Clinical Research Papers:
Outcomes of re-treatment with first-line trastuzumab plus a taxane in HER2 positive metastatic breast cancer patients after (neo)adjuvant trastuzumab: A prospective multicenter study
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Binghe Xu1, Xichun Hu2, Hong Zheng3, Xiaojia Wang4, Qingyuan Zhang5, Shude Cui6, Donggeng Liu7, Ning Liao8, Rongcheng Luo9, Qiang Sun10 and Shiying Yu11
1 Department of Medical Oncology, Cancer Hospital, Chinese Academy of Medical Sciences, Peking Union Medical College, Panjiayuan, Chaoyang District, Beijing, China
2 Department of Medical Oncology, Fudan University Shanghai Cancer Center, Department of Oncology, Shanghai Medical College, Fudan University, Shanghai, China
3 Laboratory of Molecular Diagnosis of Cancer, State Key Laboratory of the Biotherapy and Cancer Center, West China Hospital , Sichuan University, Chengdu, China
4 Department of Medical Oncology, the Key Laboratory of Integrated Chinese and Western Medical Oncology in Zhejiang Province, Zhejiang Cancer Hospital, Hangzhou, China
5 Department of Medical Oncology, Harbin Medical University Cancer Hospital, Harbin, China
6 Breast Disease Center, Henan Cancer Hospital & Affiliated Cancer Hospital, Zhengzhou University, Zhengzhou, China
7 Department of Medical Oncology, State Key Laboratory of Oncology in South China, Sun Yat-sen University Cancer Center, Guangzhou, China
8 Department of Breast Cancer, Cancer Center, Guangdong General Hospital, Guangzhou, China
9 Cancer Center, Southern Medical University, Guangzhou, China
10 Department of Breast Surgery, Peking Union Medical College Hospital, Beijing, China
11 Cancer Center, Tongji Hospital of Tongji Medical College, Hua Zhong University of Science and Technology, Wuhan, China
Binghe Xu, email:
Keywords: trastuzumab; human epidermal growth factor receptor 2 (HER2); metastatic breast cancer; (neo)adjuvant trastuzumab; re-treatment
Received: February 03, 2016 Accepted: April 28, 2016 Published: May 27, 2016
Trastuzumab is the backbone of HER2-positive early breast cancer (eBC) and metastatic breast cancer (mBC) treatment, but limited data exist as to re-treatment in relapsed patients. In this prospective, single arm, multicenter trial, we assessed efficacy and safety of trastuzumab and taxane combination in Chinese patients with HER2-positive mBC relapsed after prior (neo)adjuvant trastuzumab. Patients with previous (neo)adjuvant trastuzumab treatment for≥9 weeks and a relapse-free interval ≥6 months were assigned to trastuzumab treatment with paclitaxel or docetaxel. The primary endpoint was progression free survival (PFS). Secondary endpoints included overall response rate (ORR), clinical benefit rate (CBR), duration of response (DOR), time to progression (TTP), overall survival (OS) and safety profile. Thirty-two patients were enrolled and treated for a median duration of 33.5 weeks. The median PFS was 9.9 months (95% CI, 6.28 - 13.63 months). The ORR was 81.3% (95% CI, 63.6% - 92.8%) and CBR (CR+PR+SD≥6months) was 81.3% (95% CI, 63.6% - 92.8%). The median DOR was 9.8 months (95% CI, 5.82 - 11.60 months) and median TTP was 9.9 months (95% CI, 6.28-13.63 months). OS median follow-up time was 20.1 months and 25% OS time was 25.5 months. The safety profile was acceptable with common adverse events including leukopenia (59.4%), neutropenia (56.3%), hypoaesthesia (34.4%) and granulocytopenia (31.3%). In conclusion, re-treatment with trastuzumab plus a taxane as first-line therapy is an effective regimen for patients with HER2-positive mBC relapsed after (neo)adjuvant trastuzumab. The safety profile was good and the adverse reactions were tolerable and manageable.
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