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

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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/NCT 02240472).

OriginalsprogEngelsk
TidsskriftBreast
Vol/bind63
Sider (fra-til)16-23
Antal sider8
ISSN0960-9776
DOI
StatusUdgivet - 2022

Bibliografisk note

Funding Information:
The SENOMAC trial is supported by grants from the Swedish Cancer Society [grant number CAN2015/437 ]; the Swedish Scientific Council [grant number 2015-00760 , 2021–02128 ]; the Nordic Cancer Union [grant number R241-A14982 , R217-A13260-18-S65 ]; and the Swedish Association for Breast Cancer .

Funding Information:
Robert Szulkin contributed with statistical expertise and support. We gratefully acknowledge all staff at all Swedish and Danish site who are doing a highly estimated work including patients into the SENOMAC trial: Aalborg University Hospital (Ute Hoyer), Aarhus University Hospital (Peer Christiansen), Kar Karlskrona Hospital (Maria Erngrund), Capio St Göran's Hospital (Sophie Norenstedt), Gävle Hospital (Karin Åhlander Lindwall), Halmstad Hospital (Kristina Åhsberg), Varberg Hospital (Michael Wallberg), Helsingborg Hospital (Anna-Karin Falck, Katrin Lange-Norström), Herlev Hospital and Rigshospitalet (Tove Filtenborg Tvedskov), Kalmar County Hospital (Lena Myrskog), Karlstad Central Hospital (Caroline Holsti), Karolinska University Hospital (Helena Sackey), Kristianstad Central Hospital (Tor Svensjö), Vejle Hospital (Christina Kjær, Marianne Lautrup), Linköping University Hospital (Eva Vikhe Patil), Odense University Hospital (Katrine Søe), Randers Regional Hospital (Eva Balling), Viborg Regional Hospital (Inge Scheel Andersen), Ryhov County Hospital (Rebecka Ruderfors Malterling), Sahlgrenska University Hospital (Roger Olofsson Bagge), Skaraborg Hospital Linköping/Skövde (Per Nyman), Skåne University Hospital (Lisa Rydén), Sundsvall County Hospital (Charlotta Wadsten), Södersjukhuset (Fuat Celebioglu, Ann-Charlott Docherty-Skogh), Southern Älvsborg Hospital (Jeanette Liljestrand Sigvardsson), Sønderjylland Hospital Aabenraa (Jürgen Handler), Sydvestjysk Hospital Esbjerg (Lena Carstensen), Uddevalla Hospital (Carin Wångblad), Umeå University Hospital (Malin Sund), Uppsala University Hospital (Camilla André), Västervik Hospital (Emma Starck), Västmanland County Hospital Västerås (Yvette Andersson), Växjö Central Hospital (Johanna Björkman), Örebro University Hospital (Maria Wedin). The SENOMAC trial is supported by grants from the Swedish Cancer Society [grant number CAN2015/437]; the Swedish Scientific Council [grant number 2015-00760, 2021–02128]; the Nordic Cancer Union [grant number R241-A14982, R217-A13260-18-S65]; and the Swedish Association for Breast Cancer.

Publisher Copyright:
© 2022 The Authors

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