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Omitting axillary d...
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de Boniface, J.Departments of Molecular Medicine and Surgery, Sweden; Department of Surgery, Capio St. Göran’s Hospital,, Sweden
(author)
Omitting axillary dissection in breast cancer with sentinel-node metastases
- Article/chapterEnglish2024
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LIBRIS-ID:oai:DiVA.org:umu-223647
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https://urn.kb.se/resolve?urn=urn:nbn:se:umu:diva-223647URI
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https://doi.org/10.1056/NEJMoa2313487DOI
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Language:English
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Summary in:English
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Subject category:ref swepub-contenttype
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Subject category:art swepub-publicationtype
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BACKGROUND Trials evaluating the omission of completion axillary-lymph-node dissection in patients with clinically node-negative breast cancer and sentinel-lymph-node metastases have been compromised by limited statistical power, uncertain nodal radiotherapy target volumes, and a scarcity of data on relevant clinical subgroups.METHODS We conducted a noninferiority trial in which patients with clinically node-negative primary T1 to T3 breast cancer (tumor size, T1, ≤20 mm; T2, 21 to 50 mm; and T3, >50 mm in the largest dimension) with one or two sentinel-node macrometastases (metastasis size, >2 mm in the largest dimension) were randomly assigned in a 1:1 ratio to completion axillary-lymph-node dissection or its omission (sentinel-node biopsy only). Adjuvant treatment and radiation therapy were used in accordance with national guidelines. The primary end point was overall survival. We report here the per-protocol and modified intention-to-treat analyses of the prespecified secondary end point of recurrence-free survival. To show noninferiority of sentinel-node biopsy only, the upper boundary of the confidence interval for the hazard ratio for recurrence or death had to be below 1.44.RESULTS Between January 2015 and December 2021, a total of 2766 patients were enrolled across five countries. The per-protocol population included 2540 patients, of whom 1335 were assigned to undergo sentinel-node biopsy only and 1205 to undergo completion axillary-lymph-node dissection (dissection group). Radiation therapy including nodal target volumes was administered to 1192 of 1326 patients (89.9%) in the sentinel-node biopsy–only group and to 1058 of 1197 (88.4%) in the dissection group. The median follow-up was 46.8 months (range, 1.5 to 94.5). Overall, 191 patients had recurrence or died. The estimated 5-year recurrence-free survival was 89.7% (95% confidence interval [CI], 87.5 to 91.9) in the sentinel-node biopsy–only group and 88.7% (95% CI, 86.3 to 91.1) in the dissection group, with a country-adjusted hazard ratio for recurrence or death of 0.89 (95% CI, 0.66 to 1.19), which was significantly (P<0.001) below the prespecified noninferiority margin.CONCLUSIONS The omission of completion axillary-lymph-node dissection was noninferior to the more extensive surgery in patients with clinically node-negative breast cancer who had sentinel-node macrometastases, most of whom received nodal radiation therapy. (Funded by the Swedish Research Council and others; SENOMAC ClinicalTrials.gov number, NCT02240472.).
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Tvedskov, T. FiltenborgFaculty of Health and Medical Sciences, University of Copenhagen, Denmark; Department of Breast Surgery, Gentofte Hospital, Denmark
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Rydén, L.Faculty of Medicine, Institute of Clinical Sciences, Lund University, Sweden
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Szulkin, R.Medical Epidemiology and Biostatistics, Karolinska Institutet, Sweden; Department of Surgery, Capio St. Göran’s Hospital,, Sweden
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Reimer, T.Department of Obstetrics and Gynecology, University of Rostock, Rostock Breast Center, Die Filderklinik, Germany
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Kühn, T.Department of Obstetrics and Gynecology, University of Rostock, Rostock Breast Center, Die Filderklinik, Germany; Department of Gynecology and Obstetrics, University of Ulm, Germany
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Kontos, M.First Department of Surgery, National and Kapodistrian University of Athens, Greece
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Gentilini, O.D.Department of Breast Surgery, IRCCS Ospedale San Raffaele, Italy; Vita-Salute San Raffaele University,, Italy
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Bagge, R. OlofssonSkåne University Hospital Lund, Sweden; Departments of Surgery, Institute of Clinical Sciences, Sahlgrenska Academy at Gothenburg University, Sweden
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Sund, MalinUmeå universitet,Kirurgi,Departments of Surgery, Sahlgrenska University Hospital, Sweden; Department of Surgery, University of Helsinki and Helsinki University Hospital, Italy(Swepub:umu)masu0021
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Lundstedt, D.Departments of Oncology, Institute of Clinical Sciences, Sahlgrenska Academy at Gothenburg University, Sweden; Departments of Oncology, Sahlgrenska University Hospital, Sweden
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Appelgren, M.Departments of Molecular Medicine and Surgery, Sweden; Department of Surgery, Capio St. Göran’s Hospital,, Sweden
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Ahlgren, J.Department of Oncology, Faculty of Medicine and Health, Örebro University, Sweden; Regional Cancer Center of Mid-Sweden, Sweden
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Norenstedt, S.Departments of Molecular Medicine and Surgery, Sweden; Department of Surgery, Capio St. Göran’s Hospital,, Sweden
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Celebioglu, F.Department of Surgery, Sweden
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Sackey, H.Breast Center Karolinska, Karolinska Comprehensive Cancer Center, Karolinska University Hospital, Sweden
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Andersen, I. ScheelDepartment of Surgery, Breast Clinic, Viborg Hospital, Denmark
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Hoyer, U.Department of Plastic and Breast Surgery, Aalborg University Hospital, Denmark
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Nyman, P.F.Department of Surgery, Skaraborg Hospital, Sweden
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Patil, E. VikheLinköping University, and the Department of Surgery, Linköping University Hospital, Linköping, Sweden
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Wieslander, E.Radiation Physics, Department of Hematology, Oncology, and Radiation Physics, Sweden
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Nissen, H. DahlDepartment of Oncology, Vejle Hospital, University Hospital of Southern Denmark, Denmark
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Alkner, S.Faculty of Medicine, Institute of Clinical Sciences, Lund University, Sweden; Department of Hematology, Oncology, and Radiation Physics, Skåne University Hospital Lund, Sweden
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Andersson, Y.Center for Clinical Research, Uppsala University and Region Vastmanland, Vastmanland Hospital, Sweden
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Offersen, B.V.Departments of Oncology and Plastic and Breast Surgery, Denmark; University Hospital, the Departments of Oncology, Denmark; Department of Experimental Clinical Oncology, Danish Center for Particle Therapy, Denmark
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Bergkvist, L.Center for Clinical Research, Uppsala University and Region Vastmanland, Vastmanland Hospital, Sweden
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Frisell, J.Breast Center Karolinska, Karolinska Comprehensive Cancer Center, Karolinska University Hospital, Sweden
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Christiansen, P.Departments of Oncology and Plastic and Breast Surgery, Denmark; Clinical Medicine, Aarhus University, Denmark
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Departments of Molecular Medicine and Surgery, Sweden; Department of Surgery, Capio St. Göran’s Hospital,, SwedenFaculty of Health and Medical Sciences, University of Copenhagen, Denmark; Department of Breast Surgery, Gentofte Hospital, Denmark
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In:New England Journal of Medicine390:13, s. 1163-11750028-47931533-4406
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de Boniface, J.
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Tvedskov, T. Fil ...
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Rydén, L.
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Szulkin, R.
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Reimer, T.
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Kühn, T.
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Kontos, M.
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Gentilini, O.D.
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Bagge, R. Olofss ...
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Sund, Malin
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Lundstedt, D.
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Appelgren, M.
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Ahlgren, J.
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Norenstedt, S.
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Celebioglu, F.
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Sackey, H.
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Andersen, I. Sch ...
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Hoyer, U.
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Nyman, P.F.
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Patil, E. Vikhe
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Wieslander, E.
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Nissen, H. Dahl
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Alkner, S.
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Andersson, Y.
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Offersen, B.V.
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Bergkvist, L.
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Frisell, J.
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Christiansen, P.
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