中国抗癌协会乳腺癌诊治指南与规范（2024年版）

doi:10.19401/j.cnki.1007-3639.2023.12.004

摘要/Abstract

摘要：

世界卫生组织（World Health Organization，WHO）国际癌症研究机构最新发布的数据显示，乳腺癌现已成为全球发病率最高的恶性肿瘤，严重危害广大女性的身心健康。中国抗癌协会乳腺癌专业委员会2007年首次制订《中国抗癌协会乳腺癌诊治指南与规范（2007版）》以来共更新8版，指南一直与时俱进，兼顾证据的权威性、知识的前沿性和在广大基层医疗机构的适用性。本次制订的《中国抗癌协会乳腺癌诊治指南与规范（2024年版）》在2021年版的基础上进行了相应的更新，纳入了乳腺癌诊断和分类的新理念、精准治疗的新工具、手术操作的新规范和综合治疗的新方案，旨在为乳腺癌防控及诊治领域的医务工作者提供指导和依据。

关键词: 乳腺癌, 诊断, 治疗, 指南

Abstract:

According to the latest data released by the International Agency for Research on Cancer of the World Health Organization (WHO), breast cancer has become the malignant tumor with the highest incidence rate around the world, seriously endangering the physical and mental health of women. Since the Society of Breast Cancer China Anti-Cancer Association firstly formulated “guidelines for breast cancer diagnosis and treatment by China Anti-Cancer Association (2007 edition)” in 2007, a total of 8 editions have been updated. The guidelines have been keeping pace with the times, taking into account the authority of evidence, the cutting-edge knowledge and the practicality in the vast grassroots. The “guidelines for breast cancer diagnosis and treatment by China Anti-Cancer Association (2024 edition)” has been updated on the basis of the 2021 Edition, incorporating new concepts of breast cancer diagnosis and classification, new methods for precision treatment, new specifications for surgical procedures and new plans for comprehensive treatment, aiming to provide guidance and basis for medical staff in the field of breast cancer prevention, control, diagnosis and treatment.

Key words: Breast cancer, Diagnosis, Treatment, Guideline

中图分类号:

R737.9

中国抗癌协会乳腺癌专业委员会, 中华医学会肿瘤学分会乳腺肿瘤学组. 中国抗癌协会乳腺癌诊治指南与规范（2024年版）[J]. 中国癌症杂志, 2023, 33(12): 1092-1187.

The Society of Breast Cancer China Anti-Cancer Association, Breast Oncology Group of the Oncology Branch of the Chinese Medical Association. Guidelines for breast cancer diagnosis and treatment by China Anti-cancer Association (2024 edition)[J]. China Oncology, 2023, 33(12): 1092-1187.

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适应证	禁忌证	豁免前哨淋巴结活检
早期浸润性乳腺癌	炎性乳腺癌	肿瘤完整切除并经石蜡包埋组织病理完全评估为DCIS
性别不限	临床ALN阳性（cN+）并经穿刺活检证实	≥70岁（伴随疾病），cT₁N₀M₀，HR阳性HER2阴性，辅助治疗不受腋窝状态影响^g
临床ALN阴性（cN₀） ^a	cN+新辅助治疗后仍为阳性	cT₁N₀且影像±穿刺活检评估腋淋巴结阴性、接受保乳手术及全乳照射^h
单灶或多中心性病变	cN_2-3新辅助治疗后临床阴性
DCIS全乳切除手术或保乳手术原发肿瘤切除影响随后SLNB成功率和准确性^b
cN0新辅助治疗后临床腋窝阴性
穿刺证实的cN₁新辅助治疗后临床腋窝阴性^c
妊娠患者^d
保乳联合SLNB术后同侧乳房复发/再发^e
腋窝淋巴结临床查体阴性但影像学1 ~ 2枚异常并穿刺活检证实转移（有争议的适应证）^f

危险度^a	判别要点
危险度^a	区域淋巴结转移	其他情况
低危	阴性	同时具备以下条件^b：pT≤2 cm；组织学Ⅰ级； LVI阴性； HER2阴性；年龄>35岁； ER/PR阳性^c； Ki-67增殖指数≤20%或实验室中位值
		ER阳性HER2阴性时, 不满足上述其他条件但多基因检测低危
中危	不符合低/高危定义的其他情况
高危	1 ~ 3枚阳性	ER/PR阳性且HER2阴性时, 满足以下条件之一^d：组织学III级； pT>5 cm；多基因检测高危
		ER阴性且PR阴性；或HER2阳性
	≥4枚阳性	任何情况

内在分子分型	基于IHC4的分子分型	备注
Luminal A型	Luminal A样 ER/PR阳性且PR高表达HER2阴性 Ki-67增殖指数低	ER、PR表达及Ki-67增殖指数的判定值建议采用报告阳性细胞的百分比。 Ki-67增殖指数的判定值在不同病理实验中心可能不同，可采用20%~30%作为判断Ki-67增殖指数高低的界值；同时，以20%作为PR表达高低的判定界值^*，可进一步区分Luminal A样和Luminal B样（HER2阴性）
Luminal B型	Luminal B样（HER2阴性） ER/PR阳性 HER2阴性且Ki-67增殖指数高或PR低表达	上述不满足Luminal A样条件的Luminal样肿瘤均可作为Luminal B样亚型
	Luminal B样（HER2阳性） ER/PR阳性 HER2阳性（蛋白过表达或基因扩增）任何状态的Ki-67增殖指数
ERBB2+型	HER2阳性 HER2阳性（蛋白过表达或基因扩增） ER阴性和PR阴性
Basal-like型	三阴性（非特殊型浸润性导管癌） ER阴性 PR阴性HER2阴性	TNBC和Basal-like型乳腺癌之间的吻合度约80%；但是TNBC也包含一些特殊类型乳腺癌如分泌性癌和腺样囊性癌等

复发风险度	激素受体阳性HER2阴性	HER2阳性	TNBC
低危	豁免化疗	不适用	不适用
中危且pN₀^b	·T₃及以上推荐化疗 ·T_1b-T₂：考虑多基因检测工具，目前指导辅助化疗的主要是21基因或70基因检测 - 21基因：年龄>50岁且RS>25 推荐化疗 - 21基因：年龄≤50岁日RS≥16 推荐化疗 - 70基因：临床高风险^a且70基因高风险推荐化疗 - 70基因：临床高风险^a且年龄≤50岁且70基因低风险考虑化疗 ·T_1b~T₂：未接受基因检测，具有如下特征之一的可考虑化疗：ER低表达组织学3级，LVI阳性，年龄≤35岁，高Ki-67增殖指数^c ·T_1a：原则上豁免化疗，除非同时伴有多个风险因素时个体化综合考虑	·T_1c及以上推荐 ·T_1a-b考虑^d ·T_1mic原则上不考虑，需个体化综合评估，如年龄、LVI、多灶与否等	·T_1c及以上推荐 ·T_1a-b考虑 ·T_1mic原则上不考虑，需个体化综合评估，如年龄、LVI、多灶与否等
中危且pN₁	·均推荐化疗 ·除非T_1-2且接受21基因或70基因检测时，如下结果才考虑豁免化疗： - 21基因： RS≤11的患者^e - 70基因：临床高风险^a，70基因低风险且年龄>50岁的患者	不适用	不适用
高危	均推荐化疗	均推荐化疗	均推荐化疗

风险度分层	初始治疗			后续强化治疗
风险度分层	推荐	考虑	可选	推荐	考虑	可选
中危（pT_1aN₀）	·缺乏高级别证据	·wP+H	·TC+H ·其他个体化方案或临床研究（如口服化疗+H，H+内分泌治疗）	·无	-	-
中危（pT_1bN₀）	·wP+H	·TC+H	·TCbH ·EC-T(wP)+H	·无	-	-
中危（pT_1c及以上，N₀）	·EC-T(wP)+H ·TCB+H	·TC+H	·EC-T(wP)+HP ·TCb+HP	·无	-	·奈拉替尼
高危（任何pN⁺）	·EC-T(wP)+HP ·TCb+HP	-	-	-	·奈拉替尼	·其他TKI