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 : 001837 ( Pmc/Checkpoint ); précédent : 001836; suivant : 001838Radiotherapy 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 [ 1470-2045 ] ; 2014.
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.
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.
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.
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.
EORTC Charitable Trust.
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DOI: 10.1016/S1470-2045(14)70460-7
PubMed: 25439688
PubMed Central: 4291166
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<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></author><author><name sortKey="Van Tienhoven, Geertjan" sort="Van Tienhoven, Geertjan" uniqKey="Van Tienhoven G" first="Geertjan" last="Van Tienhoven">Geertjan Van Tienhoven</name></author><author><name sortKey="Straver, Marieke E" sort="Straver, Marieke E" uniqKey="Straver M" first="Marieke E" last="Straver">Marieke E. Straver</name></author><author><name sortKey="Meijnen, Philip" sort="Meijnen, Philip" uniqKey="Meijnen P" first="Philip" last="Meijnen">Philip Meijnen</name></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></author><author><name sortKey="Mansel, Robert E" sort="Mansel, Robert E" uniqKey="Mansel R" first="Robert E" last="Mansel">Robert E. Mansel</name></author><author><name sortKey="Cataliotti, Luigi" sort="Cataliotti, Luigi" uniqKey="Cataliotti L" first="Luigi" last="Cataliotti">Luigi Cataliotti</name></author><author><name sortKey="Westenberg, A Helen" sort="Westenberg, A Helen" uniqKey="Westenberg A" first="A Helen" last="Westenberg">A Helen Westenberg</name></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></author><author><name sortKey="Orzalesi, Lorenzo" sort="Orzalesi, Lorenzo" uniqKey="Orzalesi L" first="Lorenzo" last="Orzalesi">Lorenzo Orzalesi</name></author><author><name sortKey="Bouma, Willem H" sort="Bouma, Willem H" uniqKey="Bouma W" first="Willem H" last="Bouma">Willem H. Bouma</name></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></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></author><author><name sortKey="Veltkamp, Sanne C" sort="Veltkamp, Sanne C" uniqKey="Veltkamp S" first="Sanne C" last="Veltkamp">Sanne C. 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Merkus</name></author><author><name sortKey="Belkacemi, Yazid" sort="Belkacemi, Yazid" uniqKey="Belkacemi Y" first="Yazid" last="Belkacemi">Yazid Belkacemi</name></author><author><name sortKey="Petignat, Patrick" sort="Petignat, Patrick" uniqKey="Petignat P" first="Patrick" last="Petignat">Patrick Petignat</name></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></author><author><name sortKey="Coens, Corneel" sort="Coens, Corneel" uniqKey="Coens C" first="Corneel" last="Coens">Corneel Coens</name></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. 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Straver</name></author><author><name sortKey="Meijnen, Philip" sort="Meijnen, Philip" uniqKey="Meijnen P" first="Philip" last="Meijnen">Philip Meijnen</name></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></author><author><name sortKey="Mansel, Robert E" sort="Mansel, Robert E" uniqKey="Mansel R" first="Robert E" last="Mansel">Robert E. Mansel</name></author><author><name sortKey="Cataliotti, Luigi" sort="Cataliotti, Luigi" uniqKey="Cataliotti L" first="Luigi" last="Cataliotti">Luigi Cataliotti</name></author><author><name sortKey="Westenberg, A Helen" sort="Westenberg, A Helen" uniqKey="Westenberg A" first="A Helen" last="Westenberg">A Helen Westenberg</name></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></author><author><name sortKey="Orzalesi, Lorenzo" sort="Orzalesi, Lorenzo" uniqKey="Orzalesi L" first="Lorenzo" last="Orzalesi">Lorenzo Orzalesi</name></author><author><name sortKey="Bouma, Willem H" sort="Bouma, Willem H" uniqKey="Bouma W" first="Willem H" last="Bouma">Willem H. Bouma</name></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></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></author><author><name sortKey="Veltkamp, Sanne C" sort="Veltkamp, Sanne C" uniqKey="Veltkamp S" first="Sanne C" last="Veltkamp">Sanne C. Veltkamp</name></author><author><name sortKey="Slaets, Leen" sort="Slaets, Leen" uniqKey="Slaets L" first="Leen" last="Slaets">Leen Slaets</name></author><author><name sortKey="Duez, Nicole J" sort="Duez, Nicole J" uniqKey="Duez N" first="Nicole J" last="Duez">Nicole J. Duez</name></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></author><author><name sortKey="Van Dalen, Thijs" sort="Van Dalen, Thijs" uniqKey="Van Dalen T" first="Thijs" last="Van Dalen">Thijs Van Dalen</name></author><author><name sortKey="Marinelli, Andreas" sort="Marinelli, Andreas" uniqKey="Marinelli A" first="Andreas" last="Marinelli">Andreas Marinelli</name></author><author><name sortKey="Rijna, Herman" sort="Rijna, Herman" uniqKey="Rijna H" first="Herman" last="Rijna">Herman Rijna</name></author><author><name sortKey="Snoj, Marko" sort="Snoj, Marko" uniqKey="Snoj M" first="Marko" last="Snoj">Marko Snoj</name></author><author><name sortKey="Bundred, Nigel J" sort="Bundred, Nigel J" uniqKey="Bundred N" first="Nigel J" last="Bundred">Nigel J. Bundred</name></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></author><author><name sortKey="Belkacemi, Yazid" sort="Belkacemi, Yazid" uniqKey="Belkacemi Y" first="Yazid" last="Belkacemi">Yazid Belkacemi</name></author><author><name sortKey="Petignat, Patrick" sort="Petignat, Patrick" uniqKey="Petignat P" first="Patrick" last="Petignat">Patrick Petignat</name></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></author><author><name sortKey="Coens, Corneel" sort="Coens, Corneel" uniqKey="Coens C" first="Corneel" last="Coens">Corneel Coens</name></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></author><author><name sortKey="Bogaerts, Jan" sort="Bogaerts, Jan" uniqKey="Bogaerts J" first="Jan" last="Bogaerts">Jan Bogaerts</name></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></author></analytic><series><title level="j">The Lancet. Oncology</title><idno type="ISSN">1470-2045</idno><idno type="eISSN">1474-5488</idno><imprint><date when="2014">2014</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en"><title>Summary</title><sec id="S1"><title>Background</title><p id="P3">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.</p></sec><sec id="S2"><title>Methods</title><p id="P4">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.</p></sec><sec id="S3"><title>Findings</title><p id="P5">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.</p></sec><sec id="S4"><title>Interpretation</title><p id="P6">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.</p></sec><sec id="S5"><title>Funding</title><p id="P7">EORTC Charitable Trust.</p></sec></div></front></TEI><pmc article-type="research-article"><pmc-comment>The publisher of this article does not allow downloading of the full text in XML form.</pmc-comment>
<pmc-dir>properties manuscript</pmc-dir>
<front><journal-meta><journal-id journal-id-type="nlm-journal-id">100957246</journal-id><journal-id journal-id-type="pubmed-jr-id">27004</journal-id><journal-id journal-id-type="nlm-ta">Lancet Oncol</journal-id><journal-id journal-id-type="iso-abbrev">Lancet Oncol.</journal-id><journal-title-group><journal-title>The Lancet. Oncology</journal-title></journal-title-group><issn pub-type="ppub">1470-2045</issn><issn pub-type="epub">1474-5488</issn></journal-meta><article-meta><article-id pub-id-type="pmid">25439688</article-id><article-id pub-id-type="pmc">4291166</article-id><article-id pub-id-type="doi">10.1016/S1470-2045(14)70460-7</article-id><article-id pub-id-type="manuscript">NIHMS646194</article-id><article-categories><subj-group subj-group-type="heading"><subject>Article</subject></subj-group></article-categories><title-group><article-title>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</article-title></title-group><contrib-group><contrib contrib-type="author"><name><surname>Donker</surname><given-names>Mila</given-names></name></contrib><contrib contrib-type="author"><name><surname>van Tienhoven</surname><given-names>Geertjan</given-names></name></contrib><contrib contrib-type="author"><name><surname>Straver</surname><given-names>Marieke E</given-names></name></contrib><contrib contrib-type="author"><name><surname>Meijnen</surname><given-names>Philip</given-names></name></contrib><contrib contrib-type="author"><name><surname>van de Velde</surname><given-names>Cornelis J H</given-names></name></contrib><contrib contrib-type="author"><name><surname>Mansel</surname><given-names>Robert E</given-names></name></contrib><contrib contrib-type="author"><name><surname>Cataliotti</surname><given-names>Luigi</given-names></name></contrib><contrib contrib-type="author"><name><surname>Westenberg</surname><given-names>A Helen</given-names></name></contrib><contrib contrib-type="author"><name><surname>Klinkenbijl</surname><given-names>Jean H G</given-names></name></contrib><contrib contrib-type="author"><name><surname>Orzalesi</surname><given-names>Lorenzo</given-names></name></contrib><contrib contrib-type="author"><name><surname>Bouma</surname><given-names>Willem H</given-names></name></contrib><contrib contrib-type="author"><name><surname>van der Mijle</surname><given-names>Huub C J</given-names></name></contrib><contrib contrib-type="author"><name><surname>Nieuwenhuijzen</surname><given-names>Grard A P</given-names></name></contrib><contrib contrib-type="author"><name><surname>Veltkamp</surname><given-names>Sanne C</given-names></name></contrib><contrib contrib-type="author"><name><surname>Slaets</surname><given-names>Leen</given-names></name></contrib><contrib contrib-type="author"><name><surname>Duez</surname><given-names>Nicole J</given-names></name></contrib><contrib contrib-type="author"><name><surname>de Graaf</surname><given-names>Peter W</given-names></name></contrib><contrib contrib-type="author"><name><surname>van Dalen</surname><given-names>Thijs</given-names></name></contrib><contrib contrib-type="author"><name><surname>Marinelli</surname><given-names>Andreas</given-names></name></contrib><contrib contrib-type="author"><name><surname>Rijna</surname><given-names>Herman</given-names></name></contrib><contrib contrib-type="author"><name><surname>Snoj</surname><given-names>Marko</given-names></name></contrib><contrib contrib-type="author"><name><surname>Bundred</surname><given-names>Nigel J</given-names></name></contrib><contrib contrib-type="author"><name><surname>Merkus</surname><given-names>Jos W S</given-names></name></contrib><contrib contrib-type="author"><name><surname>Belkacemi</surname><given-names>Yazid</given-names></name></contrib><contrib contrib-type="author"><name><surname>Petignat</surname><given-names>Patrick</given-names></name></contrib><contrib contrib-type="author"><name><surname>Schinagl</surname><given-names>Dominic A X</given-names></name></contrib><contrib contrib-type="author"><name><surname>Coens</surname><given-names>Corneel</given-names></name></contrib><contrib contrib-type="author"><name><surname>Messina</surname><given-names>Carlo G M</given-names></name></contrib><contrib contrib-type="author"><name><surname>Bogaerts</surname><given-names>Jan</given-names></name></contrib><contrib contrib-type="author"><name><surname>Rutgers</surname><given-names>Emiel J T</given-names></name></contrib><aff id="A1">Department of Surgical Oncology (M Donker MD, M E Straver MD, Prof E J T Rutgers MD), Department of Radiation Oncology (P Meijnen MD), Netherlands Cancer Institute, Amsterdam, Netherlands; Department of Radiation Oncology, Academic Medical Centre, Amsterdam, Netherlands (G van Tienhoven MD); Department of Surgery, University Medical Centre, Leiden, Netherlands (Prof C J H van de Velde MD); Department of Surgery, Cardiff University, Cardiff, UK (Prof R E Mansel MD); Breast Unit, Careggi University Hospital, Florence, Italy (Prof L Cataliotti MD, L Orzalesi MD); Institute for Radiation Oncology Arnhem, Arnhem, Netherlands (A H Westenberg MD); Department of Surgery, Rijnstate Hospital, Arnhem, Netherlands (Prof J H G Klinkenbijl MD); Department of Surgery, Gelre Hospital, Apeldoorn, Netherlands (W H Bouma MD); Department of Surgery, Nij Smellinghe Hospital, Drachten, Netherlands (H C J van der Mijle MD); Department of Surgery, Catharina Hospital, Eindhoven, Netherlands (G A P Nieuwenhuijzen MD); Department of Surgery, Amstelland Hospital, Amstelveen, Netherlands (S C Veltkamp MD); European Organisation for Research and Treatment of Cancer, Brussels, Belgium (L Slaets PhD, N J Duez MSc); Department of Surgery, Reinier de Graaf Hospital, Delft, Netherlands (P W de Graaf MD); Department of Radiation Oncology, University Medical Center, Utrecht, Netherlands (T van Dalen MD); Department of Surgery, Medical Center Haaglanden, Westeinde, Den Haag, Netherlands (A Marinelli MD); Department of Surgery, Kennemer Gasthuis, Haarlem, Netherlands (H Rijna MD); Department of Surgery, Institute of Oncology, Ljubljana, Slovenia (Prof M Snoj MD); Department of Surgery, Manchester University Hospital, Manchester, UK (Prof N J Bundred MD); Department of Surgery, Haga Hospital, Den Haag, Netherlands (J W S Merkus MD); Department of Radiation Oncology, Centre Oscar Lambret, Lille, France (Prof Y Belkacemi MD); Division of Gynecology, University Hospitals of Geneva, Geneva, Switzerland (Prof P Petignat MD); Department of Radiation Oncology, Radboud University Nijmegen Medical Centre, Nijmegen, Netherlands (D A X Schinagl MD); European Organisation for Research and Treatment of Cancer, Brussels, Belgium (C Coens MSc, C G M Messina MD, J Bogaerts PhD)</aff></contrib-group><author-notes><corresp id="CR1">Correspondence to: Prof Emiel J T Rutgers, Department of Surgical, Oncology, Netherlands Cancer, Institute, 1066 CX Amsterdam, Netherlands, <email>e.rutgers@nki.nl</email></corresp><fn id="FN1"><p id="P1"><bold>Contributors</bold></p><p id="P2">CJHvdV and EJTR conceived and designed the trial. GvT, CJHvdV, REM, LC, AHW, JHGK, LO, WHB, HCJvdM, GAPN, SCV, PWdG, TvD, AM, HR, MS, NJB, JWSM, YB, PP, DAXS, and EJTR provided study materials or patients. MD, MES, PM, NJD, and CGMM collected and assembled data. MD, GvT, LS, CC, JB, and EJTR analysed and interpreted data. MD, GvT, LS, JB, and EJTR drafted the manuscript. All authors critically revised the manuscript.</p></fn></author-notes><pub-date pub-type="nihms-submitted"><day>5</day><month>12</month><year>2014</year></pub-date><pub-date pub-type="epub"><day>15</day><month>10</month><year>2014</year></pub-date><pub-date pub-type="ppub"><month>11</month><year>2014</year></pub-date><pub-date pub-type="pmc-release"><day>12</day><month>1</month><year>2015</year></pub-date><volume>15</volume><issue>12</issue><fpage>1303</fpage><lpage>1310</lpage><pmc-comment>elocation-id from pubmed: 10.1016/S1470-2045(14)70460-7</pmc-comment>
<abstract><title>Summary</title><sec id="S1"><title>Background</title><p id="P3">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.</p></sec><sec id="S2"><title>Methods</title><p id="P4">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.</p></sec><sec id="S3"><title>Findings</title><p id="P5">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.</p></sec><sec id="S4"><title>Interpretation</title><p id="P6">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.</p></sec><sec id="S5"><title>Funding</title><p id="P7">EORTC Charitable Trust.</p></sec></abstract></article-meta></front></pmc><affiliations><list></list><tree><noCountry><name sortKey="Belkacemi, Yazid" sort="Belkacemi, Yazid" uniqKey="Belkacemi Y" first="Yazid" last="Belkacemi">Yazid Belkacemi</name><name sortKey="Bogaerts, Jan" sort="Bogaerts, Jan" uniqKey="Bogaerts J" first="Jan" last="Bogaerts">Jan Bogaerts</name><name sortKey="Bouma, Willem H" sort="Bouma, Willem H" uniqKey="Bouma W" first="Willem H" last="Bouma">Willem H. Bouma</name><name sortKey="Bundred, Nigel J" sort="Bundred, Nigel J" uniqKey="Bundred N" first="Nigel J" last="Bundred">Nigel J. Bundred</name><name sortKey="Cataliotti, Luigi" sort="Cataliotti, Luigi" uniqKey="Cataliotti L" first="Luigi" last="Cataliotti">Luigi Cataliotti</name><name sortKey="Coens, Corneel" sort="Coens, Corneel" uniqKey="Coens C" first="Corneel" last="Coens">Corneel Coens</name><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><name sortKey="Donker, Mila" sort="Donker, Mila" uniqKey="Donker M" first="Mila" last="Donker">Mila Donker</name><name sortKey="Duez, Nicole J" sort="Duez, Nicole J" uniqKey="Duez N" first="Nicole J" last="Duez">Nicole J. Duez</name><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><name sortKey="Mansel, Robert E" sort="Mansel, Robert E" uniqKey="Mansel R" first="Robert E" last="Mansel">Robert E. Mansel</name><name sortKey="Marinelli, Andreas" sort="Marinelli, Andreas" uniqKey="Marinelli A" first="Andreas" last="Marinelli">Andreas Marinelli</name><name sortKey="Meijnen, Philip" sort="Meijnen, Philip" uniqKey="Meijnen P" first="Philip" last="Meijnen">Philip Meijnen</name><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><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><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><name sortKey="Orzalesi, Lorenzo" sort="Orzalesi, Lorenzo" uniqKey="Orzalesi L" first="Lorenzo" last="Orzalesi">Lorenzo Orzalesi</name><name sortKey="Petignat, Patrick" sort="Petignat, Patrick" uniqKey="Petignat P" first="Patrick" last="Petignat">Patrick Petignat</name><name sortKey="Rijna, Herman" sort="Rijna, Herman" uniqKey="Rijna H" first="Herman" last="Rijna">Herman Rijna</name><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><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><name sortKey="Slaets, Leen" sort="Slaets, Leen" uniqKey="Slaets L" first="Leen" last="Slaets">Leen Slaets</name><name sortKey="Snoj, Marko" sort="Snoj, Marko" uniqKey="Snoj M" first="Marko" last="Snoj">Marko Snoj</name><name sortKey="Straver, Marieke E" sort="Straver, Marieke E" uniqKey="Straver M" first="Marieke E" last="Straver">Marieke E. Straver</name><name sortKey="Van Dalen, Thijs" sort="Van Dalen, Thijs" uniqKey="Van Dalen T" first="Thijs" last="Van Dalen">Thijs Van Dalen</name><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><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><name sortKey="Van Tienhoven, Geertjan" sort="Van Tienhoven, Geertjan" uniqKey="Van Tienhoven G" first="Geertjan" last="Van Tienhoven">Geertjan Van Tienhoven</name><name sortKey="Veltkamp, Sanne C" sort="Veltkamp, Sanne C" uniqKey="Veltkamp S" first="Sanne C" last="Veltkamp">Sanne C. Veltkamp</name><name sortKey="Westenberg, A Helen" sort="Westenberg, A Helen" uniqKey="Westenberg A" first="A Helen" last="Westenberg">A Helen Westenberg</name></noCountry></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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