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Multicenter Study
. 2022 Nov 1;276(5):e553-e562.
doi: 10.1097/SLA.0000000000004572. Epub 2020 Nov 4.

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

Sherko Kuemmel  1   2 , Joerg Heil  3 , Anna Rueland  1 , Christine Seiberling  1 , Hakima Harrach  1 , Dorothea Schindowski  1 , Juliane Lubitz  1 , Karin Hellerhoff  4 , Christine Ankel  4 , Sven-Thomas Graßhoff  5 , Petra Deuschle  6 , Volker Hanf  7 , Kerstin Belke  8 , Peter Dall  9 , Julia Dorn  10 , Gabriele Kaltenecker  11 , Thorsten Kuehn  12 , Ulrike Beckmann  13 , Jochem Potenberg  14 , Jens-Uwe Blohmer  15 , Athina Kostara  1 , Elisabeth Breit  1 , Johannes Holtschmidt  16 , Eugen Traut  1 , Mattea Reinisch  1
Affiliations
Multicenter Study

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

Sherko Kuemmel et al. Ann Surg. .

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.

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Conflict of interest statement

S. Kuemmel reports personal fees from Somatex, during the conduct of the study; personal fees from Roche/Genentech, Genomic Health, Lilly, Novartis, Amgen, Celgene, Daiichi Sankyo, Astra Zeneca, Somatex, MSD, Pfizer, Püma Biotechnology, PFM medical, non-financial support from Roche, Daiichi Sankyo, Somatex, and Sonoscape outside the submitted work. J. Heil reports non-financial support from Somatex, during the conduct of the study; non-financial support from BARD and pfm medical, personal fees from Siemens and Roche, outside the submitted work. C. Ankel reports personal fees from PMF medicals, grants from Sebbin, outside the submitted work. P. Dall reports personal fees from Roche Pharma, Novartis, Astra Zeneca, Pfizer, Eisai, Amgen, Hexal, Genomic Health, outside the submitted work. T. Kuehn reports personal fees from Roche and Pfizer, travel expenses from Celgene, SABCS, outside the submitted work. J.-U. Blohmer reports personal fees from Amgen, Astra Zeneca, MSD, Novartis, Pfizer, Roche, and Sonoscape, travel expenses from Roche and Pfizer, outside the submitted work. A. Kostara reports personal fees from Astra Zeneca, travel expenses from Tessaro, MSD, Somatex, outside the submitted work. E. Breit reports personal fees from Sysmex, Olympus, Merck Serono, and Daiichi Sankyo, outside the submitted work. J. Holtschmidtreports personal fees and non-financial support from Roche Pharma, non-financial support from PharmaMar, personal fees from Merck Sharp Dome and Hologic, outside the submitted work. M. Reinisch reports personal fees from Somatex, during the conduct of the study, personal fees and other from Novartis, personal fees and other from Pfizer, personal fees from MSD, AstraZeneca, Roche, and Lilly, other from Celgene, outside the submitted work. The authors report no conflicts of interest.

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