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)

J H Volders; M H Haloua; N M A Krekel; V L Negenborn; R H E Kolk; A M F Lopes Cardozo; A M Bosch; L M de Widt-Levert; H van der Veen; H Rijna; A H M Taets van Amerongen; K Jóźwiak; S Meijer; M P van den Tol

doi:10.1016/j.ejso.2016.11.004

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)

Eur J Surg Oncol. 2017 Apr;43(4):649-657. doi: 10.1016/j.ejso.2016.11.004. Epub 2016 Nov 23.

Authors

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

Affiliations

¹ Department of Surgery, Gelderse Vallei Hospital, Willy Brandtlaan 10, 6716 RP Ede, The Netherlands. Electronic address: [email protected].
² Department of Surgical Oncology, VU University Medical Center, De Boelelaan 1117, 1081 HV Amsterdam, The Netherlands. Electronic address: [email protected].
³ Department of Surgical Oncology, VU University Medical Center, De Boelelaan 1117, 1081 HV Amsterdam, The Netherlands. Electronic address: [email protected].
⁴ Department of Surgical Oncology, VU University Medical Center, De Boelelaan 1117, 1081 HV Amsterdam, The Netherlands. Electronic address: [email protected].
⁵ Department of Surgical Oncology, VU University Medical Center, De Boelelaan 1117, 1081 HV Amsterdam, The Netherlands. Electronic address: [email protected].
⁶ Department of Surgery, Northwest Clinics, Wilhelminalaan 12, 1815JD Alkmaar, The Netherlands. Electronic address: [email protected].
⁷ Department of Surgery, Gelderse Vallei Hospital, Willy Brandtlaan 10, 6716 RP Ede, The Netherlands. Electronic address: [email protected].
⁸ Department of Surgery, Waterland Hospital, Waterlandlaan 250, 1441 RN Purmerend, The Netherlands. Electronic address: [email protected].
⁹ Department of Surgery, Red Cross Hospital, Vondellaan 13, 1942 LE Beverwijk, The Netherlands. Electronic address: [email protected].
¹⁰ Department of Surgery, Kennemergasthuis, Boerhaavelaan 22, 2035 RC Haarlem, The Netherlands. Electronic address: [email protected].
¹¹ Department of Radiology, VU University Medical Center, De Boelelaan 1117, 1081 HV Amsterdam, The Netherlands. Electronic address: [email protected].
¹² Department of Epidemiology and Biostatistics, NKI-AVL, Plesmanlaan 121, 1066 CX Amsterdam, The Netherlands. Electronic address: [email protected].
¹³ Department of Surgical Oncology, VU University Medical Center, De Boelelaan 1117, 1081 HV Amsterdam, The Netherlands. Electronic address: [email protected].
¹⁴ Department of Surgical Oncology, VU University Medical Center, De Boelelaan 1117, 1081 HV Amsterdam, The Netherlands. Electronic address: [email protected].

PMID: 27916314
DOI: 10.1016/j.ejso.2016.11.004

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.

Keywords: Breast cancer; Cosmetic outcome; Margins; Palpation guided surgery; Quality of life; Ultrasound guided surgey.

Publication types

Multicenter Study
Randomized Controlled Trial

MeSH terms

Adult
Aged
Axilla
Body Image
Breast Neoplasms / diagnostic imaging
Breast Neoplasms / pathology
Breast Neoplasms / surgery*
Carcinoma, Ductal, Breast / diagnostic imaging
Carcinoma, Ductal, Breast / pathology
Carcinoma, Ductal, Breast / surgery*
Carcinoma, Lobular / diagnostic imaging
Carcinoma, Lobular / pathology
Carcinoma, Lobular / surgery*
Esthetics
Female
Humans
Lymph Node Excision
Margins of Excision
Mastectomy, Segmental / methods*
Middle Aged
Neoplasm Recurrence, Local / epidemiology
Neoplasm Staging
Patient Reported Outcome Measures
Patient Satisfaction*
Quality of Life
Reproductive Health
Surgery, Computer-Assisted / methods*
Surveys and Questionnaires
Treatment Outcome
Ultrasonography, Mammary