International journal of surgery (London, England) · 2026
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.
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Xie Haitong, Wang Xin, Gu Xianlin, Wu Chihua, Guo Wanying, Li Rui, Qiu Binxu, Zhang Zhihao, Gao Peng, Meng Xiangyue, Du Liang, Liu Shengchun, Gnant Michael, Chen Jie
Аннотация
BACKGROUND: 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.
METHODS: 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.
RESULTS: 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; Pnoninferiority = 0.005). Primary findings were consistent across subgroups and sensitivity analyses.
CONCLUSION: 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.
METHODS: 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.
RESULTS: 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; Pnoninferiority = 0.005). Primary findings were consistent across subgroups and sensitivity analyses.
CONCLUSION: 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.