Clinical Research Papers:
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
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Abstract
Liang Huang1,2,*, Sheng Chen1,2,*, Wentao Yang2,3, Binghe Xu4, Tao Huang5, Hongjian Yang6, Hong Zheng7, Yongsheng Wang8, Erwei Song9, Jin Zhang10, Shude Cui11, Da Pang12, Lili Tang13, Yutao Lei14, Cuizhi Geng15 and Zhiming Shao1,2
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
6 Department of Breast Tumor Surgery, Zhejiang Cancer Hospital, Hangzhou, Zhejiang, China
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
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
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
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
* These authors have contributed equally to this work
Correspondence to:
Zhiming Shao, email:
Keywords: neoadjuvant chemotherapy, trastuzumab, pathological complete response, clinical trial, carboplatin, anthracycline
Received: March 23, 2015 Accepted: May 18, 2015 Published: June 02, 2015
Abstract
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.
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