接受新辅助化疗的淋巴结阳性乳腺癌患者微创腋窝手术的疗效及肿瘤学安全性：一项网状Meta回归和试验序贯分析

The efficacy and oncological safety of minimally invasive axillary procedures in patients with node-positive breast cancer receiving neoadjuvant chemotherapy: A network meta-regression and trial sequential analysis.

作者信息

Lucocq James, Baig Hassan, McNeill Esther, Dixon J Michael

机构信息

Edinburgh Breast Unit, Western General Hospital, Edinburgh University of Edinburgh, United Kingdom.

Department of Breast Surgery, Ninewells Hospital, Dundee, United Kingdom.

出版信息

Eur J Surg Oncol. 2025 Jul;51(7):109689. doi: 10.1016/j.ejso.2025.109689. Epub 2025 Feb 20.

DOI:10.1016/j.ejso.2025.109689

PMID:40133030

Abstract

BACKGROUND

Neoadjuvant chemotherapy (NAC) can downstage axillary nodes in breast cancer, prompting debate over the optimal axillary management after NAC. While axillary dissection (ALND) provides detailed assessment of node status, minimally invasive methods such as sentinel lymph node biopsy (SLNB), marked lymph node biopsy (MLNB) and targeted axillary dissection (TAD) are showing promise. This meta-analysis aims to assess the efficacy and safety of these strategies.

METHODS

A systematic search of Medline, Embase and Cochrane Central was conducted and relevant RCTs were identified. Random-effects meta-analysis, meta-regression and trial sequential analysis (TSA) were conducted for diagnostic outcomes (identification rates [IFR], false negative rates [FNR] and negative predictive value [NPV]) and survival outcomes (overall survival [OS], disease-free survival [DFS]) to compare SLNB, MLNB and TAD with ALND.

RESULTS

Twenty-eight studies (SLNB, n = 3392; MLNB, n = 1130; TAD, n = 946) investigated diagnostic outcomes and nine studies investigated survival outcomes (n = 5647). The pooled IFR, FNR and NPV of TAD was 96.8 %, 4.7 % and 93.2 %, respectively, and all values were superior to SLNB (91.9 %, 13.7 % and 84.8 %; meta-regression, p < 0.001) (SLNB vs. MLNB concordance = 73 %). The FNR of SLNB decreased with the number of nodes removed (≥3 nodes, 8.1 %) but remained inferior to TAD (p = 0.001). The IFR of SLNB in the ycN0 group was statistically lower than all patients (ycN0/+), 85.8 % vs. 91.9 % (p < 0.001). Pooled hazard ratios for DFS in SLNB/TAD, SLNB and TAD were 0.90 (95%CI, 0.77-1.04; p = 0.45), 0.89 (95%CI, 0.74-1.08; p = 0.25) and 0.91 (95%CI, 0.64-1.29; p = 0.58) (TSA 2.08>threshold). Indirect comparison between TAD and SLNB demonstrated no significant difference in DFS (HR 0.98; 0.64-1.32; 95%CI, p = 0.95).

CONCLUSION

Targeted axillary dissection is the optimal minimally invasive axillary technique in terms of diagnostic accuracy. De-escalation of axillary surgery following NAC does not negatively impact DFS in patients with node-positive breast cancer.

摘要

背景

新辅助化疗（NAC）可降低乳腺癌腋窝淋巴结分期，引发了关于NAC后最佳腋窝处理方式的讨论。虽然腋窝淋巴结清扫术（ALND）能提供详细的淋巴结状态评估，但前哨淋巴结活检（SLNB）、标记淋巴结活检（MLNB）和靶向腋窝淋巴结清扫术（TAD）等微创方法也展现出前景。本荟萃分析旨在评估这些策略的疗效和安全性。

方法

对Medline、Embase和Cochrane中心进行系统检索，识别相关随机对照试验（RCT）。对诊断结果（识别率[IFR]、假阴性率[FNR]和阴性预测值[NPV]）和生存结果（总生存[OS]、无病生存[DFS]）进行随机效应荟萃分析、荟萃回归和试验序贯分析（TSA），以比较SLNB、MLNB和TAD与ALND。

结果

28项研究（SLNB，n = 3392；MLNB，n = 1130；TAD，n = 946）研究了诊断结果，9项研究研究了生存结果（n = 5647）。TAD的合并IFR、FNR和NPV分别为96.8%、4.7%和93.2%，所有数值均优于SLNB（91.9%、13.7%和84.8%；荟萃回归，p < 0.001）（SLNB与MLNB一致性 = 73%）。SLNB的FNR随切除淋巴结数量增加而降低（≥3个淋巴结，8.1%），但仍低于TAD（p = 0.001）。ycN0组中SLNB的IFR在统计学上低于所有患者（ycN0/+），分别为85.8%和91.9%（p < 0.001）。SLNB/TAD、SLNB和TAD中DFS的合并风险比分别为0.90（95%CI，0.77 - 1.04；p = 0.45）、0.89（95%CI，0.74 - 1.08；p = 0.25）和0.91（95%CI，0.64 - 1.29；p = 0.58）（TSA 2.08>阈值）。TAD和SLNB之间的间接比较显示DFS无显著差异（HR 0.98；0.64 - 1.32；95%CI，p = 0.95）。