Clinically node negative breast cancer patients undergoing breast conserving therapy, sentinel lymph node procedure versus follow-up: a Dutch randomized controlled multicentre trial (BOOG 2013-08)

BACKGROUND: Studies showed that axillary lymph node dissection can be safely omitted in presence of positive sentinel lymph node(s) in breast cancer patients treated with breast conserving therapy. Since the outcome of the sentinel lymph node biopsy has no clinical consequence, the value of the proc...

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Autores principales: van Roozendaal, L. M., Vane, M. L. G., van Dalen, T., van der Hage, J. A., Strobbe, L. J. A., Boersma, L. J., Linn, S. C., Lobbes, M. B. I., Poortmans, P. M. P., Tjan-Heijnen, V. C. G., Van de Vijver, K. K. B. T., de Vries, J., Westenberg, A. H., Kessels, A. G. H., de Wilt, J. H. W., Smidt, M. L.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2017
Materias:
Study Protocol
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5494134/
https://www.ncbi.nlm.nih.gov/pubmed/28668073
http://dx.doi.org/10.1186/s12885-017-3443-x
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author van Roozendaal, L. M.
Vane, M. L. G.
van Dalen, T.
van der Hage, J. A.
Strobbe, L. J. A.
Boersma, L. J.
Linn, S. C.
Lobbes, M. B. I.
Poortmans, P. M. P.
Tjan-Heijnen, V. C. G.
Van de Vijver, K. K. B. T.
de Vries, J.
Westenberg, A. H.
Kessels, A. G. H.
de Wilt, J. H. W.
Smidt, M. L.
author_facet van Roozendaal, L. M.
Vane, M. L. G.
van Dalen, T.
van der Hage, J. A.
Strobbe, L. J. A.
Boersma, L. J.
Linn, S. C.
Lobbes, M. B. I.
Poortmans, P. M. P.
Tjan-Heijnen, V. C. G.
Van de Vijver, K. K. B. T.
de Vries, J.
Westenberg, A. H.
Kessels, A. G. H.
de Wilt, J. H. W.
Smidt, M. L.
author_sort van Roozendaal, L. M.
collection PubMed
description BACKGROUND: Studies showed that axillary lymph node dissection can be safely omitted in presence of positive sentinel lymph node(s) in breast cancer patients treated with breast conserving therapy. Since the outcome of the sentinel lymph node biopsy has no clinical consequence, the value of the procedure itself is being questioned. The aim of the BOOG 2013–08 trial is to investigate whether the sentinel lymph node biopsy can be safely omitted in clinically node negative breast cancer patients treated with breast conserving therapy. METHODS: The BOOG 2013–08 is a Dutch prospective non-inferiority randomized multicentre trial. Women with pathologically confirmed clinically node negative T1–2 invasive breast cancer undergoing breast conserving therapy will be randomized for sentinel lymph node biopsy versus no sentinel lymph node biopsy. Endpoints include regional recurrence after 5 (primary endpoint) and 10 years of follow-up, distant-disease free and overall survival, quality of life, morbidity and cost-effectiveness. Previous data indicate a 5-year regional recurrence free survival rate of 99% for the control arm and 96% for the study arm. In combination with a non-inferiority limit of 5% and probability of 0.8, this result in a sample size of 1.644 patients including a lost to follow-up rate of 10%. Primary and secondary endpoints will be reported after 5 and 10 years of follow-up. DISCUSSION: If the sentinel lymph node biopsy can be safely omitted in clinically node negative breast cancer patients undergoing breast conserving therapy, this study will cost-effectively lead to a decreased axillary morbidity rate and thereby improved quality of life with non-inferior regional control, distant-disease free survival and overall survival. TRIAL REGISTRATION: The BOOG 2013–08 study is registered in ClinicalTrials.gov since October 20, 2014, Identifier: NCT02271828. https://clinicaltrials.gov/ct2/show/NCT02271828
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spelling pubmed-54941342017-07-05 Clinically node negative breast cancer patients undergoing breast conserving therapy, sentinel lymph node procedure versus follow-up: a Dutch randomized controlled multicentre trial (BOOG 2013-08) van Roozendaal, L. M. Vane, M. L. G. van Dalen, T. van der Hage, J. A. Strobbe, L. J. A. Boersma, L. J. Linn, S. C. Lobbes, M. B. I. Poortmans, P. M. P. Tjan-Heijnen, V. C. G. Van de Vijver, K. K. B. T. de Vries, J. Westenberg, A. H. Kessels, A. G. H. de Wilt, J. H. W. Smidt, M. L. BMC Cancer Study Protocol BACKGROUND: Studies showed that axillary lymph node dissection can be safely omitted in presence of positive sentinel lymph node(s) in breast cancer patients treated with breast conserving therapy. Since the outcome of the sentinel lymph node biopsy has no clinical consequence, the value of the procedure itself is being questioned. The aim of the BOOG 2013–08 trial is to investigate whether the sentinel lymph node biopsy can be safely omitted in clinically node negative breast cancer patients treated with breast conserving therapy. METHODS: The BOOG 2013–08 is a Dutch prospective non-inferiority randomized multicentre trial. Women with pathologically confirmed clinically node negative T1–2 invasive breast cancer undergoing breast conserving therapy will be randomized for sentinel lymph node biopsy versus no sentinel lymph node biopsy. Endpoints include regional recurrence after 5 (primary endpoint) and 10 years of follow-up, distant-disease free and overall survival, quality of life, morbidity and cost-effectiveness. Previous data indicate a 5-year regional recurrence free survival rate of 99% for the control arm and 96% for the study arm. In combination with a non-inferiority limit of 5% and probability of 0.8, this result in a sample size of 1.644 patients including a lost to follow-up rate of 10%. Primary and secondary endpoints will be reported after 5 and 10 years of follow-up. DISCUSSION: If the sentinel lymph node biopsy can be safely omitted in clinically node negative breast cancer patients undergoing breast conserving therapy, this study will cost-effectively lead to a decreased axillary morbidity rate and thereby improved quality of life with non-inferior regional control, distant-disease free survival and overall survival. TRIAL REGISTRATION: The BOOG 2013–08 study is registered in ClinicalTrials.gov since October 20, 2014, Identifier: NCT02271828. https://clinicaltrials.gov/ct2/show/NCT02271828 BioMed Central 2017-07-01 /pmc/articles/PMC5494134/ /pubmed/28668073 http://dx.doi.org/10.1186/s12885-017-3443-x Text en © The Author(s). 2017 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 Study Protocol
van Roozendaal, L. M.
Vane, M. L. G.
van Dalen, T.
van der Hage, J. A.
Strobbe, L. J. A.
Boersma, L. J.
Linn, S. C.
Lobbes, M. B. I.
Poortmans, P. M. P.
Tjan-Heijnen, V. C. G.
Van de Vijver, K. K. B. T.
de Vries, J.
Westenberg, A. H.
Kessels, A. G. H.
de Wilt, J. H. W.
Smidt, M. L.
Clinically node negative breast cancer patients undergoing breast conserving therapy, sentinel lymph node procedure versus follow-up: a Dutch randomized controlled multicentre trial (BOOG 2013-08)
title Clinically node negative breast cancer patients undergoing breast conserving therapy, sentinel lymph node procedure versus follow-up: a Dutch randomized controlled multicentre trial (BOOG 2013-08)
title_full Clinically node negative breast cancer patients undergoing breast conserving therapy, sentinel lymph node procedure versus follow-up: a Dutch randomized controlled multicentre trial (BOOG 2013-08)
title_fullStr Clinically node negative breast cancer patients undergoing breast conserving therapy, sentinel lymph node procedure versus follow-up: a Dutch randomized controlled multicentre trial (BOOG 2013-08)
title_full_unstemmed Clinically node negative breast cancer patients undergoing breast conserving therapy, sentinel lymph node procedure versus follow-up: a Dutch randomized controlled multicentre trial (BOOG 2013-08)
title_short Clinically node negative breast cancer patients undergoing breast conserving therapy, sentinel lymph node procedure versus follow-up: a Dutch randomized controlled multicentre trial (BOOG 2013-08)
title_sort clinically node negative breast cancer patients undergoing breast conserving therapy, sentinel lymph node procedure versus follow-up: a dutch randomized controlled multicentre trial (boog 2013-08)
topic Study Protocol
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5494134/
https://www.ncbi.nlm.nih.gov/pubmed/28668073
http://dx.doi.org/10.1186/s12885-017-3443-x
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