机构：[1]Department of Breast and Thyroid Surgery, Southwest Hospital, Army Medical University, Chongqing, China[2]The Eighth Medical Center of Chinese PLA General Hospital, Beijing, China[3]Department of Breast Surgery, Chongqing University Three Gorges Hospital, Chongqing, China[4]Department of Thyroid and Breast Surgery, Zigong First People’s Hospital, Zigong, Sichuan, China[5]Department of Breast surgery, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan, China[6]Department of General Surgery, Xiangyang Central Hospital, Xiangyang, Hubei, China[7]Department of Breast Surgery, The First Hospital of Hunan University of Chinese Medicine, Changsha, Hunan, China[8]Department of Breast Surgery, Guangxi Medical University Cancer Hospital, Nanning, Guangxi, China[9]Department of Breast Surgery, The Third Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan, China[10]Department of Breast and Thyroid Surgery, The First People’s Hospital of Yunnan Province, Kunming, Yunnan, China外科片乳腺甲状腺外科云南省第一人民医院[11]Department of Breast and Thyroid Surgery, The Central Hospital of Wuhan, Wuhan, Hubei, China[12]Department of Breast and Thyroid Surgery, Hubei General Hospital, Wuhan, Hubei, China[13]Department of Breast and Thyroid Surgery, Huaihua First People’s Hospital, Huaihua, Hunan, China[14]Department of Breast and Thyroid Surgery, The Third Xiangya Hospital of Central South University, Changsha, Hunan, China[15]Department of Breast and Thyroid Surgery, Zhongnan Hospital of Wuhan University, Wuhan, Hubei, China[16]Department of Thyroid and Breast Surgery, Huaihe Hospital of Henan University, Kaifeng, Henan, China[17]Department of Breast and Thyroid Surgery, Xuchang Central Hospital, Xuchang, Henan, China
The objective of this multicenter, single-arm trial (ChiCTR1900022293) was to explore the efficacy and safety of neoadjuvant therapy with epirubicin, cyclophosphamide, and pyrotinib followed by docetaxel, trastuzumab, and pyrotinib (ECPy-THPy) in the treatment of patients with stage II-III HER2-positive breast cancer. The present study enrolled patients with stage II-III HER2-positive breast cancer. Epirubicin and cyclophosphamide were administrated for four 21-day cycles, followed by four cycles of docetaxel and trastuzumab. Pyrotinib was taken orally once per day throughout the treatment period. The primary endpoint was total pathological complete response (tpCR, ypT0/is ypN0) rate in the modified intention-to-treat (mITT) population. In total, 175 patients were included. The tpCR rate was 68.6% (95% CI, 60.7-75.8%), while the objective response rate was 89.1%. In the post-hoc subgroup analysis, no association between clinical characteristics and the tpCR rate was observed. The most common grade >= 3 adverse events were diarrhea (54.3%), followed by white blood cell count decreased (5.1%), and neutrophil count decreased (4.6%). In conclusion, the neoadjuvant regimen with ECPy-THPy showed promising pathological response and clinical benefits with an acceptable safety profile in patients with stage II-III HER2-positive breast cancer. In this multicenter, single-arm trial, we investigated the efficacy and safety of the ECPy-THPy regimen (epirubicin, cyclophosphamide, and pyrotinib followed by docetaxel, trastuzumab, and pyrotinib) as neoadjuvant therapy for patients with stage II-III HER2-positive breast cancer. Our results revealed that tpCR was achieved in 107 (68.6%) out of 156 patients, which was in line with our previous pilot study and numerically higher than the tpCR rate in previous phase III KRISTINE trial and the phase III POENY trial.image
基金：
Chongqing Science and Health
Committee, Grant/Award Number:
2023GDRC011; Chaoyang Cancer
Research Foundation, Grant/Award
Number: Y-Young2022-0205; Shanghai
Cancer Prevention and Anti-cancer
Development Foundation, Grant/Award
Number: CYBER-2022-004; Health
Industry Research Project, Grant/Award
Number: 201302016; Chongqing
Technology Innovation and Application
Development Key Projects, Grant/Award
Number: CSTB2022TIAD-KPX0168
第一作者机构：[1]Department of Breast and Thyroid Surgery, Southwest Hospital, Army Medical University, Chongqing, China[2]The Eighth Medical Center of Chinese PLA General Hospital, Beijing, China
通讯作者：
通讯机构：[1]Department of Breast and Thyroid Surgery, Southwest Hospital, Army Medical University, Chongqing, China[*1]Department of Breast and Thyroid Surgery, Southwest Hospital, Army Medical University,No. 30 Gaotanyan Street, Shapingba District, Chongqing 400038, China.
推荐引用方式(GB/T 7714)：
Qiyun Shi,Xiaowei Qi,Peng Tang,et al.A multicenter single-arm trial of neoadjuvant pyrotinib and trastuzumab plus chemotherapy for HER2-positive breast cancer[J].MEDCOMM.2023,4(6):doi:10.1002/mco2.435.
APA：
Qiyun Shi,Xiaowei Qi,Peng Tang,Linjun Fan,Li Chen...&Jun Jiang.(2023).A multicenter single-arm trial of neoadjuvant pyrotinib and trastuzumab plus chemotherapy for HER2-positive breast cancer.MEDCOMM,4,(6)
MLA：
Qiyun Shi,et al."A multicenter single-arm trial of neoadjuvant pyrotinib and trastuzumab plus chemotherapy for HER2-positive breast cancer".MEDCOMM 4..6(2023)
