2024年改变早期乳腺癌临床实践的重要研究成果及进展

黎星; 彭子琪; 于鑫淼; 金锋

doi:10.19401/j.cnki.1007-3639.2025.02.004

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2024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

- 2024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 2024
- 中国癌症杂志 2025年35卷第2期页码：176-185
- 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：
  
  [ "黎星（ORCID：0009-0004-3710-7351），博士研究生。" ]
  [ "金锋，中国医科大学附属第一医院乳腺外科二级教授、主任医师、博士研究生导师、博士后合作导师，是国务院特殊津贴获得者，获国之名医、辽宁名医、辽宁省学术头雁等荣誉称号。担任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名誉副组长，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常务委员，中华医学会外科学分会乳腺外科学组委员，北京乳腺病防治学会第四届理事会副理事长，中国人体健康科技促进会乳腺疾病专业委员会副主任委员，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等职务。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；以第一作者/通信作者在Cell Reports、Cell Death Differ、Oncogene等期刊上发表论文180余篇。获辽宁省科技进步一等奖1项、二等奖5项。执笔国家级专家共识指南3部，参编国家级指南30余部。" ]
- 基金信息：
- DOI：10.19401/j.cnki.1007-3639.2025.02.004
  中图分类号： R737.9
- 收稿：2024-12-31，
  
  修回：2025-02-06，
  
  纸质出版：2025-02-28
- 稿件说明：
移动端阅览
黎星, 彭子琪, 于鑫淼, 等. 2024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, 2025,35(2):176-185.

Xing LI, Ziqi PENG, Xinmiao YU, et al. Important research progress in clinical practice for early breast cancer in 2024[J]. China Oncology, 2025, 35(2): 176-185.
黎星, 彭子琪, 于鑫淼, 等. 2024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, 2025,35(2):176-185. DOI： 10.19401/j.cnki.1007-3639.2025.02.004.

Xing LI, Ziqi PENG, Xinmiao YU, et al. Important research progress in clinical practice for early breast cancer in 2024[J]. China Oncology, 2025, 35(2): 176-185. DOI： 10.19401/j.cnki.1007-3639.2025.02.004.

摘要

随着肿瘤筛查的普及和人们健康意识的提高，早期乳腺癌的诊断率明显提高。临床研究作为指南及共识的证据基础，可为乳腺癌的治疗提供更加优化的治疗方案。本文根据2023—2024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，包括新辅助治疗及辅助治疗的优化、辅助内分泌治疗的升阶梯、局部治疗的优化，以及患者生活质量等。在新辅助治疗和辅助治疗的优化方面，KEYNOTE-522研究确立了帕博利珠单抗联合化疗在早期高危三阴性乳腺癌（triple-negative breast cancer，TNBC）中的治疗地位。FDChina研究则证实了曲妥珠单抗联合帕妥珠单抗（H+P）的皮下注射制剂在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中的非劣效性，为患者提供了更便利的给药方式。KATHERINE研究明确了恩美曲妥珠单抗（trastuzumab emtansine，T-DM1）在新辅助治疗后未达到病理学完全缓解（pathologic complete response

pCR）的HER2阳性乳腺癌患者中的辅助治疗作用。在辅助内分泌治疗的升阶梯方面，MonarchE和NATALEE研究分别证实了阿贝西利和瑞波西利联合内分泌治疗在高风险激素受体（hormone receptor，HR）阳性HER2阴性早期乳腺癌患者中的疗效，推动了细胞周期蛋白依赖性激酶4/6（cyclin dependent kinase，CDK4/6）抑制剂在早期乳腺癌治疗中的应用。在局部治疗优化方面，ACOSOG Z11102研究支持了多中心病灶乳腺癌行保乳手术的可行性，SENOMAC研究为前哨淋巴结（sentinel lymph node，SLN）低负荷乳腺癌患者豁免腋窝淋巴结清扫（axillary lymph node dissection，ALND）提供了证据，SOUND研究支持T1且cN0期的乳腺癌患者可免除前哨淋巴结活检（sentinel lymph node biopsy，SLNB），ICARO研究提示新辅助化疗后SLNB或靶向腋窝清扫（targeted axillary dissection，TAD）发现孤立肿瘤细胞（isolated tumor cell，ITC）豁免ALND具有可行性。NSABP B-51/RTOG 1304研究为新辅助治疗后ypN0乳腺癌豁免区域淋巴结照射（regional lymph node irradiation，RNI）和腋窝局部治疗的降阶提供了可行性依据。在生活质量和化学预防方面，POSITIVE研究为有生育需求的乳腺癌患者提出了暂停内分泌治疗的方案，TAM-01和IBIS-Ⅱ研究则为高风险乳腺癌患者的化学预防提供了有力的循证医学证据。这些重要的临床研究对早期乳腺癌的临床实践产生了深远影响，不仅优化了相关治疗方案，还关注了乳腺癌患者的生活质量和疾病预防。本文将围绕国内外乳腺癌诊疗指南与共识的更新展开，针对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 diagnosis rate of early breast cancer has significantly increased with the proliferation of tumor screening and heightened health awareness. Clinical research

as the evidence base for guidelines and consensus

provides optimized treatment plans for breast cancer. This article summarized and classified several pivotal clinical studies that changed the clinical practice of early breast cancer

according to updates in domestic and international guidelines and consensus from 2023 to 2024. These included the optimization of neoadjuvant and adjuvant therapies

the escalation of adjuvant endocrine therapy

the optimization of local treatment

and attention to quality of life

etc. In the optimization of neoadjuvant and adjuvant therapies

the KEYNOTE-522 study established the therapeutic role of pembrolizumab combined with chemotherapy in early high-risk triple-negative breast cancer (TNBC). The FDChina study confirmed the non-inferiority of the subcutaneous formulation of trastuzumab combined with pertuzumab (H+P) in neoadjuvant treatment of human epidermal growth factor receptor 2 (HER2)-positive breast cancer

offering a more convenient administration method. The KATHERINE study clarified the adjuvant role of trastuzumab emtansine (T-DM1) in HER2-positive breast cancer patients who did not achieve a pathologic complete response (pCR) after neoadjuvant therapy. In the escalation of adjuvant endocrine therapy

the MonarchE and NATALEE studies confirmed the efficacy of abemaciclib and ribociclib combined with endocrine therapy in high-risk hormone receptor (HR)-positive HER2-negative early breast cancer patients

promoting the application of cyclin-dependent kinase (CDK) 4/6 inhibitors in early breast cancer treatment. In the optimization of local treatment

the ACOSOG Z11102 study supported the feasibility of breast-conserving surgery for multicentric breast cancer

the SENOMAC study provided evidence for exempting sentinel lymph node (SLN) low-burden breast cancer patients from axillary lymph node dissection (ALND)

the SOUND study supported the exemption of sentinel lymph node biopsy (SLNB) for T1 and cN0 breast cancer patients

and the ICARO study suggested the feasibility of exempting ALND for patients with isolated tumor cells (ITCs) found after neoadjuvant chemotherapy with SLNB or targeted axillary dissection (TAD). The NSABP B-51/RTOG 1304 study provided a basis for the de-escalation of regional lymph node irradiation (RNI) and local treatment in ypN0 breast cancer after neoadjuvant therapy. In terms of quality of life and chemoprevention

the POSITIVE study proposed a protocol for pausing endocrine therapy for breast cancer patients with fertility needs

and the TAM-01 and IBIS-Ⅱ studies provided strong evidence-based medical evidence for chemoprevention in high-risk breast cancer patients. These pivotal clinical studies have profoundly impacted the clinical practice of early-stage breast cancer

not only optimizing treatment plans but also focusing on the quality of life and disease prevention of breast cancer patients. This article discussed the impact of the aforementioned clinical studies on the clinical practice of early breast cancer

centered on updates to various domestic and international breast cancer diagnosis and treatment guidelines and consensus.

关键词

Keywords

references

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