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SYSTEMATIC REVIEW article

Front. Oncol.

Sec. Breast Cancer

Volume 15 - 2025 | doi: 10.3389/fonc.2025.1620034

Safety analysis of omitting axillary lymph node dissection in early-stage breast cancer with 1-2 sentinel lymph nodes macro-metastases: a meta-analysis

Provisionally accepted
Yu  ChenYu Chen1Xiaoming  ZhangXiaoming Zhang2Qingping  WuQingping Wu2Shanshan  GaoShanshan Gao3Lu  WangLu Wang3Minxia  ZengMinxia Zeng3Lihu  GuLihu Gu4*Changrui  ShengChangrui Sheng3*
  • 1The Graduate School, Zhejiang Chinese Medical University, Hangzhou, China
  • 2The First Clinical Medical College, Zhejiang Chinese Medical University, Hangzhou, China
  • 3Department of Ultrasound, Ningbo No. 2 Hospital, Hangzhou, China
  • 4Department of General Surgery, Ningbo No. 2 Hospital, Hangzhou, China

The final, formatted version of the article will be published soon.

Background: Currently, the axillary management strategy of omitting axillary lymph node dissection (ALND) in early-stage breast cancer (BC) patients with cT1-2, clinically node-negative (cN0), and sentinel lymph node biopsy (SLNB) revealing 1-2 sentinel lymph nodes (SLNs) macro-metastases remains controversial. This study aims to systematically evaluate the safety of omitting ALND in this population. Methods: This study was conducted in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines and was registered with the registration number: CRD42025645388. A systematic literature search was conducted across five electronic databases (PubMed, Web of Science, Cochrane Library, Ovid Medline, and Embase) from inception through December 2024. Randomized controlled trials (RCTs) and cohort studies meeting the predefined eligibility criteria were included. Primary outcomes included disease-free survival (DFS) and overall survival (OS). The association between ALND omission and long-term outcomes was assessed using pooled hazard ratios (HRs) with 95% confidence intervals (CIs). Results: Fifteen studies (6 RCTs, 9 cohort studies) involving 33,599 patients in the SLNB-only group and 95,711 controls receiving SLNB+ALND were analyzed. No significant differences in DFS (HR=0.99, 95%CI:0.85-1.14, p=0.857) or OS (HR=1.03, 95%CI: 0.92-1.14 p=0.251) were observed in both groups. Subgroup analyses by follow-up duration (5-years and 10-years), study design (RCTs and cohort studies), and region (Eastern and Western) showed no survival differences between the experimental and control groups. (all p values are greater than 0.05) Conclusion: Omitting ALND is safe for early-stage BC patients with cT1-2, cN0, and 1-2 SLNs macro-metastases.

Keywords: Omitting, early-stage breast cancer, Sentinel Lymph Node Biopsy, Axillary lymph node dissection, Macro-metastases, Meta-analysis

Received: 29 Apr 2025; Accepted: 09 Sep 2025.

Copyright: © 2025 Chen, Zhang, Wu, Gao, Wang, Zeng, Gu and Sheng. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.

* Correspondence:
Lihu Gu, Department of General Surgery, Ningbo No. 2 Hospital, Hangzhou, China
Changrui Sheng, Department of Ultrasound, Ningbo No. 2 Hospital, Hangzhou, China

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