Prospective Evaluation of Residual Breast Tissue After Skin- or Nipple-Sparing Mastectomy: Results of the SKINI-Trial.

OBJECTIVE: This study was designed to investigate the presence of residual breast tissue (RBT) after skin-sparing mastectomy (SSM) and nipple-sparing mastectomy (NSM) and to analyse patient- and therapy-related factors associated with RBT. Skin-sparing mastectomy and NSM are increasingly used surgical procedures. Prospective data on the completeness of breast tissue resection is lacking. However, such data are crucial for assessing oncologic safety of risk-reducing and curative mastectomies. METHODS: Between April 2016 and August 2017, 99 SSM and 61 NSM were performed according to the SKINI-trial protocol, under either curative (n = 109) or risk-reducing (n = 51) indication. After breast removal, biopsies from the skin envelope (10 biopsies per SSM, 14 biopsies per NSM) were taken in predefined radial localizations and assessed histologically for the presence of RBT and of residual disease. RESULTS: Residual breast tissue was detected in 82 (51.3%) mastectomies. The median RBT percentage per breast was 7.1%. Of all factors considered, only type of surgery (40.4% for SSM vs. 68.9% for NSM; P < 0.001) and surgeon (P < 0.001) were significantly associated with RBT. None of the remaining factors, e.g., skin flap necrosis, was associated significantly with RBT. Residual disease was detected in three biopsies. CONCLUSIONS: Residual breast tissue is commonly observed after SSM and NSM. In contrast, invasive or in situ carcinomas are rarely found in the skin envelope. Radicality of mastectomy in this trial is not associated with increased incidence of skin flap necrosis. ClinicalTrials.gov Identifier NCT03470909.

Clinical scoring system for vulvar lichen sclerosus.

INTRODUCTION: Vulvar lichen sclerosus (LS) is a chronic inflammatory and mutilating disease, which goes often undetected for years. Advanced disease severely affects quality of life like sexual disorders and is also associated with an increased risk of vulvar cancer. AIM: To develop and validate a patient-administered symptom score and a physician-administered clinical score for the diagnosis and evaluation of vulvar LS. METHODS: We included 24 patients with established LS diagnosis and 49 with other vulvar disease. The physician-administered score was based on six clinical features and the patient-administered score was a symptom-based four-item composite score. We determined inter-item correlations and internal consistency of both scores, and estimated sensitivities, specificities, likelihood ratios, and posttest probabilities for different cutoffs of the physician-administered score. MAIN OUTCOME MEASURES: Characteristics of patients with and without LS were compared using χ(2) and unpaired t-test as required. We then determined Cronbach's alpha as a measure of the overall consistency of scores and calculated positive and negative likelihoods. RESULTS: Lack of redundancy of items (correlation coefficients < 0.90) and internal consistency (Cronbach's α ≥ 0.70) suggested that final composite scores were valid and yielded excellent power to rule in LS. CONCLUSION: Scores may be useful for assessing symptoms of vulvar disorders, to ease diagnosis of LS and to evaluate treatment response over time.

An adjustable sling in the management of recurrent urodynamic stress incontinence after previous failed midurethral tape.

OBJECTIVE: The aim of this prospective study was to evaluate the feasibility and outcome of an adjustable sling system AMI in patients with recurrent urinary stress incontinence after failed suburethral sling insertion. PATIENTS AND METHODS: Twenty-five patients with recurrent urinary stress incontinence treated with an adjustable sling system AMI were analyzed for feasibility and outcome. Patients' incontinence bother was quantified using the Visual Analogue Scale (VAS) from 0 to 10. Multichannel urodynamics and pad tests were pre- and postoperatively performed. Time of adjustment, time of the surgical intervention, and clinical outcome were also recorded. RESULTS: Twenty-five patients were treated with the adjustable sling system AMI. Median time of adjustment was 3 days (range 1-8) and a median follow up time of 12 months. Twenty-one out of 25 patients were continent, four patients suffered from persisting incontinence. One patient was put on clean intermittent self-catheterization (CISC). Detrusor pressure at maximum flow rate (pdet/Qmax) increased significantly as did the maximum urethral closure pressure (MUCP). Patient satisfaction improved significantly. CONCLUSION: Adjustable slings in women with stress urinary incontinence might be indicated in difficult situations after surgical failure. As we present a selective group of patients these findings may not apply to other patients with recurrent stress incontinence.

The impact of overweight and obesity on breast cancer: data from Switzerland, so far a country little affected by the current global obesity epidemic.

This review presents results from the project "The Impact of Overweight/Obesity on Breast Cancer: data from Switzerland". Swiss data is interesting because the general female population is distinctive in two areas when compared to that of most other industrialized countries: Switzerland has comparatively low rates of overweight (22-23%) and obesity (7-8%) and has rather stable rates of overweight and obesity. The entire project comprised three major issues: (I) etiology of breast cancer (BC). There is a consistently shown association between obesity and postmenopausal BC risk in countries with high obesity prevalence rates in the literature. In our Swiss study group, however, we did not find higher rates of overweight and obesity in postmenopausal BC cases than in the general population. A possible explanation for this observation may be a curvilinear dose-response relationship between BMI and postmenopausal BC risk, so that an increased risk may only be observed in populations with a high prevalence of obese/very obese women; (II) tumor characteristics. BMI was significantly associated with tumor size; this applied not only to the cases where the tumor was found by self-detection, but also to lesions detected by radiological breast examinations. In addition, a higher BMI was positively correlated with advanced TNM stage, unfavorable grading and a higher St. Gallen risk score. No associations were observed between BMI and histological subtype, estrogen receptor status, HER2 status and triple negative BC; (III) patient compliance and persistence towards adjuvant BC therapy. Many studies found that the prognosis of overweight/obese BC patients was significantly lower than that of normal weight patients. However, failure of compliance and persistence towards therapy on the part of the patient is not a contributing factor for this observed unfavorable prognosis. In most therapy modes, patients with increasing BMI demonstrated greater motivation and perseverance towards the recommended treatment.

Bone metastases in breast cancer: Frequency, metastatic pattern and non-systemic locoregional therapy.

BACKGROUND: The study evaluates the frequency of and indications for bone-metastases (BM)-related surgery and/or radiotherapy in the palliative breast cancer (BC) situation and analyzes in which phase of the palliative disease course surgery and/or radiotherapy was applied. METHODS: 340 patients who developed distant metastatic disease (DMD) and died (i.e. patients with completed disease courses) were analyzed. RESULTS: From the entire study cohort, 237 patients (69.7%) were diagnosed with BM. Out of these, 116 patients (48.9%) received BM-related radiotherapy and/or surgery during the palliative situation. RADIOTHERAPY: 108 patients (45.6%) received 161 series (range: 1-5) with 217 volumina (range: 1-8) on 300 osseous sites. At 75.3% of the radiated sites, the spine was the most frequent radiated location. Eighty-eight series (54.7%) were performed in the first third of the metastatic disease survival (MDS) period. The median survival after radiotherapy was 14 months (range: 0.2-121 months). SURGERY: In 37 patients (15.6%), 50 procedures (range: 1-4) were necessary to stabilize BM. The femur predominated with 56.0% of the procedures. Twenty procedures (40.0%) were performed in the first third of survival follow-up. The median survival after surgery was 13.5 months (range: 0.5-49 months). BC patients with BM had a significantly improved MDS when radiotherapy and/or surgery for skeletal metastases was embedded in the palliative approach (27.5 months vs. 19.5 months, p<0.001). From the 118 patients who had a MDS of ≥24 months, the majority (54.2%) had BM-related radiotherapy and/or surgery during the palliative course. CONCLUSIONS: Metastatic BC has become increasingly viewed as a chronic disease process. In a general palliative therapy approach, which allows for treatment according to the principles of a chronic disease, non-systemic therapy for BM, in particular radiotherapy, has a clearly established role in the therapy concept.