1. Intraoperative ultrasound guidance in breast-conserving surgery shows superiority in oncological outcome, long-term cosmetic and patient-reported outcomes: Final outcomes of a randomized controlled trial (COBALT).
- Author
-
Volders JH, Haloua MH, Krekel NM, Negenborn VL, Kolk RH, Lopes Cardozo AM, Bosch AM, de Widt-Levert LM, van der Veen H, Rijna H, Taets van Amerongen AH, Jóźwiak K, Meijer S, and van den Tol MP
- Subjects
- Adult, Aged, Axilla, Body Image, Breast Neoplasms diagnostic imaging, Breast Neoplasms pathology, Carcinoma, Ductal, Breast diagnostic imaging, Carcinoma, Ductal, Breast pathology, Carcinoma, Lobular diagnostic imaging, Carcinoma, Lobular pathology, Esthetics, Female, Humans, Lymph Node Excision, Margins of Excision, Middle Aged, Neoplasm Recurrence, Local epidemiology, Neoplasm Staging, Patient Reported Outcome Measures, Quality of Life, Reproductive Health, Surveys and Questionnaires, Treatment Outcome, Ultrasonography, Mammary, Breast Neoplasms surgery, Carcinoma, Ductal, Breast surgery, Carcinoma, Lobular surgery, Mastectomy, Segmental methods, Patient Satisfaction, Surgery, Computer-Assisted methods
- 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., (Copyright © 2016 Elsevier Ltd, BASO ~ The Association for Cancer Surgery, and the European Society of Surgical Oncology. All rights reserved.)
- Published
- 2017
- Full Text
- View/download PDF