Matthew Castelo1,2,3,4, Shu Yang Hu5, Fahima Dossa1,2,3,4, Sergio A Acuna1,2,3,4, Adena S Scheer6,7,8,9. 1. Division of General Surgery, Department of Surgery, St. Michael's Hospital, University of Toronto, Toronto, ON, Canada. 2. Institute of Health Policy, Management and Evaluation, Dalla Lana School of Public Health, University of Toronto, Toronto, ON, Canada. 3. Li Ka Shing Knowledge Institute, St. Michael's Hospital, Toronto, ON, Canada. 4. Department of Surgery, St. Michael's Hospital, Toronto, ON, Canada. 5. School of Medicine, Royal College of Surgeons in Ireland, Dublin, Ireland. 6. Division of General Surgery, Department of Surgery, St. Michael's Hospital, University of Toronto, Toronto, ON, Canada. adena.scheer@unityhealth.to. 7. Institute of Health Policy, Management and Evaluation, Dalla Lana School of Public Health, University of Toronto, Toronto, ON, Canada. adena.scheer@unityhealth.to. 8. Li Ka Shing Knowledge Institute, St. Michael's Hospital, Toronto, ON, Canada. adena.scheer@unityhealth.to. 9. Department of Surgery, St. Michael's Hospital, Toronto, ON, Canada. adena.scheer@unityhealth.to.
Abstract
PURPOSE: Several randomized controlled trials (RCTs) have investigated observation or axillary radiotherapy (ART) in place of completion axillary lymph node dissection (cALND) for management of positive sentinel nodes (SNs) in clinically node-negative women with breast cancer. The optimal treatment strategy for this population is not known. METHODS: MEDLINE, Embase, and EBM Reviews-NHS Economic Evaluation Database were searched from inception until July 2019. A systematic review and narrative summary was performed of RCTs comparing observation or ART versus cALND in clinically node-negative female breast cancer patients with positive SNs. The Cochrane risk of bias tool for RCTs was used to assess risk of bias. Outcomes of interest included overall survival (OS), disease-free survival (DFS), axillary recurrence, and axillary surgery-related morbidity. RESULTS: Three trials compared observation with cALND, and two trials compared ART with cALND. No studies blinded participants or personnel, and there was heterogeneity in inclusion criteria, study design, and follow-up. Neither observation nor ART resulted in statistically inferior 5- or 8-year OS or DFS compared with cALND. There was also no statistically significant increase in axillary recurrences associated with either approach. Four trials reported morbidity outcomes, and all showed cALND was associated with significantly more lymphedema, paresthesia, and shoulder dysfunction compared with observation or ART. CONCLUSIONS: Women with clinically node-negative breast cancer and positive SNs can safely be managed without cALND.
PURPOSE: Several randomized controlled trials (RCTs) have investigated observation or axillary radiotherapy (ART) in place of completion axillary lymph node dissection (cALND) for management of positive sentinel nodes (SNs) in clinically node-negative women with breast cancer. The optimal treatment strategy for this population is not known. METHODS: MEDLINE, Embase, and EBM Reviews-NHS Economic Evaluation Database were searched from inception until July 2019. A systematic review and narrative summary was performed of RCTs comparing observation or ART versus cALND in clinically node-negative female breast cancerpatients with positive SNs. The Cochrane risk of bias tool for RCTs was used to assess risk of bias. Outcomes of interest included overall survival (OS), disease-free survival (DFS), axillary recurrence, and axillary surgery-related morbidity. RESULTS: Three trials compared observation with cALND, and two trials compared ART with cALND. No studies blinded participants or personnel, and there was heterogeneity in inclusion criteria, study design, and follow-up. Neither observation nor ART resulted in statistically inferior 5- or 8-year OS or DFS compared with cALND. There was also no statistically significant increase in axillary recurrences associated with either approach. Four trials reported morbidity outcomes, and all showed cALND was associated with significantly more lymphedema, paresthesia, and shoulder dysfunction compared with observation or ART. CONCLUSIONS:Women with clinically node-negative breast cancer and positive SNs can safely be managed without cALND.
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