Omitting Axillary Dissection in Breast Cancer with Sentinel-Node Metastases.
Journal
The New England journal of medicine
ISSN: 1533-4406
Titre abrégé: N Engl J Med
Pays: United States
ID NLM: 0255562
Informations de publication
Date de publication:
04 Apr 2024
04 Apr 2024
Historique:
medline:
10
4
2024
pubmed:
10
4
2024
entrez:
10
4
2024
Statut:
ppublish
Résumé
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. 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. 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. 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.).
Sections du résumé
BACKGROUND
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
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
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
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.).
Identifiants
pubmed: 38598571
doi: 10.1056/NEJMoa2313487
doi:
Banques de données
ClinicalTrials.gov
['NCT02240472']
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
1163-1175Subventions
Organisme : Vetenskapsrådet
ID : 2015-00760
Organisme : Vetenskapsrådet
ID : 2021-02128
Organisme : Cancerfonden
ID : 22 2061 Pj
Organisme : Cancerfonden
ID : CAN 2015/437
Organisme : Cancerfonden
ID : NA
Organisme : Kreftforeningen
ID : R217-A13260
Organisme : Kreftforeningen
ID : R241-A14982
Investigateurs
Sophie Norenstedt
(S)
Helena Sackey
(H)
Fuat Celebioglu
(F)
Yvete Andersson
(Y)
Eva Vikhe Patil
(EV)
Fredrik Wärnberg
(F)
Roger Olofsson Bagge
(R)
Maria Wedin
(M)
Lisa Rydén
(L)
Anna-Karin Falck
(AK)
Maria Erngrund
(M)
Per Nyman
(P)
Malin Sund
(M)
Michael Wallberg
(M)
Kristina Åhsberg
(K)
Carin Wångblad
(C)
Caroline Holsti
(C)
Lena Myrskog
(L)
Emma Starck
(E)
Karin Åhlander Lindwall
(K)
Charlota Wadsten
(C)
Johanna Björkman
(J)
Rebecka Ruderfors Malterling
(R)
Jeanete Liljestrand Sigvardsson
(J)
Tor Svensjö
(T)
Jürgen Handler
(J)
Ute Hoyer
(U)
Peer Christiansen
(P)
Lena Carstensen
(L)
Tove Tvedskov Filtenborg
(T)
Katrine Lydolph Soe
(K)
Eva Balling
(E)
Lone Bak Hansen
(LB)
Christina Kjaer
(C)
Inge Scheel Andersen
(IS)
Gabriele Bonatz
(G)
Thorsten Kühn
(T)
Cristin Kühn
(C)
Angrit Stachs
(A)
Oumar Camara
(O)
Stephan Hausmüller
(S)
Silke Polata
(S)
Andrea Stefek
(A)
Stefan Ollig
(S)
Henning Eichler
(H)
Thomas Müller
(T)
Arno Franzen
(A)
Peter Ledwon
(P)
Caroline Hammerle
(C)
Gabriele Feisel-Schwickardi
(G)
Christoph Lindner
(C)
Susen Schirrmeister
(S)
Stefan Renner
(S)
Sybille Perez
(S)
Hans-Joachim Stritmater
(HJ)
Antje Hahn
(A)
Markus Keller
(M)
Antje Nixdorf
(A)
Ralf Ohlinger
(R)
Dorothea Fischer
(D)
Sara Brucker
(S)
Axel Gatzweiler
(A)
Liudmila Melnichuk
(L)
Jens-Paul Seldte
(JP)
Michalis Kontos
(M)
Konstantinos Kontzoglou
(K)
Ioannis Askoxylakis
(I)
George Metaxas
(G)
Eleni Faliakou
(E)
Nikiforita Poulakaki
(N)
Vassilos Venizelos
(V)
Ioannis Kaklamanos
(I)
Nikolaos Michalopoulos
(N)
Oreste Gentilini
(O)
Viviana Galimberti
(V)
Gianluca Fogazzi
(G)
Paolo Cristofolini
(P)
Carlos Garcia-Etienne
(C)
Alfredo Fucito
(A)
Informations de copyright
Copyright © 2024 Massachusetts Medical Society.