J H Volders1, M H Haloua2, N M A Krekel3, V L Negenborn4, R H E Kolk5, A M F Lopes Cardozo6, A M Bosch7, L M de Widt-Levert8, H van der Veen9, H Rijna10, A H M Taets van Amerongen11, K Jóźwiak12, S Meijer13, M P van den Tol14. 1. Department of Surgery, Gelderse Vallei Hospital, Willy Brandtlaan 10, 6716 RP Ede, The Netherlands. Electronic address: voldersjh@gmail.com. 2. Department of Surgical Oncology, VU University Medical Center, De Boelelaan 1117, 1081 HV Amsterdam, The Netherlands. Electronic address: mhaloua@gmail.com. 3. Department of Surgical Oncology, VU University Medical Center, De Boelelaan 1117, 1081 HV Amsterdam, The Netherlands. Electronic address: n.krekel@vumc.nl. 4. Department of Surgical Oncology, VU University Medical Center, De Boelelaan 1117, 1081 HV Amsterdam, The Netherlands. Electronic address: vlnegenborn@gmail.com. 5. Department of Surgical Oncology, VU University Medical Center, De Boelelaan 1117, 1081 HV Amsterdam, The Netherlands. Electronic address: r.h.e.kolk@student.vu.nl. 6. Department of Surgery, Northwest Clinics, Wilhelminalaan 12, 1815JD Alkmaar, The Netherlands. Electronic address: a.m.f.lopes.cardozo@nwz.nl. 7. Department of Surgery, Gelderse Vallei Hospital, Willy Brandtlaan 10, 6716 RP Ede, The Netherlands. Electronic address: BoschA1@zgv.nl. 8. Department of Surgery, Waterland Hospital, Waterlandlaan 250, 1441 RN Purmerend, The Netherlands. Electronic address: ldewidt@wlz.nl. 9. Department of Surgery, Red Cross Hospital, Vondellaan 13, 1942 LE Beverwijk, The Netherlands. Electronic address: hvanderveen@rkz.nl. 10. Department of Surgery, Kennemergasthuis, Boerhaavelaan 22, 2035 RC Haarlem, The Netherlands. Electronic address: rijna@kg.nl. 11. Department of Radiology, VU University Medical Center, De Boelelaan 1117, 1081 HV Amsterdam, The Netherlands. Electronic address: a.h.m.taets@gmail.com. 12. Department of Epidemiology and Biostatistics, NKI-AVL, Plesmanlaan 121, 1066 CX Amsterdam, The Netherlands. Electronic address: k.jozwiak@nki.nl. 13. Department of Surgical Oncology, VU University Medical Center, De Boelelaan 1117, 1081 HV Amsterdam, The Netherlands. Electronic address: s.meijer52@kpnplanet.nl. 14. Department of Surgical Oncology, VU University Medical Center, De Boelelaan 1117, 1081 HV Amsterdam, The Netherlands. Electronic address: MP.vandentol@vumc.nl.
Abstract
BACKGROUND: The multicenter randomized controlled COBALT trial demonstrated that ultrasound-guided breast-conserving surgery (USS) results in a significant reduction of margin involvement (3.1% vs. 13%) and excision volumes compared to palpation-guided surgery (PGS). The aim of the present study was to determine long term oncological and patient-reported outcomes including quality of life (QoL), together with their progress over time. METHODS:134 patients with T1-T2 breast cancer were randomized to USS (N = 65) or PGS (N = 69). Cosmetic outcomes were assessed with the Breast Cancer Conservative Treatment cosmetic results (BCCT.core) software, panel-evaluation and patient self-evaluation on a 4-point Likert-scale. QoL was measured using the EORTC QLQ-C30/-BR23 questionnaire. RESULTS: No locoregional recurrences were reported after mean follow-up of 41 months. Seven patients (5%) developed distant metastatic disease (USS 6.3%, PGS 4.4%, p = 0.466), of whom six died of disease (95.5% overall survival). USS achieved better cosmetic outcomes compared to PGS, with poor outcomes of 11% and 21% respectively, a result mainly attributable to mastectomies due to involved margins following PGS. There was no difference after 1 and 3 years in cosmetic outcome. Dissatisfied patients included those with larger excision volumes, additional local therapies and worse QoL. Patients with poor/fair cosmetic outcomes scored significantly lower on aspects of QoL, including breast-symptoms, body image and sexual enjoyment. CONCLUSION: By significantly reducing positive margin status and lowering resection volumes, USS improves the rate of good cosmetic outcomes and increases patient-satisfaction. Considering the large impact of cosmetic outcome on QoL, USS has great potential to improve QoL following breast-conserving therapy.
RCT Entities:
BACKGROUND: The multicenter randomized controlled COBALT trial demonstrated that ultrasound-guided breast-conserving surgery (USS) results in a significant reduction of margin involvement (3.1% vs. 13%) and excision volumes compared to palpation-guided surgery (PGS). The aim of the present study was to determine long term oncological and patient-reported outcomes including quality of life (QoL), together with their progress over time. METHODS: 134 patients with T1-T2 breast cancer were randomized to USS (N = 65) or PGS (N = 69). Cosmetic outcomes were assessed with the Breast Cancer Conservative Treatment cosmetic results (BCCT.core) software, panel-evaluation and patient self-evaluation on a 4-point Likert-scale. QoL was measured using the EORTC QLQ-C30/-BR23 questionnaire. RESULTS: No locoregional recurrences were reported after mean follow-up of 41 months. Seven patients (5%) developed distant metastatic disease (USS 6.3%, PGS 4.4%, p = 0.466), of whom six died of disease (95.5% overall survival). USS achieved better cosmetic outcomes compared to PGS, with poor outcomes of 11% and 21% respectively, a result mainly attributable to mastectomies due to involved margins following PGS. There was no difference after 1 and 3 years in cosmetic outcome. Dissatisfied patients included those with larger excision volumes, additional local therapies and worse QoL. Patients with poor/fair cosmetic outcomes scored significantly lower on aspects of QoL, including breast-symptoms, body image and sexual enjoyment. CONCLUSION: By significantly reducing positive margin status and lowering resection volumes, USS improves the rate of good cosmetic outcomes and increases patient-satisfaction. Considering the large impact of cosmetic outcome on QoL, USS has great potential to improve QoL following breast-conserving therapy.
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