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Omitting axillary dissection in breast cancer with sentinel-node metastases

de Boniface, J. (författare)
Departments of Molecular Medicine and Surgery, Sweden; Department of Surgery, Capio St. Göran’s Hospital,, Sweden
Tvedskov, T. Filtenborg (författare)
Faculty of Health and Medical Sciences, University of Copenhagen, Denmark; Department of Breast Surgery, Gentofte Hospital, Denmark
Rydén, L. (författare)
Faculty of Medicine, Institute of Clinical Sciences, Lund University, Sweden
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Szulkin, R. (författare)
Medical Epidemiology and Biostatistics, Karolinska Institutet, Sweden; Department of Surgery, Capio St. Göran’s Hospital,, Sweden
Reimer, T. (författare)
Department of Obstetrics and Gynecology, University of Rostock, Rostock Breast Center, Die Filderklinik, Germany
Kühn, T. (författare)
Department of Obstetrics and Gynecology, University of Rostock, Rostock Breast Center, Die Filderklinik, Germany; Department of Gynecology and Obstetrics, University of Ulm, Germany
Kontos, M. (författare)
First Department of Surgery, National and Kapodistrian University of Athens, Greece
Gentilini, O.D. (författare)
Department of Breast Surgery, IRCCS Ospedale San Raffaele, Italy; Vita-Salute San Raffaele University,, Italy
Bagge, R. Olofsson (författare)
Skåne University Hospital Lund, Sweden; Departments of Surgery, Institute of Clinical Sciences, Sahlgrenska Academy at Gothenburg University, Sweden
Sund, Malin (författare)
Umeå universitet,Kirurgi,Departments of Surgery, Sahlgrenska University Hospital, Sweden; Department of Surgery, University of Helsinki and Helsinki University Hospital, Italy
Lundstedt, D. (författare)
Departments of Oncology, Institute of Clinical Sciences, Sahlgrenska Academy at Gothenburg University, Sweden; Departments of Oncology, Sahlgrenska University Hospital, Sweden
Appelgren, M. (författare)
Departments of Molecular Medicine and Surgery, Sweden; Department of Surgery, Capio St. Göran’s Hospital,, Sweden
Ahlgren, J. (författare)
Department of Oncology, Faculty of Medicine and Health, Örebro University, Sweden; Regional Cancer Center of Mid-Sweden, Sweden
Norenstedt, S. (författare)
Departments of Molecular Medicine and Surgery, Sweden; Department of Surgery, Capio St. Göran’s Hospital,, Sweden
Celebioglu, F. (författare)
Department of Surgery, Sweden
Sackey, H. (författare)
Breast Center Karolinska, Karolinska Comprehensive Cancer Center, Karolinska University Hospital, Sweden
Andersen, I. Scheel (författare)
Department of Surgery, Breast Clinic, Viborg Hospital, Denmark
Hoyer, U. (författare)
Department of Plastic and Breast Surgery, Aalborg University Hospital, Denmark
Nyman, P.F. (författare)
Department of Surgery, Skaraborg Hospital, Sweden
Patil, E. Vikhe (författare)
Linköping University, and the Department of Surgery, Linköping University Hospital, Linköping, Sweden
Wieslander, E. (författare)
Radiation Physics, Department of Hematology, Oncology, and Radiation Physics, Sweden
Nissen, H. Dahl (författare)
Department of Oncology, Vejle Hospital, University Hospital of Southern Denmark, Denmark
Alkner, S. (författare)
Faculty of Medicine, Institute of Clinical Sciences, Lund University, Sweden; Department of Hematology, Oncology, and Radiation Physics, Skåne University Hospital Lund, Sweden
Andersson, Y. (författare)
Center for Clinical Research, Uppsala University and Region Vastmanland, Vastmanland Hospital, Sweden
Offersen, B.V. (författare)
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
Bergkvist, L. (författare)
Center for Clinical Research, Uppsala University and Region Vastmanland, Vastmanland Hospital, Sweden
Frisell, J. (författare)
Breast Center Karolinska, Karolinska Comprehensive Cancer Center, Karolinska University Hospital, Sweden
Christiansen, P. (författare)
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,, Sweden Faculty of Health and Medical Sciences, University of Copenhagen, Denmark; Department of Breast Surgery, Gentofte Hospital, Denmark (creator_code:org_t)
2024
2024
Engelska.
Ingår i: New England Journal of Medicine. - 0028-4793 .- 1533-4406. ; 390:13, s. 1163-1175
Relaterad länk:
https://urn.kb.se/re...
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https://doi.org/10.1...
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  • Tidskriftsartikel (refereegranskat)
Abstract Ämnesord
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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.).

Ämnesord

MEDICIN OCH HÄLSOVETENSKAP  -- Klinisk medicin -- Cancer och onkologi (hsv//swe)
MEDICAL AND HEALTH SCIENCES  -- Clinical Medicine -- Cancer and Oncology (hsv//eng)
MEDICIN OCH HÄLSOVETENSKAP  -- Klinisk medicin -- Kirurgi (hsv//swe)
MEDICAL AND HEALTH SCIENCES  -- Clinical Medicine -- Surgery (hsv//eng)

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