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中华乳腺病杂志(电子版) ›› 2026, Vol. 20 ›› Issue (05) : 265 -271. doi: 10.3877/cma.j.issn.1674-0807.2026.05.001

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早期乳腺癌腋窝降阶梯治疗的循证医学证据与临床决策
孔祥溢, 白裕涵, 王翔宇, 张文祥, 陈力, 伍娟, 王仲照, 方仪, 王靖†()   
  1. 100021 北京,国家癌症中心/国家肿瘤临床医学研究中心/中国医学科学院北京协和医学院肿瘤医院乳腺外科
  • 收稿日期:2026-04-16 出版日期:2026-10-01
  • 通信作者: 王靖
  • 基金资助:
    国家自然科学基金项目(82371842)

Evidence and clinical decision-making in axillary de-escalation for early breast cancer

Xiangyi Kong, Yuhan Bai, Xiangyu Wang, Wenxiang Zhang, Li Chen, Juan Wu, Zhongzhao Wang, Yi Fang, Jing Wang†()   

  1. Department of Breast Surgery, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100021, China
  • Received:2026-04-16 Published:2026-10-01
  • Corresponding author: Jing Wang
引用本文:

孔祥溢, 白裕涵, 王翔宇, 张文祥, 陈力, 伍娟, 王仲照, 方仪, 王靖. 早期乳腺癌腋窝降阶梯治疗的循证医学证据与临床决策[J/OL]. 中华乳腺病杂志(电子版), 2026, 20(05): 265-271.

Xiangyi Kong, Yuhan Bai, Xiangyu Wang, Wenxiang Zhang, Li Chen, Juan Wu, Zhongzhao Wang, Yi Fang, Jing Wang. Evidence and clinical decision-making in axillary de-escalation for early breast cancer[J/OL]. Chinese Journal of Breast Disease(Electronic Edition), 2026, 20(05): 265-271.

早期乳腺癌腋窝处理的目标近年发生了明显变化。以往,腋窝手术更多被看作局部控制手段;现在,临床更关心腋窝分期信息是否影响后续治疗决策。随着抗体药物偶联物、新型内分泌治疗和放射治疗技术的发展,部分患者减少腋窝手术后仍可能获得较好的区域控制和生活质量。本文梳理三类腋窝降阶梯证据:经严格筛选的临床腋窝阴性低危患者豁免前哨淋巴结活检;部分前哨淋巴结阳性患者豁免腋窝淋巴结清扫或以腋窝放射治疗替代清扫;初始腋窝淋巴结阳性、新辅助治疗后临床转阴患者的靶向腋窝切除再分期。腋窝降阶梯应以可靠影像、规范病理和多学科讨论为基础,结合HER-2阳性、三阴性乳腺癌等分子亚型,判断手术减量是否会改变系统治疗、区域放射治疗或随访安排。

The goals of axillary management in early breast cancer have changed substantially in recent years. Whereas axillary surgery was once viewed primarily as a means of local control, current practice asks whether axillary staging information changes subsequent treatment decisions. With advances in antibody-drug conjugates, novel endocrine therapies, and radiotherapy techniques, selected patients may achieve favorable regional control and quality of life despite less extensive axillary surgery. This review summarizes evidence for three approaches to axillary de-escalation. The first is omission of sentinel lymph node biopsy in carefully selected, low-risk patients with clinically node-negative disease. The second is omission of axillary lymph node dissection or its replacement with axillary radiotherapy in selected patients with positive sentinel nodes. The third is restaging with targeted axillary dissection in initially node-positive patients who become clinically node-negative after neoadjuvant therapy. Axillary de-escalation should be based on reliable imaging, standardized pathologic assessment, and multidisciplinary discussion. Molecular subtypes, including HER-2-positive and triple negative breast cancer, should inform whether less extensive surgery would alter systemic therapy, regional radiotherapy or follow-up.

表1 早期乳腺癌腋窝降阶梯关键研究比较
研究名称 研究设计 研究人群及总例数 干预/比较 关键结果 临床适用范围
AMAROS [4] 随机3期非劣效试验 SLN阳性的cT1~2期患者;1 425例 ART与ALND 10年腋窝复发率1.82%与0.93%(HR=1.71,95%CI:0.67~4.39);5年淋巴水肿率11.9%与24.5%(P<0.001) 复发事件少,非劣效检验效能不足;替代策略需保证规范ART
SENOMAC [5,8,18] 随机非劣效试验;2026年OS/BCSS更新为会议摘要 cN0、T1~3期、1~2枚SLN宏转移;2 766例入组,2 540例符合方案 豁免ALND与ALND 5年RFS 89.7%与88.7%(HR=0.89,95%CI:0.66~1.19;界值1.44,非劣效性P<0.001);5年OS 94.4%与93.4%(HR=0.84,95%CI:0.64~1.12;界值1.44);5年BCSS 97.8%与97.3%(HR=0.86,95%CI:0.55~1.34;界值1.86) 单纯SLNB组与ALND组接受RNI的比例分别为89.9%和88.4%;全乳切除、T3期或任一亚组未分别证实非劣效
SOUND [6] 随机非劣效试验 cT1期、肿瘤最大径≤2 cm、腋窝超声阴性;1 405例 豁免腋窝手术与SLNB 5年DDFS 98.0%与97.7%(HR=0.84,90%CI:0.45~1.54;非劣效性P=0.02);局部区域复发率1.6%与1.7% 限于严格影像筛选、低肿瘤负荷且后续治疗不依赖SLN信息者
INSEMA [7] 随机非劣效试验 接受保乳手术的cN0、T1~2期患者;符合方案4 858例 豁免腋窝手术与SLNB 5年iDFS 91.9%与91.7%(HR=0.91,95%CI:0.73~1.14;HR界值1.271);首次腋窝复发率1.0%与0.3% 支持选择性保乳人群;不得外推至全部T2期或全乳切除患者
AXSANA [9,21] 前瞻性多中心非随机队列;3年主要终点结果为会议摘要报告 初始cN+、NAT后ycN0;2 632例 首次较少侵入性分期与直接ALND 3年ARFS 98.8%与99.2%;较少侵入组90%CI下限98.2%,超过固定97%单组阈值 非随机、非组间非劣效比较;95%接受RNI,实际中位随访2.0年
BOOG 2013-08 [10] 随机3期非劣效试验 临床T1~2N0期、接受保乳治疗;符合方案1 574例 豁免SLNB与SLNB 5年区域复发率1.2%与0.5%;组间差值0.7个百分点(95%CI:−0.3~1.7),界值5个百分点 需正式全文和更长期随访验证
ACOSOG Z0011 [17] 随机非劣效试验 cT1~2N0期、保乳、1~2枚SLN阳性;891例随机,856例长期分析 单纯SLNB与ALND 10年OS 86.3%与83.6%(HR=0.85,单侧95%CI:0~1.16;界值1.3,非劣效性P=0.02);DFS 80.2%与78.2% 须接受全乳放射治疗和系统治疗;DFS差异无统计学意义不等于等效
Caudle TAD [19] 诊断准确性研究 初始淋巴结阳性、NAT后接受腋窝手术者 SLNB、加入夹标结节及实际TAD FNR分别为7/69(10.1%)、1/74(1.4%)和1/50(2.0%) 不同分析集;仅支持诊断准确性,不能替代长期肿瘤学结局
OPBC-07/microNAC [22] 国际多中心回顾性队列 NAT后ypN1mi;1 585例 豁免ALND与ALND 3年腋窝复发率2.3%与1.7%(P=0.92);79.9%接受RNI 存在选择混杂;TNBC亚组结果仅为探索性信号
I-SPY2 [23] 非随机观察性试验 NAT后ypN0或ypN+;1 515例 豁免ALND与ALND ypN0者5年估计腋窝复发率2.0%与0.8%(P=0.57);ypN+者5.2%与3.6%(P=0.81) ALND选择非随机;无显著性差异不等于等效、非劣效或普遍安全
表2 中国早期乳腺癌腋窝降阶梯临床实践要点
临床情境 证据支持的策略及必要条件 主要证据及类型 不宜外推的情形
初始手术、cN0严格低危患者讨论豁免SLNB 仅在绝经后且≥50岁、单灶浸润性导管癌、肿瘤最大径≤2 cm、Nottingham分级1~2级、HR阳性/HER-2阴性、拟接受辅助内分泌治疗、初始保乳且SLN信息预计不改变治疗时讨论;术前须完成高质量腋窝超声,可疑淋巴结须经FNA或CNB证实良性并与影像一致 SOUND、INSEMA随机试验[6-7];BOOG会议摘要[10];ASCO、CACA指南[11-12];影像组学诊断研究[16] 不外推至全部cN0患者;T2期、绝经前或<50岁、TNBC、HER-2阳性、ILC及全乳切除等非ASCO推荐人群;影像组学不能替代病理分期
初始手术、1~2枚SLN宏转移患者讨论豁免ALND 保乳并接受全乳放射治疗和系统治疗者,可依据随机试验证据讨论豁免完成ALND;全乳切除仅在计划PMRT/RNI且满足指南条件时个体化讨论;若额外分期会改变系统治疗或放射治疗靶区,应保留必要分期 ACOSOG Z0011随机试验[17];SENOMAC随机试验及会议摘要[5,8,18];AMAROS随机试验[4];ASCO、CACA指南[11-12] 不外推至缺乏规范放射治疗或系统治疗保障者;SENOMAC总体结果不能证明全部全乳切除、T3期或各生物学高危亚组分别非劣效
初始cN+、NAT后ycN0患者采用TAD等降阶梯再分期 按指南取出NAT前标记的阳性结节,或采用双示踪并获取足量SLN;标记技术须在本中心稳定实施且结果可核验;若再分期阳性或结果不足以支持后续治疗决策,应保留进一步腋窝处理 CACA指南[12];Caudle TAD诊断准确性研究[19];AXSANA非随机队列会议摘要[9];AXSANA标记技术分析[21];AXSANA超声诊断研究[24] 不外推至标记结节无法取出、再分期质量不能保证或仍有高危残余病灶者;AXSANA非随机且随访较短,超声和技术检出率不能替代长期肿瘤学结局
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