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

BACKGROUND AND OBJECTIVES: 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). METHODS: Data from the randomized COBALT study was used. At 3, 12, and 36 months, 128 patients with T1-T2 breast cancer completed a questionnaire on breast-specific factors and overall cosmetic outcome and patient satisfaction, using a 4-point Likert scale. RESULTS: There was a strong positive correlation between breast-specific factors, overall cosmetic outcome,and satisfaction at all time-points. Excellent/good cosmetic outcomes and satisfaction decreased during follow-up. A shift was noted in the degree of influence of the various breast-specific factors. At 3 years, symmetry factors such as size, shape, and nipple position largely determined a patient's opinion on the final cosmesis, followed by firmness. The risk of an unacceptable outcome was associated with young age and large excision volumes. CONCLUSION: A questionnaire including breast-specific questions provides important information on final cosmetic results and satisfaction after BCT. These outcomes can also be of great value as quality indicators and pre-operative counseling. The major influence of breast-specific factors on asymmetry underlines the importance of achieving an optimal excision volume at the initial procedure.

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

INTRODUCTION: 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. METHODS: A total of 128 breast cancer patients who underwent BCT as part of a prospective randomized controlled trial were included. QoL was measured using the EORTC QLQ-C30 and QLQ-BR23 at baseline, 3, 6, 12, and 36 months. Cosmetic outcome was determined by patient self-evaluation, panel evaluation, and BCCT.core software. RESULTS: By 36 months, all QoL factors except arm symptoms had returned to baseline or improved. After adjustment for patient and tumor characteristics, a significantly better QoL in terms of body image, pain, and arm and breast symptoms was found for good/excellent cosmetic outcomes compared to fair/poor outcomes, as measured by both patient self-evaluation and panel evaluation. The BCCT.core showed no correlation with any QoL factors. CONCLUSION: There is a high correlation between poor cosmetic outcome and low scores on quality of life indicators, underlining the importance of achieving a good cosmetic outcome after BCT.

Intraoperative Ultrasound Guidance in Breast-Conserving Surgery Improves Cosmetic Outcomes and Patient Satisfaction: Results of a Multicenter Randomized Controlled Trial (COBALT).

BACKGROUND: Ultrasound-guided breast-conserving surgery (USS) results in a significant reduction in both margin involvement and excision volumes (COBALT trial). Objective. The aim of the present study was to determine whether USS also leads to improvements in cosmetic outcome and patient satisfaction when compared with standard palpation-guided surgery (PGS). METHODS: A total of 134 patients with T1­T2 invasive breast cancer were included in the COBALT trial (NTR2579) and randomized to either USS (65 patients) or PGS (69 patients). Cosmetic outcomes were assessed by a three-member panel using computerized software Breast Cancer Conservative Treatment cosmetic results (BCCT.- core) and by patient self-evaluation, including patient satisfaction. Time points for follow-up were 3, 6, and 12 months after surgery. Overall cosmetic outcome and patient satisfaction were scored on a 4-point Likert scale (excellent, good, fair, or poor), and outcomes were analyzed using a multilevel, mixed effect, proportional odds model for ordinal responses. RESULTS: Ultrasound-guided breast-conserving surgery achieved better cosmetic outcomes, with 20 % excellence overall and only 6 % rated as poor, whereas 14 % of PGS outcomes were rated excellent and 13 % as poor. USS also had consistently lower odds for worse cosmetic outcomes (odds ratio 0.55, p = 0.067) than PGS. The chance of having a worse outcome was significantly increased by a larger lumpectomy volume (ptrend = 0.002); a volume [40 cc showed odds 2.78-fold higher for a worse outcome than a volume B40 cc. USS resulted in higher patient satisfaction compared with PGS. CONCLUSION: Ultrasound-guided breast-conserving surgery achieved better overall cosmetic outcomes and patient satisfaction than PGS. Lumpectomy volumes[40 cc resulted in significantly worse cosmetic outcomes.

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.

A systematic review of oncoplastic breast-conserving surgery: current weaknesses and future prospects.

OBJECTIVE: The primary objectives of this systematic review on oncoplastic breast surgery (OPBS) were to evaluate the oncological and cosmetic outcomes of OPBS. The secondary objectives were to assess morbidity, quality of life, and applied algorithms. BACKGROUND: Breast-conserving therapy (BCT) has become the standard of care, and survival is now excellent. Consequently, the focus of BCT has increasingly shifted to cosmetic outcome, quality of life, and patient satisfaction. Nonetheless, excision of certain tumors still presents a considerable challenge. Specialized approaches combining oncological surgery and plastic surgery techniques are collectively referred to as OPBS. A summary of OPBS outcomes would facilitate decision-making and best treatment selection by both clinicians and patients. METHODS: Using specific inclusion and exclusion criteria to analyze 2090 abstracts on the topic of OPBS published between 2000 and 2011, the authors evaluated each study with respect to design and outcomes. RESULTS: A total of 88 articles were identified for potential inclusion and reviewed in detail by the lead authors. No randomized controlled trials were identified. Eleven prospective observational or comparative studies fulfilled inclusion criteria and were selected. In these studies, 80% to 93% of the tumors were invasive. Tumor-free resection margins were observed in 78% to 93%, resulting in a 3% to 16% mastectomy rate. Local recurrence was observed in 0% to 7% of the patients. Good cosmetic outcome was obtained in 84% to 89% of patients. However, most studies showed significant weaknesses including lack of robust design and important methodological shortcomings, negatively influencing generalizability. CONCLUSIONS: This systematic review reveals that current evidence supporting the efficacy of OPBS is based on poorly designed and underpowered studies. Given the increasing importance and application of OPBS, there is a pressing need for robust comparative studies, including both randomized controlled trials and well-designed, multicenter prospective longitudinal studies.

Semmes-weinstein monofilaments: influence of temperature, humidity, and age.

PURPOSE: To determine whether the buckling force of Semmes-Weinstein monofilaments is influenced by changes in temperature, humidity, and aging. METHODS: We tested 16 Semmes-Weinstein monofilaments from North Coast Medical, varying in age from new to 12 years old. From each kit, we used the 2.83/0.07 g, 3.61/0.4 g, 4.31/2g, and 4.56/4 g filaments. Four observers tested the filaments under temperature/humidity conditions of 26°C/33%, 26°C/80%, 37°C/33%, and 37°C/80%. RESULTS: Air temperature and humidity both significantly influence buckling force. At 26°C/33% the buckling force varies by an average of 2% from the standard data supplied by the manufacturer, whereas in the other 3 conditions (26°C/80%, 37°C/33%, and 37°C/80%), the buckling force can decrease by as much as 39%. Effect of age was small and not clinically relevant. CONCLUSIONS: The significant changes in buckling force of the Semmes-Weinstein monofilaments in different temperature and humidity conditions might lead to a potential misinterpretation by the examiner regarding the level of peripheral nerve function loss. This could lead to incorrect diagnosis and treatment. CLINICAL RELEVANCE: Examiners should be aware when using Semmes-Weinstein monofilaments that the environmental effects of temperature and humidity can affect the accuracy of measurement.

Breast-conserving therapy for breast cancer: Cosmetic results and options for delayed reconstruction.

OBJECTIVES: Optimisation of the cosmetic outcome after breast-conserving therapy (BCT) is important. We aimed to determine the cosmetic outcome following BCT and factors influencing this cosmesis and identify the most favourable options for delayed breast reconstruction. MATERIALS AND METHODS: Four reconstructive surgeons evaluated the cosmetic outcome of 109 patients after BCT. Additionally, the surgeons indicated which patients were amenable for delayed reconstruction and the preferred type of reconstruction. The inter- and intra-observer agreement of the surgeons was rated. RESULTS: The mean overall cosmetic outcome was rated as fair (2.7/4.0, SD 0.9, 1.0-4.0). Risk factors for a poor cosmesis were larger breast size (OR 3.81, p = 0.040), larger tumour (OR 1.63, p = 0.028) and axillary lymph node dissection (ALND) (OR 3.09, p = 0.013). Reconstruction of the ipsilateral side was recommended in 55.6% and 94.5% and contralateral reconstruction in 16.7% and 73.3% of patients with good and poor cosmesis, respectively. Flap reconstruction and lipofilling were most commonly reported for the ipsilateral, and breast reduction for the contralateral breast, with reasonable improvement expected (2.2/4.0, SD 0.5, 1.08-3.3). The inter- (0.5-0.7) and intra-observer (0.63-0.79) agreement of the cosmesis was moderate to good, however, poor regarding the recommended reconstruction techniques (mainly < 0.50). CONCLUSION: Cosmetic outcome after BCT is influenced by breast and tumour size and ALND. Although several reconstructive options are available, the optimal method for revision surgery has not yet been determined. Future studies are necessary to obtain evidence-based guidelines for reconstructive surgery after BCT.

Current status of ultrasound-guided surgery in the treatment of breast cancer.

The primary goal of breast-conserving surgery (BCS) is to obtain tumour-free resection margins. Margins positive or focally positive for tumour cells are associated with a high risk of local recurrence, and in the case of tumour-positive margins, re-excision or even mastectomy are sometimes needed to achieve definite clear margins. Unfortunately, tumour-involved margins and re-excisions after lumpectomy are still reported in up to 40% of patients and additionally, unnecessary large excision volumes are described. A secondary goal of BCS is the cosmetic outcome and one of the main determinants of worse cosmetic outcome is a large excision volume. Up to 30% of unsatisfied cosmetic outcome is reported. Therefore, the search for better surgical techniques to improve margin status, excision volume and consequently, cosmetic outcome has continued. Nowadays, the most commonly used localization methods for BCS of non-palpable breast cancers are wire-guided localization (WGL) and radio-guided localization (RGL). WGL and RGL are invasive procedures that need to be performed pre-operatively with technical and scheduling difficulties. For palpable breast cancer, tumour excision is usually guided by tactile skills of the surgeon performing "blind" surgery. One of the surgical techniques pursuing the aims of radicality and small excision volumes includes intra-operative ultrasound (IOUS). The best evidence available demonstrates benefits of IOUS with a significantly high proportion of negative margins compared with other localization techniques in palpable and non-palpable breast cancer. Additionally, IOUS is non-invasive, easy to learn and can centralize the tumour in the excised specimen with low amount of healthy breast tissue being excised. This could lead to better cosmetic results of BCS. Despite the advantages of IOUS, only a small amount of surgeons are performing this technique. This review aims to highlight the position of ultrasound-guided surgery for malignant breast tumours in the search for better oncological and cosmetic outcomes.

[Breast-conserving surgery for breast cancer: still much to be gained]. / Mammasparende chirurgie voor borstkanker: er is nog winst te behalen.

OBJECTIVE: To conduct qualitative research into breast-conserving surgery for palpable and non-palpable breast tumours and the various methods of excising these, measured by the volume exised and surgical radicality. DESIGN: Retrospective, multicentre study. METHOD: The pathology reports from 726 patients who had undergone breast-conserving surgery for invasive breast cancer were reviewed for excision volume and radicality. Any excess resected breast tissue was expressed by a Calculated Resection Ratio (CRR) and calculated by dividing the volume of the surgical specimen by the tumour volume plus an ideal 1-cm-margin of tumour-free breast tissue. A CRR of 1.0 meant that the volume excised was ideal; a CRR of 2.0 meant that twice the necessary amount of tissue had been removed. RESULTS: Of all the 726 tumours, 72% appeared to be palpable. The median CRR in this group was 2.2 (range: 0.1 - 43.0) and the percentage of tumour-involved margins (irradicality) was 22.5%. Of all the non-palpable tumour (n = 201) excisions, 58% had been guided by wire-localisation, 26% by ultrasonography, and 16% by ROLL (Radio-guided Occult Lesion Localization). The CRRs were 2.8, 3.2 and 3.8, respectively (p < 0.05). Ultrasound-guided surgery resulted in the lowest rate of tumour-involved margins (ultrasound-guided: 3.8%, wire-guided localisation: 21.4%, ROLL: 25.0% (p = 0.05)). CONCLUSION: Breast-conserving surgery is associated with an average of a 2 to 4-fold removal of excessive tissue. Nevertheless, 1 out of 5 excisions are not radical. Ultrasound-guided surgery for non-palpable breast cancer is the most effective method for achieving radical excision. A multicentre, prospective, randomised trial has been started to assess whether ultrasound-guided lumpectomy for palpable breast cancer can lead to optimisation of the excision volume and radicality.