![]() Five-year distant DDFS was 97.7% in the SLNB group and 98.0% in the no axillary surgery group (log-rank P =. The median (IQR) follow-up for disease assessment was 5.7 (5.0-6.8) years in the SLNB group and 5.7 (5.0-6.6) years in the no axillary surgery group. In the SLNB group, 97 patients (13.7%) had positive axillary nodes. Overall, the median (IQR) tumor size was 1.1 (0.8-1.5) cm, and 1234 patients (87.8%) had estrogen receptor-positive ERBB2 (formerly HER2 or HER2/neu), nonoverexpressing BC. ![]() Secondary end points were the cumulative incidence of distant recurrences, the cumulative incidence of axillary recurrences, DFS, overall survival (OS), and the adjuvant treatment recommendations.Īmong 1405 women (median age, 60 years) included in the intention-to-treat analysis, 708 were randomized to the SLNB group, and 697 were randomized to the no axillary surgery group. The primary end point of the study was distant disease-free survival (DDFS) at 5 years, analyzed as intention to treat. Data were analyzed from October 10, 2022, to January 13, 2023.Įligible patients were randomized on a 1:1 ratio to receive SLNB (SLNB group) or no axillary surgery (no axillary surgery group). Of those, 1405 were included in the intention-to-treat analysis. A total of 1463 women of any age with BC up to 2 cm and a negative preoperative axillary ultrasonography result were enrolled and randomized between February 6, 2012, and June 30, 2017. The SOUND (Sentinel Node vs Observation After Axillary Ultra-Sound) trial was a prospective noninferiority phase 3 randomized clinical trial conducted in Italy, Switzerland, Spain, and Chile. To determine whether the omission of axillary surgery is noninferior to SLNB in patients with small BC and a negative result on preoperative axillary lymph node ultrasonography. Sentinel lymph node biopsy (SLNB) is the standard of care for axillary node staging of patients with early breast cancer (BC), but its necessity can be questioned since surgery for examination of axillary nodes is not performed with curative intent. 25 Division of Breast Surgery, Arturo Lopez Perez Foundation, Providencia, Chile.24 Department of Biomedical Sciences, Humanitas University, Pieve Emanuele, Milan, Italy.23 Breast Unit, IRCCS Humanitas Research Hospital, Rozzano, Milan, Italy.22 Frauenklinik Inselpital Hospital, Theodor-Kocher-Haus, Bern, Switzerland.21 Breast Cancer Unit, Hospital Universitario y Politecnico La Fe´, Valencia, Spain.20 Medical Oncology Division, Azienda Sanitaria dell'Alto Adige, Bolzano, Italy.19 Breast Unit, Spedali Civili di Brescia, Brescia, Italy.18 SC di Chirurgia Oncologica e Senologia, Ospedale Oncologico, Azienda Ospedaliera Brotzu, Selargius, Cagliari, Italy.17 Struttura Semplice Dipartimentale di Chirurgia Senologica Azienda Socio-Sanitaria Territoriale (ASST), Mantova, Italy.16 Department of General Surgery, Sant'Anna Hospital, Como, Italy.Matteo Foundation, University of Pavia, Pavia, Italy. 15 Breast Center, Department of Surgical Sciences, IRCCS Policlinico S.14 Struttura Complessa (SC) di Chirurgia Oncologica di Senologia, Istituto Nazionale Tumori Napoli, IRCCS, Fondazione Pascale, Naples, Italy.13 Breast Surgery Unit, Piacenza Hospital, Piacenza, Italy.12 Department of Radiotherapy, European Institute of Oncology IRCCS, Milan, Italy.11 Division of Medical Oncology, European Institute of Oncology IRCCS, Milan, Italy.10 Division of Breast Imaging, European Institute of Oncology IRCCS, Milan, Italy.9 Oncology and Oncohematology Department, University of Milan, Milan, Italy.8 Division of Pathology and Laboratory Medicine, European Institute of Oncology IRCCS, Milan, Italy.7 Breast Surgery Unit, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy.6 Department of Surgical Sciences Gynecology and Obstetrics, City of Health and Science of Turin, Sant'Anna Hospital, University of Turin, Turin, Italy.5 Clinical Trial Office, European Institute of Oncology IRCCS, Milan, Italy.4 Department of Research, Cancer Registry of Norway, Oslo, Norway.3 Division of Epidemiology and Biostatistics, European Institute of Oncology IRCCS, Milan, Italy.2 Breast Surgery Unit, San Raffaele Scientific and Research Hospital, Milan, Italy.1 Division of Breast Surgery, European Institute of Oncology Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS), Milan, Italy.
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