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Overview of the pathological results and treatment characteristics in the first 1000 patients randomized in the SERC trial: axillary dissection versus no axillary dissection in patients with involved sentinel node

BACKGROUND: Three randomized trials have concluded at non inferiority of omission of complementary axillary lymph node dissection (cALND) for patients with involved sentinel node (SN). However, we can outline strong limitations of these trials to validate this attitude with a high scientific level....

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Autores principales: Houvenaeghel, Gilles, Cohen, Monique, Raro, Pédro, De Troyer, Jérémy, de Lara, Christine Tunon, Gimbergues, Pierre, Gauthier, Tristan, Faure-Virelizier, Christelle, Vaini-Cowen, Véronique, Lantheaume, Stéphane, Regis, Claudia, Darai, Emile, Ceccato, Vivien, D’Halluin, Gauthier, Del Piano, Francesco, Villet, Richard, Jouve, Eva, Beedassy, Bassoodéo, Theret, Pierrick, Gabelle, Philippe, Zinzindohoue, Cécile, Opinel, Pierre, Marsollier-Ferrer, Catherine, Dhainaut-Speyer, Caroline, Colombo, Pierre-Emmanuel, Lambaudie, Eric, Tallet, Agnès, Boher, Jean-Marie
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2018
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6249981/
https://www.ncbi.nlm.nih.gov/pubmed/30463611
http://dx.doi.org/10.1186/s12885-018-5053-7
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author Houvenaeghel, Gilles
Cohen, Monique
Raro, Pédro
De Troyer, Jérémy
de Lara, Christine Tunon
Gimbergues, Pierre
Gauthier, Tristan
Faure-Virelizier, Christelle
Vaini-Cowen, Véronique
Lantheaume, Stéphane
Regis, Claudia
Darai, Emile
Ceccato, Vivien
D’Halluin, Gauthier
Del Piano, Francesco
Villet, Richard
Jouve, Eva
Beedassy, Bassoodéo
Theret, Pierrick
Gabelle, Philippe
Zinzindohoue, Cécile
Opinel, Pierre
Marsollier-Ferrer, Catherine
Dhainaut-Speyer, Caroline
Colombo, Pierre-Emmanuel
Lambaudie, Eric
Tallet, Agnès
Boher, Jean-Marie
author_facet Houvenaeghel, Gilles
Cohen, Monique
Raro, Pédro
De Troyer, Jérémy
de Lara, Christine Tunon
Gimbergues, Pierre
Gauthier, Tristan
Faure-Virelizier, Christelle
Vaini-Cowen, Véronique
Lantheaume, Stéphane
Regis, Claudia
Darai, Emile
Ceccato, Vivien
D’Halluin, Gauthier
Del Piano, Francesco
Villet, Richard
Jouve, Eva
Beedassy, Bassoodéo
Theret, Pierrick
Gabelle, Philippe
Zinzindohoue, Cécile
Opinel, Pierre
Marsollier-Ferrer, Catherine
Dhainaut-Speyer, Caroline
Colombo, Pierre-Emmanuel
Lambaudie, Eric
Tallet, Agnès
Boher, Jean-Marie
author_sort Houvenaeghel, Gilles
collection PubMed
description BACKGROUND: Three randomized trials have concluded at non inferiority of omission of complementary axillary lymph node dissection (cALND) for patients with involved sentinel node (SN). However, we can outline strong limitations of these trials to validate this attitude with a high scientific level. We designed the SERC randomized trial (ClinicalTrials.gov, number NCT01717131) to compare outcomes in patients with SN involvement treated with ALND or no further axillary treatment. The aim of this study was to analyze results of the first 1000 patients included. METHODS: SERC trial is a multicenter non-inferiority phase 3 trial. Multivariate logistic regression analysis was used to identify independent factors associated with adjuvant chemotherapy administration and non-sentinel node (NSN) involvement. RESULTS: Of the 963 patients included in the analysis set, 478 were randomized to receive cALND and 485 SLNB alone. All patient demographics and tumor characteristics were balanced between the two arms. SN ITC was present in 6.3% patients (57/903), micro metastases in 33.0% (298), macro metastases in 60.7% (548) and 289 (34.2%) were non eligible to Z0011 trial criteria. Whole breast or chest wall irradiation was delivered in 95.9% (896/934) of patients, adjuvant chemotherapy in 69.5% (644/926), endocrine therapy in 89.6% (673/751) and the proportions were similar in the two arms. The overall rate of positive NSN was 19% (84/442) for patients with cALND. Crude rates of positive NSN according to SN status were 4.5% for ITC (1/22), 9.5% for micro metastases (13/137), 23.9% for macro metastases (61/255) and were respectively 29.36% (64/218), 9.33% (7/75) and 7.94% (10/126) when chemotherapy was administered after cALND, before cALND and for patients without chemotherapy. CONCLUSION: The main objective of SERC trial is to demonstrate non inferiority of cALND omission. A strong interaction between timing of cALND and chemotherapy with positive NSN rate was observed. TRIAL REGISTRATION: This study is registered with ClinicalTrials.gov, number NCT01717131 October 19, 2012. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (10.1186/s12885-018-5053-7) contains supplementary material, which is available to authorized users.
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spelling pubmed-62499812018-11-26 Overview of the pathological results and treatment characteristics in the first 1000 patients randomized in the SERC trial: axillary dissection versus no axillary dissection in patients with involved sentinel node Houvenaeghel, Gilles Cohen, Monique Raro, Pédro De Troyer, Jérémy de Lara, Christine Tunon Gimbergues, Pierre Gauthier, Tristan Faure-Virelizier, Christelle Vaini-Cowen, Véronique Lantheaume, Stéphane Regis, Claudia Darai, Emile Ceccato, Vivien D’Halluin, Gauthier Del Piano, Francesco Villet, Richard Jouve, Eva Beedassy, Bassoodéo Theret, Pierrick Gabelle, Philippe Zinzindohoue, Cécile Opinel, Pierre Marsollier-Ferrer, Catherine Dhainaut-Speyer, Caroline Colombo, Pierre-Emmanuel Lambaudie, Eric Tallet, Agnès Boher, Jean-Marie BMC Cancer Research Article BACKGROUND: Three randomized trials have concluded at non inferiority of omission of complementary axillary lymph node dissection (cALND) for patients with involved sentinel node (SN). However, we can outline strong limitations of these trials to validate this attitude with a high scientific level. We designed the SERC randomized trial (ClinicalTrials.gov, number NCT01717131) to compare outcomes in patients with SN involvement treated with ALND or no further axillary treatment. The aim of this study was to analyze results of the first 1000 patients included. METHODS: SERC trial is a multicenter non-inferiority phase 3 trial. Multivariate logistic regression analysis was used to identify independent factors associated with adjuvant chemotherapy administration and non-sentinel node (NSN) involvement. RESULTS: Of the 963 patients included in the analysis set, 478 were randomized to receive cALND and 485 SLNB alone. All patient demographics and tumor characteristics were balanced between the two arms. SN ITC was present in 6.3% patients (57/903), micro metastases in 33.0% (298), macro metastases in 60.7% (548) and 289 (34.2%) were non eligible to Z0011 trial criteria. Whole breast or chest wall irradiation was delivered in 95.9% (896/934) of patients, adjuvant chemotherapy in 69.5% (644/926), endocrine therapy in 89.6% (673/751) and the proportions were similar in the two arms. The overall rate of positive NSN was 19% (84/442) for patients with cALND. Crude rates of positive NSN according to SN status were 4.5% for ITC (1/22), 9.5% for micro metastases (13/137), 23.9% for macro metastases (61/255) and were respectively 29.36% (64/218), 9.33% (7/75) and 7.94% (10/126) when chemotherapy was administered after cALND, before cALND and for patients without chemotherapy. CONCLUSION: The main objective of SERC trial is to demonstrate non inferiority of cALND omission. A strong interaction between timing of cALND and chemotherapy with positive NSN rate was observed. TRIAL REGISTRATION: This study is registered with ClinicalTrials.gov, number NCT01717131 October 19, 2012. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (10.1186/s12885-018-5053-7) contains supplementary material, which is available to authorized users. BioMed Central 2018-11-21 /pmc/articles/PMC6249981/ /pubmed/30463611 http://dx.doi.org/10.1186/s12885-018-5053-7 Text en © The Author(s). 2018 Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.
spellingShingle Research Article
Houvenaeghel, Gilles
Cohen, Monique
Raro, Pédro
De Troyer, Jérémy
de Lara, Christine Tunon
Gimbergues, Pierre
Gauthier, Tristan
Faure-Virelizier, Christelle
Vaini-Cowen, Véronique
Lantheaume, Stéphane
Regis, Claudia
Darai, Emile
Ceccato, Vivien
D’Halluin, Gauthier
Del Piano, Francesco
Villet, Richard
Jouve, Eva
Beedassy, Bassoodéo
Theret, Pierrick
Gabelle, Philippe
Zinzindohoue, Cécile
Opinel, Pierre
Marsollier-Ferrer, Catherine
Dhainaut-Speyer, Caroline
Colombo, Pierre-Emmanuel
Lambaudie, Eric
Tallet, Agnès
Boher, Jean-Marie
Overview of the pathological results and treatment characteristics in the first 1000 patients randomized in the SERC trial: axillary dissection versus no axillary dissection in patients with involved sentinel node
title Overview of the pathological results and treatment characteristics in the first 1000 patients randomized in the SERC trial: axillary dissection versus no axillary dissection in patients with involved sentinel node
title_full Overview of the pathological results and treatment characteristics in the first 1000 patients randomized in the SERC trial: axillary dissection versus no axillary dissection in patients with involved sentinel node
title_fullStr Overview of the pathological results and treatment characteristics in the first 1000 patients randomized in the SERC trial: axillary dissection versus no axillary dissection in patients with involved sentinel node
title_full_unstemmed Overview of the pathological results and treatment characteristics in the first 1000 patients randomized in the SERC trial: axillary dissection versus no axillary dissection in patients with involved sentinel node
title_short Overview of the pathological results and treatment characteristics in the first 1000 patients randomized in the SERC trial: axillary dissection versus no axillary dissection in patients with involved sentinel node
title_sort overview of the pathological results and treatment characteristics in the first 1000 patients randomized in the serc trial: axillary dissection versus no axillary dissection in patients with involved sentinel node
topic Research Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6249981/
https://www.ncbi.nlm.nih.gov/pubmed/30463611
http://dx.doi.org/10.1186/s12885-018-5053-7
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