Patient-reported outcomes one year after positive sentinel lymph node biopsy with or without axillary lymph node dissection in the randomized SENOMAC trial.
Arm morbidity
Axillary lymph node dissection
Breast cancer
Health-related quality of life
Patient-reported outcome measures
Sentinel lymph node biopsy
Journal
Breast (Edinburgh, Scotland)
ISSN: 1532-3080
Titre abrégé: Breast
Pays: Netherlands
ID NLM: 9213011
Informations de publication
Date de publication:
Jun 2022
Jun 2022
Historique:
received:
10
12
2021
revised:
10
02
2022
accepted:
28
02
2022
pubmed:
14
3
2022
medline:
4
5
2022
entrez:
13
3
2022
Statut:
ppublish
Résumé
This report evaluates whether health related quality of life (HRQoL) and patient-reported arm morbidity one year after axillary surgery are affected by the omission of axillary lymph node dissection (ALND). The ongoing international non-inferiority SENOMAC trial randomizes clinically node-negative breast cancer patients (T1-T3) with 1-2 sentinel lymph node (SLN) macrometastases to completion ALND or no further axillary surgery. For this analysis, the first 1181 patients enrolled in Sweden and Denmark between March 2015, and June 2019, were eligible. Data extraction from the trial database was on November 2020. This report covers the secondary outcomes of the SENOMAC trial: HRQoL and patient-reported arm morbidity. The EORTC QLQ-C30, EORTC QLQ-BR23 and Lymph-ICF questionnaires were completed in the early postoperative phase and at one-year follow-up. Adjusted one-year mean scores and mean differences between the groups are presented corrected for multiple testing. Overall, 976 questionnaires (501 in the SLN biopsy only group and 475 in the completion ALND group) were analysed, corresponding to a response rate of 82.6%. No significant group differences in overall HRQoL were identified. Participants receiving SLN biopsy only, reported significantly lower symptom scores on the EORTC subscales of pain, arm symptoms and breast symptoms. The Lymph-ICF domain scores of physical function, mental function and mobility activities were significantly in favour of the SLN biopsy only group. One year after surgery, arm morbidity is significantly worse affected by ALND than by SLN biopsy only. The results underline the importance of ongoing attempts to safely de-escalate axillary surgery. The trial was registered at clinicaltrials.gov prior to initiation (https://clinicaltrials.gov/ct2/show/NCT02240472).
Identifiants
pubmed: 35279508
pii: S0960-9776(22)00040-6
doi: 10.1016/j.breast.2022.02.013
pmc: PMC8920917
pii:
doi:
Banques de données
ClinicalTrials.gov
['NCT02240472']
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
16-23Informations de copyright
Copyright © 2022 The Authors. Published by Elsevier Ltd.. All rights reserved.