M.H. Haloua

Intraoperative ultrasound guidance for palpable breast cancer excision (COBALT trial): a multicentre, randomised controlled trial

BACKGROUND Breast-conserving surgery for palpable breast cancer is associated with tumour-involved margins in up to 41% of cases and excessively large excision volumes. Ultrasound-guided surgery has the potential to resolve both of these problems, thereby improving surgical accuracy for palpable breast cancer. We aimed to compare ultrasound-guided surgery with the standard for palpable breast cancer-palpation-guided surgery-with respect to margin status and extent of healthy breast tissue resection. METHODS In this randomised controlled trial, patients with palpable T1-T2 invasive breast cancer were recruited from six medical centres in the Netherlands between October, 2010, and March, 2012. Eligible participants were randomly assigned to either ultrasound-guided surgery or palpation-guided surgery in a 1:1 ratio via a computer-generated random sequence and were stratified by study centre. Patients and investigators were aware of treatment assignments. Primary outcomes were surgical margin involvement, need for additional treatment, and excess healthy tissue resection (defined with a calculated resection ratio derived from excision volume and tumour diameter). Data were analysed by intention to treat. This trial is registered at http://www.TrialRegister.nl, number NTR2579. FINDINGS 134 patients were eligible for random allocation. Two (3%) of 65 patients allocated ultrasound-guided surgery had tumour-involved margins compared with 12 (17%) of 69 who were assigned palpation-guided surgery (difference 14%, 95% CI 4-25; p=0·0093). Seven (11%) patients who received ultrasound-guided surgery and 19 (28%) of those who received palpation-guided surgery required additional treatment (17%, 3-30; p=0·015). Ultrasound-guided surgery also resulted in smaller excision volumes (38 [SD 26] vs 57 [41] cm(3); difference 19 cm(3), 95% CI 7-31; p=0·002) and a reduced calculated resection ratio (1·0 [SD 0·5] vs 1·7 [1·2]; difference 0·7, 95% CI 0·4-1·0; p=0·0001) compared with palpation-guided surgery. INTERPRETATION Compared with palpation-guided surgery, ultrasound-guided surgery can significantly lower the proportion of tumour-involved resection margins, thus reducing the need for re-excision, mastectomy, and radiotherapy boost. By achieving optimum resection volumes, ultrasound-guided surgery reduces unnecessary resection of healthy breast tissue and could contribute to improved cosmetic results and quality of life. FUNDING Dutch Pink Ribbon Foundation, Osinga-Kluis Foundation, Toshiba Medical Systems.

Cosmetic Outcome Assessment following Breast-Conserving Therapy: A Comparison between BCCT.core Software and Panel Evaluation

Purpose. Over recent decades, no consensus has yet been reached on the optimal approach to cosmetic evaluation following breast-conserving therapy (BCT). The present study compared the strengths and weaknesses of the BCCT.core software with a 10-member panel from various backgrounds. Methods. Digital photographs of 109 consecutive patients after BCT were evaluated for 7 items by a panel consisting of 2 breast surgeons, 2 residents, 2 laypersons, and 4 plastic surgeons. All photographs were objectively evaluated using the BCCT.core software (version 20), and an overall cosmetic outcome score was reached using a four-point Likert scale. Results. Based on the mean BCCT.core software score, 41% of all patients had fair or poor overall cosmetic results (10% poor), compared with 51% (14% poor) obtained with panel evaluation. Mean overall BCCT.core score and mean overall panel score substantially agreed (weighted kappa: 0.68). By contrast, analysis of the evaluation of scar tissue revealed large discrepancies between the BCCT.core software and the panel. The analysis of subgroups formed from different combinations of the panel members still showed substantial agreement with the BCCT.core software (range 0.64–0.69), independent of personal background. Conclusions. Although the analysis of scar tissue by the software shows room for improvement, the BCCT.core represents a valid and efficient alternative to panel evaluation.

Cosmetic outcome and quality of life are inextricably linked in breast-conserving therapy

Cosmetic results and quality of life (QoL) are increasingly important in the treatment of breast cancer. This study was designed to determine the relationship between QoL and both subjectively and objectively measured cosmetic outcomes of breast‐conserving therapy (BCT), and its course over time.

Abstract PD04-01: Intra-operative ultrasound in breast-conserving surgery for palpable breast cancer significantly improves both surgical accuracy and cosmetic outcome while saving costs.

Background: Breast-conserving surgery for palpable breast cancer is worldwide associated with a high rate of tumour-involved margins and excessive healthy tissue resection. This results in additional treatment and poor cosmetic outcome. Ultrasound-guided surgery (USS) may resolve both problems by improving surgical accuracy. A randomised controlled trial was initiated to compare USS with the standard palpation-guided surgery (PGS) for palpable breast cancer. Methods: A total of 134 eligible patients with palpable T1-T2 invasive breast cancer were randomised to either USS (n = 65) or PGS (n = 69). Outcome measures included resection margin status, re-excision rates, mastectomy rates and additional radiotherapy. A calculated resection ratio (CRR) was derived from specimen volumes and tumour diameters, indicating healthy tissue resection. Secondary outcome measures were operative time, complications cosmetic outcome and cost-effectiveness. The costs of purchasing the US-system were included in the USS-group. The mean total costs per patient were calculated and compared between both study groups. Results: In the USS-group, 3.1% of margins were involved, compared with 17.4% in the PGS-group (p = 0.009). The use of intra-operative US resulted in a significant reduction in additional therapies (p = 0.015); in the PGS-group re-excisions were necessary in 3 patients (4.3%) and in 1 patient (1.5%) in the USS-group, mastectomies were performed in 5 patients (7.2%) of the PGS-group and in none of the patients of the USS-group, and additional radiotherapy boosts in 11 patients (15.9%) of the PGS-group and 6 patients in the USS-group (9.2%). Excision volumes and CRR were both reduced with USS (38cc vs. 58cc and 1.0 vs. 1.7, respectively; both P Conclusion: USS can prevent the unacceptably high rate of tumour-involved resection margins in palpable breast cancer excision, thus not only improving oncological and cosmetic outcomes by avoiding subsequent surgery or radiotherapy, but also considerably reducing treatment costs. In addition to palpable breast cancer surgery, USS might be used for non-papable breast cancer surgery, mastectomies and oncoplastic procedures. Therefore even greater cost-savings might be achieved by using a US-system for breast cancer surgery. Long term results of cosmetic outcome and quality of life of this trial are expected in 2013. Citation Information: Cancer Res 2012;72(24 Suppl):Abstract nr PD04-01.

Breast-specific factors determine cosmetic outcome and patient satisfaction after breast-conserving therapy: Results from the randomized COBALT study

To identify breast‐specific factors and the role of tumor, treatment, and patient‐related items in influencing patient opinion on cosmesis and satisfaction after breast‐conserving therapy (BCT).

Response to “The CUBE Technique: Continuous Ultrasound-Guided Breast Excision,” Published in August 2014 by Tummel et al. Amsterdam, 28th January 2015

We read the article ‘‘The CUBE technique: continuous ultrasound-guided breast excision,’’ published in August 2014 by Tummel et al. We congratulate the authors on their study and the positive results concerning intraoperative ultrasonography for breast cancer surgery. However, if the authors had performed a review of the literature on this subject, they would have realized that the described technique is actually not as ‘‘novel’’ as they opine. Over the past years, our study group has extensively published on this subject, resulting in a multicenter, randomized controlled trial including 134 patients. Although the term ‘‘CUBE’’ is indeed novel, the technique itself is an exact copy of the technique we—among other authors—have repeatedly described. Needless to say, it would have been appropriate for the authors to refer to these studies while presenting their results, and we are somewhat disappointed that the journal did not revise the literature list on behalf of the authors. We recommend that the authors repeat our randomized controlled trial on use of intraoperative ultrasound, so we can convince all surgical oncologists to use this excellent technique in the operating theater. It would be highly appreciated if the authors could respond to our letter, and we await their reply. REFERENCES