一项关于 HER2 阳性乳腺癌双靶点新辅助疗法疗效的多中心研究,以及米勒-佩恩和 RCB 病理评估系统对新辅助疗法疗效评估的一致性分析(CSBrS-026)。

IF 7 2区 医学 Q1 ONCOLOGY Chinese Journal of Cancer Research Pub Date : 2023-12-30 DOI:10.21147/j.issn.1000-9604.2023.06.13
Hongyu Xiang, Ling Xin, Jingming Ye, Ling Xu, Hong Zhang, Shuang Zhang, Yinhua Liu
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引用次数: 0

摘要

研究目的本研究旨在探讨影响接受新辅助双靶点[曲妥珠单抗(H)+百妥珠单抗(P)]疗法联合化疗的早期乳腺癌患者病理完全应答率(pCR)的因素。此外,还分析了米勒-佩恩(Miller-Payne)系统和残留癌负担(RCB)系统在评估早期人表皮生长因子受体-2(HER2)+乳腺癌新辅助治疗疗效方面的一致性:收集2019年3月至2021年12月在中华医学会乳腺外科学分会(CSBrS)26家医院接受双靶点新辅助治疗的早期HER2+乳腺癌女性患者的临床病理资料。患者被分为四组:HER2免疫组化(IHC)3+/激素受体(HR)-组、IHC3+/HR+组、IHC2+原位杂交(ISH)+/HR-组和IHC2+ ISH+/HR+组。分析了患者的总体 pCR 率、各组的 pCR 率以及影响 pCR 率的因素。分析了米勒-佩恩系统和RCB系统在评估新辅助治疗疗效方面的一致性:从2019年3月1日至2021年12月31日,26家医院共治疗了77376名早期乳腺癌女性患者,其中18853名(24.4%)患者为HER2+。在排除不合格患者后,本研究纳入了 2395 名接受新辅助双靶点(H+P)疗法联合化疗的患者。总的 pCR 率为 53.0%,患者的 HR 状态和不同的 HER2+ 状态与 pCR 率显著相关(P0.05)。Miller-Payne和RCB系统评估的病理疗效一致性为88.0%(κ=0.717,P0.001):不同的HER2表达状态和HR表达状态与HER2+乳腺癌患者接受双靶点新辅助治疗后的pCR率相关。在评估HER2+乳腺癌新辅助治疗的病理学疗效方面,Miller-Payne和RCB系统具有较好的一致性。
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A multicenter study on efficacy of dual-target neoadjuvant therapy for HER2-positive breast cancer and a consistent analysis of efficacy evaluation of neoadjuvant therapy by Miller-Payne and RCB pathological evaluation systems (CSBrS-026).

Objective: The aim of this study was to investigate the factors influencing pathological complete response (pCR) rate in early breast cancer patients receiving neoadjuvant dual-target [trastuzumab (H) + pertuzumab (P)] therapy combined with chemotherapy. Additionally, the consistency of the Miller-Payne and residual cancer burden (RCB) systems in evaluating the efficacy of neoadjuvant therapy for early human epidermal growth factor receptor-2 (HER2)+ breast cancer was analyzed.

Methods: The clinicopathological data of female patients with early-stage HER2+ breast cancer who received dual-target neoadjuvant therapy at 26 hospitals of the Chinese Society of Breast Surgery (CSBrS) from March 2019 to December 2021 were collected. Patients were allocated to four groups: the HER2 immunohistochemistry (IHC) 3+/hormone receptor (HR)-, IHC3+/HR+, IHC2+ in situ hybridization (ISH)+/HR- and IHC2+ ISH+/HR+ groups. The overall pCR rate for patients, the pCR rate in each group and the factors affecting the pCR rate were analyzed. The consistency between the Miller-Payne and RCB systems in assessing the efficacy of neoadjuvant therapy was analyzed.

Results: From March 1, 2019, to December 31, 2021, 77,376 female patients with early-stage breast cancer were treated at 26 hospitals; 18,853 (24.4%) of these patients were HER2+. After exclusion of unqualified patients, 2,395 patients who received neoadjuvant dual-target (H+P) therapy combined with chemotherapy were included in this study. The overall pCR rate was 53.0%, and the patients' HR statuses and different HER2+ statuses were significantly correlated with the pCR rate (P<0.05). The consistency of the pathological efficacy assessed by the Miller-Payne and RCB systems was 88.0% (κ=0.717, P<0.001).

Conclusions: Different HER2 expression statuses and HR expression statuses are correlated with the pCR rate after dual-target neoadjuvant therapy in HER2+ breast cancer patients. There is a relatively good consistency between Miller-Payne and RCB systems in evaluating the pathologic efficacy of neoadjuvant therapy for HER2+ breast cancer.

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来源期刊
自引率
9.80%
发文量
1726
审稿时长
4.5 months
期刊介绍: Chinese Journal of Cancer Research (CJCR; Print ISSN: 1000-9604; Online ISSN:1993-0631) is published by AME Publishing Company in association with Chinese Anti-Cancer Association.It was launched in March 1995 as a quarterly publication and is now published bi-monthly since February 2013. CJCR is published bi-monthly in English, and is an international journal devoted to the life sciences and medical sciences. It publishes peer-reviewed original articles of basic investigations and clinical observations, reviews and brief communications providing a forum for the recent experimental and clinical advances in cancer research. This journal is indexed in Science Citation Index Expanded (SCIE), PubMed/PubMed Central (PMC), Scopus, SciSearch, Chemistry Abstracts (CA), the Excerpta Medica/EMBASE, Chinainfo, CNKI, CSCI, etc.
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