Antibiotic prophylaxis in breast cancer surgery (PAUS trial): randomised clinical double-blind parallel-group multicentre superiority trial.

BACKGROUND: Participants were patients with invasive breast cancer undergoing primary surgery. The aim was to test whether a single dose of amoxicillin-clavulanic acid would reduce wound infection at 30 days postoperatively, and to identify risk factors for infection. METHODS: Participants were randomised to either a single bolus of 1.2 g intravenous amoxicillin-clavulanic acid after the induction of anaesthesia (intervention) or no antibiotic (control). The primary outcome was the incidence of wound infection at 30 days postoperatively. RESULTS: There were 871 evaluable patients. Of these, 438 received prophylactic antibiotic and 433 served as controls. Seventy-one (16.2 per cent) patients in the intervention group developed a wound infection by 30 days, while there were 83 (19.2 per cent) infections in the control group. This was not statistically significant (odds ratio (OR) 0.82, 95 per cent c.i. 0.58 to 1.15; P = 0.250). The risk of infection increased for every 5 kg/m2 of BMI (OR 1.29, 95 per cent c.i. 1.10 to 1.52; P = 0.003). Patients who were preoperative carriers of Staphylococcus aureus had an increased risk of postoperative wound infection; however, there was no benefit of preoperative antibiotics for patients with either a high BMI or who were carriers of S. aureus. CONCLUSION: There was no statistically significant or clinically meaningful reduction in wound infection at 30 days following breast cancer surgery in patients who received a single dose of amoxicillin-clavulanic acid preoperatively. REGISTRATION NUMBER: N0399145605 (National Research Register).

There is little research about antibiotics in breast cancer surgery. Surgeons are not certain whether or not to use antibiotics for their patients. The aim of the Prophylactic Antibiotic Use in Surgery (PAUS) trial was to ask a question, 'Do preoperative antibiotics have any benefit for patients having surgery for breast cancer?' In the PAUS trial patients were given information to decide whether they wished to take part in the trial or not. Participants were randomly placed in one of two groups. Half were given one dose of the amoxicillin­clavulanic acid antibiotic at the time of their operation. The other half had no antibiotic. Neither the patient nor the surgeon knew which group the patient was in. Patients were carefully checked until 30 days after their operation for signs of wound infection. Altogether, 871 patients agreed to take part in the PAUS trial. Of these, 438 patients had the antibiotic and 433 had no antibiotic. The PAUS trial showed that there was no difference in the number of wound infections when comparing the two groups. Seventy-one patients (16.2 per cent) who had been given the antibiotic developed a wound infection by 30 days versus 83 (19.2 per cent) in the group who had not been given the antibiotic. This trial shows that antibiotics may not be needed for breast cancer surgery. PAUS may help to cut down on unnecessary antibiotic use.

[Intraoperative, postoperative and long-term oncosurgical safety of therapeutic mammaplasty]. / Terápiás emloplasztika intraoperatív, közvetlen posztoperatív és hosszú távú onkosebészeti biztonsága.

INTRODUCTION: (Pre)malignant lesion in the breast requiring mastectomy conventionally may be treated with breast conservation by using oncoplastic breast surgical techniques, which is called therapeutic mammaplasty. However, no reliable data has been published so far as regards the oncological safety of this method. AIM: The aim of the authors was to analyse the oncological safety of therapeutic mammaplasty in a series of patients. METHOD: 99 patients were treated with therapeutic mammaplasty and data were collected in a breast surgical database prospectively. Results were analysed with respect to intraoperative, postoperative and long-term oncological safety. RESULTS: Incomplete resection rate was 14.1%, which correlated with tumour size (p = 0.023), and multifocality (p = 0.012). Time between surgery (therapeutic mammaplasty) and chemotherapy was similar to time between conventional breast surgeries (wide excision, mastectomy, mastectomy with immediate reconstruction) and chemotherapy (mean 29-31 days; p<0.05). Overall recurrence rate was 6.1%, locoregional recurrence rate was 2% during 27 month (1-88) mean follow-up. CONCLUSIONS: Since literature data are based on relatively short follow-up and low patient number, it is highly important that all data on therapeutic mammaplasty is collected in a prospectively maintained breast surgical database in order to determine true recurrence after long-follow-up.

[Oncologic safety of skin-sparing mastectomy followed by immediate breast reconstruction: rate and localization of recurrences, and impact of reconstruction techniques]. / Borkímélo (skin-sparing) mastectomia és azonnali emlorekonstrukció onkológiai biztonságossága a recidívaarány, recidívalokalizáció és a rekonstrukciós technika függvényében.

INTRODUCTION: Oncological safety of skin-sparing mastectomy followed by immediate breast reconstruction is widely debated. Current evidence is relatively poor since it is based mostly on short-term follow-up data of highly selected patient populations. AIM: Recurrence rates of a large cohort of non-selected patients, i. e. "all-comers" were analyzed during a 10-year follow up. METHODS: Patient records and follow-up data of 253 consecutive cases treated with of skin-sparing mastectomy and immediate breast reconstruction between 1995 and 2000 were studied. During this time period "all-comers" policy was applied, which meant that all patients treated with mastectomy were offered immediate breast reconstruction regardless of tumour stage. RESULTS: "All-comers" approach resulted in a large proportion of patients with more advanced disease. During the 112 months mean follow-up 8.2% locoregional, 2.9% local, 10.6% distal and 18.8% overall recurrence rates were detected. Breast cancer specific survival rate was 90.9%. Autologous breast reconstruction was applied more frequently in patients with higher tumour stage; therefore recurrence rate was higher compared to patients undergoing implant-based reconstruction. CONCLUSION: Based on these long-term follow-up data skin-sparing mastectomy combined with immediate breast reconstruction is an oncologically safe treatment option. Therefore, application of "all-comers" policy for breast cancer patients treated with skin-sparing mastectomy followed by immediate breast reconstruction is feasible.

Extreme Oncoplasty: Breast Conservation in Patients with Large, Multifocal, and Multicentric Breast Cancer.

INTRODUCTION: Extreme Oncoplastic Breast Conservation Surgery (EOBCS) is offered in selected patients with multifocal or multicentric breast cancer (MFMC). Recent evidence has suggested that EOBCS may be a valuable resource for patients with MFMC who may avoid the risk associated with mastectomy in favour of the benefits of breast conservation without risking their oncological outcomes. Our study examined the practice of EOBCS in two regional breast units in Glasgow, United Kingdom. MATERIALS AND METHODS: A prospectively collected database of 50 patients treated with EOBC in two breast units in Glasgow between 2007 and 2018 were evaluated, and clinical outcomes were observed. RESULTS: Fifty patients (median age 55) underwent EOBCS, of which 43 (86%) had invasive disease. Median tumour size was 55mm (50-90) and multifocal disease was identified in 22 (44%) patients. Nine patients (18%) were found to have positive margins and underwent a second procedure, with 6 (12%) proceeding to mastectomy. Five-year disease free survival rate was 91.5%, while cancer-specific survival was 95.7%. CONCLUSION: EOBCS is oncologically safe in short-term follow-up. Large scale studies are required to confirm these preliminary results, in order to offer EOBCS as a valid option to patients with advanced or multifocal breast cancer.

A prospective cohort study of the safety of breast cancer surgery during COVID-19 pandemic in the West of Scotland.

INTRODUCTION: In order to minimise the risk of breast cancer patients for COVID-19 infection related morbidity and mortality prioritisation of care has utmost importance since the onset of the pandemic. However, COVID-19 related risk in patients undergoing breast cancer surgery has not been studied yet. We evaluated the safety of breast cancer surgery during COVID-19 pandemic in the West of Scotland region. METHODS: A prospective cohort study of patients having breast cancer surgery was carried out in a geographical region during the first eight weeks of the hospital lockdown and outcomes were compared to the regional cancer registry data of pre-COVID-19 patients of the same units (n = 1415). RESULTS: 188 operations were carried out in 179 patients. Tumour size was significantly larger in patients undergoing surgery during hospital lockdown than before (cT3-4: 16.8% vs. 7.4%; p < 0.001; pT2 - pT4: 45.5% vs. 35.6%; p = 0.002). ER negative and HER-2 positive rate was significantly higher during lockdown (ER negative: 41.3% vs. 17%, p < 0.001; HER-2 positive: 23.4% vs. 14.8%; p = 0.004). While breast conservation rate was lower during lockdown (58.6% vs. 65%; p < 0.001), level II oncoplastic conservation was significantly higher in order to reduce mastectomy rate (22.8% vs. 5.6%; p < 0.001). No immediate reconstruction was offered during lockdown. 51.2% had co-morbidity, and 7.8% developed postoperative complications in lockdown. There was no peri-operative COVID-19 infection related morbidity or mortality. CONCLUSION: breast cancer can be safely provided during COVID-19 pandemic in selected patients.

Variation in the management of elderly patients in two neighboring breast units is due to preferences and attitudes of health professionals.

Introduction: Elderly breast cancer patients have been shown to be managed less aggressively than younger patients. There is evidence that their management varies between institutions. We audited the management of elderly patients in two neighboring units in Glasgow and aimed to identify reasons for any differences in practice found. Methods: Patients aged ≥70 years, who were managed for a new diagnosis of breast cancer in the two units between 2009 and 2013, were identified from a prospectively maintained database. Tumor pathology, treatment details, postcode and consultant in charge of care were obtained from the same database. Comorbidities were obtained from each patient's electronic clinical record. Questionnaires were distributed to members of each multidisciplinary teams. Results: 487 elderly patients in Unit 1 and 467 in Unit 2 were identified. 76.2% patients in Unit 1 were managed surgically compared to 63.7% in Unit 2 (p<0.0001). There was no difference between the two units in patient age, tumor pathology, deprivation or comorbidity. 16.2% patients managed surgically in Unit 1 had a comorbidity score of 6 and above compared to 11% of surgically managed patients in Unit 2 (p=0.036). Responses to questionnaires suggested that staff at Unit 1 were more confident of the safety of general anesthetic in elderly patients and were more willing to consider local anesthetic procedures. Conclusion: A higher proportion of patients aged >70 years with breast cancer were managed surgically in Unit 1 compared to Unit 2. Reasons for variation in practice seem to be related to attitudes of medical professionals toward surgery in the elderly, rather than patient or pathological factors.

Oncoplastic breast conservation occupies a niche between standard breast conservation and mastectomy - A population-based prospective audit in Scotland.

INTRODUCTION: The role of oncoplastic breast conservation (OBC) surgery is not fully defined in terms of whether it is equivalent to standard breast conservation (SBC), or more an alternative to mastectomy, or whether it occupies its own niche somewhere between the two. Therefore, we have carried out a population-based prospective audit of the current OBC practice in Scotland. METHODS: All patients diagnosed with breast cancer in the whole of Scotland between 01/01/2014 and 31/12/2015 were prospectively recorded within the National Managed Clinical Networks databases. Patients treated with OBC were compared to patients who had SBC, mastectomy and mastectomy with immediate reconstruction (MIR). RESULTS: 8075 patients were included (OBC:217(2.7%); SBC:5241(64.9%); mastectomy:1907(23.6%); MIR:710(8.8%)). OBC patients were younger than SBC or mastectomy, but older than MIR (p < 0.0001). OBC patients were between SBC and mastectomy patients in terms of clinical and pathological tumour size (all p < 0.001), rates of lobular cancers (v.SBC:p = 0.015 and v.mastectomy:p < 0.001), high-grade tumours (v.SBC:p = 0.030 and v.mastectomy:p = 0.008), ER negative (v.SBC: p = 0.042) and HER-2 positive (v.SBC: p = 0.003) tumours, and nodal metastasis (v.mastectomy: p < 0.001). More OBC patients received (neo)adjuvant chemo- and hormonal therapy (p ≤ 0.001), adjuvant radiotherapy (p = 0.005), trastuzumab (p < 0.001) than SBC. More OBC patients presented through screening (v.mastectomy/MIR: p < 0.0001). Time to surgery from diagnosis was longer for OBC than SBC/mastectomy (p < 0.0001), but shorter than MIR (p = 0.007). CONCLUSION: This national audit demonstrates that OBC occupies its own niche between SBC, mastectomy and MIR in the surgical treatment of breast cancer in Scotland. We recommend that OBC should be recorded separately in other national breast cancer registries.

Managing vulvovaginal atrophy after breast cancer.

Cancer treatment may result in loss of ovarian function through surgical removal of the ovaries, chemotherapy or radiation. While menopausal symptoms, such as hot flushes, night sweats, sleep disturbance, memory concerns and mood issues can be extremely bothersome to some women going through menopause naturally, women who undergo an induced menopause usually experience more sudden and severe symptoms. Pain and vaginal dryness can occur whether a woman has a sexual partner or not. In women with breast cancer, the aetiology of impaired sexual functioning, and lowered sexual desire, is often multifactorial, and may be related to physical and/or psychological reasons. Pain and vaginal dryness in women without a history of breast cancer can usually be safely treated with vaginal estrogens, in the form of a cream, pessary or ring, and simple lubricants or vaginal moisturisers. Safe usage of vaginal estrogen replacement therapy in breast cancer patients has not been studied within randomised clinical trials of long duration; the guidelines below reflect a clinical consensus.

A population-based audit of surgical practice and outcomes of oncoplastic breast conservations in Scotland - An analysis of 589 patients.

INTRODUCTION: Current evidence for oncoplastic breast conservation (OBC) is based on single institutional series. Therefore, we carried out a population-based audit of OBC practice and outcomes in Scotland. METHODS: A predefined database of patients treated with OBC was completed retrospectively in all breast units practicing OBC in Scotland. RESULTS: 589 patients were included from 11 units. Patients were diagnosed between September 2005 and March 2017. High volume units performed a mean of 19.3 OBCs per year vs. low volume units who did 11.1 (p = 0.012). 23 different surgical techniques were used. High volume units offered a wider range of techniques (8-14) than low volume units (3-6) (p = 0.004). OBC was carried out as a joint operation involving a breast and a plastic surgeon in 389 patients. Immediate contralateral symmetrisation rate was significantly higher when OBC was performed as a joint operation (70.7% vs. not joint operations: 29.8%; p < 0.001). The incomplete excision rate was 10.4% and was significantly higher after surgery for invasive lobular carcinoma (18.9%; p = 0.0292), but was significantly lower after neoadjuvant chemotherapy (3%; p = 0.031). 9.2% of patients developed major complications requiring hospital admission. Overall the complication rate was significantly lower after neoadjuvant chemotherapy (p = 0.035). The 5 year local recurrence rate was 2.7%, which was higher after OBC for DCIS (8.3%) than invasive ductal cancer (1.6%; p = 0.026). 5-year disease-free survival was 91.7%, overall survival was 93.8%, and cancer-specific survival was 96.1%. CONCLUSION: This study demonstrated that measured outcomes of OBC in a population-based multi-centre setting can be comparable to the outcomes of large volume single centre series.

Oncological Outcomes and Complications After Volume Replacement Oncoplastic Breast Conservations-The Glasgow Experience.

INTRODUCTION: Oncoplastic breast conservation surgery (OBCS) combines the principles of surgical oncology and plastic surgery. OBCS has now become a growing option for the treatment of breast cancer and forms a part of breast-conserving therapy (BCT). We sought to investigate and report our experience in two breast units in Glasgow (Victoria Infirmary and Western Infirmary) on volume replacement OBCS. MATERIALS AND METHODS: Details of patients treated with volume replacement OBCS were identified from a prospectively recorded database from November 2010 to October 2015. The clinical records included in the oncoplastic dataset were analyzed for demographics, tumor, treatment characteristics, and recurrences. The data were analyzed for follow-up to determine the pattern and timing of recurrence up to April 2016. The primary outcome of this study was tumor-free margin resection rates, and the secondary outcomes were locoregional and distant recurrence rates as these correlate with the overall oncological safety of volume replacement oncoplastic breast surgery (OPBS). RESULTS: A total of 30 volume replacement oncoplastic breast conservation procedures have been carried out in this time period. The mean age of the former group was 51 years. Twice as many patients presented symptomatically than had tumors detected on screening. The mean preoperative tumor size on radiology was 25.4 mm. Patients underwent 13 thoracoepigastric flaps, 5 lateral intercostal artery perforator (LICAP) flaps, 2 thoracodorsal artery perforator (TDAP) flaps, 1 lateral thoracic artery perforator (LTAP) flap, 1 crescent flap volume replacement surgery, and 8 matrix rotations. Two patients had neoadjuvant chemotherapy. Fourteen patients had adjuvant chemotherapy, and all patients were treated with adjuvant radiotherapy. Twenty-two patients were treated with hormonal therapy and four patients were treated with Herceptin. The rate of incomplete excision was 10%. Median follow-up time was 48.5 months. Only one regional recurrence was detected. Eight patients encountered some form of complication. CONCLUSION: This study continues to show the relative oncological safety of volume replacement oncoplastic conservations as an option for reconstruction in breast cancer patients. Further research is urgently needed to build robust evidence supporting the long-term oncological safety.

Six-year follow-up of patients treated with oncoplastic reduction mammoplasty: A cohort study.

BACKGROUND: Current evidence for the oncological safety of oncoplastic breast conservation is poor as it is based mostly on short-term follow-up data. Hence, we report long-term recurrence rates in patients treated with oncoplastic reduction mammoplasty (ORM). METHODS: A prospectively maintained database was searched to identify patients who underwent ORM between 2005 and 2010. A retrospective review of medical records was carried out, including patients with ductal carcinoma in situ and invasive breast cancer. RESULTS: Follow-up data from 65 consecutive patients with ORM were reviewed, of which 50 patients were eligible to measure long-term recurrence rates. The average weight of the resected tissue was 272 g altogether. The mean preoperative tumour size was 2.95 cm on imaging. 64% of patients had stage II - III cancers. Incomplete excision rate after ORM was 16.1%, completion mastectomy rate was 10.7%. During a median follow-up of 72 months, 2% local, 6% distant recurrence rates were detected. The breast cancer-specific survival rate was 96% per cent. CONCLUSIONS: Based on these long-term follow-up data, ORM is an oncologically safe treatment option.

Imaging Results Following Oncoplastic and Standard Breast Conserving Surgery.

BACKGROUND: Oncoplastic breast-conserving surgery (OBCS) requires more complex surgical techniques than standard wide local excision (WLE) and the postoperative complication rate may be higher. Since these can have an impact on postoperative imaging, we compared imaging and biopsy results after OBCS and WLE. METHODS: Findings for patients undergoing OBCS (n = 83) or standard WLE (n = 128) were compared. Numbers, indications and outcomes of mammograms, breast ultrasounds, magnetic resonance imaging scans and biopsies done within 2 years after surgery were analysed. RESULTS: OBCS was applied for more advanced malignancy. Significantly more patients required breast ultrasound after OBCS than WLE (20/71 vs. 17/116; p = 0.024). Breast Imaging Reporting and Data System (BI-RADS) category 3 or 4 ultrasound results were found only in patients with OBCS (6/29 vs. 0/19; p = 0.034). Significantly more biopsies were required after OBCS (9/71 vs. 3/116; p = 0.006). New lumps or lumpiness were the commonest indications, and pathology confirmed fat necrosis in the majority (7/12). The rate of fat necrosis after OBCS was 18% on clinical examination (13/71), 15% with ultrasound (11/71) and 7% confirmed on pathology (5/71). CONCLUSION: Patients treated with OBCS require significantly more ultrasound scans and consequent biopsies than patients who underwent WLE. This is mainly due to fat necrosis developing after OBCS in the majority of cases.

Factors influencing postoperative length of hospital stay after breast cancer surgery.

As part of a feasibility study to restructure the breast cancer services in Glasgow, factors influencing 'postoperative length of stay' (LOS) and bed utilisation in patients undergoing surgery for breast cancer were examined. Data for patients admitted at five hospitals between March 2007 and February 2008 was collected prospectively. Age, socio-demographic and clinico-pathologic factors were recorded. Independent affects of variables predicting prolonged LOS were assessed using binary logistic regression analysis. Of the 519 women, 252(49%) had screen-detected cancers with a median LOS of 1 day while 267(51%) had symptomatic cancers with a median LOS of 4 days (p < 0.001). On multivariate analysis, axillary procedure performed independently influenced prolonged LOS in both screen-detected and symptomatic cancers. In symptomatic cancers, comorbidities and deprivation also had some influence. While mastectomy with or without axillary surgery utilised 51% of the bed days, a further 20% were utilised by patients having re-operations. This study has helped in the planning of ambulatory surgery services and inpatient bed requirements for patients undergoing breast cancer surgery in Glasgow.