pathological complete response ; clinical trial ; carboplatin ; anthracycline
刊名: ONCOTARGET
发表日期: 2015-07-30
卷: 6, 期:21, 页:18683-18692
收录类别: SCI
文章类型: Article
WOS标题词: Science & Technology
类目[WOS]: Oncology ; Cell Biology
研究领域[WOS]: Oncology ; Cell Biology
关键词[WOS]: PATHOLOGICAL COMPLETE RESPONSE ; PIK3CA MUTATIONS ; ADJUVANT TRASTUZUMAB ; CARDIAC SAFETY ; CHEMOTHERAPY ; DOXORUBICIN ; RESISTANCE ; POLYMORPHISMS ; WOMEN ; ACTIVATION
英文摘要:

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.

语种: 英语
项目资助者: Shanghai Roche Pharmaceuticals Limited ; China Breast Cancer Clinical Study Group
WOS记录号: WOS:000359015900039
Citation statistics:
内容类型: 期刊论文
URI标识: http://ir.bjmu.edu.cn/handle/400002259/64887
Appears in Collections:北京大学第三临床医学院_期刊论文

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作者单位: 1.Fudan Univ, Inst Canc, Dept Breast Surg, Shanghai Canc Ctr, Shanghai 200433, Peoples R China
2.Ctr Canc, Inst Canc, Dept Pathol, Shanghai, Peoples R China
3.Fudan Univ, Shanghai Med Coll, Dept Oncol, Shanghai 200433, Peoples R China
4.Chinese Acad Med Sci, Inst Canc, Dept Med Oncol, Beijing 100730, Peoples R China
5.Chinese Acad Med Sci, Canc Hosp, Beijing 100730, Peoples R China
6.Peking Union Med Coll, Beijing 100021, Peoples R China
7.Huazhong Univ Sci & Technol, Tongji Med Coll, Union Hosp, Dept Breast & Thyroid Surg, Wuhan 430074, Peoples R China
8.Zhejiang Canc Hosp, Dept Breast Tumor Surg, Hangzhou, Zhejiang, Peoples R China
9.Sichuan Univ, Ctr Canc, Dept Head & Neck & Mammary Oncol, Chengdu 610064, Peoples R China
10.Sichuan Univ, West China Hosp, Lab Mol Diag Canc, State Key Lab Biotherapy, Chengdu 610064, Peoples R China
11.Shandong Canc Hosp & Inst, Breast Canc Ctr, Jinan, Peoples R China
12.Sun Yat Sen Univ, Sun Yat Sen Mem Hosp, Breast Tumor Ctr, Guangzhou 510275, Guangdong, Peoples R China
13.Tianjin Med Univ, Canc Inst & Hosp, Dept Breast Canc 3, Tianjin, Peoples R China
14.Henan Canc Hosp, Henan Breast Canc Ctr, Zhengzhou, Peoples R China
15.Harbin Med Univ, Affiliated Hosp 3, Dept Breast Surg, Harbin, Peoples R China
16.Cent S Univ, Xiangya Hosp, Dept Breast Surg, Changsha, Hunan, Peoples R China
17.Peking Univ, Hosp 3, Dept Breast Surg, Beijing 100871, Peoples R China
18.Hebei Med Univ, Hosp 4, Dept Breast Canc Ctr, Shijiazhuang, Peoples R China

Recommended Citation:
Huang, Liang,Chen, Sheng,Yang, Wentao,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.
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