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Introduction The placement of intramammary marker clips has proven to be helpful for tumor localization in patients undergoing neoadjuvant chemotherapy and breast-conserving surgery. The purpose of our study was to investigate the feasibility of using a clip marker system for breast cancer localization and its influence on the imaging assessment of treatment responses after neoadjuvant chemotherapy. Patients and Methods Between March and June 2015, a total of 25 patients (n = 25), with a suspicion of invasive breast cancer with diameters of at least 2 cm (cT2), underwent preoperative sonographically guided core needle biopsy using a single-use breast biopsy system (HistoCore™) and intramammary clip marking using a directly adapted clip system based on the established O-Twist Marker™, before their scheduled preoperative neoadjuvant chemotherapy. Localization of the intramammary marker clip was controlled by sonography and digital breast tomosynthesis. Results Sonography detected no dislocation of intrammammary marker clips in 20 of 25 patients (80 %), while digital breast tomosynthesis showed accurate placement without dislocation in 24 patients (96 %) (p Conclusion Our study underscores the importance of intramammary marking clip systems before neoadjuvant chemotherapy. Placement of marker clips is advised to facilitate accurate tumor bed localization. With regard to digital breast tomosynthesis, its development continues to improve the quality of diagnostics and the therapy of breast cancer particularly for small breast cancer tumors or in neoadjuvant chemotherapy setting.

Aim: Certification of breast centers helps improve the quality of care but requires additional resources, particularly for documentation. There are currently no published data on the actual staff costs and financial resources required for such documentation. The aim of this study was to determine the time and resources required to document a patient with primary breast cancer from diagnosis to the end of follow-up, to establish a database for future strategic decisions. Material and Methods: All diagnostic and therapeutic procedures of patients with primary breast cancer were recorded at the University Breast Center of Franconia. All time points for documentation were evaluated using structured interviews. The times required to document a representative number of patients were determined and combined with the staff costs of the different professional groups, to calculate the financial resources required for documentation. Results: A total of 494 time points for documentation were identified. The study also identified 21 departments and 20 different professional groups involved in the documentation. The majority (54 %) of documentation was done by physicians. 62 % of all documentation involved outpatients. The results of different scenarios for the diagnosis, therapy and follow-up of breast cancer patients in a certified breast center showed that the time required for documentation can be as much as 105 hours, costing € 4135. Conclusion: This analysis shows the substantial staffing and financial costs required for documentation in certified centers. A multi-center study will be carried out to compare the costs for certified breast centers of varying sizes with the costs of non-certified care facilities.

New molecular and genetic tests are becoming more and more important in research and clinical practice. Using these tests to offer individualised therapy to patients with breast cancer is particularly important in the context of health economics. The targeted use of therapies increases their effectiveness and reduces follow-up costs by preventing recurrence and metastatic disease. Avoiding over-treatment additionally reduces costs. Genetic tests are initially associated with higher costs but in the longer term they can reduce costs, as shown by health economic models and cost-effectiveness analyses.

Dysmenorrhoea is the major symptom in women with endometriosis. Recently, pain modulation through Neurokinin-1-receptor (NK1R) pathways have been investigated in neuropathic pain patients. Aim of this study was, therefore, to examine the effect of a single nucleotide polymorphism (SNP) of the NK1R gene on the susceptibility for endometriosis and the disease free survival (DFS) after surgery for endometriosis.A case-control study was conducted and germline DNA was isolated. Patients were followed up for a recurrence of the disease up to 4 years. Case-control analyses were performed for parameters of the medical history and the genotype of the NK1R-SNP rs881. Furthermore, DFS probabilities were calculated.Concerning the DFS preoperative pain levels and the NK1R genotype were independent predictors for a recurrence with hazard ratios of 2.55 (95% CI: 1.32-4.95) for patients with a high preoperative pain level and 0.44 for patients with a heterozygous or homozygous variant genotype in rs881 (95% CI: 0.21-0.88).The polymorphism rs811 seems to be associated with a lower recurrence risk in endometriosis patients. Thus, there might be a clinical relevant role of the NK1 pathway in the pain perception of endometriosis patients.

OBJECTIVE: It is postulated that the establishment of specialized centers with certification can be used as a marketing tool, in addition to its quality-assurance effect, and that it influences patients' choice of a hospital. One prerequisite for this, however, must be an awareness on the part of patients about both the purpose and the availability of a specialized center. The present study investigated the extent to which patients are familiar with specialized centers. METHODS: The data were gathered from 1073 patients of the Department of Gynecology, the University Breast Center Franconia (UBF; certified in accordance with DIN EN ISO 9001, DKG, DGS, EUSOMA, ESGO, EBCOG), and the University Perinatal Center Franconia (UPF; certified in accordance with DIN EN ISO 9001; level 1, defined by GBA regulations) by means of questionnaire. Of these patients, 46.7 % (n = 501) had breast cancer. The reason for presentation was obstetric in 31.9 % (n = 342) of cases, while 18.5 % of the patients (n = 198) had benign gynecological disease. Topics investigated included whether each patient knew she would be treated in a specialized center and whether there were any differences between obstetric patients and those with breast cancer. Moreover, they were asked about whether specialized certified centers were important to them. RESULTS: Out of all the patients questioned, 34.4 % did not know what the definition of a specialized center is; 37.7 % stated that they did know, and 27.9 % stated that they knew “a little”. A total of 289 patients provided specific descriptions. While only 46.1 % of the obstetric patients knew precisely or to a minor degree what a certified specialized center is, 78.2 % of the patients at the breast center knew what it was (p < 0.001). Prior to presentation, 52.3 % of all patients knew that it was a specialized center, although only 37.5 % of the obstetric patients had this prior information, compared with 65.8 % of patients with breast cancer (p < 0.001). When compared directly, the probability of having prior information was more than three times higher among oncology patients (HR 3.19 [95 % CI 2.35 to 4.34]). When asked about importance of receiving care at a specialized certified center, this was found to be very significantly more important for patients with breast cancer (HR 6.82 [95 % CI 3.09 to 15.04]). CONCLUSION: This survey shows that obstetric patients are often unaware of the definition of a specialized certified center. Oncology patients with breast cancer are much better informed about the definition and availability of a specialized center. While the establishment of centers currently appears to be inappropriate as a marketing tool for obstetric patients, the specialization and certification of a breast center can be used for oncology patients.

Die Politik fordert hochste Versorgungsqualitat bei der Behandlung von Brustkrebs. In den letzten Jahren hat sich die Versorgungsstruktur daher deutlich geandert. Immer haufiger werden Brustkrebspatientinnen in spezialisierten und zertifizierten Zentren behandelt. Es stellen sich die Fragen, (1) ob die von politischer Seite geforderten Behandlungsstandards auch adaquat vergutet werden oder (2) eine Quersubventionierung durch andere Bereiche notwendig ist, um die Strukturen eines zertifizierten Brustzentrums vorzuhalten. Die in den einzelnen Bundeslandern herrschenden unterschiedlichsten Strukturen in Bezug auf die Finanzierung und Zulassung solcher Brustzentren erschweren jedoch eine bundesweite Vergleichbarkeit. Politicians demand high-quality medical care for breast-cancer patients. This has led to substantial changes in health-care structures in the past few years. More and more breast-cancer patients are being treated in specialized and certified centers. The question is whether the treatment standards demanded by politicians are adequately paid for or whether a cross-subsidization by other sectors will be necessary to create a breast center. However, the diverse structures existing in the different federal states with regard to the funding and accreditation of such breast centers make a nationwide comparison very difficult.

In the era of cost increases and reduced resources in the German healthcare system, the value of health services research and health economics is increasing more and more. Health services research attempts to develop concepts for the most effective ways to organise, manage, finance and deliver high-quality care and evaluates the implementation of these concepts with regard to daily routine conditions. Goals are the assessment of benefits and the economic advantages and disadvantages of new and established diagnostic methods, drugs and vaccines. Regarding these goals, it is clear that health services research goes hand in hand with health economics, which evaluates the benefits of diagnostic and therapeutic procedures in relation to the costs. Both scientific fields have focus principally on gynaecology and particularly on gynaecological oncology in Germany, as can be seen by numerous publications. These present several advantages compared with clinical trials - they uncover gaps in health care, question the material, staffing and consequently the financial resources required and they allow the estimation of value and the comparison of different innovations to identify the best options for our patients.Im Zeitalter der Kostensteigerung und reduzierten Ressourcen im deutschen Gesundheitswesen gewinnen Versorgungsforschung und Gesundheitsökonomie immer mehr an Wert. Versorgungsforschung ist die Entwicklung von Versorgungskonzepten, deren Umsetzung begleitend erforscht und unter Alltagsbedingungen evaluiert wird. Ziele der Versorgungsforschung sind u. a. die Bewertung des Nutzens wie auch der ökonomischen Vor- und Nachteile neuer diagnostischer Methoden und neuer, und auch langjährig eingesetzter Arzneimittel und Impfstoffe. Dementsprechend wird deutlich, dass dieses Hand in Hand mit der Gesundheitsökonomie einhergeht, welche die Kosten von diagnostischen und therapeutischen Maßnahmen mit dem jeweiligen Nutzen in Relation bringt. In Deutschland haben beide Forschungsbereiche vor allem einen Schwerpunkt in der Frauenheilkunde bzw. insbesondere in der gynäkologischen Onkologie, was durch zahlreiche Publikationen belegt wird. Diese haben im Vergleich zu klinischen Studien deutliche Vorteile – sie decken Lücken in der Versorgung auf, hinterfragen die notwendigen materiellen und personellen und somit auch finanziellen Ressourcen und ermöglichen erst die Ermittlung des Wertes und somit den Vergleich unterschiedlicher Innovationen, um die beste Option für Ratsuchende und Patientinnen zu identifizieren.

PLoS one 10(4), e0122106 (2015). doi:10.1371/journal.pone.0122106, Published by PLoS, Lawrence, Kan.

Hintergrund und Ziele: 10-15% aller Mammakarzinome und 25-40% der Karzinome unter dem 35. Le-bensjahr haben eine genetische Genese. Es ist deshalb essentiell, Hochrisiko-familien zu identifizieren, das individuelle Risiko zu klassifizieren und eine Ge-nanalyse einzuleiten. Zudem sind Angebote zur psychoonkologischen Betreu-ung, intensivierten Fruherkennung und prophylaktischen Operationen notwen-dig. Es stellt sich die Frage, ob dieses Betreuungskonzept im aktuell ange-spannten Gesundheitswesen finanzierbar ist und langfristig monetare Ressour-cen einsparen kann. Materialien und Methoden: Im Rahmen der gesundheitsokonomischen Evaluation wurde der gesamte Pro-zess von Erstberatung bis zur intensivierten Fruherkennung und prophylakti-schen Operation betrachtet. Dabei diente das Tumorrisikosprechstundenkollek-tiv des Universitats-Brustzentrums Franken als Grundlage. Es wurden die Per-sonalkosten anhand Realzeiten und die diagnostischen bzw. operativen Kosten anhand Kostentragerrechnungen berechnet und den Erlosen gegenuber ge-stellt. Dabei wurde fur ambulante Leistungen der EBM und fur stationare Leis-tungen DRG´s verwendet. Als Perspektive wurde sowohl die des Kostentragers als auch des Leistungserbringers gewahlt. Ergebnisse: Mittels genetischer Testung, intensivierter Fruherkennung und prophylaktischer Operation lassen sich Folgekosten fur das Gesundheitssystem durch vermie-dene Karzinome reduzieren. Im genannten Kollektiv mit 370 beratenen Patien-tinnen lagen 44 BRCA1- und 26 BRCA2-Mutationstrager vor. Wird bei nur 50% dieser Mutationstragerinnen eine prophylaktische Mastektomie vorgenommen, so spart sich das Gesundheitssystem im Vergleich zu keiner durchgefuhrten prophylaktischen Masnahme 136.295,22 €. Ausgegangen von einer Sal-pingoovariektomie sind es 791.652,73 €. Fur den Leistungserbringer sind je-doch Teilbereiche deutlich unterfinanziert. Beispiele sind die intensivierte Fruh-erkennung mit einem Verlust von -466,08 € pro Patientin und Jahr, sowie die prophylaktische Operation. So zeigt sich bei einer prophylaktischen Ablatio mit primarem Aufbau durch Allotransplantate (J24A) ein Defizit von -3.504,09 €. Eine Ablatio mit primaren Aufbau durch einen DIEP (J01Z) fuhrt zu einem Ver-lust von -851,65€. Wird einzeitig die prophylaktische Adnexektomie durchge-fuhrt, bleibt der Erlos identisch, das Defizit wird entsprechend hoher. Mit Berucksichtigung der zusatzlich gewonnenen Lebensjahre ist die Betreuung aus der Kostentragerperspektive unabhangig vom durchgefuhrten Eingriff kos-teneffektiv. Aus Perspektive des Leistungserbringers ist es deutlich davon ab-hangig, welcher operative Eingriff durchgefuhrt wird. So lasst sich eine mit Ad-nexektomie kombinierte prophylaktische Mastektomie im Alter von 40 Jahren, welches dem Durchschnittsalter des Kollektivs entspricht, mit +83,29 € pro ge-wonnenem Lebensjahr kosteneffektiv durchfuhren. Wird eine Adnexektomie und prophylaktische Ablatio mit primarem Aufbau durch Allotransplantate vor-genommen, so kostet dem Leistungserbringer ein gewonnenes Lebensjahr -949,35 €. Dies ist fur das Gesundheitswesen naturlich der Idealfall einer gesundheitsoko-nomischen Masnahme. Mit zunehmendem Alter steigen bei sinkender Effektivi-tat der operativen Eingriffe sowohl fur Gesundheitswesen und Leistungserbrin-ger die Kosten pro gewonnenes Lebensjahr. Schlussfolgerung: Die Betreuung von Hochrisikofamilien ist aus Sicht des Gesundheitswesens kosteneffektiv. Langfristig lassen sich durch genetische Testung, intensivierte Fruherkennung und prophylaktische Masnahmen deutlich monetare Ressour-cen einsparen. Dies gilt jedoch nicht fur den Leistungserbringer, da viele Teilbe-reiche der enorm wichtigen Betreuung zu einem finanziellen Defizit fuhren. Ins-besondere die spezialisierten Zentren mit Betreuung zahlreicher Familien beno-tigen Zuschlage, um das Angebot langfristig aufrechterhalten zu konnen.

Introduction: For early detection of breast cancer, the development of robust blood-based biomarkers that accurately reflect the host tumor is mandatory. We investigated DNA methylation in circulating free DNA (cfDNA) from blood of breast cancer patients and matched controls to establish a biomarker panel potentially useful for early detection of breast cancer. Methods: We examined promoter methylation of seven putative tumor-suppressor genes (SFRP1, SFRP2, SFRP5, ITIH5, WIF1, DKK3, and RASSF1A) in cfDNA extracted from serum. Clinical performance was first determined in a test set (n = 261 sera). In an independent validation set (n = 343 sera), we validated the most promising genes for further use in early breast cancer detection. Sera from 59 benign breast disease and 58 colon cancer patients were included for additional specificity testing. Results: Based on the test set, we determined ITIH5 and DKK3 promoter methylation as candidate biomarkers with the best sensitivity and specificity. In both the test and validation set combined, ITIH5 and DKK3 methylation achieved 41% sensitivity with a specificity of 93% and 100% in healthy and benign disease controls, respectively. Combination of these genes with RASSF1A methylation increased the sensitivity to 67% with a specificity of 69% and 82% in healthy controls and benign disease controls, respectively. Conclusions: Tumor-specific methylation of the three-gene panel (ITIH5, DKK3, and RASSF1A) might be a valuable biomarker for the early detection of breast cancer.

Purpose: Mammographic characteristics are known to be correlated to breast cancer risk. Percent mammographic density (PMD), as assessed by computer-assisted methods, is an established risk factor for breast cancer. Along with this assessment the absolute dense area (DA) of the breast is reported as well. Aim of this study was to assess the predictive value of DA concerning breast cancer risk in addition to other risk factors and in addition to PMD. Methods: We conducted a case control study with hospital-based patients with a diagnosis of invasive breast cancer and healthy women as controls. A total of 561 patients and 376 controls with available mammographic density were included into this study. We describe the differences concerning the common risk factors BMI, parital status, use of hormone replacement therapy (HRT) and menopause between cases and controls and estimate the odds ratios for PMD and DA, adjusted for the mentioned risk factors. Furthermore we compare the prediction models with each other to find out whether the addition of DA improves the model. Results: Mammographic density and DA were highly correlated with each other. Both variables were as well correlated to the commonly known risk factors with an expected direction and strength, however PMD (ρ = −0.56) was stronger correlated to BMI than DA (ρ = −0.11). The group of women within the highest quartil of PMD had an OR of 2.12 (95 % CI: 1.25–3.62). This could not be seen for the fourth quartile concerning DA. However the assessment of breast cancer risk could be improved by including DA in a prediction model in addition to common risk factors and PMD. Conclusions: The inclusion of the parameter DA into a prediction model for breast cancer in addition to established risk factors and PMD could improve the breast cancer risk assessment. As DA is measured together with PMD in the process of computer-assisted assessment of PMD it might be considered to include it as one additional breast cancer risk factor that is obtained from breast imaging.