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.

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