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; SENOMAC Trialists' Group

doi:10.1016/j.breast.2022.02.013

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

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

Authors

Matilda Appelgren¹, Helena Sackey², Yvonne Wengström³, Karin Johansson⁴, Johan Ahlgren⁵, Yvette Andersson⁶, Leif Bergkvist⁷, Jan Frisell⁸, Dan Lundstedt⁹, Lisa Rydén¹⁰, Malin Sund¹¹, Sara Alkner¹², Birgitte Vrou Offersen¹³, Tove Filtenborg Tvedskov¹⁴, Peer Christiansen¹⁵, Jana de Boniface¹⁶; SENOMAC Trialists' Group

Affiliations

¹ Department of Molecular Medicine and Surgery, Karolinska Institutet, 171 76, Stockholm, Sweden. Electronic address: [email protected].
² 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.
³ 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.
⁴ Department of Health Sciences, Lund University, 221 00, Lund, Sweden.
⁵ Department of Oncology, University Hospital, 701 85, Örebro, Sweden; Regional Oncology Centre, Mid-Sweden Health Care Region, 751 85, Uppsala, Sweden.
⁶ Department of Surgery, Västmanland County Hospital, 721 89, Västerås, Sweden; Västmanland County Hospital, Center for Clinical Research, Uppsala University, 721 89, Västerås, Sweden.
⁷ Västmanland County Hospital, Center for Clinical Research, Uppsala University, 721 89, Västerås, Sweden.
⁸ Division of Cancer, Department of Breast, Endocrine Tumors and Sarcoma, Karolinska University Hospital, 171 64, Solna, Sweden.
⁹ Department of Oncology, Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg, Sahlgrenska University Hospital, 413 45, Gothenburg, Sweden.
¹⁰ 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.
¹¹ 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.
¹² Division of Oncology, Department of Clinical Sciences Lund, Skåne University Hospital, Lund University, 221 84, Lund, Sweden.
¹³ 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.
¹⁴ Department of Breast Surgery, Rigshospitalet, 2100, Copenhagen, Denmark.
¹⁵ 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.
¹⁶ Department of Molecular Medicine and Surgery, Karolinska Institutet, 171 76, Stockholm, Sweden; Department of Surgery, Capio St Göran's Hospital, 112 19, Stockholm, Sweden.

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.

MeSH terms

Axilla / pathology
Breast Neoplasms* / pathology
Breast Neoplasms* / surgery
Female
Humans
Lymph Node Excision / methods
Lymphatic Metastasis / pathology
Patient Reported Outcome Measures
Quality of Life
Sentinel Lymph Node Biopsy / methods
Sentinel Lymph Node* / pathology

Associated data

ClinicalTrials.gov/NCT02240472