Research Article| Volume 43, ISSUE 4, P649-657, April 2017

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)
Published:November 23, 2016DOI:



      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.


      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.


      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.


      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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        • Veronesi U.
        • Cascinelli N.
        • Mariani L.
        • et al.
        Twenty-year follow-up of a randomized study comparing breast-conserving surgery with radical mastectomy for early breast cancer.
        N Engl J Med. 2002; 347: 1227-1231
        • Moran M.S.
        • Schnitt S.J.
        • Giuliano A.E.
        • et al.
        Society of Surgical Oncology–American Society for Radiation Oncology consensus guideline on margins for breast-conserving surgery with whole-breast irradiation in stages I and II invasive breast cancer.
        Ann Surg Oncol. 2014; 21: 704-716
        • Coopey S.
        • Smith B.L.
        • Hanson S.
        • et al.
        The safety of multiple re-excisions after lumpectomy for breast cancer.
        Ann Surg Oncol. 2011; 18: 3797-3801
        • Hau E.
        • Browne L.
        • Capp A.
        • et al.
        The impact of breast cosmetic and functional outcomes on quality of life: long-term results from the St. George and Wollongong randomized breast boost trial.
        Breast Cancer Res Treat. 2013; 139: 115-123
        • Hennigs A.
        • Hartmann B.
        • Rauch G.
        • et al.
        Long-term objective esthetic outcome after breast-conserving therapy.
        Breast Cancer Res Treat. 2015; 153: 345-351
        • Taylor M.
        • Perez C.
        • Halverson K.
        Factors influencing cosmetic results after conservation therapy for breast cancer.
        Int J Radiat Oncol Biol Phys. 1995; 31: 753-764
        • Parvez E.
        • Cornacchi S.D.
        • Hodgson N.
        • et al.
        A cosmesis outcome substudy in a prospective, randomized trial comparing radioguided seed localization with standard wire localization for nonpalpable, invasive, and in situ breast carcinomas.
        Am J Surg. 2014; 208: 711-718
        • Hill-Kayser C.E.
        • Vachani C.
        • Hampshire M.K.
        • Di Lullo G.A.
        • Metz J.M.
        Cosmetic outcomes and complications reported by patients having undergone breast-conserving treatment.
        Int J Radiat Oncol Biol Phys. 2012; 83: 839-844
        • Vrieling C.
        • Collette L.
        • Fourquet A.
        • et al.
        The influence of patient, tumour and treatment factors on the cosmetic results after breast-conserving therapy in the EORTC “boost vs. no boost” trial.
        Radiother Oncol. 2000; 55: 219-232
        • Kim M.K.
        • Kim T.
        • Moon H.G.
        • et al.
        Effect of cosmetic outcome on quality of life after breast cancer surgery.
        Eur J Surg Oncol. 2015; 41: 426-432
        • Waljee J.F.
        • Hu E.S.
        • Ubel P a
        • Smith D.M.
        • Newman L a
        • Alderman A.K.
        Effect of esthetic outcome after breast-conserving surgery on psychosocial functioning and quality of life.
        J Clin Oncol. 2008 Jul 10; 26: 3331-3337
        • Fallowfield L.
        • Blamey R.W.
        Does cosmetic outcome from treatment of primary breast cancer influence psychosocial morbidity?.
        Eur J Surg Oncol. 1999 Dec; 25: 571-573
        • Immink J.M.
        • Putter H.
        • Bartelink H.
        • et al.
        Long-term cosmetic changes after breast-conserving treatment of patients with stage I–II breast cancer and included in the EORTC “boost versus no boost” trial.
        Ann Oncol. 2012; 23: 2591-2598
        • Cochrane R.A.
        • Valasiadou P.
        • Wilson A.R.
        • Al-Ghazal S.K.
        • Macmillan R.D.
        Cosmesis and satisfaction after breast-conserving surgery correlates with the percentage of breast volume excised.
        Br J Surg. 2003; 90: 1505-1509
        • Krekel N.M.
        • Haloua M.H.
        • Lopes Cardozo A.M.F.
        • et al.
        Intraoperative ultrasound guidance for palpable breast cancer excision (COBALT trial): a multicentre, randomised controlled trial.
        Lancet Oncol. 2013; 14: 48-54
        • Haloua M.H.
        • Volders J.H.
        • Krekel N.M.A.
        • et al.
        Intraoperative ultrasound guidance in breast-conserving surgery improves cosmetic outcomes and patient satisfaction: results of a multicenter randomized controlled trial (COBALT).
        Ann Surg Oncol. 2016 Jan; 23: 30-37
        • Krekel N.M.A.
        • Lopes Cardozo A.M.F.
        • Muller S.
        • Bergers E.
        • Meijer S.
        • Van Den Tol M.P.
        Optimising surgical accuracy in palpable breast cancer with intra-operative breast ultrasound – feasibility and surgeons' learning curve.
        Eur J Surg Oncol. 2011; 37: 1044-1050
        • Moore M.M.
        • Whitney L a
        • Cerilli L.
        • et al.
        Intraoperative ultrasound is associated with clear lumpectomy margins for palpable infiltrating ductal breast cancer.
        Ann Surg. 2001; 233: 761-768
        • Karanlik H.
        • Ozgur I.
        • Sahin D.
        • Fayda M.
        • Onder S.
        • Yavuz E.
        Intraoperative ultrasound reduces the need for re-excision in breast-conserving surgery.
        World J Surg Oncol. 2015; 13: 321
        • Pan H.
        • Wu N.
        • Ding H.
        • et al.
        Intraoperative ultrasound guidance is associated with clear lumpectomy margins for breast cancer: a systematic review and meta-analysis.
        PLoS One. 2013; 8: 1-8
        • Ahmed M.
        • Douek M.
        Intra-operative ultrasound versus wire-guided localization in the surgical management of non-palpable breast cancers: systematic review and meta-analysis.
        Breast Cancer Res Treat. 2013; 140: 435-446
        • Klimberg V.S.
        Intraoperative image-guided breast-conservation surgery should be gold stand.
        . November 2015; 2016: 4-5
        • Espinosa-Bravo M.
        • Rubio I.T.
        Intraoperative ultrasound guided breast surgery: paving the way for personalized surgery.
        Gland Surg. 2016; 5: 366-368
        • Wilke L.G.
        • Czechura T.
        • Wang C.
        • et al.
        Repeat surgery after breast conservation for the treatment of stage 0 to II breast carcinoma.
        JAMA Surg. 2014; 149: 1296
        • Foersterling E.
        • Golatta M.
        • Hennigs A.
        • et al.
        Predictors of early poor aesthetic outcome after breast-conserving surgery in patients with breast cancer: initial results of a prospective cohort study at a single institution.
        J Surg Oncol. 2014; 110: 801-806
        • Krekel N.
        • Zonderhuis B.
        • Muller S.
        • et al.
        Excessive resections in breast-conserving surgery: a retrospective multicentre study.
        Breast J. 2011; 17: 602-609
        • De Lorenzi F.
        • Hubner G.
        • Rotmensz N.
        • et al.
        Oncological results of oncoplastic breast-conserving surgery: long term follow-up of a large series at a single institution.
        Eur J Surg Oncol. 2016 Jan; 42: 71-77
        • Jagsi R.
        • Li Y.
        • Morrow M.
        • et al.
        Patient-reported quality of life and satisfaction with cosmetic outcomes after breast conservation and mastectomy with and without reconstruction.
        Ann Surg. 2015; 261: 1198-1206
        • Exner R.
        • Krois W.
        • Mittlböck M.
        • et al.
        Objectively measured breast symmetry has no influence on quality of life in breast cancer patients.
        Eur J Surg Oncol. 2012; 38: 130-136