Sentinel Lymph Node Biopsy vs No Axillary Surgery in Patients With Small Breast Cancer and Negative Results on Ultrasonography of Axillary Lymph Nodes-Reference-Cited by-同舟云学术

Sentinel Lymph Node Biopsy vs No Axillary Surgery in Patients With Small Breast Cancer and Negative Results on Ultrasonography of Axillary Lymph Nodes

Published:2023-11-01 Issue:11 Volume:9 Page:1557
ISSN:2374-2437
Container-title:JAMA Oncology
language:en
Short-container-title:JAMA Oncol

Author:

Gentilini Oreste Davide¹²,Botteri Edoardo³⁴,Sangalli Claudia⁵,Galimberti Viviana¹,Porpiglia Mauro⁶,Agresti Roberto⁷,Luini Alberto¹,Viale Giuseppe⁸⁹,Cassano Enrico¹⁰,Peradze Nickolas¹,Toesca Antonio¹,Massari Giulia¹,Sacchini Virgilio¹⁹,Munzone Elisabetta¹¹,Leonardi Maria Cristina¹²,Cattadori Francesca¹³,Di Micco Rosa²,Esposito Emanuela¹⁴,Sgarella Adele¹⁵,Cattaneo Silvia¹⁶,Busani Massimo¹⁷,Dessena Massimo¹⁸,Bianchi Anna¹⁹,Cretella Elisabetta²⁰,Ripoll Orts Francisco²¹,Mueller Michael²²,Tinterri Corrado²³²⁴,Chahuan Manzur Badir Jorge²⁵,Benedetto Chiara⁶,Veronesi Paolo¹⁹,Bassi Fabio D.²⁶,Borella Fulvio²⁶,Caldarella Pietro²⁶,Colleoni Marco A.²⁶,Corso Giovanni²⁶,Dellapasqua Silvia²⁶,Ferrari Alberta²⁶,Garcia-Etienne Carlos²⁶,Gentile Damiano²⁶,Germano Alessandro²⁶,Grosso Luigi P.²⁶,Intra Mattia²⁶,Iorfida Monica²⁶,Vila Josè²⁶,Limite Gennaro²⁶,Lissidini Germana²⁶,Macellari Giorgio²⁶,Magnoni Francesca²⁶,Maugeri Ilaria²⁶,Mazza Manuelita²⁶,Montagna Emilia²⁶,Naninato Paola²⁶,Nicosia Luca²⁶,Orecchia Roberto²⁶,Pierini Alberto F.²⁶,Rauh Claudia²⁶,Rinaldo Massimo²⁶,Rotili Anna²⁶,Rotmensz Nicole²⁶,Vento Anna R.²⁶,Zuber Veronica²⁶,

Affiliation:

1. Division of Breast Surgery, European Institute of Oncology Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS), Milan, Italy

2. Breast Surgery Unit, San Raffaele Scientific and Research Hospital, Milan, Italy

3. Division of Epidemiology and Biostatistics, European Institute of Oncology IRCCS, Milan, Italy

4. Department of Research, Cancer Registry of Norway, Oslo, Norway

5. Clinical Trial Office, European Institute of Oncology IRCCS, 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

7. Breast Surgery Unit, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy

8. Division of Pathology and Laboratory Medicine, European Institute of Oncology IRCCS, Milan, Italy

9. Oncology and Oncohematology Department, University of Milan, Milan, Italy

10. Division of Breast Imaging, European Institute of Oncology IRCCS, Milan, Italy

11. Division of Medical Oncology, European Institute of Oncology IRCCS, Milan, Italy

12. Department of Radiotherapy, European Institute of Oncology IRCCS, Milan, Italy

13. Breast Surgery Unit, Piacenza Hospital, Piacenza, Italy

14. Struttura Complessa (SC) di Chirurgia Oncologica di Senologia, Istituto Nazionale Tumori Napoli, IRCCS, Fondazione Pascale, Naples, Italy

15. Breast Center, Department of Surgical Sciences, IRCCS Policlinico S. Matteo Foundation, University of Pavia, Pavia, Italy

16. Department of General Surgery, Sant’Anna Hospital, Como, Italy

17. Struttura Semplice Dipartimentale di Chirurgia Senologica Azienda Socio-Sanitaria Territoriale (ASST), Mantova, Italy

18. SC di Chirurgia Oncologica e Senologia, Ospedale Oncologico, Azienda Ospedaliera Brotzu, Selargius, Cagliari, Italy

19. Breast Unit, Spedali Civili di Brescia, Brescia, Italy

20. Medical Oncology Division, Azienda Sanitaria dell’Alto Adige, Bolzano, Italy

21. Breast Cancer Unit, Hospital Universitario y Politecnico La Fe´, Valencia, Spain

22. Frauenklinik Inselpital Hospital, Theodor-Kocher-Haus, Bern, Switzerland

23. Breast Unit, IRCCS Humanitas Research Hospital, Rozzano, Milan, Italy

24. Department of Biomedical Sciences, Humanitas University, Pieve Emanuele, Milan, Italy

25. Division of Breast Surgery, Arturo Lopez Perez Foundation, Providencia, Chile

26. for the SOUND Trial Group

Abstract

ImportanceSentinel 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.ObjectiveTo 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.Design, Setting, and ParticipantsThe 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. 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. Of those, 1405 were included in the intention-to-treat analysis. Data were analyzed from October 10, 2022, to January 13, 2023.InterventionEligible patients were randomized on a 1:1 ratio to receive SLNB (SLNB group) or no axillary surgery (no axillary surgery group).Main Outcomes and MeasuresThe primary end point of the study was distant disease–free survival (DDFS) at 5 years, analyzed as intention to treat. 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.ResultsAmong 1405 women (median [IQR] age, 60 [52-68] 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. 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. In the SLNB group, 97 patients (13.7%) had positive axillary nodes. 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. Five-year distant DDFS was 97.7% in the SLNB group and 98.0% in the no axillary surgery group (log-rank P = .67; hazard ratio, 0.84; 90% CI, 0.45-1.54; noninferiority P = .02). A total of 12 (1.7%) locoregional relapses, 13 (1.8%) distant metastases, and 21 (3.0%) deaths were observed in the SLNB group, and 11 (1.6%) locoregional relapses, 14 (2.0%) distant metastases, and 18 (2.6%) deaths were observed in the no axillary surgery group.Conclusions and RelevanceIn this randomized clinical trial, omission of axillary surgery was noninferior to SLNB in patients with small BC and a negative result on ultrasonography of the axillary lymph nodes. These results suggest that patients with these features can be safely spared any axillary surgery whenever the lack of pathological information does not affect the postoperative treatment plan.Trial RegistrationClinicalTrials.gov Identifier: NCT02167490

Publisher

American Medical Association (AMA)

Subject

Oncology,Cancer Research

Link

https://jamanetwork.com/journals/jamaoncology/articlepdf/2809872/jamaoncology_gentilini_2023_oi_230048_1699901575.40871.pdf

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