IBCSG 23-01 randomised controlled trial comparing axillary dissection versus no axillary dissection in patients with sentinel node micrometastases
Identifieur interne : 003448 ( Pmc/Corpus ); précédent : 003447; suivant : 003449IBCSG 23-01 randomised controlled trial comparing axillary dissection versus no axillary dissection in patients with sentinel node micrometastases
Auteurs : Viviana Galimberti ; Bernard F. Cole ; Stefano Zurrida ; Giuseppe Viale ; Alberto Luini ; Paolo Veronesi ; Paola Baratella ; Camelia Chifu ; Manuela Sargenti ; Mattia Intra ; Oreste Gentilini ; Mauro G. Mastropasqua ; Giovanni Mazzarol ; Samuele Massarut ; Jean-Remi Garbay ; Janez Zgajnar ; Hanne Galatius ; Angelo Recalcati ; David Littlejohn ; Monika Bamert ; Marco Colleoni ; Karen N. Price ; Meredith M. Regan ; Aron Goldhirsch ; Alan S. Coates ; Richard D. Gelber ; Umberto VeronesiSource :
- The lancet oncology [ 1470-2045 ] ; 2013.
Abstract
For breast cancer patients with a metastatic sentinel node (SN), axillary dissection (AD) has been standard treatment. However, for patients with minimal SN involvement, AD may be overtreatment. IBCSG Trial 23-01 was designed to determine whether no AD is non-inferior to AD in patients with one or more micrometastatic (≤2 mm) SNs and tumour ≤5 cm.
In this multicentre trial patients were randomised to AD or no AD. Eligibility was limited to patients with clinically-palpable axillary lymph node(s) and a primary tumour ≤ 5 cm who, after sentinel node biopsy, had one or more micrometastatic (≤ 2 mm) sentinel lymphs nodes with no extracapsular extension. The primary endpoint was disease-free survival (DFS). Non-inferiority was defined as a hazard ratio of <1·25 for no AD vs. AD. The analysis was intention to treat. Patients were randomly allocated in a 1:1 ratio to AD or no AD with stratification by centre and menopausal status. There was no attempt to blind the treatment assignment. The trial is registered with ClinicalTrials.gov, NCT00072293. Per protocol, disease and survival information continues to be collected yearly.
From 2001 to 2010, 934 patients were randomised; 931 were evaluable (464 in the AD group and 467 in the no AD group). After a median follow-up of 5·0 (IQR 3.6–7.3) years, there were 124 DFS events, including breast-cancer-related events in 95 patients (local, 18; contralateral breast, 12; regional, 6; and distant, 59), and other events in 29 (second malignancy, 26; death without prior cancer event, 3). Five-year DFS was 87·8% (95% CI 84·4%–91·2%) in the no AD group and 84·4% (95% CI 80·7%–88·1%) in the AD group (log-rank p=0·16) (HR no AD vs. AD=0·78, 95% CI 0·55–1·11, non-inferiority p=0·0042). Patients with reported long-term surgical events (grade 3–4) included 1 sensory neuropathy (grade 3), 3 lymphedema (2 grade 3 and 1 grade 4), and 3 motor neuropathy (grade 3), all in the AD group, and 1 grade 3 motor neuropathy in the no AD group. One serious adverse event was reported, a post-operative infection in the axilla in the AD group.
AD in patients with early breast cancer represented in this study (most had tumours < 3 cm (92%; 856/931), received breast conserving surgery (91%; 845/931) and adjuvant systemic therapy (96%; 892/931)) should be avoided when the SN is minimally involved, thus eliminating complications of axillary surgery with no adverse effect on survival.
Supported in part: local participating centres, IBCSG central funds, CA075362 from the U.S. National Cancer Institute, and Swiss Cancer League/Cancer Research- Switzerland/Oncosuisse (ICPOCS 01688-03-2005). No pharmaceutical company funds were used.
Url:
DOI: 10.1016/S1470-2045(13)70035-4
PubMed: 23491275
PubMed Central: 3935346
Links to Exploration step
PMC:3935346Le document en format XML
<record><TEI><teiHeader><fileDesc><titleStmt><title xml:lang="en">IBCSG 23-01 randomised controlled trial comparing axillary dissection versus no axillary dissection in patients with sentinel node micrometastases</title><author><name sortKey="Galimberti, Viviana" sort="Galimberti, Viviana" uniqKey="Galimberti V" first="Viviana" last="Galimberti">Viviana Galimberti</name><affiliation><nlm:aff id="A1">Molecular Senology Unit, Senology Division, European Institute of Oncology, Via Ripamonti, 435, 20141 Milan, Italy</nlm:aff></affiliation></author><author><name sortKey="Cole, Bernard F" sort="Cole, Bernard F" uniqKey="Cole B" first="Bernard F." last="Cole">Bernard F. Cole</name><affiliation><nlm:aff id="A2">Department of Mathematics and Statistics, College of Engineering and Mathematical Sciences, University of Vermont, 33 Colchester Ave, Burlington, VT, 05405, USA</nlm:aff></affiliation><affiliation><nlm:aff id="A3">IBCSG Statistical Center, Department of Biostatistics and Computational Biology, Dana-Farber Cancer Institute, 450 Brookline Ave, Boston, MA, 02215, USA</nlm:aff></affiliation></author><author><name sortKey="Zurrida, Stefano" sort="Zurrida, Stefano" uniqKey="Zurrida S" first="Stefano" last="Zurrida">Stefano Zurrida</name><affiliation><nlm:aff id="A4">Breast Diagnosis and Surgery Unit, Senology Division, European Institute of Oncology, Via Ripamonti, 435, 20141 Milan, Italy</nlm:aff></affiliation></author><author><name sortKey="Viale, Giuseppe" sort="Viale, Giuseppe" uniqKey="Viale G" first="Giuseppe" last="Viale">Giuseppe Viale</name><affiliation><nlm:aff id="A5">IBCSG Central Pathology Office, Division of Pathology and Laboratory Medicine, European Institute of Oncology, Via Ripamonti, 435, 20141 Milan, Italy</nlm:aff></affiliation><affiliation><nlm:aff id="A6">University of Milan, Milan, Italy</nlm:aff></affiliation></author><author><name sortKey="Luini, Alberto" sort="Luini, Alberto" uniqKey="Luini A" first="Alberto" last="Luini">Alberto Luini</name><affiliation><nlm:aff id="A7">Senology Division, European Institute of Oncology, Via Ripamonti, 435, 20141 Milan, Italy</nlm:aff></affiliation></author><author><name sortKey="Veronesi, Paolo" sort="Veronesi, Paolo" uniqKey="Veronesi P" first="Paolo" last="Veronesi">Paolo Veronesi</name><affiliation><nlm:aff id="A6">University of Milan, Milan, Italy</nlm:aff></affiliation><affiliation><nlm:aff id="A8">Integrated Breast Surgery Unit, Senology Division, European Institute of Oncology, Via Ripamonti, 435, 20141 Milan, Italy</nlm:aff></affiliation></author><author><name sortKey="Baratella, Paola" sort="Baratella, Paola" uniqKey="Baratella P" first="Paola" last="Baratella">Paola Baratella</name><affiliation><nlm:aff id="A7">Senology Division, European Institute of Oncology, Via Ripamonti, 435, 20141 Milan, Italy</nlm:aff></affiliation></author><author><name sortKey="Chifu, Camelia" sort="Chifu, Camelia" uniqKey="Chifu C" first="Camelia" last="Chifu">Camelia Chifu</name><affiliation><nlm:aff id="A7">Senology Division, European Institute of Oncology, Via Ripamonti, 435, 20141 Milan, Italy</nlm:aff></affiliation></author><author><name sortKey="Sargenti, Manuela" sort="Sargenti, Manuela" uniqKey="Sargenti M" first="Manuela" last="Sargenti">Manuela Sargenti</name><affiliation><nlm:aff id="A7">Senology Division, European Institute of Oncology, Via Ripamonti, 435, 20141 Milan, Italy</nlm:aff></affiliation></author><author><name sortKey="Intra, Mattia" sort="Intra, Mattia" uniqKey="Intra M" first="Mattia" last="Intra">Mattia Intra</name><affiliation><nlm:aff id="A7">Senology Division, European Institute of Oncology, Via Ripamonti, 435, 20141 Milan, Italy</nlm:aff></affiliation></author><author><name sortKey="Gentilini, Oreste" sort="Gentilini, Oreste" uniqKey="Gentilini O" first="Oreste" last="Gentilini">Oreste Gentilini</name><affiliation><nlm:aff id="A7">Senology Division, European Institute of Oncology, Via Ripamonti, 435, 20141 Milan, Italy</nlm:aff></affiliation></author><author><name sortKey="Mastropasqua, Mauro G" sort="Mastropasqua, Mauro G" uniqKey="Mastropasqua M" first="Mauro G." last="Mastropasqua">Mauro G. Mastropasqua</name><affiliation><nlm:aff id="A5">IBCSG Central Pathology Office, Division of Pathology and Laboratory Medicine, European Institute of Oncology, Via Ripamonti, 435, 20141 Milan, Italy</nlm:aff></affiliation></author><author><name sortKey="Mazzarol, Giovanni" sort="Mazzarol, Giovanni" uniqKey="Mazzarol G" first="Giovanni" last="Mazzarol">Giovanni Mazzarol</name><affiliation><nlm:aff id="A5">IBCSG Central Pathology Office, Division of Pathology and Laboratory Medicine, European Institute of Oncology, Via Ripamonti, 435, 20141 Milan, Italy</nlm:aff></affiliation></author><author><name sortKey="Massarut, Samuele" sort="Massarut, Samuele" uniqKey="Massarut S" first="Samuele" last="Massarut">Samuele Massarut</name><affiliation><nlm:aff id="A9">Breast Surgery Division, Centro di Riferimento Oncologico, Via Franco Gallini 2, I-33081 Aviano, Italy</nlm:aff></affiliation></author><author><name sortKey="Garbay, Jean Remi" sort="Garbay, Jean Remi" uniqKey="Garbay J" first="Jean-Remi" last="Garbay">Jean-Remi Garbay</name><affiliation><nlm:aff id="A10">Department of Surgery, Institut Gustave Roussy, 114 rue E. Vaillant, 94805 Villejuif, France</nlm:aff></affiliation></author><author><name sortKey="Zgajnar, Janez" sort="Zgajnar, Janez" uniqKey="Zgajnar J" first="Janez" last="Zgajnar">Janez Zgajnar</name><affiliation><nlm:aff id="A11">Department of Surgical Oncology, Institute of Oncology, Zaloska 5, 1000 Ljubljana, Slovenia</nlm:aff></affiliation></author><author><name sortKey="Galatius, Hanne" sort="Galatius, Hanne" uniqKey="Galatius H" first="Hanne" last="Galatius">Hanne Galatius</name><affiliation><nlm:aff id="A12">Department of Breastsurgery F118, Herlev Hospital, 2730 Herlev, Denmark</nlm:aff></affiliation></author><author><name sortKey="Recalcati, Angelo" sort="Recalcati, Angelo" uniqKey="Recalcati A" first="Angelo" last="Recalcati">Angelo Recalcati</name><affiliation><nlm:aff id="A13">Department of Surgery, Ospedale ‘Alessandro Manzoni,’ Via dell’Eremo, 9/11, I-23900, Lecco, Italy</nlm:aff></affiliation></author><author><name sortKey="Littlejohn, David" sort="Littlejohn, David" uniqKey="Littlejohn D" first="David" last="Littlejohn">David Littlejohn</name><affiliation><nlm:aff id="A14">Riverina Cancer Care Centre, 31 Meurant Avenue, Wagga Wagga, NSW 2650, Australia</nlm:aff></affiliation></author><author><name sortKey="Bamert, Monika" sort="Bamert, Monika" uniqKey="Bamert M" first="Monika" last="Bamert">Monika Bamert</name><affiliation><nlm:aff id="A15">Breast Center, Kantonsspital, 9007 St. Gallen, Switzerland</nlm:aff></affiliation></author><author><name sortKey="Colleoni, Marco" sort="Colleoni, Marco" uniqKey="Colleoni M" first="Marco" last="Colleoni">Marco Colleoni</name><affiliation><nlm:aff id="A16">Research Unit in Medical Senology, Department of Medicine, European Institute of Oncology, Milan, Italy</nlm:aff></affiliation></author><author><name sortKey="Price, Karen N" sort="Price, Karen N" uniqKey="Price K" first="Karen N." last="Price">Karen N. Price</name><affiliation><nlm:aff id="A3">IBCSG Statistical Center, Department of Biostatistics and Computational Biology, Dana-Farber Cancer Institute, 450 Brookline Ave, Boston, MA, 02215, USA</nlm:aff></affiliation><affiliation><nlm:aff id="A17">Frontier Science and Technology Research Foundation, Boston, MA, USA</nlm:aff></affiliation></author><author><name sortKey="Regan, Meredith M" sort="Regan, Meredith M" uniqKey="Regan M" first="Meredith M." last="Regan">Meredith M. Regan</name><affiliation><nlm:aff id="A3">IBCSG Statistical Center, Department of Biostatistics and Computational Biology, Dana-Farber Cancer Institute, 450 Brookline Ave, Boston, MA, 02215, USA</nlm:aff></affiliation><affiliation><nlm:aff id="A18">Harvard Medical School, Boston, MA, USA</nlm:aff></affiliation></author><author><name sortKey="Goldhirsch, Aron" sort="Goldhirsch, Aron" uniqKey="Goldhirsch A" first="Aron" last="Goldhirsch">Aron Goldhirsch</name><affiliation><nlm:aff id="A19">Department of Medicine. European Institute of Oncology, Via Ripamonti, 435, 20141 Milan, Italy</nlm:aff></affiliation></author><author><name sortKey="Coates, Alan S" sort="Coates, Alan S" uniqKey="Coates A" first="Alan S." last="Coates">Alan S. Coates</name><affiliation><nlm:aff id="A20">International Breast Cancer Study Group and University of Sydney, 40 Cook Rd, Centennial Park, NSW 2021, Australia</nlm:aff></affiliation></author><author><name sortKey="Gelber, Richard D" sort="Gelber, Richard D" uniqKey="Gelber R" first="Richard D." last="Gelber">Richard D. Gelber</name><affiliation><nlm:aff id="A3">IBCSG Statistical Center, Department of Biostatistics and Computational Biology, Dana-Farber Cancer Institute, 450 Brookline Ave, Boston, MA, 02215, USA</nlm:aff></affiliation><affiliation><nlm:aff id="A17">Frontier Science and Technology Research Foundation, Boston, MA, USA</nlm:aff></affiliation><affiliation><nlm:aff id="A18">Harvard Medical School, Boston, MA, USA</nlm:aff></affiliation><affiliation><nlm:aff id="A21">Harvard School of Public Health, Boston, MA, USA</nlm:aff></affiliation></author><author><name sortKey="Veronesi, Umberto" sort="Veronesi, Umberto" uniqKey="Veronesi U" first="Umberto" last="Veronesi">Umberto Veronesi</name><affiliation><nlm:aff id="A22">European Institute of Oncology, Via Ripamonti, 435, 20141 Milan, Italy</nlm:aff></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">PMC</idno><idno type="pmid">23491275</idno><idno type="pmc">3935346</idno><idno type="url">http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3935346</idno><idno type="RBID">PMC:3935346</idno><idno type="doi">10.1016/S1470-2045(13)70035-4</idno><date when="2013">2013</date><idno type="wicri:Area/Pmc/Corpus">003448</idno><idno type="wicri:explorRef" wicri:stream="Pmc" wicri:step="Corpus" wicri:corpus="PMC">003448</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en" level="a" type="main">IBCSG 23-01 randomised controlled trial comparing axillary dissection versus no axillary dissection in patients with sentinel node micrometastases</title><author><name sortKey="Galimberti, Viviana" sort="Galimberti, Viviana" uniqKey="Galimberti V" first="Viviana" last="Galimberti">Viviana Galimberti</name><affiliation><nlm:aff id="A1">Molecular Senology Unit, Senology Division, European Institute of Oncology, Via Ripamonti, 435, 20141 Milan, Italy</nlm:aff></affiliation></author><author><name sortKey="Cole, Bernard F" sort="Cole, Bernard F" uniqKey="Cole B" first="Bernard F." last="Cole">Bernard F. Cole</name><affiliation><nlm:aff id="A2">Department of Mathematics and Statistics, College of Engineering and Mathematical Sciences, University of Vermont, 33 Colchester Ave, Burlington, VT, 05405, USA</nlm:aff></affiliation><affiliation><nlm:aff id="A3">IBCSG Statistical Center, Department of Biostatistics and Computational Biology, Dana-Farber Cancer Institute, 450 Brookline Ave, Boston, MA, 02215, USA</nlm:aff></affiliation></author><author><name sortKey="Zurrida, Stefano" sort="Zurrida, Stefano" uniqKey="Zurrida S" first="Stefano" last="Zurrida">Stefano Zurrida</name><affiliation><nlm:aff id="A4">Breast Diagnosis and Surgery Unit, Senology Division, European Institute of Oncology, Via Ripamonti, 435, 20141 Milan, Italy</nlm:aff></affiliation></author><author><name sortKey="Viale, Giuseppe" sort="Viale, Giuseppe" uniqKey="Viale G" first="Giuseppe" last="Viale">Giuseppe Viale</name><affiliation><nlm:aff id="A5">IBCSG Central Pathology Office, Division of Pathology and Laboratory Medicine, European Institute of Oncology, Via Ripamonti, 435, 20141 Milan, Italy</nlm:aff></affiliation><affiliation><nlm:aff id="A6">University of Milan, Milan, Italy</nlm:aff></affiliation></author><author><name sortKey="Luini, Alberto" sort="Luini, Alberto" uniqKey="Luini A" first="Alberto" last="Luini">Alberto Luini</name><affiliation><nlm:aff id="A7">Senology Division, European Institute of Oncology, Via Ripamonti, 435, 20141 Milan, Italy</nlm:aff></affiliation></author><author><name sortKey="Veronesi, Paolo" sort="Veronesi, Paolo" uniqKey="Veronesi P" first="Paolo" last="Veronesi">Paolo Veronesi</name><affiliation><nlm:aff id="A6">University of Milan, Milan, Italy</nlm:aff></affiliation><affiliation><nlm:aff id="A8">Integrated Breast Surgery Unit, Senology Division, European Institute of Oncology, Via Ripamonti, 435, 20141 Milan, Italy</nlm:aff></affiliation></author><author><name sortKey="Baratella, Paola" sort="Baratella, Paola" uniqKey="Baratella P" first="Paola" last="Baratella">Paola Baratella</name><affiliation><nlm:aff id="A7">Senology Division, European Institute of Oncology, Via Ripamonti, 435, 20141 Milan, Italy</nlm:aff></affiliation></author><author><name sortKey="Chifu, Camelia" sort="Chifu, Camelia" uniqKey="Chifu C" first="Camelia" last="Chifu">Camelia Chifu</name><affiliation><nlm:aff id="A7">Senology Division, European Institute of Oncology, Via Ripamonti, 435, 20141 Milan, Italy</nlm:aff></affiliation></author><author><name sortKey="Sargenti, Manuela" sort="Sargenti, Manuela" uniqKey="Sargenti M" first="Manuela" last="Sargenti">Manuela Sargenti</name><affiliation><nlm:aff id="A7">Senology Division, European Institute of Oncology, Via Ripamonti, 435, 20141 Milan, Italy</nlm:aff></affiliation></author><author><name sortKey="Intra, Mattia" sort="Intra, Mattia" uniqKey="Intra M" first="Mattia" last="Intra">Mattia Intra</name><affiliation><nlm:aff id="A7">Senology Division, European Institute of Oncology, Via Ripamonti, 435, 20141 Milan, Italy</nlm:aff></affiliation></author><author><name sortKey="Gentilini, Oreste" sort="Gentilini, Oreste" uniqKey="Gentilini O" first="Oreste" last="Gentilini">Oreste Gentilini</name><affiliation><nlm:aff id="A7">Senology Division, European Institute of Oncology, Via Ripamonti, 435, 20141 Milan, Italy</nlm:aff></affiliation></author><author><name sortKey="Mastropasqua, Mauro G" sort="Mastropasqua, Mauro G" uniqKey="Mastropasqua M" first="Mauro G." last="Mastropasqua">Mauro G. Mastropasqua</name><affiliation><nlm:aff id="A5">IBCSG Central Pathology Office, Division of Pathology and Laboratory Medicine, European Institute of Oncology, Via Ripamonti, 435, 20141 Milan, Italy</nlm:aff></affiliation></author><author><name sortKey="Mazzarol, Giovanni" sort="Mazzarol, Giovanni" uniqKey="Mazzarol G" first="Giovanni" last="Mazzarol">Giovanni Mazzarol</name><affiliation><nlm:aff id="A5">IBCSG Central Pathology Office, Division of Pathology and Laboratory Medicine, European Institute of Oncology, Via Ripamonti, 435, 20141 Milan, Italy</nlm:aff></affiliation></author><author><name sortKey="Massarut, Samuele" sort="Massarut, Samuele" uniqKey="Massarut S" first="Samuele" last="Massarut">Samuele Massarut</name><affiliation><nlm:aff id="A9">Breast Surgery Division, Centro di Riferimento Oncologico, Via Franco Gallini 2, I-33081 Aviano, Italy</nlm:aff></affiliation></author><author><name sortKey="Garbay, Jean Remi" sort="Garbay, Jean Remi" uniqKey="Garbay J" first="Jean-Remi" last="Garbay">Jean-Remi Garbay</name><affiliation><nlm:aff id="A10">Department of Surgery, Institut Gustave Roussy, 114 rue E. Vaillant, 94805 Villejuif, France</nlm:aff></affiliation></author><author><name sortKey="Zgajnar, Janez" sort="Zgajnar, Janez" uniqKey="Zgajnar J" first="Janez" last="Zgajnar">Janez Zgajnar</name><affiliation><nlm:aff id="A11">Department of Surgical Oncology, Institute of Oncology, Zaloska 5, 1000 Ljubljana, Slovenia</nlm:aff></affiliation></author><author><name sortKey="Galatius, Hanne" sort="Galatius, Hanne" uniqKey="Galatius H" first="Hanne" last="Galatius">Hanne Galatius</name><affiliation><nlm:aff id="A12">Department of Breastsurgery F118, Herlev Hospital, 2730 Herlev, Denmark</nlm:aff></affiliation></author><author><name sortKey="Recalcati, Angelo" sort="Recalcati, Angelo" uniqKey="Recalcati A" first="Angelo" last="Recalcati">Angelo Recalcati</name><affiliation><nlm:aff id="A13">Department of Surgery, Ospedale ‘Alessandro Manzoni,’ Via dell’Eremo, 9/11, I-23900, Lecco, Italy</nlm:aff></affiliation></author><author><name sortKey="Littlejohn, David" sort="Littlejohn, David" uniqKey="Littlejohn D" first="David" last="Littlejohn">David Littlejohn</name><affiliation><nlm:aff id="A14">Riverina Cancer Care Centre, 31 Meurant Avenue, Wagga Wagga, NSW 2650, Australia</nlm:aff></affiliation></author><author><name sortKey="Bamert, Monika" sort="Bamert, Monika" uniqKey="Bamert M" first="Monika" last="Bamert">Monika Bamert</name><affiliation><nlm:aff id="A15">Breast Center, Kantonsspital, 9007 St. Gallen, Switzerland</nlm:aff></affiliation></author><author><name sortKey="Colleoni, Marco" sort="Colleoni, Marco" uniqKey="Colleoni M" first="Marco" last="Colleoni">Marco Colleoni</name><affiliation><nlm:aff id="A16">Research Unit in Medical Senology, Department of Medicine, European Institute of Oncology, Milan, Italy</nlm:aff></affiliation></author><author><name sortKey="Price, Karen N" sort="Price, Karen N" uniqKey="Price K" first="Karen N." last="Price">Karen N. Price</name><affiliation><nlm:aff id="A3">IBCSG Statistical Center, Department of Biostatistics and Computational Biology, Dana-Farber Cancer Institute, 450 Brookline Ave, Boston, MA, 02215, USA</nlm:aff></affiliation><affiliation><nlm:aff id="A17">Frontier Science and Technology Research Foundation, Boston, MA, USA</nlm:aff></affiliation></author><author><name sortKey="Regan, Meredith M" sort="Regan, Meredith M" uniqKey="Regan M" first="Meredith M." last="Regan">Meredith M. Regan</name><affiliation><nlm:aff id="A3">IBCSG Statistical Center, Department of Biostatistics and Computational Biology, Dana-Farber Cancer Institute, 450 Brookline Ave, Boston, MA, 02215, USA</nlm:aff></affiliation><affiliation><nlm:aff id="A18">Harvard Medical School, Boston, MA, USA</nlm:aff></affiliation></author><author><name sortKey="Goldhirsch, Aron" sort="Goldhirsch, Aron" uniqKey="Goldhirsch A" first="Aron" last="Goldhirsch">Aron Goldhirsch</name><affiliation><nlm:aff id="A19">Department of Medicine. European Institute of Oncology, Via Ripamonti, 435, 20141 Milan, Italy</nlm:aff></affiliation></author><author><name sortKey="Coates, Alan S" sort="Coates, Alan S" uniqKey="Coates A" first="Alan S." last="Coates">Alan S. Coates</name><affiliation><nlm:aff id="A20">International Breast Cancer Study Group and University of Sydney, 40 Cook Rd, Centennial Park, NSW 2021, Australia</nlm:aff></affiliation></author><author><name sortKey="Gelber, Richard D" sort="Gelber, Richard D" uniqKey="Gelber R" first="Richard D." last="Gelber">Richard D. Gelber</name><affiliation><nlm:aff id="A3">IBCSG Statistical Center, Department of Biostatistics and Computational Biology, Dana-Farber Cancer Institute, 450 Brookline Ave, Boston, MA, 02215, USA</nlm:aff></affiliation><affiliation><nlm:aff id="A17">Frontier Science and Technology Research Foundation, Boston, MA, USA</nlm:aff></affiliation><affiliation><nlm:aff id="A18">Harvard Medical School, Boston, MA, USA</nlm:aff></affiliation><affiliation><nlm:aff id="A21">Harvard School of Public Health, Boston, MA, USA</nlm:aff></affiliation></author><author><name sortKey="Veronesi, Umberto" sort="Veronesi, Umberto" uniqKey="Veronesi U" first="Umberto" last="Veronesi">Umberto Veronesi</name><affiliation><nlm:aff id="A22">European Institute of Oncology, Via Ripamonti, 435, 20141 Milan, Italy</nlm:aff></affiliation></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="2013">2013</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en"><sec id="S1"><title>Background</title><p id="P2">For breast cancer patients with a metastatic sentinel node (SN), axillary dissection (AD) has been standard treatment. However, for patients with minimal SN involvement, AD may be overtreatment. IBCSG Trial 23-01 was designed to determine whether no AD is non-inferior to AD in patients with one or more micrometastatic (≤2 mm) SNs and tumour ≤5 cm.</p></sec><sec id="S2"><title>Methods</title><p id="P3">In this multicentre trial patients were randomised to AD or no AD. Eligibility was limited to patients with clinically-palpable axillary lymph node(s) and a primary tumour ≤ 5 cm who, after sentinel node biopsy, had one or more micrometastatic (≤ 2 mm) sentinel lymphs nodes with no extracapsular extension. The primary endpoint was disease-free survival (DFS). Non-inferiority was defined as a hazard ratio of <1·25 for no AD vs. AD. The analysis was intention to treat. Patients were randomly allocated in a 1:1 ratio to AD or no AD with stratification by centre and menopausal status. There was no attempt to blind the treatment assignment. The trial is registered with ClinicalTrials.gov, NCT00072293. Per protocol, disease and survival information continues to be collected yearly.</p></sec><sec id="S3"><title>Findings</title><p id="P4">From 2001 to 2010, 934 patients were randomised; 931 were evaluable (464 in the AD group and 467 in the no AD group). After a median follow-up of 5·0 (IQR 3.6–7.3) years, there were 124 DFS events, including breast-cancer-related events in 95 patients (local, 18; contralateral breast, 12; regional, 6; and distant, 59), and other events in 29 (second malignancy, 26; death without prior cancer event, 3). Five-year DFS was 87·8% (95% CI 84·4%–91·2%) in the no AD group and 84·4% (95% CI 80·7%–88·1%) in the AD group (log-rank p=0·16) (HR no AD vs. AD=0·78, 95% CI 0·55–1·11, non-inferiority p=0·0042). Patients with reported long-term surgical events (grade 3–4) included 1 sensory neuropathy (grade 3), 3 lymphedema (2 grade 3 and 1 grade 4), and 3 motor neuropathy (grade 3), all in the AD group, and 1 grade 3 motor neuropathy in the no AD group. One serious adverse event was reported, a post-operative infection in the axilla in the AD group.</p></sec><sec id="S4"><title>Interpretation</title><p id="P5">AD in patients with early breast cancer represented in this study (most had tumours < 3 cm (92%; 856/931), received breast conserving surgery (91%; 845/931) and adjuvant systemic therapy (96%; 892/931)) should be avoided when the SN is minimally involved, thus eliminating complications of axillary surgery with no adverse effect on survival.</p></sec><sec id="S5"><title>Funding</title><p id="P6">Supported in part: local participating centres, IBCSG central funds, CA075362 from the U.S. National Cancer Institute, and Swiss Cancer League/Cancer Research- Switzerland/Oncosuisse (ICPOCS 01688-03-2005). No pharmaceutical company funds were used.</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">23491275</article-id><article-id pub-id-type="pmc">3935346</article-id><article-id pub-id-type="doi">10.1016/S1470-2045(13)70035-4</article-id><article-id pub-id-type="manuscript">NIHMS539645</article-id><article-categories><subj-group subj-group-type="heading"><subject>Article</subject></subj-group></article-categories><title-group><article-title>IBCSG 23-01 randomised controlled trial comparing axillary dissection versus no axillary dissection in patients with sentinel node micrometastases</article-title></title-group><contrib-group><contrib contrib-type="author"><name><surname>Galimberti</surname><given-names>Viviana</given-names></name><degrees>MD</degrees><xref ref-type="aff" rid="A1">1</xref></contrib><contrib contrib-type="author"><name><surname>Cole</surname><given-names>Bernard F.</given-names></name><degrees>PhD</degrees><xref ref-type="aff" rid="A2">2</xref><xref ref-type="aff" rid="A3">3</xref></contrib><contrib contrib-type="author"><name><surname>Zurrida</surname><given-names>Stefano</given-names></name><degrees>MD</degrees><xref ref-type="aff" rid="A4">4</xref></contrib><contrib contrib-type="author"><name><surname>Viale</surname><given-names>Giuseppe</given-names></name><degrees>MD</degrees><xref ref-type="aff" rid="A5">5</xref><xref ref-type="aff" rid="A6">6</xref></contrib><contrib contrib-type="author"><name><surname>Luini</surname><given-names>Alberto</given-names></name><degrees>MD</degrees><xref ref-type="aff" rid="A7">7</xref></contrib><contrib contrib-type="author"><name><surname>Veronesi</surname><given-names>Paolo</given-names></name><degrees>MD</degrees><xref ref-type="aff" rid="A6">6</xref><xref ref-type="aff" rid="A8">8</xref></contrib><contrib contrib-type="author"><name><surname>Baratella</surname><given-names>Paola</given-names></name><degrees>MD</degrees><xref ref-type="aff" rid="A7">7</xref></contrib><contrib contrib-type="author"><name><surname>Chifu</surname><given-names>Camelia</given-names></name><degrees>MD</degrees><xref ref-type="aff" rid="A7">7</xref></contrib><contrib contrib-type="author"><name><surname>Sargenti</surname><given-names>Manuela</given-names></name><degrees>MD</degrees><xref ref-type="aff" rid="A7">7</xref></contrib><contrib contrib-type="author"><name><surname>Intra</surname><given-names>Mattia</given-names></name><degrees>MD</degrees><xref ref-type="aff" rid="A7">7</xref></contrib><contrib contrib-type="author"><name><surname>Gentilini</surname><given-names>Oreste</given-names></name><degrees>MD</degrees><xref ref-type="aff" rid="A7">7</xref></contrib><contrib contrib-type="author"><name><surname>Mastropasqua</surname><given-names>Mauro G.</given-names></name><degrees>MD</degrees><xref ref-type="aff" rid="A5">5</xref></contrib><contrib contrib-type="author"><name><surname>Mazzarol</surname><given-names>Giovanni</given-names></name><degrees>MD</degrees><xref ref-type="aff" rid="A5">5</xref></contrib><contrib contrib-type="author"><name><surname>Massarut</surname><given-names>Samuele</given-names></name><degrees>MD</degrees><xref ref-type="aff" rid="A9">9</xref></contrib><contrib contrib-type="author"><name><surname>Garbay</surname><given-names>Jean-Remi</given-names></name><degrees>MD</degrees><xref ref-type="aff" rid="A10">10</xref></contrib><contrib contrib-type="author"><name><surname>Zgajnar</surname><given-names>Janez</given-names></name><degrees>MD</degrees><xref ref-type="aff" rid="A11">11</xref></contrib><contrib contrib-type="author"><name><surname>Galatius</surname><given-names>Hanne</given-names></name><degrees>MD</degrees><xref ref-type="aff" rid="A12">12</xref></contrib><contrib contrib-type="author"><name><surname>Recalcati</surname><given-names>Angelo</given-names></name><degrees>MD</degrees><xref ref-type="aff" rid="A13">13</xref></contrib><contrib contrib-type="author"><name><surname>Littlejohn</surname><given-names>David</given-names></name><degrees>MBBS, FRACS</degrees><xref ref-type="aff" rid="A14">14</xref></contrib><contrib contrib-type="author"><name><surname>Bamert</surname><given-names>Monika</given-names></name><degrees>MD</degrees><xref ref-type="aff" rid="A15">15</xref></contrib><contrib contrib-type="author"><name><surname>Colleoni</surname><given-names>Marco</given-names></name><degrees>MD</degrees><xref ref-type="aff" rid="A16">16</xref></contrib><contrib contrib-type="author"><name><surname>Price</surname><given-names>Karen N.</given-names></name><degrees>BS</degrees><xref ref-type="aff" rid="A3">3</xref><xref ref-type="aff" rid="A17">17</xref></contrib><contrib contrib-type="author"><name><surname>Regan</surname><given-names>Meredith M.</given-names></name><degrees>SD</degrees><xref ref-type="aff" rid="A3">3</xref><xref ref-type="aff" rid="A18">18</xref></contrib><contrib contrib-type="author"><name><surname>Goldhirsch</surname><given-names>Aron</given-names></name><degrees>MD</degrees><xref ref-type="aff" rid="A19">19</xref></contrib><contrib contrib-type="author"><name><surname>Coates</surname><given-names>Alan S.</given-names></name><degrees>MD</degrees><xref ref-type="aff" rid="A20">20</xref></contrib><contrib contrib-type="author"><name><surname>Gelber</surname><given-names>Richard D.</given-names></name><degrees>PhD</degrees><xref ref-type="aff" rid="A3">3</xref><xref ref-type="aff" rid="A17">17</xref><xref ref-type="aff" rid="A18">18</xref><xref ref-type="aff" rid="A21">21</xref></contrib><contrib contrib-type="author"><name><surname>Veronesi</surname><given-names>Umberto</given-names></name><degrees>MD</degrees><xref ref-type="aff" rid="A22">22</xref></contrib><on-behalf-of>for the International Breast Cancer Study Group Trial 23-01 investigators</on-behalf-of></contrib-group><aff id="A1"><label>1</label>Molecular Senology Unit, Senology Division, European Institute of Oncology, Via Ripamonti, 435, 20141 Milan, Italy</aff><aff id="A2"><label>2</label>Department of Mathematics and Statistics, College of Engineering and Mathematical Sciences, University of Vermont, 33 Colchester Ave, Burlington, VT, 05405, USA</aff><aff id="A3"><label>3</label>IBCSG Statistical Center, Department of Biostatistics and Computational Biology, Dana-Farber Cancer Institute, 450 Brookline Ave, Boston, MA, 02215, USA</aff><aff id="A4"><label>4</label>Breast Diagnosis and Surgery Unit, Senology Division, European Institute of Oncology, Via Ripamonti, 435, 20141 Milan, Italy</aff><aff id="A5"><label>5</label>IBCSG Central Pathology Office, Division of Pathology and Laboratory Medicine, European Institute of Oncology, Via Ripamonti, 435, 20141 Milan, Italy</aff><aff id="A6"><label>6</label>University of Milan, Milan, Italy</aff><aff id="A7"><label>7</label>Senology Division, European Institute of Oncology, Via Ripamonti, 435, 20141 Milan, Italy</aff><aff id="A8"><label>8</label>Integrated Breast Surgery Unit, Senology Division, European Institute of Oncology, Via Ripamonti, 435, 20141 Milan, Italy</aff><aff id="A9"><label>9</label>Breast Surgery Division, Centro di Riferimento Oncologico, Via Franco Gallini 2, I-33081 Aviano, Italy</aff><aff id="A10"><label>10</label>Department of Surgery, Institut Gustave Roussy, 114 rue E. Vaillant, 94805 Villejuif, France</aff><aff id="A11"><label>11</label>Department of Surgical Oncology, Institute of Oncology, Zaloska 5, 1000 Ljubljana, Slovenia</aff><aff id="A12"><label>12</label>Department of Breastsurgery F118, Herlev Hospital, 2730 Herlev, Denmark</aff><aff id="A13"><label>13</label>Department of Surgery, Ospedale ‘Alessandro Manzoni,’ Via dell’Eremo, 9/11, I-23900, Lecco, Italy</aff><aff id="A14"><label>14</label>Riverina Cancer Care Centre, 31 Meurant Avenue, Wagga Wagga, NSW 2650, Australia</aff><aff id="A15"><label>15</label>Breast Center, Kantonsspital, 9007 St. Gallen, Switzerland</aff><aff id="A16"><label>16</label>Research Unit in Medical Senology, Department of Medicine, European Institute of Oncology, Milan, Italy</aff><aff id="A17"><label>17</label>Frontier Science and Technology Research Foundation, Boston, MA, USA</aff><aff id="A18"><label>18</label>Harvard Medical School, Boston, MA, USA</aff><aff id="A19"><label>19</label>Department of Medicine. European Institute of Oncology, Via Ripamonti, 435, 20141 Milan, Italy</aff><aff id="A20"><label>20</label>International Breast Cancer Study Group and University of Sydney, 40 Cook Rd, Centennial Park, NSW 2021, Australia</aff><aff id="A21"><label>21</label>Harvard School of Public Health, Boston, MA, USA</aff><aff id="A22"><label>22</label>European Institute of Oncology, Via Ripamonti, 435, 20141 Milan, Italy</aff><author-notes><corresp id="FN1">Corresponding author prior to publication: Karen N. Price. IBCSG Statistical Center, Dana-Farber Cancer Institute, 450 Brookline Ave, Boston, MA 02215, USA, <email>price@jimmy.harvard.edu</email>; Telephone 617-632-2459</corresp><corresp id="FN2">Corresponding author after publication: Dr. Viviana Galimberti. Department of Surgery, European Institute of Oncology, Via Ripamonti, 435, 20141 Milan, Italy. <email>viviana.galimberti@ieo.it</email>; Telephone: +39 02 57489717</corresp></author-notes><pub-date pub-type="nihms-submitted"><day>22</day><month>1</month><year>2014</year></pub-date><pub-date pub-type="epub"><day>11</day><month>3</month><year>2013</year></pub-date><pub-date pub-type="ppub"><month>4</month><year>2013</year></pub-date><pub-date pub-type="pmc-release"><day>26</day><month>2</month><year>2014</year></pub-date><volume>14</volume><issue>4</issue><fpage>297</fpage><lpage>305</lpage><pmc-comment>elocation-id from pubmed: 10.1016/S1470-2045(13)70035-4</pmc-comment>
<permissions><copyright-statement>© 2013 Elsevier Ltd. All rights reserved.</copyright-statement><copyright-year>2013</copyright-year></permissions><abstract><sec id="S1"><title>Background</title><p id="P2">For breast cancer patients with a metastatic sentinel node (SN), axillary dissection (AD) has been standard treatment. However, for patients with minimal SN involvement, AD may be overtreatment. IBCSG Trial 23-01 was designed to determine whether no AD is non-inferior to AD in patients with one or more micrometastatic (≤2 mm) SNs and tumour ≤5 cm.</p></sec><sec id="S2"><title>Methods</title><p id="P3">In this multicentre trial patients were randomised to AD or no AD. Eligibility was limited to patients with clinically-palpable axillary lymph node(s) and a primary tumour ≤ 5 cm who, after sentinel node biopsy, had one or more micrometastatic (≤ 2 mm) sentinel lymphs nodes with no extracapsular extension. The primary endpoint was disease-free survival (DFS). Non-inferiority was defined as a hazard ratio of <1·25 for no AD vs. AD. The analysis was intention to treat. Patients were randomly allocated in a 1:1 ratio to AD or no AD with stratification by centre and menopausal status. There was no attempt to blind the treatment assignment. The trial is registered with ClinicalTrials.gov, NCT00072293. Per protocol, disease and survival information continues to be collected yearly.</p></sec><sec id="S3"><title>Findings</title><p id="P4">From 2001 to 2010, 934 patients were randomised; 931 were evaluable (464 in the AD group and 467 in the no AD group). After a median follow-up of 5·0 (IQR 3.6–7.3) years, there were 124 DFS events, including breast-cancer-related events in 95 patients (local, 18; contralateral breast, 12; regional, 6; and distant, 59), and other events in 29 (second malignancy, 26; death without prior cancer event, 3). Five-year DFS was 87·8% (95% CI 84·4%–91·2%) in the no AD group and 84·4% (95% CI 80·7%–88·1%) in the AD group (log-rank p=0·16) (HR no AD vs. AD=0·78, 95% CI 0·55–1·11, non-inferiority p=0·0042). Patients with reported long-term surgical events (grade 3–4) included 1 sensory neuropathy (grade 3), 3 lymphedema (2 grade 3 and 1 grade 4), and 3 motor neuropathy (grade 3), all in the AD group, and 1 grade 3 motor neuropathy in the no AD group. One serious adverse event was reported, a post-operative infection in the axilla in the AD group.</p></sec><sec id="S4"><title>Interpretation</title><p id="P5">AD in patients with early breast cancer represented in this study (most had tumours < 3 cm (92%; 856/931), received breast conserving surgery (91%; 845/931) and adjuvant systemic therapy (96%; 892/931)) should be avoided when the SN is minimally involved, thus eliminating complications of axillary surgery with no adverse effect on survival.</p></sec><sec id="S5"><title>Funding</title><p id="P6">Supported in part: local participating centres, IBCSG central funds, CA075362 from the U.S. National Cancer Institute, and Swiss Cancer League/Cancer Research- Switzerland/Oncosuisse (ICPOCS 01688-03-2005). No pharmaceutical company funds were used.</p></sec></abstract><kwd-group><kwd>breast cancer</kwd><kwd>sentinel node</kwd><kwd>axillary node</kwd><kwd>micrometastasis</kwd><kwd>sentinel node biopsy</kwd><kwd>axillary dissection</kwd><kwd>lymph node</kwd></kwd-group><funding-group><award-group><funding-source country="United States">National Cancer Institute : NCI</funding-source><award-id>U24 CA075362 || CA</award-id></award-group></funding-group></article-meta></front></pmc></record>Pour manipuler ce document sous Unix (Dilib)
EXPLOR_STEP=$WICRI_ROOT/Wicri/Sante/explor/LymphedemaV1/Data/Pmc/Corpus
HfdSelect -h $EXPLOR_STEP/biblio.hfd -nk 003448 | SxmlIndent | more
Ou
HfdSelect -h $EXPLOR_AREA/Data/Pmc/Corpus/biblio.hfd -nk 003448 | SxmlIndent | more
Pour mettre un lien sur cette page dans le réseau Wicri
{{Explor lien
|wiki= Wicri/Sante
|area= LymphedemaV1
|flux= Pmc
|étape= Corpus
|type= RBID
|clé= PMC:3935346
|texte= IBCSG 23-01 randomised controlled trial comparing axillary dissection versus no axillary dissection in patients with sentinel node micrometastases
}}
Pour générer des pages wiki
HfdIndexSelect -h $EXPLOR_AREA/Data/Pmc/Corpus/RBID.i -Sk "pubmed:23491275" \
| HfdSelect -Kh $EXPLOR_AREA/Data/Pmc/Corpus/biblio.hfd \
| NlmPubMed2Wicri -a LymphedemaV1
| This area was generated with Dilib version V0.6.31. |  |