A Prospective, Multicenter Registry Study to Evaluate the Clinical Feasibility of Targeted Axillary Dissection (TAD) in Node-positive Breast Cancer Patients

Abstract

Objective: This study aimed to investigate the feasibility and accuracy of non-radioactive TLN biopsy and TAD in routine clinical practice. Background Data: TAD involves TLN biopsy (TLNB) and sentinel lymph node biopsy and was recently introduced as a new standard for less invasive axillary staging in BC patients undergoing neoadjuvant systemic therapy (NST); however, clinical evidence is limited. Methods: The SenTa study is a prospective registry study conducted at 50 centers. Patients with invasive BC who nderwent clip insertion into the most suspicious axillary lymph node were eligible. Axillary surgery was performed with or without sentinel lymph node biopsy, TLNB, and/or axillary lymph node dissection (ALND). Main endpoints were the detection rate and FNR of TLNB and TAD after NST. Results: Between 2017 and 2018, 548 consecutive BC patients underwent clip placement into biopsy-confirmed positive lymph nodes. After NST (n = 473), the clipped TLN was intraoperatively resected in 329 of 423 patients [77.8%, 95% confidence interval (CI): 74.0–82.0]. TAD was successful in 199 of 229 patients (detection rate: 86.9%, 95% CI: 81.8–91.0), the SLN and TLN were identical in 129 patient (64.8%). FNRs were 7.2% (8 of 111, 95% CI: 3.1–13.6) for TLNB followed by ALND (n = 203) and 4.3% (2 of 46, 95% CI: 0.5–14.8) for TAD followed by ALND (n = 77). Conclusions: The SenTa study demonstrates the feasibility of TAD in a real-world cohort of BC patients. Our findings are of great importance for de-escalation of surgical strategies.

Surgical Management of the Axilla in Clinically Node-Positive Breast Cancer Patients Converting to Clinical Node Negativity through Neoadjuvant Chemotherapy: Current Status, Knowledge Gaps, and Rationale for the EUBREAST-03 AXSANA Study

“…Similarly, in the largest study on carbon solution-based TAD, 25% of patients had ≥4 and 4% had ≥10 suspicious nodes before NACT [47]. 124 out of 423 (29%) patients enrolled in the SENTA trial had at least three abnormal nodes [29]. Intuitively, the more nodes appear suspicious on initial ultrasound, the more probable it is for the TAD to miss residual disease, especially in case only one node was marked, thus resulting in a higher FNR [60].…”

“…The results of the prospective German multicenter SENTA register study were presented at the ESMO conference in 2019 and are now available as a full publication [28,29]. In this study, the TLN was clipped before NACT in 473 patients.…”

Treatment of Patients with Early Breast Cancer: Evidence, Controversies, Consensus

“…Although the German experts emphasise that the AGO recommends both: TAD and ALND in the situation of ycN0. If the TLN corresponds to the SLN, a negative SLN suffices 14 , 15 . More than 80% of SG-BCC panellists (82%) recommend ALND when a patient with cN1 status (biopsy confirmed) has not responded or has only responded marginally to NAST (ypN1).…”

Behandlung von Patientinnen mit frühem Mammakarzinom: Evidenz, Kontroversen, Konsens – Meinungsbild deutscher Expert*innen zur 17. Internationalen St.-Gallen-Konsensuskonferenz

“…Die deutsche Expertengruppe betont, dass auf eine ALND verzichtet werden kann, wenn sowohl der TLN als auch der SLN tumorfrei ist. Entspricht der TLN dem SLN, reicht ein negativer SLN aus [14,15]. Über 80 % der SG-BCC-Panelisten (82 %) empfehlen eine ALND, wenn eine Patientin mit cN1-Status (bioptisch gesichert) nicht oder nur marginal auf eine NAST angesprochen hat (ypN1).…”