2023年改变早期乳腺癌临床实践的重要研究成果及进展

王昭卜; 黎星; 于鑫淼; 金锋

doi:10.19401/j.cnki.1007-3639.2024.02.003

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2023年改变早期乳腺癌临床实践的重要研究成果及进展

专家述评 | 更新时间：2025-12-31

- 2023年改变早期乳腺癌临床实践的重要研究成果及进展
- Important research progress in clinical practice for early breast cancer in 2023
- 中国癌症杂志 2024年34卷第2期页码：151-160
- 作者机构：
  
  中国医科大学附属第一医院乳腺外科，辽宁沈阳 110001
- 作者简介：
  
  [ "王昭卜（ORCID: 0009-0001-0555-2731），博士研究生在读。" ]
  [ "金锋，中国医科大学附属第一医院乳腺外科主任、二级教授、主任医师、博士研究生导师、博士后合作导师。国务院特殊津贴获得者、国之名医、辽宁名医、辽宁省学术头雁。金锋教授作为国内著名的乳腺外科专家，在国家及地区乳腺专业领域学术组织中担任重要职务，主要有中国抗癌协会乳腺癌专业委员会副主任委员，中华医学会肿瘤学分会乳腺肿瘤学组副组长，中国医师协会外科医师分会乳腺外科专家工作组副组长，中国临床肿瘤学会乳腺癌专家委员会（CSCO-BC）常委，中华医学会外科学分会乳腺外科学组委员，辽宁省医学会乳腺外科分会主任委员，辽宁省抗癌协会乳腺癌专委会主任委员，北京乳腺病防治学会外科专业委员会副主任委员等。承担国家科技部重点研发项目1项、国家自然科学基金4项、省部级课题10余项；在国内外期刊发表论文170余篇，其中以第一作者或通讯作者在SCI收录期刊上发表的论文累计影响因子410余分，代表杂志有Cell Reports、Cell Death & Differentiation、Oncogene、Genomics Proteomics Bioinformatics等。获辽宁省科技进步一等奖1项、二等奖5项。主笔国家级专家共识指南3部，参编国家级指南30余部。招收博士后10名、培养博士、硕士研究生80余人。" ]
- 基金信息：
- DOI：10.19401/j.cnki.1007-3639.2024.02.003
  中图分类号： R737.9
- 收稿：2024-01-22，
  
  修回：2024-02-16，
  
  纸质出版：2024-02-29
- 稿件说明：
移动端阅览
王昭卜, 黎星, 于鑫淼, 等. 2023年改变早期乳腺癌临床实践的重要研究成果及进展[J]. 中国癌症杂志, 2024,34(2):151-160.

Zhaobu WANG, Xing LI, Xinmiao YU, et al. Important research progress in clinical practice for early breast cancer in 2023[J]. China Oncology, 2024, 34(2): 151-160.
王昭卜, 黎星, 于鑫淼, 等. 2023年改变早期乳腺癌临床实践的重要研究成果及进展[J]. 中国癌症杂志, 2024,34(2):151-160. DOI： 10.19401/j.cnki.1007-3639.2024.02.003.

Zhaobu WANG, Xing LI, Xinmiao YU, et al. Important research progress in clinical practice for early breast cancer in 2023[J]. China Oncology, 2024, 34(2): 151-160. DOI： 10.19401/j.cnki.1007-3639.2024.02.003.

摘要

乳腺癌发病率逐年升高，随着肿瘤筛查的普及和人民健康意识的增强，早期乳腺癌的诊断率也明显提高。早期乳腺癌广义上指无远处器官转移的乳腺癌，是相较于晚期乳腺癌的概念。治愈是早期乳腺癌的治疗目标。临床实践的开展应依据循证医学证据，参考指南与共识，给予患者个体化的精准治疗。临床研究作为指南及共识的证据基础，为乳腺癌患者带来更加优化的治疗方案。本文根据2022—2023年国内外重要指南及共识更新，对改变早期乳腺癌临床实践的多项重要临床研究进行归纳和分类，这些研究以分子分型为基础，可分为乳腺癌新辅助治疗和辅助治疗的优化、辅助治疗的升阶梯和降阶梯、局部治疗的优化：人表皮生长因子受体-2（human epidermal growth factor receptor 2 ，HER2）阳性乳腺癌新辅助治疗和辅助优化治疗的相关研究包括国产原研小分子酪氨酸激酶抑制剂（tyrosine kinase inhibitors，TKI）吡咯替尼应用于新辅助治疗的PHEDRA研究；奈拉替尼辅助强化治疗的ExteNET研究；曲妥珠单抗和帕妥珠单抗皮下注射制剂（pertuzumab trastuzumab fixed dose combination subcutaneous injection，PH FDC SC）药代动力学、疗效及安全性的FDChina研究；三阴性乳腺癌（triple-negative breast cancer，TNBC）新辅助治疗和辅助优化治疗的相关研究主要为KEYNOTE-522研究。在辅助治疗的升阶梯方面：高危HER2阳性乳腺癌中曲妥珠单抗（trastuzumab，H）加入帕妥珠单抗（pertuzumab，P）疗效的APHINITY研究；阿贝西利及瑞波西利在早期高危激素受体阳性乳腺癌患者中应用的MonarchE和NATALEE研究；高危绝经前乳腺癌应用卵巢功能抑制剂（ovarian function suppression，OFS）及联合依西美坦或他莫昔芬的SOFT TEXT研究。辅助治疗的降阶梯相关研究为HER2阴性早期中高危乳腺癌6个周期多西他赛联合环磷酰胺辅助化疗的PLAN B研究。在乳腺癌局部治疗相关研究中，包括多中心病灶乳腺癌保乳可行性的ACOSOG Z11102研究，低危乳腺癌豁免腋窝手术的SOUND研究，老年低危乳腺癌患者保乳术后是否可豁免放疗的PRIME Ⅱ研究，对比保乳术后全乳放疗后不同加强放疗方案的IMPORT HIGH研究，超大分割放疗的FAST-Forward研究。这些研究为临床实践、诊疗指南和共识的制定提供了扎实的循证医学依据。本文将围绕国内外各项乳腺癌诊疗指南、共识的更新展开，重点就以上重要临床研究对早期乳腺癌临床实践的影响进行讨论。

Abstract

The incidence of breast cancer is rising annually. Along with the broader implementation of tumor screening and increased health awareness

there has been a significant uptick in the diagnosis of early-stage breast cancer. Early-stage breast cancer is generalized to breast cancer without distant metastasis

which is compared to the concept of late-stage breast cancer. The aim of treatment for early-stage breast cancer is to achieve a cure. Treatment is guided by evidence-based medicine

following guidelines and consensus to administer personalized and precise therapies to patients. Clinical research

as the foundational evidence for these guidelines and consensus

brings more optimized treatment for breast cancer patients. According to the updates of domestic and international guidelines and consensus between 2022 and 2023

this review summarized and classified the important clinical studies that have changed the clinical practice for early-stage breast cancer. These studies were based on molecular sub-types and categorized into optimization of neoadjuvant and adjuvant treatment of early breast cancer

escalating and de-escalating of adjuvant treatment

and the optimization of local treatment. The studies related to the optimization of neoadjuvant and adjuvant treatment of human epidermal growth factor receptor 2 (HER2)-positive breast cancer included the PHEDRA study which aimed at the application of pyrotinib

a small molecule tyrosine kinase inhibitor (TKI)

to neoadjuvant treatment

the ExteNET study which investigated adjuvant treatment of neratinib

and FDChina study which confirmed the efficacy and safety of pertuzumab and trastuzumab fixed dose combination subcutaneous injection (PH FDC SC). The primary study addressing the optimization of neoadjuvant and adjuvant therapy in triple-negative breast cancer (TNBC) was the KEYNOTE-522 study. In terms of escalating in adjuvant therapy

the APHINITY study evaluated the efficacy of pertuzumab added to trastuzumab in high-risk HER2-positive breast cancer. MonarchE and NATALEE focused on the efficacy of abemaciclib and ribociclib in patients with hormone receptor-positive breast cancer. The SOFT TEXT study focused on ovarian function suppression (OFS) combining exemestane or tamoxifen in high-risk premenopausal breast cancer. Descending related studies in adjuvant therapy included the PLAN B study confirming 6 cycles of docetaxel in combination with cyclophosphamide in HER2 negative early intermediate to high-risk breast cancer. Among the studies related to the local treatment of breast cancer

the ACOSOG Z11102 study explored the feasibility of breast conservation in multicenter focal breast cancer. The SOUND study explored the exemption from axillary surgery in people with low-risk breast cancer. The PRIME Ⅱ study explored the possibility of exemption from radiotherapy after breast conservation in elderly patients with low-risk breast cancer

and the IMPORT HIGH study compared different dose-escalated simultaneous integrated boost radiotherapy regimens after breast conservation surgery. The FAST-Forward study focused on hypofractionated breast radiotherapy. These studies provided robust evidence for the implementation of clinical practice and the formulation of diagnostic and treatment guidelines and consensus. In this review

we focused on the update of domestic and international breast cancer treatment guidelines

and the impact of these studies on the clinical practice for early-stage breast cancer.

关键词

Keywords

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