The value of completion axillary treatment in sentinel node positive breast cancer patients undergoing a mastectomy: a Dutch randomized controlled multicentre trial (BOOG 2013-07)
Identifieur interne : 001694 ( Main/Exploration ); précédent : 001693; suivant : 001695The value of completion axillary treatment in sentinel node positive breast cancer patients undergoing a mastectomy: a Dutch randomized controlled multicentre trial (BOOG 2013-07)
Auteurs : L. M. Van Roozendaal [Pays-Bas] ; J. Hw De Wilt [Pays-Bas] ; T. Van Dalen [Pays-Bas] ; J. A. Van Der Hage [Pays-Bas] ; L. Ja Strobbe [Pays-Bas] ; L. J. Boersma [Pays-Bas] ; S. C. Linn [Pays-Bas] ; M. Bi Lobbes [Pays-Bas] ; P. Mp Poortmans [Pays-Bas] ; V. Cg Tjan-Heijnen [Pays-Bas] ; K. Kbt Van De Vijver [Pays-Bas] ; J. De Vries [Pays-Bas] ; A. H. Westenberg [Pays-Bas] ; A. Gh Kessels [Pays-Bas] ; M. L. Smidt [Pays-Bas]Source :
- BMC Cancer [ 1471-2407 ] ; 2015.
Abstract
Trials failed to demonstrate additional value of completion axillary lymph node dissection in case of limited sentinel lymph node metastases in breast cancer patients undergoing breast conserving therapy. It has been suggested that the low regional recurrence rates in these trials might partially be ascribed to accidental irradiation of part of the axilla by whole breast radiation therapy, which precludes extrapolation of results to mastectomy patients. The aim of the randomized controlled BOOG 2013–07 trial is therefore to investigate whether completion axillary treatment can be safely omitted in sentinel lymph node positive breast cancer patients treated with mastectomy.
This study is designed as a non-inferiority randomized controlled multicentre trial. Women aged 18 years or older diagnosed with unilateral invasive clinically T1-2 N0 breast cancer who are treated with mastectomy, and who have a maximum of three axillary sentinel lymph nodes containing micro- and/or macrometastases, will be randomized for completion axillary treatment versus no completion axillary treatment. Completion axillary treatment can consist of completion axillary lymph node dissection or axillary radiation therapy. Primary endpoint is regional recurrence rate at 5 years. Based on a 5-year regional recurrence free survival rate of 98 % among controls and 96 % for study subjects, the sample size amounts 439 per arm (including 10 % lost to follow-up), to be able to reject the null hypothesis that the rate for study and control subjects is inferior by at least 5 % with a probability of 0.8. Results will be reported after 5 and 10 years of follow-up.
We hypothesize that completion axillary treatment can be safely omitted in sentinel node positive breast cancer patients undergoing mastectomy. If confirmed, this study will significantly decrease the number of breast cancer patients receiving extensive treatment of the axilla, thereby diminishing the risk of morbidity and improving quality of life, while maintaining excellent regional control and without affecting survival.
The BOOG 2013–07 study is registered in the register of ClinicalTrials.gov since April 10, 2014, Identifier:
The online version of this article (doi:10.1186/s12885-015-1613-2) contains supplementary material, which is available to authorized users.
Url:
DOI: 10.1186/s12885-015-1613-2
PubMed: 26335105
PubMed Central: 4559064
Affiliations:
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Van Roozendaal</name><affiliation wicri:level="1"><nlm:aff id="Aff1">Division of Surgical Oncology, Maastricht University Medical Centre, Maastricht, The Netherlands</nlm:aff><country xml:lang="fr">Pays-Bas</country><wicri:regionArea>Division of Surgical Oncology, Maastricht University Medical Centre, Maastricht</wicri:regionArea><wicri:noRegion>Maastricht</wicri:noRegion></affiliation><affiliation wicri:level="1"><nlm:aff id="Aff15">GROW - School for Oncology and Developmental Biology, Maastricht University Medical Centre, Maastricht, The Netherlands</nlm:aff><country xml:lang="fr">Pays-Bas</country><wicri:regionArea>GROW - School for Oncology and Developmental Biology, Maastricht University Medical Centre, Maastricht</wicri:regionArea><wicri:noRegion>Maastricht</wicri:noRegion></affiliation><affiliation wicri:level="1"><nlm:aff id="Aff16">Department of Surgical Oncology, Maastricht University Medical Centre, P.O. 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Ja Strobbe</name><affiliation wicri:level="3"><nlm:aff id="Aff5">Division of Surgical Oncology, Canisius-Wilhelmina Hospital, Nijmegen, The Netherlands</nlm:aff><country xml:lang="fr">Pays-Bas</country><wicri:regionArea>Division of Surgical Oncology, Canisius-Wilhelmina Hospital, Nijmegen</wicri:regionArea><placeName><settlement type="city">Nimègue</settlement><region type="province" nuts="2">Gueldre</region></placeName></affiliation></author><author><name sortKey="Boersma, L J" sort="Boersma, L J" uniqKey="Boersma L" first="L. J." last="Boersma">L. J. Boersma</name><affiliation wicri:level="1"><nlm:aff id="Aff6">Department of Radiation Oncology, Maastricht University Medical Centre (MAASTRO clinic), Maastricht, The Netherlands</nlm:aff><country xml:lang="fr">Pays-Bas</country><wicri:regionArea>Department of Radiation Oncology, Maastricht University Medical Centre (MAASTRO clinic), Maastricht</wicri:regionArea><wicri:noRegion>Maastricht</wicri:noRegion></affiliation><affiliation wicri:level="1"><nlm:aff id="Aff15">GROW - School for Oncology and Developmental Biology, Maastricht University Medical Centre, Maastricht, The Netherlands</nlm:aff><country xml:lang="fr">Pays-Bas</country><wicri:regionArea>GROW - School for Oncology and Developmental Biology, Maastricht University Medical Centre, Maastricht</wicri:regionArea><wicri:noRegion>Maastricht</wicri:noRegion></affiliation></author><author><name sortKey="Linn, S C" sort="Linn, S C" uniqKey="Linn S" first="S. C." last="Linn">S. C. Linn</name><affiliation wicri:level="3"><nlm:aff id="Aff7">Division of Medical Oncology, Netherlands Cancer Institute, Antoni van Leeuwenhoek Hospital, Amsterdam, The Netherlands</nlm:aff><country xml:lang="fr">Pays-Bas</country><wicri:regionArea>Division of Medical Oncology, Netherlands Cancer Institute, Antoni van Leeuwenhoek Hospital, Amsterdam</wicri:regionArea><placeName><settlement type="city">Amsterdam</settlement><region nuts="2" type="province">Hollande-Septentrionale</region></placeName></affiliation></author><author><name sortKey="Lobbes, M Bi" sort="Lobbes, M Bi" uniqKey="Lobbes M" first="M. Bi" last="Lobbes">M. 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Cg Tjan-Heijnen</name><affiliation wicri:level="1"><nlm:aff id="Aff10">Division of Medical Oncology, Maastricht University Medical Centre, Maastricht, The Netherlands</nlm:aff><country xml:lang="fr">Pays-Bas</country><wicri:regionArea>Division of Medical Oncology, Maastricht University Medical Centre, Maastricht</wicri:regionArea><wicri:noRegion>Maastricht</wicri:noRegion></affiliation><affiliation wicri:level="1"><nlm:aff id="Aff15">GROW - School for Oncology and Developmental Biology, Maastricht University Medical Centre, Maastricht, The Netherlands</nlm:aff><country xml:lang="fr">Pays-Bas</country><wicri:regionArea>GROW - School for Oncology and Developmental Biology, Maastricht University Medical Centre, Maastricht</wicri:regionArea><wicri:noRegion>Maastricht</wicri:noRegion></affiliation></author><author><name sortKey="Van De Vijver, K Kbt" sort="Van De Vijver, K Kbt" uniqKey="Van De Vijver K" first="K. Kbt" last="Van De Vijver">K. Kbt Van De Vijver</name><affiliation wicri:level="3"><nlm:aff id="Aff11">Department of Pathology, Netherlands Cancer Institute, Antoni van Leeuwenhoek Hospital, Amsterdam, The Netherlands</nlm:aff><country xml:lang="fr">Pays-Bas</country><wicri:regionArea>Department of Pathology, Netherlands Cancer Institute, Antoni van Leeuwenhoek Hospital, Amsterdam</wicri:regionArea><placeName><settlement type="city">Amsterdam</settlement><region nuts="2" type="province">Hollande-Septentrionale</region></placeName></affiliation></author><author><name sortKey="De Vries, J" sort="De Vries, J" uniqKey="De Vries J" first="J." last="De Vries">J. De Vries</name><affiliation wicri:level="1"><nlm:aff id="Aff12">Department of Medical and Clinical Psychology, Tilburg University, Tilburg, The Netherlands</nlm:aff><country xml:lang="fr">Pays-Bas</country><wicri:regionArea>Department of Medical and Clinical Psychology, Tilburg University, Tilburg</wicri:regionArea><wicri:noRegion>Tilburg</wicri:noRegion></affiliation></author><author><name sortKey="Westenberg, A H" sort="Westenberg, A H" uniqKey="Westenberg A" first="A. H." last="Westenberg">A. H. Westenberg</name><affiliation wicri:level="1"><nlm:aff id="Aff13">Radiation Oncology, Arnhem Institute for Radiation Oncology, Arnhem, The Netherlands</nlm:aff><country xml:lang="fr">Pays-Bas</country><wicri:regionArea>Radiation Oncology, Arnhem Institute for Radiation Oncology, Arnhem</wicri:regionArea><wicri:noRegion>Arnhem</wicri:noRegion></affiliation></author><author><name sortKey="Kessels, A Gh" sort="Kessels, A Gh" uniqKey="Kessels A" first="A. Gh" last="Kessels">A. Gh Kessels</name><affiliation wicri:level="1"><nlm:aff id="Aff14">Department of Clinical Epidemiology and Medical Technology Assessment, Maastricht University Medical Centre, Maastricht, The Netherlands</nlm:aff><country xml:lang="fr">Pays-Bas</country><wicri:regionArea>Department of Clinical Epidemiology and Medical Technology Assessment, Maastricht University Medical Centre, Maastricht</wicri:regionArea><wicri:noRegion>Maastricht</wicri:noRegion></affiliation></author><author><name sortKey="Smidt, M L" sort="Smidt, M L" uniqKey="Smidt M" first="M. L." last="Smidt">M. L. 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M." last="Van Roozendaal">L. M. Van Roozendaal</name><affiliation wicri:level="1"><nlm:aff id="Aff1">Division of Surgical Oncology, Maastricht University Medical Centre, Maastricht, The Netherlands</nlm:aff><country xml:lang="fr">Pays-Bas</country><wicri:regionArea>Division of Surgical Oncology, Maastricht University Medical Centre, Maastricht</wicri:regionArea><wicri:noRegion>Maastricht</wicri:noRegion></affiliation><affiliation wicri:level="1"><nlm:aff id="Aff15">GROW - School for Oncology and Developmental Biology, Maastricht University Medical Centre, Maastricht, The Netherlands</nlm:aff><country xml:lang="fr">Pays-Bas</country><wicri:regionArea>GROW - School for Oncology and Developmental Biology, Maastricht University Medical Centre, Maastricht</wicri:regionArea><wicri:noRegion>Maastricht</wicri:noRegion></affiliation><affiliation wicri:level="1"><nlm:aff id="Aff16">Department of Surgical Oncology, Maastricht University Medical Centre, P.O. Box 5800 6202 AZ, Maastricht, The Netherlands</nlm:aff><country xml:lang="fr">Pays-Bas</country><wicri:regionArea>Department of Surgical Oncology, Maastricht University Medical Centre, P.O. Box 5800 6202 AZ, Maastricht</wicri:regionArea><wicri:noRegion>Maastricht</wicri:noRegion></affiliation></author><author><name sortKey="De Wilt, J Hw" sort="De Wilt, J Hw" uniqKey="De Wilt J" first="J. Hw" last="De Wilt">J. Hw De Wilt</name><affiliation wicri:level="3"><nlm:aff id="Aff2">Division of Surgical Oncology, Radboud university medical centre, Nijmegen, The Netherlands</nlm:aff><country xml:lang="fr">Pays-Bas</country><wicri:regionArea>Division of Surgical Oncology, Radboud university medical centre, Nijmegen</wicri:regionArea><placeName><settlement type="city">Nimègue</settlement><region type="province" nuts="2">Gueldre</region></placeName></affiliation></author><author><name sortKey="Van Dalen, T" sort="Van Dalen, T" uniqKey="Van Dalen T" first="T." last="Van Dalen">T. Van Dalen</name><affiliation wicri:level="3"><nlm:aff id="Aff3">Division of Surgical Oncology, Diakonessenhuis Hospital, Utrecht, The Netherlands</nlm:aff><country xml:lang="fr">Pays-Bas</country><wicri:regionArea>Division of Surgical Oncology, Diakonessenhuis Hospital, Utrecht</wicri:regionArea><placeName><settlement type="city">Utrecht</settlement><region nuts="2" type="province">Utrecht (province)</region></placeName></affiliation></author><author><name sortKey="Van Der Hage, J A" sort="Van Der Hage, J A" uniqKey="Van Der Hage J" first="J. A." last="Van Der Hage">J. A. Van Der Hage</name><affiliation wicri:level="3"><nlm:aff id="Aff4">Division of Surgical Oncology, Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital, Amsterdam, The Netherlands</nlm:aff><country xml:lang="fr">Pays-Bas</country><wicri:regionArea>Division of Surgical Oncology, Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital, Amsterdam</wicri:regionArea><placeName><settlement type="city">Amsterdam</settlement><region nuts="2" type="province">Hollande-Septentrionale</region></placeName></affiliation></author><author><name sortKey="Strobbe, L Ja" sort="Strobbe, L Ja" uniqKey="Strobbe L" first="L. Ja" last="Strobbe">L. Ja Strobbe</name><affiliation wicri:level="3"><nlm:aff id="Aff5">Division of Surgical Oncology, Canisius-Wilhelmina Hospital, Nijmegen, The Netherlands</nlm:aff><country xml:lang="fr">Pays-Bas</country><wicri:regionArea>Division of Surgical Oncology, Canisius-Wilhelmina Hospital, Nijmegen</wicri:regionArea><placeName><settlement type="city">Nimègue</settlement><region type="province" nuts="2">Gueldre</region></placeName></affiliation></author><author><name sortKey="Boersma, L J" sort="Boersma, L J" uniqKey="Boersma L" first="L. J." last="Boersma">L. J. Boersma</name><affiliation wicri:level="1"><nlm:aff id="Aff6">Department of Radiation Oncology, Maastricht University Medical Centre (MAASTRO clinic), Maastricht, The Netherlands</nlm:aff><country xml:lang="fr">Pays-Bas</country><wicri:regionArea>Department of Radiation Oncology, Maastricht University Medical Centre (MAASTRO clinic), Maastricht</wicri:regionArea><wicri:noRegion>Maastricht</wicri:noRegion></affiliation><affiliation wicri:level="1"><nlm:aff id="Aff15">GROW - School for Oncology and Developmental Biology, Maastricht University Medical Centre, Maastricht, The Netherlands</nlm:aff><country xml:lang="fr">Pays-Bas</country><wicri:regionArea>GROW - School for Oncology and Developmental Biology, Maastricht University Medical Centre, Maastricht</wicri:regionArea><wicri:noRegion>Maastricht</wicri:noRegion></affiliation></author><author><name sortKey="Linn, S C" sort="Linn, S C" uniqKey="Linn S" first="S. C." last="Linn">S. C. Linn</name><affiliation wicri:level="3"><nlm:aff id="Aff7">Division of Medical Oncology, Netherlands Cancer Institute, Antoni van Leeuwenhoek Hospital, Amsterdam, The Netherlands</nlm:aff><country xml:lang="fr">Pays-Bas</country><wicri:regionArea>Division of Medical Oncology, Netherlands Cancer Institute, Antoni van Leeuwenhoek Hospital, Amsterdam</wicri:regionArea><placeName><settlement type="city">Amsterdam</settlement><region nuts="2" type="province">Hollande-Septentrionale</region></placeName></affiliation></author><author><name sortKey="Lobbes, M Bi" sort="Lobbes, M Bi" uniqKey="Lobbes M" first="M. Bi" last="Lobbes">M. Bi Lobbes</name><affiliation wicri:level="1"><nlm:aff id="Aff8">Department of Radiology and Nuclear Medicine, Maastricht University Medical Centre, Maastricht, The Netherlands</nlm:aff><country xml:lang="fr">Pays-Bas</country><wicri:regionArea>Department of Radiology and Nuclear Medicine, Maastricht University Medical Centre, Maastricht</wicri:regionArea><wicri:noRegion>Maastricht</wicri:noRegion></affiliation><affiliation wicri:level="1"><nlm:aff id="Aff15">GROW - School for Oncology and Developmental Biology, Maastricht University Medical Centre, Maastricht, The Netherlands</nlm:aff><country xml:lang="fr">Pays-Bas</country><wicri:regionArea>GROW - School for Oncology and Developmental Biology, Maastricht University Medical Centre, Maastricht</wicri:regionArea><wicri:noRegion>Maastricht</wicri:noRegion></affiliation></author><author><name sortKey="Poortmans, P Mp" sort="Poortmans, P Mp" uniqKey="Poortmans P" first="P. Mp" last="Poortmans">P. Mp Poortmans</name><affiliation wicri:level="3"><nlm:aff id="Aff9">Department of Radiation Oncology, Radboud university medical centre, Nijmegen, The Netherlands</nlm:aff><country xml:lang="fr">Pays-Bas</country><wicri:regionArea>Department of Radiation Oncology, Radboud university medical centre, Nijmegen</wicri:regionArea><placeName><settlement type="city">Nimègue</settlement><region type="province" nuts="2">Gueldre</region></placeName></affiliation></author><author><name sortKey="Tjan Heijnen, V Cg" sort="Tjan Heijnen, V Cg" uniqKey="Tjan Heijnen V" first="V. Cg" last="Tjan-Heijnen">V. Cg Tjan-Heijnen</name><affiliation wicri:level="1"><nlm:aff id="Aff10">Division of Medical Oncology, Maastricht University Medical Centre, Maastricht, The Netherlands</nlm:aff><country xml:lang="fr">Pays-Bas</country><wicri:regionArea>Division of Medical Oncology, Maastricht University Medical Centre, Maastricht</wicri:regionArea><wicri:noRegion>Maastricht</wicri:noRegion></affiliation><affiliation wicri:level="1"><nlm:aff id="Aff15">GROW - School for Oncology and Developmental Biology, Maastricht University Medical Centre, Maastricht, The Netherlands</nlm:aff><country xml:lang="fr">Pays-Bas</country><wicri:regionArea>GROW - School for Oncology and Developmental Biology, Maastricht University Medical Centre, Maastricht</wicri:regionArea><wicri:noRegion>Maastricht</wicri:noRegion></affiliation></author><author><name sortKey="Van De Vijver, K Kbt" sort="Van De Vijver, K Kbt" uniqKey="Van De Vijver K" first="K. Kbt" last="Van De Vijver">K. Kbt Van De Vijver</name><affiliation wicri:level="3"><nlm:aff id="Aff11">Department of Pathology, Netherlands Cancer Institute, Antoni van Leeuwenhoek Hospital, Amsterdam, The Netherlands</nlm:aff><country xml:lang="fr">Pays-Bas</country><wicri:regionArea>Department of Pathology, Netherlands Cancer Institute, Antoni van Leeuwenhoek Hospital, Amsterdam</wicri:regionArea><placeName><settlement type="city">Amsterdam</settlement><region nuts="2" type="province">Hollande-Septentrionale</region></placeName></affiliation></author><author><name sortKey="De Vries, J" sort="De Vries, J" uniqKey="De Vries J" first="J." last="De Vries">J. De Vries</name><affiliation wicri:level="1"><nlm:aff id="Aff12">Department of Medical and Clinical Psychology, Tilburg University, Tilburg, The Netherlands</nlm:aff><country xml:lang="fr">Pays-Bas</country><wicri:regionArea>Department of Medical and Clinical Psychology, Tilburg University, Tilburg</wicri:regionArea><wicri:noRegion>Tilburg</wicri:noRegion></affiliation></author><author><name sortKey="Westenberg, A H" sort="Westenberg, A H" uniqKey="Westenberg A" first="A. H." last="Westenberg">A. H. Westenberg</name><affiliation wicri:level="1"><nlm:aff id="Aff13">Radiation Oncology, Arnhem Institute for Radiation Oncology, Arnhem, The Netherlands</nlm:aff><country xml:lang="fr">Pays-Bas</country><wicri:regionArea>Radiation Oncology, Arnhem Institute for Radiation Oncology, Arnhem</wicri:regionArea><wicri:noRegion>Arnhem</wicri:noRegion></affiliation></author><author><name sortKey="Kessels, A Gh" sort="Kessels, A Gh" uniqKey="Kessels A" first="A. Gh" last="Kessels">A. Gh Kessels</name><affiliation wicri:level="1"><nlm:aff id="Aff14">Department of Clinical Epidemiology and Medical Technology Assessment, Maastricht University Medical Centre, Maastricht, The Netherlands</nlm:aff><country xml:lang="fr">Pays-Bas</country><wicri:regionArea>Department of Clinical Epidemiology and Medical Technology Assessment, Maastricht University Medical Centre, Maastricht</wicri:regionArea><wicri:noRegion>Maastricht</wicri:noRegion></affiliation></author><author><name sortKey="Smidt, M L" sort="Smidt, M L" uniqKey="Smidt M" first="M. L." last="Smidt">M. L. Smidt</name><affiliation wicri:level="1"><nlm:aff id="Aff1">Division of Surgical Oncology, Maastricht University Medical Centre, Maastricht, The Netherlands</nlm:aff><country xml:lang="fr">Pays-Bas</country><wicri:regionArea>Division of Surgical Oncology, Maastricht University Medical Centre, Maastricht</wicri:regionArea><wicri:noRegion>Maastricht</wicri:noRegion></affiliation><affiliation wicri:level="1"><nlm:aff id="Aff15">GROW - School for Oncology and Developmental Biology, Maastricht University Medical Centre, Maastricht, The Netherlands</nlm:aff><country xml:lang="fr">Pays-Bas</country><wicri:regionArea>GROW - School for Oncology and Developmental Biology, Maastricht University Medical Centre, Maastricht</wicri:regionArea><wicri:noRegion>Maastricht</wicri:noRegion></affiliation></author></analytic><series><title level="j">BMC Cancer</title><idno type="eISSN">1471-2407</idno><imprint><date when="2015">2015</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en"><sec><title>Background</title><p>Trials failed to demonstrate additional value of completion axillary lymph node dissection in case of limited sentinel lymph node metastases in breast cancer patients undergoing breast conserving therapy. It has been suggested that the low regional recurrence rates in these trials might partially be ascribed to accidental irradiation of part of the axilla by whole breast radiation therapy, which precludes extrapolation of results to mastectomy patients. The aim of the randomized controlled BOOG 2013–07 trial is therefore to investigate whether completion axillary treatment can be safely omitted in sentinel lymph node positive breast cancer patients treated with mastectomy.</p></sec><sec><title>Design</title><p>This study is designed as a non-inferiority randomized controlled multicentre trial. Women aged 18 years or older diagnosed with unilateral invasive clinically T1-2 N0 breast cancer who are treated with mastectomy, and who have a maximum of three axillary sentinel lymph nodes containing micro- and/or macrometastases, will be randomized for completion axillary treatment versus no completion axillary treatment. Completion axillary treatment can consist of completion axillary lymph node dissection or axillary radiation therapy. Primary endpoint is regional recurrence rate at 5 years. Based on a 5-year regional recurrence free survival rate of 98 % among controls and 96 % for study subjects, the sample size amounts 439 per arm (including 10 % lost to follow-up), to be able to reject the null hypothesis that the rate for study and control subjects is inferior by at least 5 % with a probability of 0.8. Results will be reported after 5 and 10 years of follow-up.</p></sec><sec><title>Discussion</title><p>We hypothesize that completion axillary treatment can be safely omitted in sentinel node positive breast cancer patients undergoing mastectomy. If confirmed, this study will significantly decrease the number of breast cancer patients receiving extensive treatment of the axilla, thereby diminishing the risk of morbidity and improving quality of life, while maintaining excellent regional control and without affecting survival.</p></sec><sec><title>Trial registration</title><p>The BOOG 2013–07 study is registered in the register of ClinicalTrials.gov since April 10, 2014, Identifier: <ext-link ext-link-type="uri" xlink:href="https://clinicaltrials.gov/ct2/show/NCT02112682">NCT02112682</ext-link>.</p></sec><sec><title>Electronic supplementary material</title><p>The online version of this article (doi:10.1186/s12885-015-1613-2) contains supplementary material, which is available to authorized users.</p></sec></div></front><back><div1 type="bibliography"><listBibl><biblStruct><analytic><author><name sortKey="Disipio, T" uniqKey="Disipio T">T Disipio</name></author><author><name sortKey="Rye, S" uniqKey="Rye S">S 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sortKey="Strobbe, Lj" uniqKey="Strobbe L">LJ Strobbe</name></author><author><name sortKey="Voogd, Ac" uniqKey="Voogd A">AC Voogd</name></author><author><name sortKey="Tjan Heijnen, Vc" uniqKey="Tjan Heijnen V">VC Tjan-Heijnen</name></author><author><name sortKey="Smidt, Ml" uniqKey="Smidt M">ML Smidt</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Jennison, C" uniqKey="Jennison C">C Jennison</name></author><author><name sortKey="Turnbull, Bw" uniqKey="Turnbull B">BW Turnbull</name></author></analytic></biblStruct></listBibl></div1></back></TEI><affiliations><list><country><li>Pays-Bas</li></country><region><li>Gueldre</li><li>Hollande-Septentrionale</li><li>Utrecht (province)</li></region><settlement><li>Amsterdam</li><li>Nimègue</li><li>Utrecht</li></settlement></list><tree><country name="Pays-Bas"><noRegion><name sortKey="Van Roozendaal, L M" sort="Van Roozendaal, L M" uniqKey="Van Roozendaal L" first="L. M." last="Van Roozendaal">L. M. Van Roozendaal</name></noRegion><name sortKey="Boersma, L J" sort="Boersma, L J" uniqKey="Boersma L" first="L. J." last="Boersma">L. J. Boersma</name><name sortKey="Boersma, L J" sort="Boersma, L J" uniqKey="Boersma L" first="L. J." last="Boersma">L. J. Boersma</name><name sortKey="De Vries, J" sort="De Vries, J" uniqKey="De Vries J" first="J." last="De Vries">J. De Vries</name><name sortKey="De Wilt, J Hw" sort="De Wilt, J Hw" uniqKey="De Wilt J" first="J. Hw" last="De Wilt">J. Hw De Wilt</name><name sortKey="Kessels, A Gh" sort="Kessels, A Gh" uniqKey="Kessels A" first="A. Gh" last="Kessels">A. Gh Kessels</name><name sortKey="Linn, S C" sort="Linn, S C" uniqKey="Linn S" first="S. C." last="Linn">S. C. Linn</name><name sortKey="Lobbes, M Bi" sort="Lobbes, M Bi" uniqKey="Lobbes M" first="M. Bi" last="Lobbes">M. Bi Lobbes</name><name sortKey="Lobbes, M Bi" sort="Lobbes, M Bi" uniqKey="Lobbes M" first="M. Bi" last="Lobbes">M. Bi Lobbes</name><name sortKey="Poortmans, P Mp" sort="Poortmans, P Mp" uniqKey="Poortmans P" first="P. Mp" last="Poortmans">P. Mp Poortmans</name><name sortKey="Smidt, M L" sort="Smidt, M L" uniqKey="Smidt M" first="M. L." last="Smidt">M. L. Smidt</name><name sortKey="Smidt, M L" sort="Smidt, M L" uniqKey="Smidt M" first="M. L." last="Smidt">M. L. Smidt</name><name sortKey="Strobbe, L Ja" sort="Strobbe, L Ja" uniqKey="Strobbe L" first="L. Ja" last="Strobbe">L. Ja Strobbe</name><name sortKey="Tjan Heijnen, V Cg" sort="Tjan Heijnen, V Cg" uniqKey="Tjan Heijnen V" first="V. Cg" last="Tjan-Heijnen">V. Cg Tjan-Heijnen</name><name sortKey="Tjan Heijnen, V Cg" sort="Tjan Heijnen, V Cg" uniqKey="Tjan Heijnen V" first="V. Cg" last="Tjan-Heijnen">V. Cg Tjan-Heijnen</name><name sortKey="Van Dalen, T" sort="Van Dalen, T" uniqKey="Van Dalen T" first="T." last="Van Dalen">T. Van Dalen</name><name sortKey="Van De Vijver, K Kbt" sort="Van De Vijver, K Kbt" uniqKey="Van De Vijver K" first="K. Kbt" last="Van De Vijver">K. Kbt Van De Vijver</name><name sortKey="Van Der Hage, J A" sort="Van Der Hage, J A" uniqKey="Van Der Hage J" first="J. A." last="Van Der Hage">J. A. Van Der Hage</name><name sortKey="Van Roozendaal, L M" sort="Van Roozendaal, L M" uniqKey="Van Roozendaal L" first="L. M." last="Van Roozendaal">L. M. Van Roozendaal</name><name sortKey="Van Roozendaal, L M" sort="Van Roozendaal, L M" uniqKey="Van Roozendaal L" first="L. M." last="Van Roozendaal">L. M. Van Roozendaal</name><name sortKey="Westenberg, A H" sort="Westenberg, A H" uniqKey="Westenberg A" first="A. H." last="Westenberg">A. H. Westenberg</name></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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