Sentinel node involvement with or without completion axillary lymph node dissection: treatment and pathologic results of randomized SERC trial

Abstract

Based on results of clinical trials, completion ALND (cALND) is frequently not performed for patients with breast conservation therapy and one or two involved sentinel nodes (SN) by micro- or macro-metastases. However, there were limitations despite a conclusion of non-inferiority for cALND omission. No trial had included patients with SN macro-metastases and total mastectomy or with >2 SN macro-metastases. The aim of the study was too analyze treatment delivered and pathologic results of patients included in SERC trial. SERC trial is a multicenter randomized non-inferiority phase-3 trial comparing no cALND with cALND in cT0-1-2, cN0 patients with SN ITC (isolated tumor cells) or micro-metastases or macro-metastases, mastectomy or breast conservative surgery. We randomized 1855 patients, 929 to receive cALND and 926 SLNB alone. No significant differences in patient’s and tumor characteristics, type of surgery, and adjuvant chemotherapy (AC) were observed between the two arms. Rates of involved SN nodes by ITC, micro-metastases, and macro-metastases were 5.91%, 28.12%, and 65.97%, respectively, without significant difference between two arms for all criteria. In multivariate analysis, two factors were associated with higher positive non-SN rate: no AC versus AC administered after ALND (OR = 3.32, p < 0.0001) and >2 involved SN versus ≤2 (OR = 3.45, p = 0.0258). Crude rates of positive NSN were 17.62% (74/420) and 26.45% (73/276) for patient’s eligible and non-eligible to ACOSOG-Z0011 trial. No significant differences in patient’s and tumor characteristics and treatment delivered were observed between the two arms. Higher positive-NSN rate was observed for patients with AC performed after ALND (17.65% for SN micro-metastases, 35.22% for SN macro-metastases) in comparison with AC administered before ALND.

Does Breast Surgery Type Alter Incidental Axillary Irradiation? A Dosimetric Analysis of the “Sentinel Envahi et Randomisation du Curage” SERC Trial

“…However, only 8% of the patients received PMRT in the SLNB arm compared to 27% in the ALND arm, which calls for an updating of the long-term outcomes in this population [ 19 ]. Three other prospective, randomized trials, whose results are pending, will soon shed light on this topic [ 20 , 21 , 22 ]. The SENOMAC trial, recently presented in an abstract form with some pre-specified secondary outcomes, investigated ALND omission in cT1-3N0 patients (whatever the surgery type) with up to two macrometastases after SLNB.…”

Trends in axillary surgery and clinical outcomes among breast cancer patients with sentinel node metastasis

“…Several nomograms were available to predict non-sentinel nodal involvement, which offers an approach other than completion ALND to guide subsequent treatment [6,23]. Ongoing trials may also address the controversy about the eligibility of omitting or selected ALND in different situations [38][39][40]. For example, SERC study, a multicenter randomized phase-3 trial, included Z0011 non-eligible patients, of whom 43 patients had more than two involved sentinel nodes in the newest publication (20 in ALND arm vs 23 in only SLNB arm) [39].…”

“…Ongoing trials may also address the controversy about the eligibility of omitting or selected ALND in different situations [38][39][40]. For example, SERC study, a multicenter randomized phase-3 trial, included Z0011 non-eligible patients, of whom 43 patients had more than two involved sentinel nodes in the newest publication (20 in ALND arm vs 23 in only SLNB arm) [39]. These ongoing prospective randomized trials would unveil the importance of ALND for the Z0011 non-eligible patients.…”

MRI Radiomics and Biological Correlations for Predicting Axillary Lymph Node Burden in Early-Stage Breast Cancer

“…Patients with three or more positive lymph nodes could be directly selected for ALND or receive a new adjuvant therapy without SLNB if a reliable method existed to predict ALN burden preoperatively [10].…”