title: 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).
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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Department of Surgery, Gelderse Vallei Hospital, Willy Brandtlaan 10, 6716 RP Ede, The Netherlands. Electronic address: voldersjh@gmail.com.
authors.forename: J H
authors.initials: JH
authors.lastname: Volders
authors.affiliation: Department of Surgical Oncology, VU University Medical Center, De Boelelaan 1117, 1081 HV Amsterdam, The Netherlands. Electronic address: mhaloua@gmail.com.
authors.forename: M H
authors.initials: MH
authors.lastname: Haloua
authors.affiliation: Department of Surgical Oncology, VU University Medical Center, De Boelelaan 1117, 1081 HV Amsterdam, The Netherlands. Electronic address: n.krekel@vumc.nl.
authors.forename: N M A
authors.initials: NM
authors.lastname: Krekel
authors.affiliation: Department of Surgical Oncology, VU University Medical Center, De Boelelaan 1117, 1081 HV Amsterdam, The Netherlands. Electronic address: vlnegenborn@gmail.com.
authors.forename: V L
authors.initials: VL
authors.lastname: Negenborn
authors.affiliation: 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.
authors.forename: R H E
authors.initials: RH
authors.lastname: Kolk
authors.affiliation: Department of Surgery, Northwest Clinics, Wilhelminalaan 12, 1815JD Alkmaar, The Netherlands. Electronic address: a.m.f.lopes.cardozo@nwz.nl.
authors.forename: A M F
authors.initials: AM
authors.lastname: Lopes Cardozo
authors.affiliation: Department of Surgery, Gelderse Vallei Hospital, Willy Brandtlaan 10, 6716 RP Ede, The Netherlands. Electronic address: BoschA1@zgv.nl.
authors.forename: A M
authors.initials: AM
authors.lastname: Bosch
authors.affiliation: Department of Surgery, Waterland Hospital, Waterlandlaan 250, 1441 RN Purmerend, The Netherlands. Electronic address: ldewidt@wlz.nl.
authors.forename: L M
authors.initials: LM
authors.lastname: de Widt-Levert
authors.affiliation: Department of Surgery, Red Cross Hospital, Vondellaan 13, 1942 LE Beverwijk, The Netherlands. Electronic address: hvanderveen@rkz.nl.
authors.forename: H
authors.initials: H
authors.lastname: van der Veen
authors.affiliation: Department of Surgery, Kennemergasthuis, Boerhaavelaan 22, 2035 RC Haarlem, The Netherlands. Electronic address: rijna@kg.nl.
authors.forename: H
authors.initials: H
authors.lastname: Rijna
authors.affiliation: Department of Radiology, VU University Medical Center, De Boelelaan 1117, 1081 HV Amsterdam, The Netherlands. Electronic address: a.h.m.taets@gmail.com.
authors.forename: A H M
authors.initials: AH
authors.lastname: Taets van Amerongen
authors.affiliation: Department of Epidemiology and Biostatistics, NKI-AVL, Plesmanlaan 121, 1066 CX Amsterdam, The Netherlands. Electronic address: k.jozwiak@nki.nl.
authors.forename: K
authors.initials: K
authors.lastname: Jóźwiak
authors.affiliation: Department of Surgical Oncology, VU University Medical Center, De Boelelaan 1117, 1081 HV Amsterdam, The Netherlands. Electronic address: s.meijer52@kpnplanet.nl.
authors.forename: S
authors.initials: S
authors.lastname: Meijer
authors.affiliation: Department of Surgical Oncology, VU University Medical Center, De Boelelaan 1117, 1081 HV Amsterdam, The Netherlands. Electronic address: MP.vandentol@vumc.nl.
authors.forename: M P
authors.initials: MP
authors.lastname: van den Tol
mesh_terms: D000328:Adult; D000368:Aged; D001365:Axilla; D001828:Body Image; D001943:Breast Neoplasms / Q000000981:diagnostic imaging / Q000473:pathology / Q000601:surgery*; D018270:Carcinoma, Ductal, Breast / Q000000981:diagnostic imaging / Q000473:pathology / Q000601:surgery*; D018275:Carcinoma, Lobular / Q000000981:diagnostic imaging / Q000473:pathology / Q000601:surgery*; D004954:Esthetics; D005260:Female; D006801:Humans; D008197:Lymph Node Excision; D000072662:Margins of Excision; D015412:Mastectomy, Segmental / Q000379:methods*; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000453:epidemiology; D009367:Neoplasm Staging; D000071066:Patient Reported Outcome Measures; D017060:Patient Satisfaction; D011788:Quality of Life; D060728:Reproductive Health; D025321:Surgery, Computer-Assisted / Q000379:methods*; D011795:Surveys and Questionnaires; D016896:Treatment Outcome; D016217:Ultrasonography, Mammary
keywords: Breast cancer; Cosmetic outcome; Margins; Palpation guided surgery; Quality of life; Ultrasound guided surgey