A patient- and assessor-blinded randomized controlled trial of axillary reverse mapping (ARM) in patients with early breast cancer |
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| Affiliation: | 1. Department of Surgery, Amphia Hospital, Breda, the Netherlands;2. Department of Radiology, Netherlands Cancer Institute, Amsterdam, the Netherlands;3. Department of Surgery, Albert Schweitzer Hospital, Dordrecht, the Netherlands;4. Department of Surgery, Medisch Spectrum Twente Hospital, Twente, the Netherlands;5. Department of Surgery, Haga Hospital, The Hague, the Netherlands;6. Department of Surgery, Catharina Hospital, Eindhoven, the Netherlands;7. Department of Surgery, Maastricht University, Maastricht, the Netherlands;8. Department of Epidemiology, Faculty of Health Medicine and Life Sciences, Research Institute Growth and Development (GROW), Maastricht University, Maastricht, the Netherlands;9. Department of Research, Netherlands Comprehensive Cancer Organisation, Utrecht, the Netherlands;1. Institute of Pathology, University Medical Center Göttingen, Göttingen, Germany;2. Clinic for Gastroenterology and Gastrointestinal Oncology, University Medical Center Göttingen, Göttingen, Germany;1. Department of Molecular Medicine and Surgery, Karolinska Institutet, and Karolinska University Hospital, Stockholm, Sweden;2. Department of Medicine/Huddinge Karolinska Institutet and ANOVA, Karolinska University Hospital, Stockholm, Sweden;3. Surgical Clinic, Sergelkliniken, Stockholm, Sweden;4. Unit of Biostatistics, Institute of Environmental Medicine, Karolinska Institutet, Stockholm, Sweden;5. Function Promoting Therapies, Waltham, MA, USA;6. Research Program in Men''s Health: Aging and Metabolism, Brigham and Women''s Hospital, Harvard Medical School, Boston, MA, USA;1. Erasmus Medical Center Rotterdam, Department of Surgical Oncology, Rotterdam, the Netherlands;2. University Medical Center Utrecht, Department of Surgical Oncology, Utrecht, the Netherlands;3. Maxima Medisch Centrum, Department of Surgical Oncology, Eindhoven, the Netherlands;4. Amphia Hospital, Department of Surgical Oncology, Breda, the Netherlands;5. Helsinki University Hospital, Department of Breast Surgery, Helsinki, Finland;6. Maastricht University Medical Center+, Department of Radiology and Nuclear Medicine, Maastricht, the Netherlands;7. Leiden University Medical Center, Department of Surgery, Leiden, the Netherlands;8. Alrijne Hospital, Department of Surgical Oncology, Leiderdorp, the Netherlands;9. Institute of Clinical Sciences, Sahlgrenska University Hospital, Department of Surgery, Göteborg, Sweden;10. Maastricht University Medical Center+, Department of Surgical Oncology, Maastricht, the Netherlands;11. Maastricht University Medical Center+, GROW – School for Oncology and Developmental Biology, Maastricht, the Netherlands;1. Department of Radiation Oncology (MAASTRO), GROW School for Oncology and Developmental Biology, Maastricht University Medical Centre+, The Netherlands;2. Department of Surgery, Maastricht University Medical Centre+, The Netherlands;3. Department of Medical Oncology, Maastricht University Medical Centre+, The Netherlands;1. Department of Radiation Oncology, Robert H. Lurie Comprehensive Cancer Center, Northwestern University Feinberg School of Medicine, Chicago, Illinois;2. Department of Preventative Medicine, Robert H. Lurie Comprehensive Cancer Center, Northwestern University Feinberg School of Medicine, Chicago, Illinois;3. School of Kinesiology and Movement Science, University of Michigan, Ann Arbor, Michigan |
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| Abstract: | BackgroundAxillary lymph node dissection (ALND) in breast cancer patients is infamous for its accompanying morbidity. Selective preservation of upper extremity lymphatic drainage and accompanying lymph nodes crossing the axillary basin - currently resected during a standard ALND - has been proposed as a valuable surgical refinement.MethodsPeroperative Axillary Reversed Mapping (ARM) was used for selective preservation of upper extremity lymphatic drainage. A multicentre patient- and assessor-blinded randomized study was performed in clinical node negative, sentinel node positive early breast cancer patients. Patients were randomized to undergo either standard-ALND or ARM-ALND. Primary outcome was the presence of surgery-related lymphedema at six, 12 and 24 months post-operatively. Secondary outcomes included patient reported and objective signs and symptoms of lymphedema, pain, paraesthesia, numbness, loss of shoulder mobility, quality of life and axillary recurrence risk.ResultsNo significant differences were found between both groups using the water displacement method with respect to measured lymphedema. ARM-ALND resulted in less reported complaints of lymphedema at six, 12 and 24 months postoperatively (p < 0.05). No axillary recurrence was found in both groups.ConclusionsIn contrast to results of volumetric measurement, patient reported outcomes support selective sparing of the upper extremity lymphatic drainage using ARM as valuable surgical refinement in case of ALND in clinically node negative, sentinel node positive early breast cancer. If completion ALND in clinically node negative, sentinel node positive early breast cancer is considered, selective sparing of upper extremity axillary lymphatics by implementing ARM should be carried out in order to reduce morbidity. |
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| Keywords: | Breast cancer Axillary lymph node dissection Lymphedema Axillary reverse mapping |
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