Home > Oncology > SABCS 2021 > Miscellaneous > Sentinel lymph node staging is non-inferior to complete axillary lymph node dissection

Sentinel lymph node staging is non-inferior to complete axillary lymph node dissection

Presented by
Dr Damiano Gentile, Humanitas Research Hospital, Italy
SABCS 2021

Axillary lymph node dissection (ALND) is an effective procedure for axillary staging. However, it is associated with a significant risk of morbidity. The minimal invasive and less morbid sentinel lymph node biopsy (SLNB) is non-inferior to ALND, results of the SINODAR ONE trial show.

Sentinel lymph node (SLN) staging is currently used to avoid complete ALND in breast cancer patients. The SLN is the only site of axillary metastasis in ≥60% of cases. Therefore, the SINODAR ONE study (NCT05160324) evaluated whether SLNB is or is not inferior to ALND. The study enrolled 889 patients between 40–75 years with a primary invasive T1-T2 tumour, axillary nodes cN0, no more than 2 macro-metastatic SLNs, no distant metastasis, no neo-adjuvant therapy, and no previous invasive breast cancer. All patients underwent SLNB and were randomised 1:1 to standard (SLNB plus ALND) or experimental (only SLNB) treatment. Dr Damiano Gentile (Humanitas Research Hospital, Italy) presented the results [1].

Most patients (77.2%) received breast-conserving surgery, while 22.8% of patients underwent mastectomy. A median of 2 SLNs were removed in both arms. Overall, only 3 micro-metastatic SNLs were found: 1 in the standard arm and 2 in the experimental arm. No statistical difference was found between the 2 treatments in terms of survival and recurrence: 5-years overall survival was 98.9% versus 98.8% and 5-year recurrence-free survival was 96.3% versus 95.6% in the standard versus experimental arm, respectively (see Table).

Table: Recurrence-free survival and overall survival after SLNB versus ALND [1].









RFS, recurrence-free survival; OS, overall survival; ITT, intention-to-treat; PP, per-protocol

“We believe randomisation between ALND and SLN staging is no longer justified. We favour the omission of complete axillary dissection in international guidelines,” concluded Dr Gentile.

  1. Gentile D, et al. Preservation of axillary lymph nodes compared to complete dissection in T1-T2 breast cancer patients presenting 1-2 metastatic sentinel lymph nodes. A multicenter randomized clinical trial. Sinodar One. GS4-05, SABCS 2021 Virtual Meeting, 7–10 December.

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