Omitting axillary dissection in breast cancer patients with one to two positive sentinel nodes undergoing mastectomy: a retrospective and prospective cohort study with a target trial emulation.

Authors

Haitong Xie, Xin Wang, Xianlin Gu, Chihua Wu, Wanying Guo, Rui Li, Binxu Qiu, Zhihao Zhang, Peng Gao, Xiangyue Meng, Liang Du, Shengchun Liu, Michael Gnant, Jie Chen

Published in

International journal of surgery (London, England). Volume 112. Issue 4. Pages 11000-11012. Epub Apr 15, 2026.

Abstract

Previous trials have demonstrated the safety of omitting axillary lymph node dissection (ALND) in cT1-3, cN0 breast cancer patients with one to two sentinel lymph node (SLN) involvement undergoing breast-conserving surgery (BCS). However, their applicability to mastectomy patients - who do not routinely receive chest wall irradiation - remains unclear. This study aimed to evaluate whether omitting ALND is noninferior to completion of ALND among patients undergoing mastectomy.
We emulated a target multicenter, nonblinded, noninferiority trial to compare sentinel lymph node biopsy only (SLNB only) and SLNB plus ALND using combined prospective and retrospective cohorts. Eligible patients had cT1-3, cN0 breast cancer with one to two SLN metastases. The primary endpoint was 5-year recurrence-free survival (RFS). Noninferiority was defined as a hazard ratio (HR) of less than 1.54 comparing the SLNB-only group to the ALND group. This study was prospectively registered with Chictr.org.cn.
Among 1090 included patients, 438 (40.2%) received SLNB only and 652 (59.8%) received ALND. After a median follow-up of 4.74 years, 88 patients experienced recurrence or died. The estimated 5-year RFS was 91.5% (95% CI, 89.1-93.9) in the SLNB only group and 91.8% (95% CI, 88.7-95.1) in the ALND group (HR = 0.83; 95% CI, 0.51-1.33; P_{noninferiority} = 0.005). Primary findings were consistent across subgroups and sensitivity analyses.
Results of this targeted trial revealed that ALND can be omitted in patients undergoing mastectomy with clinically node-negative, cT1-3 invasive breast cancer who had one to two SLN metastases. These findings further inform the de-escalation of axillary surgery in breast cancer management.

PMID:
42682276
Bibliographic data and abstract were imported from PubMed on 02 Sep 2026.

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