PMID- 36535009 OWN - NLM STAT- MEDLINE DCOM- 20221228 LR - 20230813 IS - 2542-5641 (Electronic) IS - 0366-6999 (Print) IS - 0366-6999 (Linking) VI - 135 IP - 19 DP - 2022 Oct 5 TI - Neoadjuvant therapy for early human epidermal growth factor receptor 2 positive breast cancer in China: A multicenter real-world study (CSBrS-015). PG - 2311-2318 LID - 10.1097/CM9.0000000000002197 [doi] AB - BACKGROUND: Pertuzumab has been approved for application in China by the National Medical Products Administration, and both national and international guidelines make recommendations for the use of neoadjuvant treatment with trastuzumab or trastuzumab + pertuzumab plus chemotherapy regimens for patients with indications. The goal of this study was to investigate the short-term clinical efficacy of the neoadjuvant therapies trastuzumab and trastuzumab+pertuzumab for patients with early human epidermal growth factor receptor 2 (HER2)-positive breast cancer in China. METHODS: A real-world study was conducted using the clinicopathological data of patients with early HER2-positive breast cancer who were admitted to the member hospitals of the Chinese Society of Breast Surgery, Chinese Surgical Society of Chinese Medical Association between March 2019 and December 2020. This study analyzed the efficacy and tolerance of trastuzumab+chemotherapy and trastuzumab+pertuzumab+chemotherapy in patients with early HER2-positive breast cancer. The Response Evaluation Criteria in Solid Tumors 1.1 was adopted to evaluate clinical efficacy. The pathological efficacy was evaluated using the MillerPayne grade. The Common Terminology Criteria for Adverse Events (version 5.0) was adopted to evaluate adverse events (AEs). The propensity scores were subjected to propensity score matching using the R language (1:1 matching with a maximum allowable difference of 0.05 between the two groups). Efficacy was compared using the chi-square test, and correlation analysis was performed using linear regression. RESULTS: A total of 1032 patients with early HER2-positive breast cancer met the enrollment criteria and were included in this study. Among these patients, 472 received neoadjuvant trastuzumab+chemotherapy (the trastuzumab group), and 560 received neoadjuvant trastuzumab+pertuzumab+chemotherapy (the trastuzumab+pertuzumab group). The overall pathologic complete response (pCR) rate was 47.2% (487/1032), while the pCR rates of the trastuzumab and trastuzumab+pertuzumab groups were 34.5% (163/472) and 57.9% (324/560), respectively, and the difference was significant (P < 0.001). The incidence of grade 4 AEs was 24/321 (7.5%) in the trastuzumab+pertuzumab group, and there were no cases in which the left ventricular ejection fraction decreased by more than 10%. CONCLUSIONS: Patients in the trastuzumab+pertuzumab group had a higher pCR rate than those in the trastuzumab group, and the toxic side effects were tolerable. CI - Copyright (c) 2022 The Chinese Medical Association, produced by Wolters Kluwer, Inc. under the CC-BY-NC-ND license. FAU - Cheng, Yuanjia AU - Cheng Y AD - Breast Disease Center, Peking University First Hospital, Beijing 100034, China. FAU - Xiang, Hongyu AU - Xiang H FAU - Xin, Ling AU - Xin L FAU - Duan, Xuening AU - Duan X FAU - Liu, Yinhua AU - Liu Y CN - Chinese Society of Breast Surgery (CSBrS), Chinese Society of Surgery of Chinese Medical Association LA - eng PT - Journal Article PT - Multicenter Study DEP - 20221005 PL - China TA - Chin Med J (Engl) JT - Chinese medical journal JID - 7513795 RN - EC 2.7.10.1 (ERBB2 protein, human) RN - EC 2.7.10.1 (Receptor, ErbB-2) RN - P188ANX8CK (Trastuzumab) SB - IM MH - Female MH - Humans MH - Antineoplastic Combined Chemotherapy Protocols/therapeutic use MH - *Breast Neoplasms/drug therapy MH - *Neoadjuvant Therapy MH - Receptor, ErbB-2/genetics MH - Stroke Volume MH - Trastuzumab/therapeutic use MH - Ventricular Function, Left PMC - PMC9771321 COIS- None. EDAT- 2022/12/20 06:00 MHDA- 2022/12/22 06:00 PMCR- 2022/10/05 CRDT- 2022/12/19 17:22 PHST- 2022/12/19 17:22 [entrez] PHST- 2022/12/20 06:00 [pubmed] PHST- 2022/12/22 06:00 [medline] PHST- 2022/10/05 00:00 [pmc-release] AID - 00029330-202210050-00007 [pii] AID - CMJ-2021-3498 [pii] AID - 10.1097/CM9.0000000000002197 [doi] PST - epublish SO - Chin Med J (Engl). 2022 Oct 5;135(19):2311-2318. doi: 10.1097/CM9.0000000000002197.