Axillary lymph node dissection versus radiotherapy in breast cancer with positive sentinelnodes after neoadjuvant therapy (ADARNAT trial)

Introduction: Breast cancer surgery currently focuses on de-escalating treatment without compromising patient survival. Axillary radiotherapy (ART) now replaces axillary lymph node dissection (ALND) in patients with limited sentinel lymph node (SLN) involvement during the primary surgery, and this h...

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Autores: García Tejedor, María Amparo, Ortega-Exposito, Carlos, Salinas, Sira, Luzardo González, Ana, Falo Zamora, Catalina, Martinez-Pérez, Evelyn, Pérez-Montero, Héctor, Soler-Monsó, Teresa, Bajén Lázaro, Ma. Teresa, Benítez, Ana, Ortega, Raul, Petit, Anna, Gumà Martínez, Anna, Campos, Miriam, Plà, Maria J., Pernas, Sònia, Peñafiel, Judith, Yeste, Carlos, Gil-Gil, Miguel, Guedea Edo, Ferran, Ponce i Sebastià, Jordi, Laplana, Maria
Tipo de recurso: artículo
Estado:Versión publicada
Fecha de publicación:2023
País:España
Institución:Universidad de Barcelona
Repositorio:Dipòsit Digital de la UB
OAI Identifier:oai:diposit.ub.edu:2445/208010
Acceso en línea:https://hdl.handle.net/2445/208010
Access Level:acceso abierto
Palabra clave:Ganglis sentinelles
Càncer de mama
Radioteràpia
Sentinel lymph nodes
Breast cancer
Radiotherapy
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spelling Axillary lymph node dissection versus radiotherapy in breast cancer with positive sentinelnodes after neoadjuvant therapy (ADARNAT trial)García Tejedor, María AmparoOrtega-Exposito, CarlosSalinas, SiraLuzardo González, AnaFalo Zamora, CatalinaMartinez-Pérez, EvelynPérez-Montero, HéctorSoler-Monsó, TeresaBajén Lázaro, Ma. TeresaBenítez, AnaOrtega, RaulPetit, AnnaGumà Martínez, AnnaCampos, MiriamPlà, Maria J.Pernas, SòniaPeñafiel, JudithYeste, CarlosGil-Gil, MiguelGuedea Edo, FerranPonce i Sebastià, JordiLaplana, MariaGanglis sentinellesCàncer de mamaRadioteràpiaSentinel lymph nodesBreast cancerRadiotherapyIntroduction: Breast cancer surgery currently focuses on de-escalating treatment without compromising patient survival. Axillary radiotherapy (ART) now replaces axillary lymph node dissection (ALND) in patients with limited sentinel lymph node (SLN) involvement during the primary surgery, and this has significantly reduced the incidence of lymphedema without worsening the prognosis. However, patients treated with neoadjuvant systemic treatment (NST) cannot benefit from this option despite the low incidence of residual disease in the armpit in most cases. Data regarding the use of radiotherapy instead of ALND in this population are lacking. This study will assess whether ART is non-inferior to ALND in terms of recurrence and overall survival in patients with positive SLN after NST, including whether it reduces surgery-related adverse effects. Methods and analyses: This multicenter, randomized, open-label, phase 3 trial will enroll 1660 patients with breast cancer and positive SLNs following NST in approximately 50 Spanish centers over 3 years. Patients will be stratified by NST regimen and nodal involvement (isolated tumoral cells or micrometastasis versus macrometastasis) and randomly assigned 1:1 to ART without ALND (study arm) or ALND alone (control arm). Level 3 and supraclavicular radiotherapy will be added in both arms. The primary outcome is the 5-year axillary recurrence determined by clinical and radiological examination. The secondary outcomes include lymphedema or arm dysfunction, quality of life based (EORTC QLQ-C30 and QLQ-BR23 questionnaires), disease-free survival, and overall survival. Discussion: This study aims to provide data to confirm the efficacy and safety of ART over ALND in patients with a positive SLN after NST, together with the impact on morbidity. Ethics and dissemination: The Research Ethics Committee of Bellvitge University Hospital approved this trial (Protocol Record PR148/21, version 3, 1/2/2022) and all patients must provide written informed consent. The involvement of around 50 centers across Spain will facilitate the dissemination of our results.Frontiers Media2023info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionapplication/pdfhttps://hdl.handle.net/2445/208010Articles publicats en revistes (Ciències Clíniques)reponame:Dipòsit Digital de la UBinstname:Universidad de BarcelonaInglésReproducció del document publicat a: https://doi.org/10.3389/fonc.2023.1184021Frontiers In Oncology, 2023, vol. 13https://doi.org/10.3389/fonc.2023.1184021cc-by (c) Garcia-Tejedor, A. et al., 2023http://creativecommons.org/licenses/by/4.0/info:eu-repo/semantics/openAccessoai:diposit.ub.edu:2445/2080102026-05-27T06:46:51Z
dc.title.none.fl_str_mv Axillary lymph node dissection versus radiotherapy in breast cancer with positive sentinelnodes after neoadjuvant therapy (ADARNAT trial)
title Axillary lymph node dissection versus radiotherapy in breast cancer with positive sentinelnodes after neoadjuvant therapy (ADARNAT trial)
spellingShingle Axillary lymph node dissection versus radiotherapy in breast cancer with positive sentinelnodes after neoadjuvant therapy (ADARNAT trial)
García Tejedor, María Amparo
Ganglis sentinelles
Càncer de mama
Radioteràpia
Sentinel lymph nodes
Breast cancer
Radiotherapy
title_short Axillary lymph node dissection versus radiotherapy in breast cancer with positive sentinelnodes after neoadjuvant therapy (ADARNAT trial)
title_full Axillary lymph node dissection versus radiotherapy in breast cancer with positive sentinelnodes after neoadjuvant therapy (ADARNAT trial)
title_fullStr Axillary lymph node dissection versus radiotherapy in breast cancer with positive sentinelnodes after neoadjuvant therapy (ADARNAT trial)
title_full_unstemmed Axillary lymph node dissection versus radiotherapy in breast cancer with positive sentinelnodes after neoadjuvant therapy (ADARNAT trial)
title_sort Axillary lymph node dissection versus radiotherapy in breast cancer with positive sentinelnodes after neoadjuvant therapy (ADARNAT trial)
dc.creator.none.fl_str_mv García Tejedor, María Amparo
Ortega-Exposito, Carlos
Salinas, Sira
Luzardo González, Ana
Falo Zamora, Catalina
Martinez-Pérez, Evelyn
Pérez-Montero, Héctor
Soler-Monsó, Teresa
Bajén Lázaro, Ma. Teresa
Benítez, Ana
Ortega, Raul
Petit, Anna
Gumà Martínez, Anna
Campos, Miriam
Plà, Maria J.
Pernas, Sònia
Peñafiel, Judith
Yeste, Carlos
Gil-Gil, Miguel
Guedea Edo, Ferran
Ponce i Sebastià, Jordi
Laplana, Maria
author García Tejedor, María Amparo
author_facet García Tejedor, María Amparo
Ortega-Exposito, Carlos
Salinas, Sira
Luzardo González, Ana
Falo Zamora, Catalina
Martinez-Pérez, Evelyn
Pérez-Montero, Héctor
Soler-Monsó, Teresa
Bajén Lázaro, Ma. Teresa
Benítez, Ana
Ortega, Raul
Petit, Anna
Gumà Martínez, Anna
Campos, Miriam
Plà, Maria J.
Pernas, Sònia
Peñafiel, Judith
Yeste, Carlos
Gil-Gil, Miguel
Guedea Edo, Ferran
Ponce i Sebastià, Jordi
Laplana, Maria
author_role author
author2 Ortega-Exposito, Carlos
Salinas, Sira
Luzardo González, Ana
Falo Zamora, Catalina
Martinez-Pérez, Evelyn
Pérez-Montero, Héctor
Soler-Monsó, Teresa
Bajén Lázaro, Ma. Teresa
Benítez, Ana
Ortega, Raul
Petit, Anna
Gumà Martínez, Anna
Campos, Miriam
Plà, Maria J.
Pernas, Sònia
Peñafiel, Judith
Yeste, Carlos
Gil-Gil, Miguel
Guedea Edo, Ferran
Ponce i Sebastià, Jordi
Laplana, Maria
author2_role author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
dc.subject.none.fl_str_mv Ganglis sentinelles
Càncer de mama
Radioteràpia
Sentinel lymph nodes
Breast cancer
Radiotherapy
topic Ganglis sentinelles
Càncer de mama
Radioteràpia
Sentinel lymph nodes
Breast cancer
Radiotherapy
description Introduction: Breast cancer surgery currently focuses on de-escalating treatment without compromising patient survival. Axillary radiotherapy (ART) now replaces axillary lymph node dissection (ALND) in patients with limited sentinel lymph node (SLN) involvement during the primary surgery, and this has significantly reduced the incidence of lymphedema without worsening the prognosis. However, patients treated with neoadjuvant systemic treatment (NST) cannot benefit from this option despite the low incidence of residual disease in the armpit in most cases. Data regarding the use of radiotherapy instead of ALND in this population are lacking. This study will assess whether ART is non-inferior to ALND in terms of recurrence and overall survival in patients with positive SLN after NST, including whether it reduces surgery-related adverse effects. Methods and analyses: This multicenter, randomized, open-label, phase 3 trial will enroll 1660 patients with breast cancer and positive SLNs following NST in approximately 50 Spanish centers over 3 years. Patients will be stratified by NST regimen and nodal involvement (isolated tumoral cells or micrometastasis versus macrometastasis) and randomly assigned 1:1 to ART without ALND (study arm) or ALND alone (control arm). Level 3 and supraclavicular radiotherapy will be added in both arms. The primary outcome is the 5-year axillary recurrence determined by clinical and radiological examination. The secondary outcomes include lymphedema or arm dysfunction, quality of life based (EORTC QLQ-C30 and QLQ-BR23 questionnaires), disease-free survival, and overall survival. Discussion: This study aims to provide data to confirm the efficacy and safety of ART over ALND in patients with a positive SLN after NST, together with the impact on morbidity. Ethics and dissemination: The Research Ethics Committee of Bellvitge University Hospital approved this trial (Protocol Record PR148/21, version 3, 1/2/2022) and all patients must provide written informed consent. The involvement of around 50 centers across Spain will facilitate the dissemination of our results.
publishDate 2023
dc.date.none.fl_str_mv 2023
dc.type.none.fl_str_mv info:eu-repo/semantics/article
info:eu-repo/semantics/publishedVersion
format article
status_str publishedVersion
dc.identifier.none.fl_str_mv https://hdl.handle.net/2445/208010
url https://hdl.handle.net/2445/208010
dc.language.none.fl_str_mv Inglés
language_invalid_str_mv Inglés
dc.relation.none.fl_str_mv Reproducció del document publicat a: https://doi.org/10.3389/fonc.2023.1184021
Frontiers In Oncology, 2023, vol. 13
https://doi.org/10.3389/fonc.2023.1184021
dc.rights.none.fl_str_mv cc-by (c) Garcia-Tejedor, A. et al., 2023
http://creativecommons.org/licenses/by/4.0/
info:eu-repo/semantics/openAccess
rights_invalid_str_mv cc-by (c) Garcia-Tejedor, A. et al., 2023
http://creativecommons.org/licenses/by/4.0/
eu_rights_str_mv openAccess
dc.format.none.fl_str_mv application/pdf
dc.publisher.none.fl_str_mv Frontiers Media
publisher.none.fl_str_mv Frontiers Media
dc.source.none.fl_str_mv Articles publicats en revistes (Ciències Clíniques)
reponame:Dipòsit Digital de la UB
instname:Universidad de Barcelona
instname_str Universidad de Barcelona
reponame_str Dipòsit Digital de la UB
collection Dipòsit Digital de la UB
repository.name.fl_str_mv
repository.mail.fl_str_mv
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score 15.300724

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