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. 2024 Sep 26:47:101083.
doi: 10.1016/j.lanepe.2024.101083. eCollection 2024 Dec.

Axillary clearance and chemotherapy rates in ER+HER2- breast cancer: secondary analysis of the SENOMAC trial

Tove Filtenborg Tvedskov  1   2 , Robert Szulkin  3   4 , Sara Alkner  5   6 , Yvette Andersson  7   8 , Leif Bergkvist  8 , Jan Frisell  9   10 , Oreste Davide Gentilini  11   12 , Michalis Kontos  13 , Thorsten Kühn  14   15 , Dan Lundstedt  16   17 , Birgitte Vrou Offersen  18   19 , Roger Olofsson Bagge  20   21 , Toralf Reimer  22 , Malin Sund  23   24 , Lisa Rydén  25   26 , Peer Christiansen  27   28 , Jana de Boniface  10   29 ; SENOMAC Trialists' Group
Collaborators, Affiliations

Axillary clearance and chemotherapy rates in ER+HER2- breast cancer: secondary analysis of the SENOMAC trial

Tove Filtenborg Tvedskov et al. Lancet Reg Health Eur. .

Abstract

Background: Randomized trials have shown that axillary clearance (AC) can safely be omitted in patients with sentinel lymph node-positive breast cancer. At the same time, de-escalation of chemotherapy in postmenopausal patients with ER+HER2- breast cancer may depend on detailed axillary nodal stage. The aim of this pre-specified secondary analysis of the SENOMAC trial was to investigate whether the choice of axillary staging affected the proportion of patients receiving adjuvant chemotherapy, and recurrence-free survival (RFS).

Methods: Proportion receiving adjuvant chemotherapy was calculated according to AC or sentinel lymph node biopsy (SLNB) only, menopausal status, and region of inclusion, for 2168 patients with clinically node-negative ER+HER2- breast cancer and 1-2 sentinel lymph node macrometastases included in the SENOMAC trial.

Findings: In premenopausal patients, 514 out of 615 patients (83.6%) received adjuvant chemotherapy with no significant difference between randomization arms. In postmenopausal patients, the proportion receiving chemotherapy varied considerably by region and country (36.0-82.4%). In Denmark, where 194 out of 539 postmenopausal patients (36.0%) received adjuvant chemotherapy, rates differed significantly between the AC and the SLNB only arm (41.3% vs 31.4%, p = 0.019). After a median follow-up of 44.88 months for Danish postmenopausal patients, no significant difference was seen in 5-year RFS, which was 91% (85.6%-96.6%) for the SLNB only and 90.9% (86.3%-95.6%) for the AC arm (p = 0.42).

Interpretation: When omitting axillary clearance, and thus reducing the risk of long-term arm morbidity, potential under-treatment of postmenopausal patients with ER+HER2- breast cancer may require the development of new predictive and imaging tools.

Funding: Swedish Research Council, Swedish Cancer Society, Nordic Cancer Union, Swedish Breast Cancer Association.

Keywords: Adjuvant treatment; Axillary staging; Breast cancer.

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Conflict of interest statement

Dr. RO Bagge declares research grants from BMS, Endomagnetics Ltd, Skyline Dx and NeraCare GmbH as well as participation in advisory board for Amgen, BD/BARD, Bristol-Myers Squibb (BMS), Cansr.com, Merck Sharp & Dohme (MSD), Novartis, Roche and Sanofi Genzyme and stock or stock options in SATMEG Ventures AB. Thorsten Kuehn has payment or honoraria for presentations from MSD, Novartis, Lilly, Exact Sciences, Merit Medical, Sirius Medical and EndoMag and support for attending meetings from MSD, Lilly. All other authors declare no competing interests.

Figures

Fig. 1
Fig. 1
CONSORT diagram over inclusion of SENOMAC trial patients into the present analysis.
Fig. 2
Fig. 2
Recurrence-free survival for Danish postmenopausal patients with ER+HER2− breast cancer included in the SENOMAC trial according to randomized assignment; completion AC vs SLNB only.
See this image and copyright information in PMC

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