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Importance: The increasing use of neoadjuvant systemic therapy (NST) has led to substantial pathological complete response rates in patients with initially node-positive, early breast cancer, thereby questioning the need for axillary lymph node dissection (ALND). Targeted axillary dissection (TAD) is feasible for axillary staging; however, data on oncological safety are scarce., Objective: To assess 3-year clinical outcomes in patients with node-positive breast cancer who underwent TAD alone or TAD with ALND., Design, Setting, and Participants: The SenTa study is a prospective registry study and was conducted between January 2017 and October 2018. The registry includes 50 study centers in Germany. Patients with clinically node-positive breast cancer underwent clipping of the most suspicious lymph node (LN) before NST. After NST, the marked LNs and sentinel LNs were excised (TAD) followed by ALND according to the clinician's choice. Patients who did not undergo TAD were excluded. Data analysis was performed in April 2022 after 43 months of follow-up., Exposure: TAD alone vs TAD with ALND., Main Outcomes and Measures: Three-year clinical outcomes were evaluated., Results: Of 199 female patients, the median (IQR) age was 52 (45-60) years. A total of 182 patients (91.5%) had 1 to 3 suspicious LNs; 119 received TAD alone and 80 received TAD with ALND. Unadjusted invasive disease-free survival was 82.4% (95% CI, 71.5-89.4) in the TAD with ALND group and 91.2% (95% CI, 84.2-95.1) in the TAD alone group (P = .04); axillary recurrence rates were 1.4% (95% CI, 0-54.8) and 1.8% (95% CI, 0-36.4), respectively (P = .56). Adjusted multivariate Cox regression indicated that TAD alone was not associated with an increased risk of recurrence (hazard ratio [HR], 0.83; 95% CI, 0.34-2.05; P = .69) or death (HR, 1.07; 95% CI, 0.31-3.70; P = .91). Similar results were obtained for 152 patients with clinically node-negative breast cancer after NST (invasive disease-free survival: HR, 1.26; 95% CI, 0.27-5.87; P = .77; overall survival: HR, 0.81; 95% CI, 0.15-3.83; P = .74)., Conclusions and Relevance: These results suggest that TAD alone in patients with mostly good clinical response to NST and at least 3 TAD LNs may confer survival outcomes and recurrence rates similar to TAD with ALND.

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., Competing Interests: 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., (Copyright © 2020 Wolters Kluwer Health, Inc. All rights reserved.)