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. 2023 Aug 1;158(8):807-815.
doi: 10.1001/jamasurg.2023.1772.

Safety of Targeted Axillary Dissection After Neoadjuvant Therapy in Patients With Node-Positive Breast Cancer

Sherko Kuemmel  1   2 , Joerg Heil  3 , Simona Bruzas  1 , Elisabeth Breit  1 , Dorothea Schindowski  1 , Hakima Harrach  1 , Ouafaa Chiari  1 , Karin Hellerhoff  4 , Elena Bensmann  4 , Volker Hanf  5 , Sven-Thomas Graßhoff  6 , Petra Deuschle  7 , Kerstin Belke  8 , Silke Polata  9 , Stefan Paepke  10 , Mathias Warm  11 , Johannes Meiler  12 , Christian Schindlbeck  13 , Wencke Ruhwedel  14 , Ulrike Beckmann  15 , Ulrich Groh  16 , Peter Dall  17 , Jens-Uwe Blohmer  2 , Alexander Traut  18 , Mattea Reinisch  1   2
Affiliations

Safety of Targeted Axillary Dissection After Neoadjuvant Therapy in Patients With Node-Positive Breast Cancer

Sherko Kuemmel et al. JAMA Surg. .

Abstract

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.

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Conflict of interest statement

Conflict of Interest Disclosures: Dr Kuemmel has received personal fees from Roche/Genentech, Genomic Health, Novartis, AstraZeneca, Amgen, Celgene, SOMATEX, Daiichi Sankyo, pfm medical, Pfizer, MSD Oncology, Lilly, Sonoscape, Gilead Sciences, Seagen, and Agendia outside the submitted work and is codirector of the WSG Study Group. Dr Heil has received honoraria from Roche, Siemens Healthcare Diagnostics, and BARD; personal fees from Roche, Siemens Healthcare Diagnostics, and Celgene; and research funding from BARD outside the submitted work. Dr Bruzas has received personal fees from AstraZeneca outside the submitted work. Dr Breit has received personal fees from Sysmex outside the submitted work. Dr Paepke has received personal fees from pfm medical, BD, Grünenthal, Invitroque Europe, Neodynamics, Novusscientific, Sysmex, Triconmed, Samantree, and 3MMM outside the submitted work. Dr Dall has received personal fees from Novartis, Lilly, Pfizer, AstraZeneca, Roche, MSD, Seagen, and Gilead outside the submitted work. Dr Blohmer has received personal fees from Amgen, AstraZeneca, Daiichi Sankyo, Eisai, Gilead Sciences, Lilly, Molecular Health, MSD Oncology, Novartis, Pfizer, Roche, Seagen, NOGGO eV, and AGO eV outside the submitted work. Dr Reinisch has received personal fees from AstraZeneca, Roche, Daiichi Sankyo, Gilead Sciences, Novartis, Pfizer, SOMATEX, Seagen, and Lilly as well as nonfinancial support from AstraZeneca and Novartis outside the submitted work. No other disclosures were reported.

Figures

Figure 1.
Figure 1.. CONSORT Diagram of 548 Patients With Clinically Node-Positive Breast Cancer
Of 473 patients who received neoadjuvant systemic therapy, targeted axillary dissection (TAD) lymph nodes were successfully resected in 199 patients. In 80 of 199 patients (40.2%), TAD was followed by axillary lymph node dissection (ALND) whereas the other 119 patients (59.8%) underwent TAD alone. Follow-up data were available for all patients. SLNB indicates sentinel lymph node biopsy; TLNB, target lymph node biopsy.
Figure 2.
Figure 2.. Kaplan-Meier Curves for Invasive Disease-Free and Overall Survival and Axillary Recurrence
Kaplan-Meier curves for (A) invasive disease-free survival and (B) overall survival as well as (C) cumulative incidence of ipsilateral axillary recurrence for 80 patients who underwent targeted axillary dissection (TAD) with axillary lymph node dissection (ALND) compared with 119 patients who underwent TAD alone. A total of 16 recurrences and 8 deaths occurred in the TAD with ALND group and 12 recurrences and 7 deaths occurred in the TAD alone group. One patient in the TAD with ALND group and 3 patients in the TAD alone group experienced axillary recurrence.
Figure 3.
Figure 3.. Patient Characteristics and 3-Year Clinical Outcomes According to Axillary Treatment
A total of 39 patients underwent targeted axillary dissection (TAD) alone, 77 patients underwent TAD with axillary radiotherapy (ART), 10 patients underwent TAD with axillary lymph node dissection (ALND), and 66 patients underwent TAD with ALND and ART. Less extensive axillary surgical treatment (TAD alone or TAD with ART) had a higher proportion of patients with clinically or pathologically node-negative status after neoadjuvant therapy (ycN0/ypN0), 3 or more TAD lymph nodes, and a lower proportion of patients with any recurrence or locoregional recurrence.
See this image and copyright information in PMC

Comment in

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