The Warwick Experience of the Oncotype DX® Breast Recurrence Score® Assay as a Predictor of Chemotherapy Administration.

INTRODUCTION: Oncotype DX® analyses the expression of 21 genes within tumour tissue to determine a Recurrence Score® (RS). RS is a marker of risk for distant recurrence in oestrogen receptor-positive early breast cancer, allowing patient-specific benefit of chemotherapy to be evaluated. Our aim was to determine whether the introduction of Oncotype DX led to a net reduction in chemotherapy use. METHODS: Consecutive patients that underwent Oncotype DX at Warwick Hospital were reviewed. Patients were anonymised and re-discussed at a multidisciplinary team meeting (MDM; without RS), and treatment recommendations were recorded. This was compared to the original MDM outcome (recommendations made with RS). Differences were analysed using Wilcoxon signed-rank test. RESULTS: 67 patients were identified. Proportions of high, intermediate and low risk were 28, 33 and 39% (n = 19/22/26), respectively. Without RS, 56 (84%) patients were recommended for chemotherapy and 3 were not. The remaining 8 patients were deemed borderline for requiring chemotherapy and referred for discussion with an oncologist. With availability of RS, 34 (50%) patients were recommended for chemotherapy, and 24 (43%) patients were spared chemotherapy (p < 0.0005). The net reduction in chemotherapy was 33%. CONCLUSION: There has been a significant reduction in chemotherapy usage in patients at Warwick since the introduction of Oncotype DX.

Early multicentre experience of pre-pectoral implant based immediate breast reconstruction using Braxon®.

BACKGROUND: The last two decades have seen significant changes in surgical management of breast cancer. The offer of immediate breast reconstruction (IBR) following mastectomy is currently standard practice. Skin sparing and nipple sparing mastectomy with implant-based IBR have emerged as oncologically safe treatment options. Prepectoral implant placement and complete coverage of implant with acellular dermal matrix (ADM) eliminates the need to detach the muscle from underlying chest wall in contrast to the subpectoral technique. We report short-term outcomes of a multicentre study from the United Kingdom (UK) using Braxon® in women having an IBR. METHODS: A prospective study was conducted from December 2015 to October 2016 and included all patients from three breast units in the UK who underwent a mastectomy and an implant-based IBR using Braxon®. The demographic details, co-morbidities, operative details, immediate and delayed complications were recorded. Specific complications recorded were infection, seroma, unplanned readmission and loss of implant. A comparison was made with complications reported in the National Mastectomy and Reconstruction Audit. RESULTS: Seventy-eight IBRs were included in the analysis with a median follow-up of 9.98 months. Mean age of the cohort was 50 years with a mean body mass index of 25.7 kg/m2. Mean implant volume was 365 cc. The inpatient hospital stay was 1.48 days. About 23% of patients had a seroma, 30% had erythema requiring antibiotics and the explant rate was 10.2 percent. Bilateral reconstructions were significantly associated with implant loss and peri-operative complications on univariate analysis. CONCLUSIONS: Our early experience with this novel prepectoral technique using Braxon® has shown it to be an effective technique with complication rates comparable to subpectoral IBR. The advantages of prepectoral implant-based IBR are quicker postoperative recovery and short post-operative hospital stay. Long-term studies are required to assess rippling, post-operative animation, capsular contracture and impact of radiotherapy.

Patient anxiety on the use of one step nucleic acid amplification (OSNA) during breast cancer surgery.

INTRODUCTION: Assessment of the sentinel lymph node biopsy (SLNB) is used to stage the axilla in patients with breast cancer. There are a variety of methods to assess metastatic disease within the SLN. One-step nucleic acid amplification (OSNA) has a high sensitivity for detecting metastatic disease within the SLN and avoids the use of staged axillary surgery. However there remains a paucity of data within the literature on the psychological effects upon patients with the use of OSNA. METHODS: All patients undergoing breast surgery (breast-conserving surgery or mastectomy) and assessment of the SLNB with OSNA from December 2011 to June 2012 were included in the study. A questionnaire was sent to patient within four weeks of surgery to assess their understanding and satisfaction with the OSNA procedure. RESULTS: 60 patients responded to the questionnaire (83% response rate). All patients were female with a mean age of 63 years (range 38-71 years). 19 patients had positive SLNB as assessed by OSNA and all had ALND. 15 patients expressed pre-operative anxiety about having OSNA although 97% stated that they would be happy to undergo the same procedure again. CONCLUSION: Our study has identified the anxiety points that patients experience with OSNA based management and this will allow improved direct emotional support and provision of information.

Patients' perspective on day case breast surgery.

BACKGROUND: This study assessed the views of patients undergoing breast surgery for breast cancer with a planned overnight stay, asking whether they would be happy to be discharged home on the same day of surgery. METHODS: A structured questionnaire sent out in the 6 weeks following surgery was used to ascertain the patients' views. RESULTS: The majority of patients undergoing mastectomy and axillary node clearance preferred an overnight stay, primarily for psychological reasons. CONCLUSIONS: Patients undergoing breast-conserving surgery were more prepared to go home on the day of surgery.

Intraoperative assessment of sentinel node using imprint cytology.

BACKGROUND: Sentinel lymph node (SLN) biopsy has replaced axillary sampling as the axillary staging procedure of choice in patients with breast cancer. Accurate intraoperative evaluation of the SLN would allow axillary lymph node clearance to be performed during the initial operation when the SLN is positive for metastatic disease. The aim of the present study was to assess the accuracy of intraoperative imprint cytology (IC) of the SLN in two different institutions in the United Kingdom. METHODS: All breast cancer patients who underwent a SLN biopsy using a standard protocol in two hospital breast units were included. The SLN was sent fresh to the pathology laboratory, where it was immediately processed and examined by a cytopathologist using IC. The intraoperative IC results were compared with the final histopathological results. No therapeutic decisions were made based on the results of IC in this study. RESULTS: A total of 166 patients were included, with 47 positive and 119 negative cases on final histology. Of the 47 patients who were positive on final histology, there were 29 positive and 18 negative cases on IC (sensitivity = 61.7%). All 119 patients who were negative on final histology were negative on IC (specificity, 100%). The negative and positive predictive value of the final histology was 86.9% and 100%, respectively. The accuracy of IC was 89.2%. CONCLUSIONS: The results from these two breast units are comparable with findings reported in the published literature, confirming that IC can be used to assess SLN biopsy intraoperatively. No unnecessary axillary node clearance would have been carried out based on the results of IC.

Randomized multicenter trial of sentinel node biopsy versus standard axillary treatment in operable breast cancer: the ALMANAC Trial.

BACKGROUND: Sentinel lymph node biopsy in women with operable breast cancer is routinely used in some countries for staging the axilla despite limited data from randomized trials on morbidity and mortality outcomes. We conducted a multicenter randomized trial to compare quality-of-life outcomes between patients with clinically node-negative invasive breast cancer who received sentinel lymph node biopsy and patients who received standard axillary treatment. METHODS: The primary outcome measures were arm and shoulder morbidity and quality of life. From November 1999 to October 2003, 1031 patients were randomly assigned to undergo sentinel lymph node biopsy (n = 515) or standard axillary surgery (n = 516). Patients with sentinel lymph node metastases proceeded to delayed axillary clearance or received axillary radiotherapy (depending on the protocol at the treating institution). Intention-to-treat analyses of data at 1, 3, 6, and 12 months after surgery are presented. All statistical tests were two-sided. RESULTS: The relative risks of any lymphedema and sensory loss for the sentinel lymph node biopsy group compared with the standard axillary treatment group at 12 months were 0.37 (95% confidence interval [CI] = 0.23 to 0.60; absolute rates: 5% versus 13%) and 0.37 (95% CI = 0.27 to 0.50; absolute rates: 11% versus 31%), respectively. Drain usage, length of hospital stay, and time to resumption of normal day-to-day activities after surgery were statistically significantly lower in the sentinel lymph node biopsy group (all P < .001), and axillary operative time was reduced (P = .055). Overall patient-recorded quality of life and arm functioning scores were statistically significantly better in the sentinel lymph node biopsy group throughout (all P < or = .003). These benefits were seen with no increase in anxiety levels in the sentinel lymph node biopsy group (P > .05). CONCLUSION: Sentinel lymph node biopsy is associated with reduced arm morbidity and better quality of life than standard axillary treatment and should be the treatment of choice for patients who have early-stage breast cancer with clinically negative nodes.

The learning curve in sentinel node biopsy: the ALMANAC experience.

Sentinel node biopsy (SNB) is a minimally invasive procedure to stage the axilla in patients with breast cancer. Like any new surgical procedure, it is associated with a learning curve. This article describes the learning curve as part of the ALMANAC trial. The first phase of this trial is a validation phase in which surgeons perform SNB followed by an immediate axillary dissection in a consecutive series of 40 patients with invasive breast cancer. Each surgeon completes a mandatory program of proctored training during this phase. Surgeons who achieve a localization rate of 90% or more and a false-negative rate of 5% or less are eligible to proceed to the randomized phase. All 13 surgeons who completed 40 procedures as part of the validation phase of the ALMANAC trial achieved the set target. This study shows that a standardized training program allows surgeons to achieve a satisfactory localization rate and an acceptable false-negative rate after 40 SNBs.