by Matilda Appelgren, Helena Sackey, Yvonne Wengström, Karin
Johansson, Johan Ahlgren, Yvette Andersson, Leif Bergkvist, Jan Frisell, Dan
Lundstedt, Lisa Rydén, Malin Sund, Sara Alkner, Birgitte Vrou Offersen, Tove
Filtenborg Tvedskov, Peer Christiansen, Jana de Boniface, the SENOMAC
Trialists' Group
The Breast: VOLUME 63, P16-23, JUNE
01, 2022
Introduction
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).
Methods
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.
Results
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.
Conclusion
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.
