Skip to main content

Lund University Publications

LUND UNIVERSITY LIBRARIES

Omitting Axillary Dissection in Breast Cancer with Sentinel-Node Metastases

de Boniface, Jana ; Tvedskov, Tove Filtenborg ; Rydén, Lisa LU orcid ; Szulkin, Robert ; Reimer, Toralf ; Kühn, Thorsten ; Kontos, Michalis ; Gentilini, Oreste D. ; Bagge, Roger Olofsson LU and Sund, Malin , et al. (2024) In New England Journal of Medicine 390(13). p.1163-1175
Abstract

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... (More)

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.).

(Less)
Please use this url to cite or link to this publication:
author
; ; ; ; ; ; ; ; and , et al. (More)
; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; and (Less)
author collaboration
organization
publishing date
type
Contribution to journal
publication status
published
subject
in
New England Journal of Medicine
volume
390
issue
13
pages
1163 - 1175
publisher
Massachussetts Medical Society
external identifiers
  • scopus:85190242475
  • pmid:38598571
ISSN
0028-4793
DOI
10.1056/NEJMoa2313487
language
English
LU publication?
yes
additional info
Publisher Copyright: © 2024 Massachussetts Medical Society. All rights reserved.
id
4ebc8046-ab89-4071-a91b-2025ac28ce7d
date added to LUP
2024-10-17 09:18:34
date last changed
2025-05-16 07:44:25
@article{4ebc8046-ab89-4071-a91b-2025ac28ce7d,
  abstract     = {{<p>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, &gt;50 mm in the largest dimension) with one or two sentinel-node macrometastases (metastasis size, &gt;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&lt;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.).</p>}},
  author       = {{de Boniface, Jana and Tvedskov, Tove Filtenborg and Rydén, Lisa and Szulkin, Robert and Reimer, Toralf and Kühn, Thorsten and Kontos, Michalis and Gentilini, Oreste D. and Bagge, Roger Olofsson and Sund, Malin and Lundstedt, Dan and Appelgren, Matilda and Ahlgren, Johan and Norenstedt, Sophie and Celebioglu, Fuat and Sackey, Helena and Andersen, Inge Scheel and Hoyer, Ute and Nyman, Per F. and Patil, Eva Vikhe and Wieslander, E. and Nissen, H. Dahl and Alkner, S. and Andersson, Yvette and Offersen, Birgitte V. and Bergkvist, Leif and Frisell, Jan and Christiansen, Peer}},
  issn         = {{0028-4793}},
  language     = {{eng}},
  month        = {{04}},
  number       = {{13}},
  pages        = {{1163--1175}},
  publisher    = {{Massachussetts Medical Society}},
  series       = {{New England Journal of Medicine}},
  title        = {{Omitting Axillary Dissection in Breast Cancer with Sentinel-Node Metastases}},
  url          = {{http://dx.doi.org/10.1056/NEJMoa2313487}},
  doi          = {{10.1056/NEJMoa2313487}},
  volume       = {{390}},
  year         = {{2024}},
}