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,
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
Affiliations
Matilda Appelgren
Department of Molecular Medicine and Surgery, Karolinska Institutet, 171 76, Stockholm, Sweden; Corresponding author. Department of Molecular Medicine and Surgery, Karolinska Institutet, Anna Steckséns gata 35, 17176, Stockholm, Sweden.
Helena Sackey
Department of Molecular Medicine and Surgery, Karolinska Institutet, 171 76, Stockholm, Sweden; Division of Cancer, Department of Breast, Endocrine Tumors and Sarcoma, Karolinska University Hospital, 171 64, Solna, Sweden
Yvonne Wengström
Karolinska Comprehensive Cancer Center, Karolinska University Hospital, 171 64, Solna, Sweden; Department of Neurobiology, Care Sciences and Society, Division of Nursing, Karolinska Institutet, 141 52, Huddinge, Sweden
Karin Johansson
Department of Health Sciences, Lund University, 221 00, Lund, Sweden
Johan Ahlgren
Department of Oncology, University Hospital, 701 85, Örebro, Sweden; Regional Oncology Centre, Mid-Sweden Health Care Region, 751 85, Uppsala, Sweden
Yvette Andersson
Department of Surgery, Västmanland County Hospital, 721 89, Västerås, Sweden; Västmanland County Hospital, Center for Clinical Research, Uppsala University, 721 89, Västerås, Sweden
Leif Bergkvist
Västmanland County Hospital, Center for Clinical Research, Uppsala University, 721 89, Västerås, Sweden
Jan Frisell
Division of Cancer, Department of Breast, Endocrine Tumors and Sarcoma, Karolinska University Hospital, 171 64, Solna, Sweden
Dan Lundstedt
Department of Oncology, Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg, Sahlgrenska University Hospital, 413 45, Gothenburg, Sweden
Lisa Rydén
Division of Surgery, Department of Clinical Sciences Lund, Lund University, 221 84, Lund, Sweden; Department of Surgery and Gastroenterology, Skåne University Hospital, 214 28, Malmö, Sweden
Malin Sund
Department of Surgical and Perioperative Science/Surgery, Umeå University, 709 87, Umeå, Sweden; Department of Surgery, University of Helsinki and Helsinki University Hospital, PO Box 440, Helsinki, Finland
Sara Alkner
Division of Oncology, Department of Clinical Sciences Lund, Skåne University Hospital, Lund University, 221 84, Lund, Sweden
Birgitte Vrou Offersen
Department of Experimental Clinical Oncology Aarhus University Hospital, 8200, Aarhus, Denmark; Department of Oncology, Aarhus University Hospital, 8200, Aarhus, Denmark; Danish Breast Cancer Group Center and Clinic for Late Effects, Aarhus University Hospital, 8200, Aarhus, Denmark
Tove Filtenborg Tvedskov
Department of Breast Surgery, Rigshospitalet, 2100, Copenhagen, Denmark
Peer Christiansen
Danish Breast Cancer Group Center and Clinic for Late Effects, Aarhus University Hospital, 8200, Aarhus, Denmark; Department of Plastic and Breast Surgery, Aarhus University Hospital, 8200, Aarhus, Denmark
Jana de Boniface
Department of Molecular Medicine and Surgery, Karolinska Institutet, 171 76, Stockholm, Sweden; Department of Surgery, Capio St Göran's Hospital, 112 19, Stockholm, Sweden
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).
