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 : 002606 ( Main/Exploration ); précédent : 002605; suivant : 002607Radiotherapy 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.
Descripteurs français
- KwdFr :
- Adulte d'âge moyen, Aisselle (), Biopsie de noeud lymphatique sentinelle, Europe, Femelle, Humains, Métastase lymphatique (anatomopathologie), Métastase lymphatique (radiothérapie), Noeuds lymphatiques (), Noeuds lymphatiques (anatomopathologie), Récidive tumorale locale (), Récidive tumorale locale (anatomopathologie), Récidive tumorale locale (radiothérapie), Survie sans rechute, Tumeurs du sein (), Tumeurs du sein (anatomopathologie), Tumeurs du sein (radiothérapie).
- MESH :
- anatomopathologie : Métastase lymphatique, Noeuds lymphatiques, Récidive tumorale locale, Tumeurs du sein.
- radiothérapie : Métastase lymphatique, Récidive tumorale locale, Tumeurs du sein.
- Adulte d'âge moyen, Aisselle, Biopsie de noeud lymphatique sentinelle, Europe, Femelle, Humains, Noeuds lymphatiques, Récidive tumorale locale, Survie sans rechute, Tumeurs du sein.
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.
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.
Url:
DOI: 10.1016/S1470-2045(14)70460-7
PubMed: 25439688
PubMed Central: 4291166
Affiliations:
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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><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="KwdFr" xml:lang="fr"><term>Adulte d'âge moyen</term><term>Aisselle ()</term><term>Biopsie de noeud lymphatique sentinelle</term><term>Europe</term><term>Femelle</term><term>Humains</term><term>Métastase lymphatique (anatomopathologie)</term><term>Métastase lymphatique (radiothérapie)</term><term>Noeuds lymphatiques ()</term><term>Noeuds lymphatiques (anatomopathologie)</term><term>Récidive tumorale locale ()</term><term>Récidive tumorale locale (anatomopathologie)</term><term>Récidive tumorale locale (radiothérapie)</term><term>Survie sans rechute</term><term>Tumeurs du sein ()</term><term>Tumeurs du sein (anatomopathologie)</term><term>Tumeurs du sein (radiothérapie)</term></keywords><keywords scheme="MESH" type="geographic" xml:lang="en"><term>Europe</term></keywords><keywords scheme="MESH" qualifier="anatomopathologie" xml:lang="fr"><term>Métastase lymphatique</term><term>Noeuds lymphatiques</term><term>Récidive tumorale locale</term><term>Tumeurs du sein</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="radiothérapie" xml:lang="fr"><term>Métastase lymphatique</term><term>Récidive tumorale locale</term><term>Tumeurs du sein</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><keywords scheme="MESH" xml:lang="fr"><term>Adulte d'âge moyen</term><term>Aisselle</term><term>Biopsie de noeud lymphatique sentinelle</term><term>Europe</term><term>Femelle</term><term>Humains</term><term>Noeuds lymphatiques</term><term>Récidive tumorale locale</term><term>Survie sans rechute</term><term>Tumeurs du sein</term></keywords></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><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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