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. 2022 Jun:63:16-23.
doi: 10.1016/j.breast.2022.02.013. Epub 2022 Mar 1.

Patient-reported outcomes one year after positive sentinel lymph node biopsy with or without axillary lymph node dissection in the randomized SENOMAC trial

Matilda Appelgren  1 , Helena Sackey  2 , Yvonne Wengström  3 , Karin Johansson  4 , Johan Ahlgren  5 , Yvette Andersson  6 , Leif Bergkvist  7 , Jan Frisell  8 , Dan Lundstedt  9 , Lisa Rydén  10 , Malin Sund  11 , Sara Alkner  12 , Birgitte Vrou Offersen  13 , Tove Filtenborg Tvedskov  14 , Peer Christiansen  15 , Jana de Boniface  16 ; SENOMAC Trialists' Group
Affiliations

Patient-reported outcomes one year after positive sentinel lymph node biopsy with or without axillary lymph node dissection in the randomized SENOMAC trial

Matilda Appelgren et al. Breast. 2022 Jun.

Abstract

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.

Trial registration: The trial was registered at clinicaltrials.gov prior to initiation (https://clinicaltrials.gov/ct2/show/NCT02240472).

Keywords: Arm morbidity; Axillary lymph node dissection; Breast cancer; Health-related quality of life; Patient-reported outcome measures; Sentinel lymph node biopsy.

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Conflict of interest statement

All listed authors declare that they have no conflict of interests.

Figures

Image 1
Graphical abstract
Fig. 1
Fig. 1
Trial Consort. Number of patients in the present analysis. Drop-outs include withdrawal of consent, erroneous enrolment, termination due to physician's decision, and loss to follow-up.
Fig. 2
Fig. 2
Adjusted mean differences (95% CI) between randomization groups at one-year follow-up for each subscale of the EORTC questionnaires and domains of the Lymph-ICF questionnaire with the SLNB + ALND group as a reference. Positive mean differences of black texted items indicate better function, negative mean differences of red texted items indicate less symptoms or less impaired function in comparison with reference.
See this image and copyright information in PMC

References

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