Radiotherapy or surgery of the axilla after a positive sentinel node in breast cancer (EORTC 10981-22023 AMAROS): a randomised, multicentre, open-label, phase 3 non-inferiority trial.
Identifieur interne : 001179 ( PubMed/Corpus ); précédent : 001178; suivant : 001180Radiotherapy or surgery of the axilla after a positive sentinel node in breast cancer (EORTC 10981-22023 AMAROS): a randomised, multicentre, open-label, phase 3 non-inferiority trial.
Auteurs : Mila Donker ; Geertjan Van Tienhoven ; Marieke E. Straver ; Philip Meijnen ; Cornelis J H. Van De Velde ; Robert E. Mansel ; Luigi Cataliotti ; A Helen Westenberg ; Jean H G. Klinkenbijl ; Lorenzo Orzalesi ; Willem H. Bouma ; Huub C J. Van Der Mijle ; Grard A P. Nieuwenhuijzen ; Sanne C. Veltkamp ; Leen Slaets ; Nicole J. Duez ; Peter W. De Graaf ; Thijs Van Dalen ; Andreas Marinelli ; Herman Rijna ; Marko Snoj ; Nigel J. Bundred ; Jos W S. Merkus ; Yazid Belkacemi ; Patrick Petignat ; Dominic A X. Schinagl ; Corneel Coens ; Carlo G M. Messina ; Jan Bogaerts ; Emiel J T. RutgersSource :
- The Lancet. Oncology [ 1474-5488 ] ; 2014.
English descriptors
- KwdEn :
- Axilla (surgery), Breast Neoplasms (pathology), Breast Neoplasms (radiotherapy), Breast Neoplasms (surgery), Disease-Free Survival, Europe, Female, Humans, Lymph Nodes (pathology), Lymph Nodes (surgery), Lymphatic Metastasis (pathology), Lymphatic Metastasis (radiotherapy), Middle Aged, Neoplasm Recurrence, Local (pathology), Neoplasm Recurrence, Local (radiotherapy), Neoplasm Recurrence, Local (surgery), Sentinel Lymph Node Biopsy.
- MESH :
- geographic : Europe.
- pathology : Breast Neoplasms, Lymph Nodes, Lymphatic Metastasis, Neoplasm Recurrence, Local.
- radiotherapy : Breast Neoplasms, Lymphatic Metastasis, Neoplasm Recurrence, Local.
- surgery : Axilla, Breast Neoplasms, Lymph Nodes, Neoplasm Recurrence, Local.
- Disease-Free Survival, Female, Humans, Middle Aged, Sentinel Lymph Node Biopsy.
Abstract
If treatment of the axilla is indicated in patients with breast cancer who have a positive sentinel node, axillary lymph node dissection is the present standard. Although axillary lymph node dissection provides excellent regional control, it is associated with harmful side-effects. We aimed to assess whether axillary radiotherapy provides comparable regional control with fewer side-effects.
DOI: 10.1016/S1470-2045(14)70460-7
PubMed: 25439688
Links to Exploration step
pubmed:25439688Le document en format XML
<record><TEI><teiHeader><fileDesc><titleStmt><title xml:lang="en">Radiotherapy or surgery of the axilla after a positive sentinel node in breast cancer (EORTC 10981-22023 AMAROS): a randomised, multicentre, open-label, phase 3 non-inferiority trial.</title><author><name sortKey="Donker, Mila" sort="Donker, Mila" uniqKey="Donker M" first="Mila" last="Donker">Mila Donker</name><affiliation><nlm:affiliation>Department of Surgical Oncology, Netherlands Cancer Institute, Amsterdam, Netherlands.</nlm:affiliation></affiliation></author><author><name sortKey="Van Tienhoven, Geertjan" sort="Van Tienhoven, Geertjan" uniqKey="Van Tienhoven G" first="Geertjan" last="Van Tienhoven">Geertjan Van Tienhoven</name><affiliation><nlm:affiliation>Department of Radiation Oncology, Academic Medical Centre, Amsterdam, Netherlands.</nlm:affiliation></affiliation></author><author><name sortKey="Straver, Marieke E" sort="Straver, Marieke E" uniqKey="Straver M" first="Marieke E" last="Straver">Marieke E. Straver</name><affiliation><nlm:affiliation>Department of Surgical Oncology, Netherlands Cancer Institute, Amsterdam, Netherlands.</nlm:affiliation></affiliation></author><author><name sortKey="Meijnen, Philip" sort="Meijnen, Philip" uniqKey="Meijnen P" first="Philip" last="Meijnen">Philip Meijnen</name><affiliation><nlm:affiliation>Department of Radiation Oncology, Netherlands Cancer Institute, Amsterdam, Netherlands.</nlm:affiliation></affiliation></author><author><name sortKey="Van De Velde, Cornelis J H" sort="Van De Velde, Cornelis J H" uniqKey="Van De Velde C" first="Cornelis J H" last="Van De Velde">Cornelis J H. Van De Velde</name><affiliation><nlm:affiliation>Department of Surgery, University Medical Centre, Leiden, Netherlands.</nlm:affiliation></affiliation></author><author><name sortKey="Mansel, Robert E" sort="Mansel, Robert E" uniqKey="Mansel R" first="Robert E" last="Mansel">Robert E. Mansel</name><affiliation><nlm:affiliation>Department of Surgery, Cardiff University, Cardiff, UK.</nlm:affiliation></affiliation></author><author><name sortKey="Cataliotti, Luigi" sort="Cataliotti, Luigi" uniqKey="Cataliotti L" first="Luigi" last="Cataliotti">Luigi Cataliotti</name><affiliation><nlm:affiliation>Breast Unit, Careggi University Hospital, Florence, Italy.</nlm:affiliation></affiliation></author><author><name sortKey="Westenberg, A Helen" sort="Westenberg, A Helen" uniqKey="Westenberg A" first="A Helen" last="Westenberg">A Helen Westenberg</name><affiliation><nlm:affiliation>Institute for Radiation Oncology Arnhem, Arnhem, Netherlands.</nlm:affiliation></affiliation></author><author><name sortKey="Klinkenbijl, Jean H G" sort="Klinkenbijl, Jean H G" uniqKey="Klinkenbijl J" first="Jean H G" last="Klinkenbijl">Jean H G. Klinkenbijl</name><affiliation><nlm:affiliation>Department of Surgery, Rijnstate Hospital, Arnhem, Netherlands.</nlm:affiliation></affiliation></author><author><name sortKey="Orzalesi, Lorenzo" sort="Orzalesi, Lorenzo" uniqKey="Orzalesi L" first="Lorenzo" last="Orzalesi">Lorenzo Orzalesi</name><affiliation><nlm:affiliation>Breast Unit, Careggi University Hospital, Florence, Italy.</nlm:affiliation></affiliation></author><author><name sortKey="Bouma, Willem H" sort="Bouma, Willem H" uniqKey="Bouma W" first="Willem H" last="Bouma">Willem H. Bouma</name><affiliation><nlm:affiliation>Department of Surgery, Gelre Hospital, Apeldoorn, Netherlands.</nlm:affiliation></affiliation></author><author><name sortKey="Van Der Mijle, Huub C J" sort="Van Der Mijle, Huub C J" uniqKey="Van Der Mijle H" first="Huub C J" last="Van Der Mijle">Huub C J. Van Der Mijle</name><affiliation><nlm:affiliation>Department of Surgery, Nij Smellinghe Hospital, Drachten, Netherlands.</nlm:affiliation></affiliation></author><author><name sortKey="Nieuwenhuijzen, Grard A P" sort="Nieuwenhuijzen, Grard A P" uniqKey="Nieuwenhuijzen G" first="Grard A P" last="Nieuwenhuijzen">Grard A P. Nieuwenhuijzen</name><affiliation><nlm:affiliation>Department of Surgery, Catharina Hospital, Eindhoven, Netherlands.</nlm:affiliation></affiliation></author><author><name sortKey="Veltkamp, Sanne C" sort="Veltkamp, Sanne C" uniqKey="Veltkamp S" first="Sanne C" last="Veltkamp">Sanne C. Veltkamp</name><affiliation><nlm:affiliation>Department of Surgery, Amstelland Hospital, Amstelveen, Netherlands.</nlm:affiliation></affiliation></author><author><name sortKey="Slaets, Leen" sort="Slaets, Leen" uniqKey="Slaets L" first="Leen" last="Slaets">Leen Slaets</name><affiliation><nlm:affiliation>European Organisation for Research and Treatment of Cancer, Brussels, Belgium.</nlm:affiliation></affiliation></author><author><name sortKey="Duez, Nicole J" sort="Duez, Nicole J" uniqKey="Duez N" first="Nicole J" last="Duez">Nicole J. Duez</name><affiliation><nlm:affiliation>European Organisation for Research and Treatment of Cancer, Brussels, Belgium.</nlm:affiliation></affiliation></author><author><name sortKey="De Graaf, Peter W" sort="De Graaf, Peter W" uniqKey="De Graaf P" first="Peter W" last="De Graaf">Peter W. De Graaf</name><affiliation><nlm:affiliation>Department of Surgery, Reinier de Graaf Hospital, Delft, Netherlands.</nlm:affiliation></affiliation></author><author><name sortKey="Van Dalen, Thijs" sort="Van Dalen, Thijs" uniqKey="Van Dalen T" first="Thijs" last="Van Dalen">Thijs Van Dalen</name><affiliation><nlm:affiliation>Department of Radiation Oncology, University Medical Center, Utrecht, Netherlands.</nlm:affiliation></affiliation></author><author><name sortKey="Marinelli, Andreas" sort="Marinelli, Andreas" uniqKey="Marinelli A" first="Andreas" last="Marinelli">Andreas Marinelli</name><affiliation><nlm:affiliation>Department of Surgery, Medical Center Haaglanden, Westeinde, Den Haag, Netherlands.</nlm:affiliation></affiliation></author><author><name sortKey="Rijna, Herman" sort="Rijna, Herman" uniqKey="Rijna H" first="Herman" last="Rijna">Herman Rijna</name><affiliation><nlm:affiliation>Department of Surgery, Kennemer Gasthuis, Haarlem, Netherlands.</nlm:affiliation></affiliation></author><author><name sortKey="Snoj, Marko" sort="Snoj, Marko" uniqKey="Snoj M" first="Marko" last="Snoj">Marko Snoj</name><affiliation><nlm:affiliation>Department of Surgery, Institute of Oncology, Ljubljana, Slovenia.</nlm:affiliation></affiliation></author><author><name sortKey="Bundred, Nigel J" sort="Bundred, Nigel J" uniqKey="Bundred N" first="Nigel J" last="Bundred">Nigel J. Bundred</name><affiliation><nlm:affiliation>Department of Surgery, Manchester University Hospital, Manchester, UK.</nlm:affiliation></affiliation></author><author><name sortKey="Merkus, Jos W S" sort="Merkus, Jos W S" uniqKey="Merkus J" first="Jos W S" last="Merkus">Jos W S. Merkus</name><affiliation><nlm:affiliation>Department of Surgery, Haga Hospital, Den Haag, Netherlands.</nlm:affiliation></affiliation></author><author><name sortKey="Belkacemi, Yazid" sort="Belkacemi, Yazid" uniqKey="Belkacemi Y" first="Yazid" last="Belkacemi">Yazid Belkacemi</name><affiliation><nlm:affiliation>Department of Radiation Oncology, Centre Oscar Lambret, Lille, France.</nlm:affiliation></affiliation></author><author><name sortKey="Petignat, Patrick" sort="Petignat, Patrick" uniqKey="Petignat P" first="Patrick" last="Petignat">Patrick Petignat</name><affiliation><nlm:affiliation>Division of Gynecology, University Hospitals of Geneva, Geneva, Switzerland.</nlm:affiliation></affiliation></author><author><name sortKey="Schinagl, Dominic A X" sort="Schinagl, Dominic A X" uniqKey="Schinagl D" first="Dominic A X" last="Schinagl">Dominic A X. Schinagl</name><affiliation><nlm:affiliation>Department of Radiation Oncology, Radboud University Nijmegen Medical Centre, Nijmegen, Netherlands.</nlm:affiliation></affiliation></author><author><name sortKey="Coens, Corneel" sort="Coens, Corneel" uniqKey="Coens C" first="Corneel" last="Coens">Corneel Coens</name><affiliation><nlm:affiliation>European Organisation for Research and Treatment of Cancer, Brussels, Belgium.</nlm:affiliation></affiliation></author><author><name sortKey="Messina, Carlo G M" sort="Messina, Carlo G M" uniqKey="Messina C" first="Carlo G M" last="Messina">Carlo G M. Messina</name><affiliation><nlm:affiliation>European Organisation for Research and Treatment of Cancer, Brussels, Belgium.</nlm:affiliation></affiliation></author><author><name sortKey="Bogaerts, Jan" sort="Bogaerts, Jan" uniqKey="Bogaerts J" first="Jan" last="Bogaerts">Jan Bogaerts</name><affiliation><nlm:affiliation>European Organisation for Research and Treatment of Cancer, Brussels, Belgium.</nlm:affiliation></affiliation></author><author><name sortKey="Rutgers, Emiel J T" sort="Rutgers, Emiel J T" uniqKey="Rutgers E" first="Emiel J T" last="Rutgers">Emiel J T. Rutgers</name><affiliation><nlm:affiliation>Department of Surgical Oncology, Netherlands Cancer Institute, Amsterdam, Netherlands. Electronic address: e.rutgers@nki.nl.</nlm:affiliation></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">PubMed</idno><date when="2014">2014</date><idno type="RBID">pubmed:25439688</idno><idno type="pmid">25439688</idno><idno type="doi">10.1016/S1470-2045(14)70460-7</idno><idno type="wicri:Area/PubMed/Corpus">001179</idno><idno type="wicri:explorRef" wicri:stream="PubMed" wicri:step="Corpus" wicri:corpus="PubMed">001179</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en">Radiotherapy or surgery of the axilla after a positive sentinel node in breast cancer (EORTC 10981-22023 AMAROS): a randomised, multicentre, open-label, phase 3 non-inferiority trial.</title><author><name sortKey="Donker, Mila" sort="Donker, Mila" uniqKey="Donker M" first="Mila" last="Donker">Mila Donker</name><affiliation><nlm:affiliation>Department of Surgical Oncology, Netherlands Cancer Institute, Amsterdam, Netherlands.</nlm:affiliation></affiliation></author><author><name sortKey="Van Tienhoven, Geertjan" sort="Van Tienhoven, Geertjan" uniqKey="Van Tienhoven G" first="Geertjan" last="Van Tienhoven">Geertjan Van Tienhoven</name><affiliation><nlm:affiliation>Department of Radiation Oncology, Academic Medical Centre, Amsterdam, Netherlands.</nlm:affiliation></affiliation></author><author><name sortKey="Straver, Marieke E" sort="Straver, Marieke E" uniqKey="Straver M" first="Marieke E" last="Straver">Marieke E. Straver</name><affiliation><nlm:affiliation>Department of Surgical Oncology, Netherlands Cancer Institute, Amsterdam, Netherlands.</nlm:affiliation></affiliation></author><author><name sortKey="Meijnen, Philip" sort="Meijnen, Philip" uniqKey="Meijnen P" first="Philip" last="Meijnen">Philip Meijnen</name><affiliation><nlm:affiliation>Department of Radiation Oncology, Netherlands Cancer Institute, Amsterdam, Netherlands.</nlm:affiliation></affiliation></author><author><name sortKey="Van De Velde, Cornelis J H" sort="Van De Velde, Cornelis J H" uniqKey="Van De Velde C" first="Cornelis J H" last="Van De Velde">Cornelis J H. Van De Velde</name><affiliation><nlm:affiliation>Department of Surgery, University Medical Centre, Leiden, Netherlands.</nlm:affiliation></affiliation></author><author><name sortKey="Mansel, Robert E" sort="Mansel, Robert E" uniqKey="Mansel R" first="Robert E" last="Mansel">Robert E. Mansel</name><affiliation><nlm:affiliation>Department of Surgery, Cardiff University, Cardiff, UK.</nlm:affiliation></affiliation></author><author><name sortKey="Cataliotti, Luigi" sort="Cataliotti, Luigi" uniqKey="Cataliotti L" first="Luigi" last="Cataliotti">Luigi Cataliotti</name><affiliation><nlm:affiliation>Breast Unit, Careggi University Hospital, Florence, Italy.</nlm:affiliation></affiliation></author><author><name sortKey="Westenberg, A Helen" sort="Westenberg, A Helen" uniqKey="Westenberg A" first="A Helen" last="Westenberg">A Helen Westenberg</name><affiliation><nlm:affiliation>Institute for Radiation Oncology Arnhem, Arnhem, Netherlands.</nlm:affiliation></affiliation></author><author><name sortKey="Klinkenbijl, Jean H G" sort="Klinkenbijl, Jean H G" uniqKey="Klinkenbijl J" first="Jean H G" last="Klinkenbijl">Jean H G. Klinkenbijl</name><affiliation><nlm:affiliation>Department of Surgery, Rijnstate Hospital, Arnhem, Netherlands.</nlm:affiliation></affiliation></author><author><name sortKey="Orzalesi, Lorenzo" sort="Orzalesi, Lorenzo" uniqKey="Orzalesi L" first="Lorenzo" last="Orzalesi">Lorenzo Orzalesi</name><affiliation><nlm:affiliation>Breast Unit, Careggi University Hospital, Florence, Italy.</nlm:affiliation></affiliation></author><author><name sortKey="Bouma, Willem H" sort="Bouma, Willem H" uniqKey="Bouma W" first="Willem H" last="Bouma">Willem H. Bouma</name><affiliation><nlm:affiliation>Department of Surgery, Gelre Hospital, Apeldoorn, Netherlands.</nlm:affiliation></affiliation></author><author><name sortKey="Van Der Mijle, Huub C J" sort="Van Der Mijle, Huub C J" uniqKey="Van Der Mijle H" first="Huub C J" last="Van Der Mijle">Huub C J. Van Der Mijle</name><affiliation><nlm:affiliation>Department of Surgery, Nij Smellinghe Hospital, Drachten, Netherlands.</nlm:affiliation></affiliation></author><author><name sortKey="Nieuwenhuijzen, Grard A P" sort="Nieuwenhuijzen, Grard A P" uniqKey="Nieuwenhuijzen G" first="Grard A P" last="Nieuwenhuijzen">Grard A P. Nieuwenhuijzen</name><affiliation><nlm:affiliation>Department of Surgery, Catharina Hospital, Eindhoven, Netherlands.</nlm:affiliation></affiliation></author><author><name sortKey="Veltkamp, Sanne C" sort="Veltkamp, Sanne C" uniqKey="Veltkamp S" first="Sanne C" last="Veltkamp">Sanne C. Veltkamp</name><affiliation><nlm:affiliation>Department of Surgery, Amstelland Hospital, Amstelveen, Netherlands.</nlm:affiliation></affiliation></author><author><name sortKey="Slaets, Leen" sort="Slaets, Leen" uniqKey="Slaets L" first="Leen" last="Slaets">Leen Slaets</name><affiliation><nlm:affiliation>European Organisation for Research and Treatment of Cancer, Brussels, Belgium.</nlm:affiliation></affiliation></author><author><name sortKey="Duez, Nicole J" sort="Duez, Nicole J" uniqKey="Duez N" first="Nicole J" last="Duez">Nicole J. Duez</name><affiliation><nlm:affiliation>European Organisation for Research and Treatment of Cancer, Brussels, Belgium.</nlm:affiliation></affiliation></author><author><name sortKey="De Graaf, Peter W" sort="De Graaf, Peter W" uniqKey="De Graaf P" first="Peter W" last="De Graaf">Peter W. De Graaf</name><affiliation><nlm:affiliation>Department of Surgery, Reinier de Graaf Hospital, Delft, Netherlands.</nlm:affiliation></affiliation></author><author><name sortKey="Van Dalen, Thijs" sort="Van Dalen, Thijs" uniqKey="Van Dalen T" first="Thijs" last="Van Dalen">Thijs Van Dalen</name><affiliation><nlm:affiliation>Department of Radiation Oncology, University Medical Center, Utrecht, Netherlands.</nlm:affiliation></affiliation></author><author><name sortKey="Marinelli, Andreas" sort="Marinelli, Andreas" uniqKey="Marinelli A" first="Andreas" last="Marinelli">Andreas Marinelli</name><affiliation><nlm:affiliation>Department of Surgery, Medical Center Haaglanden, Westeinde, Den Haag, Netherlands.</nlm:affiliation></affiliation></author><author><name sortKey="Rijna, Herman" sort="Rijna, Herman" uniqKey="Rijna H" first="Herman" last="Rijna">Herman Rijna</name><affiliation><nlm:affiliation>Department of Surgery, Kennemer Gasthuis, Haarlem, Netherlands.</nlm:affiliation></affiliation></author><author><name sortKey="Snoj, Marko" sort="Snoj, Marko" uniqKey="Snoj M" first="Marko" last="Snoj">Marko Snoj</name><affiliation><nlm:affiliation>Department of Surgery, Institute of Oncology, Ljubljana, Slovenia.</nlm:affiliation></affiliation></author><author><name sortKey="Bundred, Nigel J" sort="Bundred, Nigel J" uniqKey="Bundred N" first="Nigel J" last="Bundred">Nigel J. Bundred</name><affiliation><nlm:affiliation>Department of Surgery, Manchester University Hospital, Manchester, UK.</nlm:affiliation></affiliation></author><author><name sortKey="Merkus, Jos W S" sort="Merkus, Jos W S" uniqKey="Merkus J" first="Jos W S" last="Merkus">Jos W S. Merkus</name><affiliation><nlm:affiliation>Department of Surgery, Haga Hospital, Den Haag, Netherlands.</nlm:affiliation></affiliation></author><author><name sortKey="Belkacemi, Yazid" sort="Belkacemi, Yazid" uniqKey="Belkacemi Y" first="Yazid" last="Belkacemi">Yazid Belkacemi</name><affiliation><nlm:affiliation>Department of Radiation Oncology, Centre Oscar Lambret, Lille, France.</nlm:affiliation></affiliation></author><author><name sortKey="Petignat, Patrick" sort="Petignat, Patrick" uniqKey="Petignat P" first="Patrick" last="Petignat">Patrick Petignat</name><affiliation><nlm:affiliation>Division of Gynecology, University Hospitals of Geneva, Geneva, Switzerland.</nlm:affiliation></affiliation></author><author><name sortKey="Schinagl, Dominic A X" sort="Schinagl, Dominic A X" uniqKey="Schinagl D" first="Dominic A X" last="Schinagl">Dominic A X. Schinagl</name><affiliation><nlm:affiliation>Department of Radiation Oncology, Radboud University Nijmegen Medical Centre, Nijmegen, Netherlands.</nlm:affiliation></affiliation></author><author><name sortKey="Coens, Corneel" sort="Coens, Corneel" uniqKey="Coens C" first="Corneel" last="Coens">Corneel Coens</name><affiliation><nlm:affiliation>European Organisation for Research and Treatment of Cancer, Brussels, Belgium.</nlm:affiliation></affiliation></author><author><name sortKey="Messina, Carlo G M" sort="Messina, Carlo G M" uniqKey="Messina C" first="Carlo G M" last="Messina">Carlo G M. Messina</name><affiliation><nlm:affiliation>European Organisation for Research and Treatment of Cancer, Brussels, Belgium.</nlm:affiliation></affiliation></author><author><name sortKey="Bogaerts, Jan" sort="Bogaerts, Jan" uniqKey="Bogaerts J" first="Jan" last="Bogaerts">Jan Bogaerts</name><affiliation><nlm:affiliation>European Organisation for Research and Treatment of Cancer, Brussels, Belgium.</nlm:affiliation></affiliation></author><author><name sortKey="Rutgers, Emiel J T" sort="Rutgers, Emiel J T" uniqKey="Rutgers E" first="Emiel J T" last="Rutgers">Emiel J T. Rutgers</name><affiliation><nlm:affiliation>Department of Surgical Oncology, Netherlands Cancer Institute, Amsterdam, Netherlands. Electronic address: e.rutgers@nki.nl.</nlm:affiliation></affiliation></author></analytic><series><title level="j">The Lancet. Oncology</title><idno type="eISSN">1474-5488</idno><imprint><date when="2014" type="published">2014</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Axilla (surgery)</term><term>Breast Neoplasms (pathology)</term><term>Breast Neoplasms (radiotherapy)</term><term>Breast Neoplasms (surgery)</term><term>Disease-Free Survival</term><term>Europe</term><term>Female</term><term>Humans</term><term>Lymph Nodes (pathology)</term><term>Lymph Nodes (surgery)</term><term>Lymphatic Metastasis (pathology)</term><term>Lymphatic Metastasis (radiotherapy)</term><term>Middle Aged</term><term>Neoplasm Recurrence, Local (pathology)</term><term>Neoplasm Recurrence, Local (radiotherapy)</term><term>Neoplasm Recurrence, Local (surgery)</term><term>Sentinel Lymph Node Biopsy</term></keywords><keywords scheme="MESH" type="geographic" xml:lang="en"><term>Europe</term></keywords><keywords scheme="MESH" qualifier="pathology" xml:lang="en"><term>Breast Neoplasms</term><term>Lymph Nodes</term><term>Lymphatic Metastasis</term><term>Neoplasm Recurrence, Local</term></keywords><keywords scheme="MESH" qualifier="radiotherapy" xml:lang="en"><term>Breast Neoplasms</term><term>Lymphatic Metastasis</term><term>Neoplasm Recurrence, Local</term></keywords><keywords scheme="MESH" qualifier="surgery" xml:lang="en"><term>Axilla</term><term>Breast Neoplasms</term><term>Lymph Nodes</term><term>Neoplasm Recurrence, Local</term></keywords><keywords scheme="MESH" xml:lang="en"><term>Disease-Free Survival</term><term>Female</term><term>Humans</term><term>Middle Aged</term><term>Sentinel Lymph Node Biopsy</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">If treatment of the axilla is indicated in patients with breast cancer who have a positive sentinel node, axillary lymph node dissection is the present standard. Although axillary lymph node dissection provides excellent regional control, it is associated with harmful side-effects. We aimed to assess whether axillary radiotherapy provides comparable regional control with fewer side-effects.</div></front></TEI><pubmed><MedlineCitation Status="MEDLINE" Owner="NLM"><PMID Version="1">25439688</PMID><DateCreated><Year>2014</Year><Month>12</Month><Day>02</Day></DateCreated><DateCompleted><Year>2015</Year><Month>02</Month><Day>23</Day></DateCompleted><DateRevised><Year>2016</Year><Month>12</Month><Day>15</Day></DateRevised><Article PubModel="Print-Electronic"><Journal><ISSN IssnType="Electronic">1474-5488</ISSN><JournalIssue CitedMedium="Internet"><Volume>15</Volume><Issue>12</Issue><PubDate><Year>2014</Year><Month>Nov</Month></PubDate></JournalIssue><Title>The Lancet. Oncology</Title><ISOAbbreviation>Lancet Oncol.</ISOAbbreviation></Journal><ArticleTitle>Radiotherapy or surgery of the axilla after a positive sentinel node in breast cancer (EORTC 10981-22023 AMAROS): a randomised, multicentre, open-label, phase 3 non-inferiority trial.</ArticleTitle><Pagination><MedlinePgn>1303-10</MedlinePgn></Pagination><ELocationID EIdType="doi" ValidYN="Y">10.1016/S1470-2045(14)70460-7</ELocationID><ELocationID EIdType="pii" ValidYN="Y">S1470-2045(14)70460-7</ELocationID><Abstract><AbstractText Label="BACKGROUND" NlmCategory="BACKGROUND">If treatment of the axilla is indicated in patients with breast cancer who have a positive sentinel node, axillary lymph node dissection is the present standard. Although axillary lymph node dissection provides excellent regional control, it is associated with harmful side-effects. We aimed to assess whether axillary radiotherapy provides comparable regional control with fewer side-effects.</AbstractText><AbstractText Label="METHODS" NlmCategory="METHODS">Patients with T1-2 primary breast cancer and no palpable lymphadenopathy were enrolled in the randomised, multicentre, open-label, phase 3 non-inferiority EORTC 10981-22023 AMAROS trial. Patients were randomly assigned (1:1) by a computer-generated allocation schedule to receive either axillary lymph node dissection or axillary radiotherapy in case of a positive sentinel node, stratified by institution. The primary endpoint was non-inferiority of 5-year axillary recurrence, considered to be not more than 4% for the axillary radiotherapy group compared with an expected 2% in the axillary lymph node dissection group. Analyses were by intention to treat and per protocol. The AMAROS trial is registered with ClinicalTrials.gov, number NCT00014612.</AbstractText><AbstractText Label="FINDINGS" NlmCategory="RESULTS">Between Feb 19, 2001, and April 29, 2010, 4823 patients were enrolled at 34 centres from nine European countries, of whom 4806 were eligible for randomisation. 2402 patients were randomly assigned to receive axillary lymph node dissection and 2404 to receive axillary radiotherapy. Of the 1425 patients with a positive sentinel node, 744 had been randomly assigned to axillary lymph node dissection and 681 to axillary radiotherapy; these patients constituted the intention-to-treat population. Median follow-up was 6·1 years (IQR 4·1-8·0) for the patients with positive sentinel lymph nodes. In the axillary lymph node dissection group, 220 (33%) of 672 patients who underwent axillary lymph node dissection had additional positive nodes. Axillary recurrence occurred in four of 744 patients in the axillary lymph node dissection group and seven of 681 in the axillary radiotherapy group. 5-year axillary recurrence was 0·43% (95% CI 0·00-0·92) after axillary lymph node dissection versus 1·19% (0·31-2·08) after axillary radiotherapy. The planned non-inferiority test was underpowered because of the low number of events. The one-sided 95% CI for the underpowered non-inferiority test on the hazard ratio was 0·00-5·27, with a non-inferiority margin of 2. Lymphoedema in the ipsilateral arm was noted significantly more often after axillary lymph node dissection than after axillary radiotherapy at 1 year, 3 years, and 5 years.</AbstractText><AbstractText Label="INTERPRETATION" NlmCategory="CONCLUSIONS">Axillary lymph node dissection and axillary radiotherapy after a positive sentinel node provide excellent and comparable axillary control for patients with T1-2 primary breast cancer and no palpable lymphadenopathy. Axillary radiotherapy results in significantly less morbidity.</AbstractText><AbstractText Label="FUNDING" NlmCategory="BACKGROUND">EORTC Charitable Trust.</AbstractText><CopyrightInformation>Copyright © 2014 Elsevier Ltd. All rights reserved.</CopyrightInformation></Abstract><AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Donker</LastName><ForeName>Mila</ForeName><Initials>M</Initials><AffiliationInfo><Affiliation>Department of Surgical Oncology, Netherlands Cancer Institute, Amsterdam, Netherlands.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>van Tienhoven</LastName><ForeName>Geertjan</ForeName><Initials>G</Initials><AffiliationInfo><Affiliation>Department of Radiation Oncology, Academic Medical Centre, Amsterdam, Netherlands.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Straver</LastName><ForeName>Marieke E</ForeName><Initials>ME</Initials><AffiliationInfo><Affiliation>Department of Surgical Oncology, Netherlands Cancer Institute, Amsterdam, Netherlands.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Meijnen</LastName><ForeName>Philip</ForeName><Initials>P</Initials><AffiliationInfo><Affiliation>Department of Radiation Oncology, Netherlands Cancer Institute, Amsterdam, Netherlands.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>van de Velde</LastName><ForeName>Cornelis J H</ForeName><Initials>CJ</Initials><AffiliationInfo><Affiliation>Department of Surgery, University Medical Centre, Leiden, Netherlands.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Mansel</LastName><ForeName>Robert E</ForeName><Initials>RE</Initials><AffiliationInfo><Affiliation>Department of Surgery, Cardiff University, Cardiff, UK.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Cataliotti</LastName><ForeName>Luigi</ForeName><Initials>L</Initials><AffiliationInfo><Affiliation>Breast Unit, Careggi University Hospital, Florence, Italy.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Westenberg</LastName><ForeName>A Helen</ForeName><Initials>AH</Initials><AffiliationInfo><Affiliation>Institute for Radiation Oncology Arnhem, Arnhem, Netherlands.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Klinkenbijl</LastName><ForeName>Jean H G</ForeName><Initials>JH</Initials><AffiliationInfo><Affiliation>Department of Surgery, Rijnstate Hospital, Arnhem, Netherlands.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Orzalesi</LastName><ForeName>Lorenzo</ForeName><Initials>L</Initials><AffiliationInfo><Affiliation>Breast Unit, Careggi University Hospital, Florence, Italy.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Bouma</LastName><ForeName>Willem H</ForeName><Initials>WH</Initials><AffiliationInfo><Affiliation>Department of Surgery, Gelre Hospital, Apeldoorn, Netherlands.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>van der Mijle</LastName><ForeName>Huub C J</ForeName><Initials>HC</Initials><AffiliationInfo><Affiliation>Department of Surgery, Nij Smellinghe Hospital, Drachten, Netherlands.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Nieuwenhuijzen</LastName><ForeName>Grard A P</ForeName><Initials>GA</Initials><AffiliationInfo><Affiliation>Department of Surgery, Catharina Hospital, Eindhoven, Netherlands.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Veltkamp</LastName><ForeName>Sanne C</ForeName><Initials>SC</Initials><AffiliationInfo><Affiliation>Department of Surgery, Amstelland Hospital, Amstelveen, Netherlands.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Slaets</LastName><ForeName>Leen</ForeName><Initials>L</Initials><AffiliationInfo><Affiliation>European Organisation for Research and Treatment of Cancer, Brussels, Belgium.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Duez</LastName><ForeName>Nicole J</ForeName><Initials>NJ</Initials><AffiliationInfo><Affiliation>European Organisation for Research and Treatment of Cancer, Brussels, Belgium.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>de Graaf</LastName><ForeName>Peter W</ForeName><Initials>PW</Initials><AffiliationInfo><Affiliation>Department of Surgery, Reinier de Graaf Hospital, Delft, Netherlands.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>van Dalen</LastName><ForeName>Thijs</ForeName><Initials>T</Initials><AffiliationInfo><Affiliation>Department of Radiation Oncology, University Medical Center, Utrecht, Netherlands.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Marinelli</LastName><ForeName>Andreas</ForeName><Initials>A</Initials><AffiliationInfo><Affiliation>Department of Surgery, Medical Center Haaglanden, Westeinde, Den Haag, Netherlands.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Rijna</LastName><ForeName>Herman</ForeName><Initials>H</Initials><AffiliationInfo><Affiliation>Department of Surgery, Kennemer Gasthuis, Haarlem, Netherlands.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Snoj</LastName><ForeName>Marko</ForeName><Initials>M</Initials><AffiliationInfo><Affiliation>Department of Surgery, Institute of Oncology, Ljubljana, Slovenia.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Bundred</LastName><ForeName>Nigel J</ForeName><Initials>NJ</Initials><AffiliationInfo><Affiliation>Department of Surgery, Manchester University Hospital, Manchester, UK.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Merkus</LastName><ForeName>Jos W S</ForeName><Initials>JW</Initials><AffiliationInfo><Affiliation>Department of Surgery, Haga Hospital, Den Haag, Netherlands.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Belkacemi</LastName><ForeName>Yazid</ForeName><Initials>Y</Initials><AffiliationInfo><Affiliation>Department of Radiation Oncology, Centre Oscar Lambret, Lille, France.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Petignat</LastName><ForeName>Patrick</ForeName><Initials>P</Initials><AffiliationInfo><Affiliation>Division of Gynecology, University Hospitals of Geneva, Geneva, Switzerland.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Schinagl</LastName><ForeName>Dominic A X</ForeName><Initials>DA</Initials><AffiliationInfo><Affiliation>Department of Radiation Oncology, Radboud University Nijmegen Medical Centre, Nijmegen, Netherlands.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Coens</LastName><ForeName>Corneel</ForeName><Initials>C</Initials><AffiliationInfo><Affiliation>European Organisation for Research and Treatment of Cancer, Brussels, Belgium.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Messina</LastName><ForeName>Carlo G M</ForeName><Initials>CG</Initials><AffiliationInfo><Affiliation>European Organisation for Research and Treatment of Cancer, Brussels, Belgium.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Bogaerts</LastName><ForeName>Jan</ForeName><Initials>J</Initials><AffiliationInfo><Affiliation>European Organisation for Research and Treatment of Cancer, Brussels, Belgium.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Rutgers</LastName><ForeName>Emiel J T</ForeName><Initials>EJ</Initials><AffiliationInfo><Affiliation>Department of Surgical Oncology, Netherlands Cancer Institute, Amsterdam, Netherlands. Electronic address: e.rutgers@nki.nl.</Affiliation></AffiliationInfo></Author></AuthorList><Language>eng</Language><DataBankList CompleteYN="Y"><DataBank><DataBankName>ClinicalTrials.gov</DataBankName><AccessionNumberList><AccessionNumber>NCT00014612</AccessionNumber></AccessionNumberList></DataBank></DataBankList><GrantList CompleteYN="Y"><Grant><GrantID>U10 CA011488</GrantID><Acronym>CA</Acronym><Agency>NCI NIH HHS</Agency><Country>United States</Country></Grant><Grant><GrantID>2U10 CA11488-28</GrantID><Acronym>CA</Acronym><Agency>NCI NIH HHS</Agency><Country>United States</Country></Grant><Grant><GrantID>5U10 CA011488-38</GrantID><Acronym>CA</Acronym><Agency>NCI NIH HHS</Agency><Country>United States</Country></Grant></GrantList><PublicationTypeList><PublicationType UI="D017428">Clinical Trial, Phase III</PublicationType><PublicationType UI="D016428">Journal Article</PublicationType><PublicationType UI="D016448">Multicenter Study</PublicationType><PublicationType UI="D016449">Randomized Controlled Trial</PublicationType><PublicationType UI="D052061">Research Support, N.I.H., Extramural</PublicationType><PublicationType UI="D013485">Research Support, Non-U.S. Gov't</PublicationType></PublicationTypeList><ArticleDate DateType="Electronic"><Year>2014</Year><Month>10</Month><Day>15</Day></ArticleDate></Article><MedlineJournalInfo><Country>England</Country><MedlineTA>Lancet Oncol</MedlineTA><NlmUniqueID>100957246</NlmUniqueID><ISSNLinking>1470-2045</ISSNLinking></MedlineJournalInfo><CitationSubset>IM</CitationSubset><CommentsCorrectionsList><CommentsCorrections RefType="Cites"><RefSource>Surg Oncol Clin N Am. 2001 Oct;10(4):807-19, ix</RefSource><PMID Version="1">11641092</PMID></CommentsCorrections><CommentsCorrections RefType="Cites"><RefSource>J Clin Oncol. 2008 May 1;26(13):2093-8</RefSource><PMID Version="1">18445838</PMID></CommentsCorrections><CommentsCorrections RefType="Cites"><RefSource>N Engl J Med. 2003 Aug 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