Preservation of Axillary Lymph Nodes Compared with Complete Dissection in T1-2 Breast Cancer Patients Presenting One or Two Metastatic Sentinel Lymph Nodes: The SINODAR-ONE Multicenter Randomized Clinical Trial.
Journal
Annals of surgical oncology
ISSN: 1534-4681
Titre abrégé: Ann Surg Oncol
Pays: United States
ID NLM: 9420840
Informations de publication
Date de publication:
Sep 2022
Sep 2022
Historique:
received:
10
12
2021
accepted:
20
04
2022
pubmed:
14
5
2022
medline:
11
8
2022
entrez:
13
5
2022
Statut:
ppublish
Résumé
The SINODAR-ONE trial is a prospective noninferiority multicenter randomized study aimed at assessing the role of axillary lymph node dissection (ALND) in patients undergoing either breast-conserving surgery or mastectomy for T1-2 breast cancer (BC) and presenting one or two macrometastatic sentinel lymph nodes (SLNs). The endpoints were to evaluate whether SLN biopsy (SLNB) only was associated with worsening of the prognosis compared with ALND in terms of overall survival (OS) and relapse. Patients were randomly assigned (1:1 ratio) to either removal of ≥ 10 axillary level I/II non-SLNs followed by adjuvant therapy (standard arm) or no further axillary treatment (experimental arm). The trial started in April 2015 and ceased in April 2020, involving 889 patients. Median follow-up was 34.0 months. There were eight deaths (ALND, 4; SNLB only, 4), with 5-year cumulative mortality of 5.8% and 2.1% in the standard and experimental arm, respectively (p = 0.984). There were 26 recurrences (ALND 11; SNLB only, 15), with 5-year cumulative incidence of recurrence of 6.9% and 3.3% in the standard and experimental arm, respectively (p = 0.444). Only one axillary lymph node recurrence was observed in each arm. The 5-year OS rates were 98.9% and 98.8%, in the ALND and SNLB-only arm, respectively (p = 0.936). The 3-year survival and relapse rates of T1-2 BC patients with one or two macrometastatic SLNs treated with SLNB only, and adjuvant therapy, were not inferior to those of patients treated with ALND. These results do not support the use of routine ALND.
Sections du résumé
BACKGROUND
BACKGROUND
The SINODAR-ONE trial is a prospective noninferiority multicenter randomized study aimed at assessing the role of axillary lymph node dissection (ALND) in patients undergoing either breast-conserving surgery or mastectomy for T1-2 breast cancer (BC) and presenting one or two macrometastatic sentinel lymph nodes (SLNs). The endpoints were to evaluate whether SLN biopsy (SLNB) only was associated with worsening of the prognosis compared with ALND in terms of overall survival (OS) and relapse.
METHODS
METHODS
Patients were randomly assigned (1:1 ratio) to either removal of ≥ 10 axillary level I/II non-SLNs followed by adjuvant therapy (standard arm) or no further axillary treatment (experimental arm).
RESULTS
RESULTS
The trial started in April 2015 and ceased in April 2020, involving 889 patients. Median follow-up was 34.0 months. There were eight deaths (ALND, 4; SNLB only, 4), with 5-year cumulative mortality of 5.8% and 2.1% in the standard and experimental arm, respectively (p = 0.984). There were 26 recurrences (ALND 11; SNLB only, 15), with 5-year cumulative incidence of recurrence of 6.9% and 3.3% in the standard and experimental arm, respectively (p = 0.444). Only one axillary lymph node recurrence was observed in each arm. The 5-year OS rates were 98.9% and 98.8%, in the ALND and SNLB-only arm, respectively (p = 0.936).
CONCLUSIONS
CONCLUSIONS
The 3-year survival and relapse rates of T1-2 BC patients with one or two macrometastatic SLNs treated with SLNB only, and adjuvant therapy, were not inferior to those of patients treated with ALND. These results do not support the use of routine ALND.
Identifiants
pubmed: 35552930
doi: 10.1245/s10434-022-11866-w
pii: 10.1245/s10434-022-11866-w
doi:
Types de publication
Journal Article
Multicenter Study
Randomized Controlled Trial
Langues
eng
Sous-ensembles de citation
IM
Pagination
5732-5744Investigateurs
Olindo Custodero
(O)
Vito Leopoldo Troilo
(VL)
Mario Taffurelli
(M)
Maria Cristina Cucchi
(MC)
Valentina Galluzzo
(V)
Carlo Cabula
(C)
Roberta Cabula
(R)
Maria Grazia Lazzaretti
(MG)
Francesco Caruso
(F)
Gaetano Castiglione
(G)
Simona Grossi
(S)
Maria Saveria Tavoletta
(MS)
Camilla Rossi
(C)
Annalisa Curcio
(A)
Daniele Friedman
(D)
Piero Fregatti
(P)
Carla Magni
(C)
Giovanni Tazzioli
(G)
Simona Papi
(S)
Riccardo Giovanazzi
(R)
Camelia Chifu
(C)
Rossella Bettini
(R)
Modestino Pezzella
(M)
Silvia Michieletto
(S)
Tania Saibene
(T)
Manuela Roncella
(M)
Matteo Ghilli
(M)
Andrea Sibilio
(A)
Anna Cariello
(A)
Saverio Coiro
(S)
Giuseppe Falco
(G)
Emanuele Zarba Meli
(EZ)
Lucio Fortunato
(L)
Luigi Ciuffreda
(L)
Roberto Murgo
(R)
Claudio Battaglia
(C)
Luca Rubino
(L)
Nicoletta Biglia
(N)
Valentina Bounous
(V)
Francesca Angela Rovera
(FA)
Corrado Chiappa
(C)
Giovanni Pollini
(G)
Sara Mirandola
(S)
Graziano Meneghini
(G)
Francesco Di Bartolo
(F)
Informations de copyright
© 2022. Society of Surgical Oncology.
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