Publications by authors named "Tanja Fehm"

354 Publications

The influence of being pregnant during the COVID-19 pandemic on birth expectations and antenatal bonding.

J Reprod Infant Psychol 2021 Aug 18:1-11. Epub 2021 Aug 18.

Clinic for Gynecology and Obstetrics, University Clinic, Augsburg, Germany.

Purpose: The aim of the present study was to compare birth expectations and antenatal bonding of women pregnant prior to and during the COVID-19 pandemic.

Materials And Methods: In total, 74 pregnant women (mean age: 33.9 ± 4.1 years, gestational age: 36 ± 2 weeks) participated in the study, who were pregnant either during the the COVID-19 pandemic (, N = 35, April-July 2020) or before the pandemic (, N = 39, October 2017-January 2019). Birth expectations were measured using the Wijma Delivery Expectancy Questionnaire (WDEQ) and Salmon's Item List (SIL) and antenatal bonding with the Maternal Antenatal Attachment Scale (MAAS). Additionally, the indicated their level of worry regarding different pandemic-related aspects using visual analogue scales.

Results: The displayed significantly elevated fear of childbirth measured by the WDEQ and lower antenatal bonding quality compared to the . The additional items regarding COVID-19 burdens highlighted that the aspects that the partner may not be present during labour and that no visitors will be allowed in hospital were associated with the highest worries.

Conclusions: Midwives and gynaecologists should be aware of the negative impact of the COVID-19 pandemic on fear of childbirth and antenatal bonding .
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http://dx.doi.org/10.1080/02646838.2021.1962825DOI Listing
August 2021

Study protocol for a mixed methods exploratory investigation of aftercare services for gestational diabetes in women to develop a new patient-centred model in Germany: the GestDiNa_basic study.

BMJ Open 2021 08 2;11(8):e046048. Epub 2021 Aug 2.

Patient Representative, Dortmund, Nordrhein-Westfalen, Germany.

Introduction: Women with gestational diabetes mellitus (GDM) have a higher risk of developing type 2 diabetes mellitus compared with women who never had GDM. Consequently, the question of structured aftercare for GDM has emerged. In all probability, many women do not receive care according to the guidelines. In particular, the process and interaction between obstetrical, diabetic, gynaecological, paediatric and general practitioner care lacks clear definitions. Thus, our first goal is to analyse the current aftercare situation for women with GDM in Germany, for example, the participation rate in aftercare diabetes screening, as well as reasons and attitudes stated by healthcare providers to offer these services and by patients to participate (or not). Second, we want to develop an appropriate, effective and patient-centred care model.

Methods And Analysis: This is a population-based mixed methods study using both quantitative and qualitative research approaches. In various working packages, we evaluate data of the GestDiab register, of the Association of Statutory Health Insurance Physicians of North Rhine and the participating insurance companies (AOK Rheinland/Hamburg, BARMER, DAK Gesundheit, IKK classic, pronova BKK). In addition, quantitative (postal surveys) and qualitative (interviews) surveys will be conducted with randomly selected healthcare providers (diabetologists, gynaecologists, paediatricians and midwives) and affected women, to be subsequently analysed. All results will then be jointly examined and evaluated.

Ethics And Dissemination: The study was approved by the ethics committee of the Faculty of Medicine, Heinrich-Heine-University Düsseldorf (Ethics Committee No.: 2019-738). Participants of the postal surveys and interviews will be informed in detail about the study and the use of data as well as the underlying data protection regulations before voluntarily participating. The study results will be disseminated through peer-reviewed journals, conferences and public information.

Trial Registration Number: DRKS00020283.
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http://dx.doi.org/10.1136/bmjopen-2020-046048DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8330567PMC
August 2021

Prognostic effect of low-level HER2 expression in patients with clinically negative HER2 status.

Eur J Cancer 2021 Sep 23;155:1-12. Epub 2021 Jul 23.

Department of Gynecology and Obstetrics, Marienhospital Bottrop, Bottrop, Germany.

Purpose: Assessment of HER2 overexpression using immunohistochemistry (IHC) and/or in situ hybridisation (ISH) for the detection of HER2 amplifications is standard to identify patients for established HER2-directed treatments. Patients with lower HER2 expression levels have recently also become candidates for novel therapies targeting HER2. This study aimed to assess tumour and patient characteristics and prognosis in patients with advanced breast cancer (aBC), relative to low HER2 expression levels.

Methods: PRAEGNANT is a prospective aBC registry (NCT02338167), focusing on molecular biomarkers. Patients in all therapy lines receiving any kind of treatment are eligible. This analysis includes patients with conventionally HER2-negative aBC. Clinical outcome was compared in the groups with no (IHC score 0) or with low HER2 expression (IHC 1+, or IHC 2+/ISH negative).

Results: Low HER2 expression levels in triple-negative aBC patients did not influence progression-free survival. Overall survival appeared poorer in patients with IHC 2+ compared with patients with no HER2 expression in the unadjusted analysis (hazard ratio 2.24, 95% confidence interval 0.1.12-4.47). However, this effect was not maintained in the adjusted analysis. In HER2-negative, hormone receptor-positive patients, low HER2 expression appeared to have no effect on prognosis, neither progression-free survival nor overall survival.

Conclusions: We could not demonstrate that HER2 expression at a low level and assessed in clinical routine can differentiate patients into prognostic groups. However, the prevalence of patients with a low expression makes this population interesting for clinical trials with potentially active treatments using HER2 as a target.
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http://dx.doi.org/10.1016/j.ejca.2021.06.033DOI Listing
September 2021

Evaluation of Integrated HPV DNA as Individualized Biomarkers for the Detection of Recurrent CIN2/3 during Post-Treatment Surveillance.

Cancers (Basel) 2021 Jul 1;13(13). Epub 2021 Jul 1.

Klinik und Poliklinik für Frauenheilkunde und Geburtshilfe, Technische Universität Dresden, 01307 Dresden, Germany.

Purpose: Post-treatment follow-up in women with cervical pre-cancers (CIN3) is mandatory due to relapse in up to 10% of patients. Standard follow-up based on hrHPV-DNA/cytology co-testing has high sensitivity but limited specificity. The aim of our prospective, multicenter, observational study was to test the hypothesis that an individualized viral-cellular-junction test (vcj-PCR) combined with cytology has a lower false positive rate for the prediction of recurrence compared to standard co-testing.

Methods: Pre-surgical cervical swabs served for the identification of HPV16/18 DNA integration sites by next-generation-sequencing (NGS). Samples taken at 6, 12 and 24 months post-surgery were evaluated by cytology, hrHPV-DNA and the patients' individual HPV-integration sites (vcj-PCR on the basis of NGS).

Results: Integration sites were detected in 48 of 445 patients (10.8%), 39 of them had valid follow-up data. The false positive rate was 18.2% (95% CI 8.6-34.4%) for standard hrHPV/cytology at six months compared to 12.1% (95% CI 4.8-27.3%) for vcj-PCR/cytology, respectively (McNemar = 0.50). Six patients developed recurrences (1 CIN2, 5 CIN3) during follow-up. Standard co-testing detected all, whereas vcj-PCR/cytology detected only five patients with recurrences. Data of 269 patients without evidence of HPV16/18 integration were subject to post-hoc analyses. Standard co-testing revealed a false positive rate of 15.7% (95% CI 11.7-20.7%) and predicted ten of fourteen recurrences at six months.

Conclusions: Although highly specific on its own vcj-PCR could not detect all recurrent CIN2/3. Possible reasons for this unexpected result may be multifocal lesions, intratumoral heterogeneity with respect to HPV integration and/or incident CIN.
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http://dx.doi.org/10.3390/cancers13133309DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8269020PMC
July 2021

Disseminated tumour cells from the bone marrow of early breast cancer patients: Results from an international pooled analysis.

Eur J Cancer 2021 Sep 12;154:128-137. Epub 2021 Jul 12.

Department of Women's Health, University of Tuebingen, Tuebingen, Germany.

Purpose: Presence of disseminated tumour cells (DTCs) in the bone marrow (BM) has been described as a surrogate of residual disease in patients with early breast cancer (EBC). PADDY (Pooled Analysis of DTC Detection in Early Breast Cancer) is a large international analysis of pooled data that aimed to assess the prognostic impact of DTCs in patients with EBC.

Experimental Design: Individual patient data were collected from 11 centres. Patients with EBC and available follow-up data in whom BM sampling was performed at the time of primary diagnosis before receiving any anticancer treatment were eligible. DTCs were identified by antibody staining against epithelial cytokeratins. Multivariate Cox regression was used to compare the survival of DTC-positive versus DTC-negative patients.

Results: In total, 10,307 patients were included. Of these, 2814 (27.3%) were DTC-positive. DTC detection was associated with higher tumour grade, larger tumour size, nodal positivity, oestrogen receptor and progesterone receptor negativity, and HER2 positivity (all p < 0.001). Multivariate analyses showed that DTC detection was an independent prognostic marker for overall survival, disease-free survival and distant disease-free survival with hazard ratios (HR) and 95% confidence intervals (CI) of 1.23 (95% CI: 1.06-1.43, p = 0.006), 1.30 (95% CI: 1.12-1.52, p < 0.001) and 1.30 (95% CI: 1.08-1.56, p = 0.006), respectively. There was no association between locoregional relapse-free survival and DTC detection (HR 1.21; 95% CI 0.68-2.16; p = 0.512).

Conclusions: DTCs in the BM represent an independent prognostic marker in patients with EBC. The heterogeneous metastasis-initiating potential of DTCs is consistent with the concept of cancer dormancy.
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http://dx.doi.org/10.1016/j.ejca.2021.06.028DOI Listing
September 2021

The influence of maternal singing on well-being, postpartum depression and bonding - a randomised, controlled trial.

BMC Pregnancy Childbirth 2021 Jul 12;21(1):501. Epub 2021 Jul 12.

Department of Experimental Psychology, Heinrich-Heine-University Düsseldor, Universitätsstraße 1, 40225, Düsseldorf, Germany.

Background: Postpartum depression is fairly common in new mothers and moreover associated with impaired bonding and poor maternal well-being. The aim of the present study was to investigate the impact of a mother-infant singing intervention within the first three months after birth on maternal well-being, depressive symptoms and bonding.

Methods: 120 women who were recruited at the maternity ward at the University Clinic in Düsseldorf took part in this prospective, randomised-controlled study. Beside the baseline measurement 1-3 days after childbirth, depressive symptoms, maternal well-being and mother-infant bonding were evaluated with questionnaires before (two weeks after birth) and after (twelve weeks after birth) the intervention took place. The experimental group (n = 59) participated in several singing intervention sessions while the control group (n = 61) did not. In the intervention group, salivary cortisol as well as attachment and mood were assessed immediately before and after the singing sessions.

Results: The participants of the intervention group showed a significant reduction of cortisol (p = .023) and an improvement of attachment and mood from start to end of the intervention session (all p ≤ .008). However, no prolonged effects were revealed beyond the intervention sessions as the two groups did not differ regarding the alterations of the primary outcomes postpartum depression (interaction effect p = .187) and postpartum bonding (interaction effect p = .188) in the 10-week period from two up to twelve weeks after childbirth (all p > .05). Additional analyses of singing habits at home in both groups, revealed that only in the singing group more frequent singing was associated with less anxiety and more well-being of the mother.

Conclusion: Singing towards the infant seems to have positive immediate effects on the well-being of new mothers (on subjective variables as well as physiological measurements). However, the intervention did not lead to more long lasting positive effects although several limitations should be considered.

Trial Registration: DRKS00015178 (registered at the German Clinical Trial Registry), date of registration: 09.11.2018.
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http://dx.doi.org/10.1186/s12884-021-03933-zDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8273948PMC
July 2021

Update Breast Cancer 2021 Part 3 - Current Developments in the Treatment of Early Breast Cancer: Review and Assessment of Specialised Treatment Scenarios by an International Expert Panel.

Geburtshilfe Frauenheilkd 2021 Jun 21;81(6):654-665. Epub 2021 Jun 21.

Department of Obstetrics and Gynecology, University of Tübingen, Tübingen, Germany.

The continuous availability of findings from new studies repeatedly results in updated treatment recommendations and guidelines. In the case of breast carcinoma in particular, several studies have been published in the last few years that have transformed how early and advanced breast carcinoma is being treated. However, this by no means means implies that there is agreement among all experts on specific issues. It is precisely the diversity of interpretation of guidelines and study findings that reflects the constantly changing available data and its complexity, as well as the availability of new drugs. In recent years, new substances such as pertuzumab, T-DM1, neratinib and capecitabine have become available to treat patients with early stages of breast carcinoma. Furthermore, the first results on the use of CDK4/6 inhibitors for adjuvant treatment have now been published. Last but not least, the use of multigene tests to avoid the necessity of chemotherapy in certain patients is still under discussion. This review summarises the state of the data and publishes the results of the survey completed by experts at the 2021 St. Gallen Breast Cancer Conference on early-stage breast cancer.
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http://dx.doi.org/10.1055/a-1487-7642DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8216783PMC
June 2021

Prognosis of Patients With Early Breast Cancer Receiving 5 Years vs 2 Years of Adjuvant Bisphosphonate Treatment: A Phase 3 Randomized Clinical Trial.

JAMA Oncol 2021 Aug;7(8):1149-1157

Department of Gynecology and Obstetrics, University Hospital Ulm, Ulm, Germany.

Importance: Bisphosphonate treatment in patients with early breast cancer has become part of care, but the optimal treatment duration is still unclear.

Objective: To compare 2 vs 5 years of zoledronate treatment following adjuvant chemotherapy in patients with early breast cancer.

Design, Setting, And Participants: The SUCCESS A phase 3 multicenter randomized open-label clinical trial with a 2 × 2 factorial design enrolled 3754 patients from September 21, 2005, to March 12, 2007 (last patient out, May 7, 2014). Final data analysis was conducted from September 2019 to October 2020. In 250 German study centers, patients were eligible for participation in the SUCCESS A trial if they had either node-positive or high-risk node-negative (defined as at least 1 of the following: tumor size ≥ pT2, histologic grade 3, negative hormone receptor status, or age ≤35 years) primary invasive breast cancer.

Interventions: Patients were first randomized to adjuvant chemotherapy with 3 cycles of fluorouracil, epirubicin, and cyclophosphamide followed by 3 cycles of docetaxel with or without gemcitabine (not presented in this report). After chemotherapy, patients underwent a second randomization of 5 years of zoledronate treatment (4 mg intravenously every 3 months for 2 years, followed by 4 mg intravenously every 6 months for 3 years) vs 2 years of zoledronate treatment (4 mg intravenously every 3 months for 2 years).

Main Outcomes And Measures: The primary end point of the study was disease-free survival; secondary end points were overall survival, distant disease-free survival, and the incidence of skeletal-related adverse events. Survival times were measured from 2 years after the start of zoledronate treatment (landmark analysis).

Results: Overall, data on 2987 patients were available for analysis; median age was 53 (range, 21-86) years. Disease-free survival, overall survival, and distant disease-free survival did not differ significantly between the 2 treatment arms (5 vs 2 years) as shown by adjusted multivariable Cox proportional hazards regression models (disease-free survival: hazard ratio [HR], 0.97; 95% CI, 0.75-1.25; P = .81; overall survival: HR, 0.98; 95% CI, 0.67-1.42; P = .90; distant disease-free survival: HR, 0.87; 95% CI, 0.65-1.18; P = .38). Adverse events were observed more often in the 5-year (46.2%) vs 2-year (27.2%) zoledronate treatment arm, which was particularly true for the skeletal-related events bone pain (5 years, 8.3% vs 2 years, 3.7%) and arthralgia (5 years, 5.1% vs 2 years, 3.1%).

Conclusions And Relevance: The results of this phase 3 randomized clinical trial indicate that extending the zoledronate treatment beyond 2 years does not improve the prognosis of high-risk patients with early breast cancer receiving chemotherapy, suggesting that the currently recommended bisphosphonate treatment duration of 3 to 5 years could be reduced.

Trial Registration: ClinicalTrials.gov Identifier: NCT02181101.
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http://dx.doi.org/10.1001/jamaoncol.2021.1854DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8227465PMC
August 2021

The SOX2 Status of Disseminated Tumor Cells in Breast Cancer Patients Treated With Neoadjuvant Chemotherapy.

Anticancer Res 2021 Jun;41(6):2849-2858

Department of Obstetrics and Gynecology, University of Duesseldorf, Duesseldorf, Germany.

Background/aim: Detection of disseminated tumor cells (DTCs) after systemic treatment predicts poor prognosis in breast cancer patients. The aim of our study was to assess the expression of stem-cell marker SOX2 on DTCs and in the primary tumor of patients treated with neoadjuvant chemotherapy (NAT).

Materials And Methods: In 170 DTC-positive patients after NAT an additional slide of bone marrow aspirate was stained by double immunofluorescence to detect SOX2-positive DTCs. The SOX2 status of the primary tumor was assessed using the same antibody.

Results: The SOX2-status of DTCs was determined in 62 patients and 20 of those (32%) had SOX2 positive DTCs. The SOX2 status of DTCs was not associated with any of the clinicopathological factors. A total of 36% of the patients with a SOX2-negative tumor showed SOX2-positive persistent DTCs.

Conclusion: SOX2-positive DTCs can be detected in breast cancer patients after NAT, even in patients with SOX2-negative primary tumors. This suggests that these populations may have evolved independently of each other.
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http://dx.doi.org/10.21873/anticanres.15066DOI Listing
June 2021

Update Breast Cancer 2021 Part 2 - Advanced Stages, Long-Term Consequences and Biomarkers.

Geburtshilfe Frauenheilkd 2021 May 3;81(5):539-548. Epub 2021 May 3.

Klinik und Poliklinik für Gynäkologie, Universitätsklinikum Leipzig, Leipzig, Germany.

This review summarises and discusses significant aspects of recently published studies on patient treatment in advanced breast cancer and on biomarkers in breast cancer. In recent years, a large number of drugs for all molecular subtypes have been developed up to phase III trials. With regard to immune checkpoint inhibitors in metastasised breast cancer, the recent discussion has centred on the best candidate for combined chemotherapy. The oral taxanes could become a new type of oral chemotherapies. There is a growing body of data on biomarkers for the use of CDK4/6 inhibitors, which could also signify further development for other molecular subtypes. New substances have been developed for metastatic HER2+ breast cancer that still result in good remission even after massive prior treatment and/or cerebral metastasis. Similarly, knowledge is growing about targeted therapies with antibody-drug conjugates (ADC) against Trop-2, which could bolster our therapeutic armoury in triple-negative breast cancer (TNBC). In addition, the clinical focus is on understanding how to maintain fertility after breast cancer treatment. Here, pooled analyses provide new insights.
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http://dx.doi.org/10.1055/a-1464-1221DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8137275PMC
May 2021

Update Breast Cancer 2021 Part 1 - Prevention and Early Stages.

Geburtshilfe Frauenheilkd 2021 May 3;81(5):526-538. Epub 2021 May 3.

Agaplesion Markus Krankenhaus, Department of Gynecology and Gynecological Oncology, Frankfurt, Germany.

This review summarises not only the latest evidence on prevention, but also the current research on the treatment of early-stage breast cancer patients. Recent years have seen a growing body of evidence on the risk of high- and moderate-penetrance breast cancer susceptibility genes. A large international consortium has now been able to further refine the answer to the question of the significance of the so-called panel genes. Moreover, the data on treatment selection regarding endocrine efficacy and the decision for or against chemotherapy have also been advanced markedly. There is also new data on adjuvant CDK4/6 (cyclin-dependent kinase 4/6) inhibitors, which are standard in first-line treatment in patients with metastatic HER2-negative, hormone receptor-positive (HR+) breast cancer. For other therapies such as immune checkpoint inhibitors, which have successfully improved the rate of pathologic complete response (pCR) in neoadjuvant treatment settings for patients with triple-negative breast cancer (TNBC), there is a growing understanding of the quality of life and side effects. This is especially important in situations where patients could possibly be cured without such a regimen.
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http://dx.doi.org/10.1055/a-1464-0953DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8137274PMC
May 2021

Determining the axillary nodal status with four current imaging modalities including F-FDG PET/MRI in newly diagnosed breast cancer: A comparative study using histopathology as reference standard.

J Nucl Med 2021 May 20. Epub 2021 May 20.

University Dusseldorf, Medical Faculty, Department of Diagnostic and Interventional Radiology, Germany.

To compare breast magnetic resonance imaging (MRI), thoracal MRI, thoracal F-fluorodeoxyglucose positron emission tomography (F-FDG PET)/MRI and axillary sonography for the detection of axillary lymph node metastases in women with newly diagnosed breast cancer. This prospective double-center study included patients with newly diagnosed breast cancer between March 2018 and December 2019. Patients underwent thoracal (F-FDG PET/)MRI, axillary sonography, and dedicated prone breast MRI. Datasets were evaluated separately regarding nodal status (nodal+ vs. nodal-). Histopathology served as reference standard in all patients. The diagnostic performance of breast MRI, thoracal MRI, thoracal PET/MRI and axillary sonography in detecting nodal positive patients was tested by creating receiver-operating-characteristic curves (ROC) with a calculated area under the curve (AUC). Sensitivity, specificity, positive predictive value, negative predictive value, and accuracy were calculated for all four modalities. A McNemar test was used to assess differences. 112 female patients (mean age 53.04 ± 12.6 years) were evaluated. Thoracal PET/MRI showed the highest ROC-AUC with a value of 0.892. The AUC for breast MRI, thoracal MRI and sonography were 0.782, 0.814 and 0.834, respectively. Differences between thoracal PET/MRI and axillary sonography, thoracal MRI and breast MRI were statistically significant (PET/MRI vs. axillary sonography, = 0.01; PET/MRI vs. thoracal MRI, = 0.02; PET/MRI vs. breast MRI, = 0.03). PET/MRI showed the highest sensitivity (81.8%, 36/44) (95%-CI: 67.29-91.81%) while axillary sonography had the highest specificity (98.5%, 65/66), 95%-CI: 91.84-99.96%). F-FDG PET/MRI outperforms axillary sonography, breast MRI and thoracal MRI in determining the axillary lymph node status. In a clinical setting, the combination of F-FDG PET/MRI and axillary sonography might be considered to provide even more accuracy in diagnosis.
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http://dx.doi.org/10.2967/jnumed.121.262009DOI Listing
May 2021

Challenges and Opportunities for Real-World Evidence in Metastatic Luminal Breast Cancer.

Breast Care (Basel) 2021 Apr 16;16(2):108-114. Epub 2021 Mar 16.

Department of Gynecology and Obstetrics, Erlangen University Hospital, Comprehensive Cancer Center Erlangen-EMN, Friedrich Alexander University of Erlangen-Nuremberg, Erlangen, Germany.

Background: The therapeutic armamentarium for patients with metastatic breast cancer is becoming more and more specific. Recommendations from clinical trials are not available for all treatment situations and patient subgroups, and it is therefore important to collect real-world data.

Summary: To develop recommendations for up-to-date treatments and participation in clinical trials for patients with metastatic breast cancer, the Prospective Academic Translational Research PRAEGNANT Network was established to optimize the quality of oncological care in the advanced therapeutic setting. The main aim of PRAEGNANT is to systematically record medical care for patients with metastatic breast cancer in the real-life setting, including the outcome and side effects of different treatment strategies, to monitor quality-of-life changes during therapy, to identify patients eligible for participation in clinical studies, and to allow targeted therapies based on the molecular structures of breast carcinomas.

Key Messages: This article describes the PRAEGNANT network and sheds light on the question of whether the various end points from clinical trials can be transferred to the real-world treatment situation.
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http://dx.doi.org/10.1159/000515701DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8114055PMC
April 2021

[Intrahepatic cholestasis of pregnancy].

Gynakologe 2021 Apr 20:1-16. Epub 2021 Apr 20.

Klinik für Gastroenterologie, Hepatologie und Infektiologie, Universität Düsseldorf, Düsseldorf, Deutschland.

Intrahepatic cholestasis of pregnancy (ICP) is the most frequent pregnancy-specific liver disease. It is characterized by pruritus and an accompanying elevation of serum bile acid concentrations and/or alanine aminotransferase (ALT), which are the key parameters in the diagnosis. Despite good maternal prognosis, elevated bile acid concentration in maternal blood is an influencing factor to advers fetal outcome. The ICP is associated with increased rates of preterm birth, neonatal unit admission and stillbirth. This is the result of acute fetal asphyxia as opposed to a chronic uteroplacental insufficiency. Reliable monitoring or predictive tools (e.g. cardiotocography (CTG) or ultrasound) that help to prevent advers events are yet to be explored. Medicinal treatment with ursodeoxycholic acid (UDCA) does not demonstrably reduce adverse perinatal outcomes but does improve pruritus and liver function test results. Bile acid concentrations and gestational age should be used as indications to determine delivery. There is a high risk of recurrence in subsequent pregnancies.
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http://dx.doi.org/10.1007/s00129-021-04787-4DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8056200PMC
April 2021

Diagnosis and Treatment of Endometriosis. Guideline of the DGGG, SGGG and OEGGG (S2k Level, AWMF Registry Number 015/045, August 2020).

Geburtshilfe Frauenheilkd 2021 Apr 14;81(4):422-446. Epub 2021 Apr 14.

Klinik für Frauenheilkunde, Klinikum St. Marien Amberg, Amberg, Germany.

The aim of this official guideline published and coordinated by the German Society of Gynaecology and Obstetrics (DGGG) in cooperation with the Austrian Society for Gynaecology and Obstetrics (OEGGG) and the Swiss Society for Gynaecology and Obstetrics (SGGG) was to provide consensus-based recommendations for the diagnosis and treatment of endometriosis based on an evaluation of the relevant literature. This S2k guideline represents the structured consensus of a representative panel of experts with different professional backgrounds commissioned by the Guideline Committee of the DGGG, OEGGG and SGGG. Recommendations on the epidemiology, aetiology, classification, symptomatology, diagnosis and treatment of endometriosis are given and special situations are discussed.
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http://dx.doi.org/10.1055/a-1380-3693DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8046516PMC
April 2021

Mutations in and Other Panel Genes in Patients With Metastatic Breast Cancer -Association With Patient and Disease Characteristics and Effect on Prognosis.

J Clin Oncol 2021 May 29;39(15):1619-1630. Epub 2021 Mar 29.

Department of Gynecology and Obstetrics, Carl Gustav Carus Faculty of Medicine and University Hospital, Technical University of Dresden, Dresden, Germany.

Purpose: Among patients with metastatic breast cancer (mBC), the frequency of germline mutations in cancer susceptibility genes and the clinical relevance of these mutations are unclear. In this study, a prospective cohort of patients with mBC was used to determine mutation rates for breast cancer (BC) predisposition genes, to evaluate the clinical characteristics of patients with mutations, and to assess the influence of mutations on patient outcome.

Patients And Methods: Germline DNA from 2,595 patients with mBC enrolled in the prospective PRAEGNANT registry was evaluated for mutations in cancer predisposition genes. The frequencies of mutations in known BC predisposition genes were compared with results from a prospective registry of patients with nonmetastatic BC sequenced using the same QIAseq method and with public reference controls. Associations between mutation status and tumor characteristics, progression-free survival, and overall survival were assessed.

Results: Germline mutations in 12 established BC predisposition genes (including and ) were detected in 271 (10.4%) patients. A mutation in or was seen in 129 patients (5.0%). mutation carriers had a higher proportion of brain metastasis (27.1%) compared with nonmutation carriers (12.8%). Mutations were significantly enriched in PRAEGNANT patients with mBC compared with patients with nonmetastatic BC (10.4% 6.6%, < .01). Mutations did not significantly modify progression-free survival or overall survival for patients with mBC.

Conclusion: Multigene panel testing may be considered in all patients with mBC because of the high frequency of germline mutations in and other BC predisposition genes. Although the prognosis of mutation carriers and nonmutation carriers with mBC was similar, differences observed in tumor characteristics have implications for treatment and for future studies of targeted therapies.
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http://dx.doi.org/10.1200/JCO.20.01200DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8274805PMC
May 2021

Phase II study of metronomic treatment with daily oral vinorelbine as first-line chemotherapy in patients with advanced/metastatic HR+/HER2- breast cancer resistant to endocrine therapy: VinoMetro-AGO-B-046.

J Cancer Res Clin Oncol 2021 Mar 20. Epub 2021 Mar 20.

Department of Gynaecology and Obstetrics, University Medical Centre, Mainz, Germany.

Purpose: Metronomic chemotherapy (MCT) is an increasingly used treatment option in hormone receptor-positive (HR+)/human epidermal growth factor receptor 2-negative (HER2-) advanced/metastatic breast cancer (MBC) after failure of endocrine-based therapies.

Methods: VinoMetro was a multicentre, open-label, single-arm, phase II study of metronomic oral vinorelbine (VRL; 30 mg/day) as a first-line chemotherapy (CT) in patients with HR+/HER2- MBC after endocrine failure. The primary endpoint was the clinical benefit rate (CBR) at 24 weeks.

Results: Between January 2017 and April 2019, nine patients were enrolled. The CBR was 22.2% (90% confidence interval [CI] 4.1-55.0), p = 0.211. The median progression-free survival (PFS) was 12.0 weeks (95% CI 11.3-12.7). Grade 3-4 adverse events (AEs) occurred in 22.2% of patients. One patient died of febrile neutropenia.

Conclusion: VinoMetro (AGO-B-046) was closed early after nine patients and occurrence of one grade 5 toxicity in agreement with the lead institutional review board (IRB). Metronomic dosing of oral VRL in HR+/HER2- MBC as first-line CT after failure of endocrine therapies showed only limited benefit in this population.

Trial Registration Number And Date Of Registration: ClinicalTrials.gov Identifier: NCT03007992; December 15, 2016.
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http://dx.doi.org/10.1007/s00432-021-03599-2DOI Listing
March 2021

The effects of a music intervention during port catheter placement on anxiety and stress.

Sci Rep 2021 Mar 11;11(1):5807. Epub 2021 Mar 11.

Clinic for Gynecology and Obstetrics, University Clinic, Augsburg, Germany.

Studies have shown that perioperative music interventions can reduce patients' anxiety levels. However, in small operations like port catheter surgery evidence is sparse. The present single-blinded, randomised controlled two-armed study included 84 female patients undergoing port catheter placement who were randomly assigned to either listening to music during surgery vs. no music intervention. The medical staff was blind to group allocation. On the day of the surgery anxiety and stress levels were evaluated using subjective (STAI questionnaire, visual analogue scales) and objective (vital parameters, salivary cortisol) parameters at different time points (before the surgery, at the end of the surgery and 1 h post-surgery). The music group showed significant reductions of systolic blood pressure (from 136.5 mmHg ± 26.1 to 123.3 mmHg ± 22.0, p = .002) and heart rate (from 75.6 bpm ± 12.3 to 73.1 bpm ± 12.2, p = .035) from beginning of the surgery to skin suture, whereas the control group did not. No significant effects of the music intervention on subjective anxiety measures or salivary cortisol were revealed. In sum, the study demonstrates that a music intervention during port catheter placement positively influences physiological anxiety levels, whereas no effects were revealed for subjective anxiety and salivary cortisol. Thus, music can be considered as a low cost addition in clinical routine in order to reduce patients' heart rate and blood pressure. Future studies are encouraged to further explore the differential effects of intraoperative music interventions on physiological, endocrinological and subjective anxiety levels.
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http://dx.doi.org/10.1038/s41598-021-85139-zDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7970967PMC
March 2021

Immunogenicity and safety of a nine-valent human papillomavirus vaccine in women 27-45 years of age compared to women 16-26 years of age: An open-label phase 3 study.

Vaccine 2021 05 3;39(20):2800-2809. Epub 2021 Mar 3.

Merck & Co., Inc., Kenilworth, NJ, USA. Electronic address:

Background: Efficacy of the nine-valent human papillomavirus (9vHPV; HPV types 6/11/16/18/31/33/45/52/58) vaccine was demonstrated in a phase 3 study in women 16-26 years of age. We present a phase 3 immunogenicity and safety study of the 9vHPV vaccine in women 27-45 versus 16-26 years of age.

Methods: This international, open-label study (NCT03158220) was conducted in women 16-45 years of age. Participants (16-26 years, n = 570 and 27-45 years, n = 642) received a three-dose 9vHPV vaccination regimen (day 1, month 2, month 6). Month 7 geometric mean titers (GMTs) and seroconversion percentages to anti-HPV 6/11/16/18/31/33/45/52/58 were assessed. Participants were followed for safety throughout the study.

Results: At month 7, anti-HPV 6/11/16/18/31/33/45/52/58 GMTs in women 27-45 years were compared to those in women 16-26 years of age. The primary hypothesis of non-inferiority of anti-HPV 16/18/31/33/45/52/58 GMTs in older versus younger women was met. The lower bound of the GMT ratio 95% confidence interval (27-45 years to 16-26 years) was 0.60-0.67 depending on HPV type, exceeding the non-inferiority margin of 0.5 for all HPV types. Month 7 seroconversion percentages in women 27-45 years of age were >99% for all HPV types. Injection-site and vaccine-related systemic adverse events (AEs) were observed in 87.5% and 25.1% of women 16-26 years, and 85.2% and 24.1% of women 27-45 years of age, respectively; no vaccine-related serious AEs were reported and no deaths occurred during the study.

Conclusions: The 9vHPV vaccine elicited non-inferior anti-HPV GMTs in women 27-45 years compared with women 16-26 years of age for HPV 16/18/31/33/45/52/58. The vaccine was generally well tolerated with a similar AE profile across the age groups. These data support bridging 9vHPV vaccine efficacy findings in women 16-26 years to women 27-45 years of age. Clinical trial registration NCT03158220.
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http://dx.doi.org/10.1016/j.vaccine.2021.01.074DOI Listing
May 2021

Predicting Prognosis of Breast Cancer Patients with Brain Metastases in the BMBC Registry-Comparison of Three Different GPA Prognostic Scores.

Cancers (Basel) 2021 Feb 17;13(4). Epub 2021 Feb 17.

Department of Gynecology, University Medical Center Hamburg-Eppendorf, Martinistraße 52, 20246 Hamburg, Germany.

Several scores have been developed in order to estimate the prognosis of patients with brain metastases (BM) by objective criteria. The aim of this analysis was to validate all three published graded-prognostic-assessment (GPA)-scores in a subcohort of 882 breast cancer (BC) patients with BM in the Brain Metastases in the German Breast Cancer (BMBC) registry. The median age at diagnosis of BM was 57 years. All in all, 22.3% of patients ( = 197) had triple-negative, 33.4% ( = 295) luminal A like, 25.1% ( = 221) luminal B/HER2-enriched like and 19.2% ( = 169) HER2 positive like BC. Age ≥60 years, evidence of extracranial metastases (ECM), higher number of BM, triple-negative subtype and low Karnofsky-Performance-Status (KPS) were all associated with worse overall survival (OS) in univariate analysis ( < 0.001 each). All three GPA-scores were associated with OS. The breast-GPA showed the highest probability of classifying patients with survival above 12 months in the best prognostic group (specificity 68.7% compared with 48.1% for the updated breast-GPA and 21.8% for the original GPA). Sensitivities for predicting 3 months survival were very low for all scores. In this analysis, all GPA-scores showed only moderate diagnostic accuracy in predicting the OS of BC patients with BM.
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http://dx.doi.org/10.3390/cancers13040844DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7922206PMC
February 2021

Does Nutrition Affect Endometriosis?

Geburtshilfe Frauenheilkd 2021 Feb 8;81(2):191-199. Epub 2021 Feb 8.

Klinik für Geburtshilfe und Frauenheilkunde, Universitätsklinikum Düsseldorf, Düsseldorf, Germany.

Endometriosis is a hormone-related, chronic inflammation in women of childbearing age. The aetiology and pathogenesis of endometriosis are not yet fully understood. For other illnesses classed as lifestyle diseases, the link between nutrition and pathogenesis has already been researched and proven. With regard to these findings, the question continues to arise as to whether and how a specific diet and lifestyle could also influence pathogenesis and the progression of endometriosis. The aim of this review is to examine the data and determine what influence nutrition has on the development of endometriosis or on existing disease. The study results currently available do not permit a clear, scientific recommendation or indicate a detailed diet. In summary, it can be said that fish oil capsules in combination with vitamin B have been associated with a positive effect on endometriosis symptoms (particularly of dysmenorrhoea). Alcohol and increased consumption of red meat and trans fats are associated with a negative effect. The results of the studies listed with regard to fruit and vegetables, dairy products, unsaturated fats, fibre, soy products and coffee are not clear. Therefore, the general recommendations for a balanced and varied diet in line with the guidelines of the Deutsche Gesellschaft für Ernährung e. V. [German Nutrition Society] apply, along with the recommendation to cut out alcohol. In order to be able to derive more concrete recommendations, we require further studies to investigate the influence of nutrition on endometriosis.
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http://dx.doi.org/10.1055/a-1207-0557DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7870287PMC
February 2021

Use of music during vaginal birth and caesarean section: an interprofessional survey.

Arch Gynecol Obstet 2021 08 24;304(2):355-363. Epub 2021 Jan 24.

Department for Cognitive Psychology, Heinrich-Heine-University Düsseldorf, Düsseldorf, Germany.

Purpose: Evidence abounds about the beneficial effects of music on patients and healthcare professionals for many medical indications. This study aimed to evaluate the dissemination and use of music in the obstetrical setting.

Methods: Invitations to an online survey were sent to physicians and midwives of all obstetrics departments in Germany. The survey gathered descriptive data as well as information about the personal relation to music and the use of it during vaginal birth (VB) and caesarean section (CS) and whether data about positive or negative effects of music were known to the participant.

Results: In total, there were 293 respondents. The 47% that had the means to play music during CS stated that music was played in 15% of the cases. Most respondents have the means to play music during VB (97%). Music is played in 38% of VB. Regardless of the mode of delivery, music was estimated to be positive for team communication and patient communication. It was also deemed calming and mood lifting on the respondents. Regarding the patient, music during CS and VB was rated as being positive on all scales. Listening to music was recommended more often during VB (66%) than CS (38%).

Conclusions: Although healthcare professionals are mostly aware of the beneficial effects of music in obstetrics, our study shows that music plays a more important role during VB than during CS in Germanys obstetrical wards. There is a lack of equipment to play music in operation theatres where CS take place.
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http://dx.doi.org/10.1007/s00404-020-05958-9DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8277630PMC
August 2021

Therapy Algorithms for the Diagnosis and Treatment of Patients with Early and Advanced Breast Cancer.

Breast Care (Basel) 2020 Dec 2;15(6):608-618. Epub 2020 Nov 2.

Department of Gynecology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.

Background: In order to offer optimal treatment approaches based on available evidence, the Commission Breast of the Working Group Gynecologic Oncology (AGO) of the German Cancer Society developed therapy algorithms for eight complex treatment situations in primary and advanced breast cancer.

Summary: Therapy algorithms for the following complex treatment situations are outlined in this paper: (neo)adjuvant therapy of human epidermal growth factor receptor 2 (HER2)-positive breast cancer; axillary surgery and neoadjuvant chemotherapy; adjuvant endocrine therapy in premenopausal patients; adjuvant endocrine therapy in postmenopausal patients; hormone receptor (HR)-positive/HER2-negative metastatic breast cancer: strategies; HR-positive/HER2-negative metastatic breast cancer: endocrine-based first-line treatment; HER2-positive metastatic breast cancer: first to third-line; metastatic triple-negative breast cancer.

Key Messages: The therapy options shown in these algorithms are based on the current AGO recommendations updated in January 2020 but cannot represent all evidence-based treatment options. Prior therapies, performance status, comorbidities, patient preference, etc. must be taken into account for the actual treatment choice. Therefore, in individual cases, other evidence-based treatment options not listed here may also be appropriate and justified.
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http://dx.doi.org/10.1159/000511925DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7768141PMC
December 2020

The potential risk of contralateral non-sentinel groin node metastasis in women with early primary vulvar cancer following unilateral sentinel node metastasis: a single center evaluation in University Hospital of Düsseldorf.

BMC Womens Health 2021 01 12;21(1):23. Epub 2021 Jan 12.

Department of Obstetrics and Gynecology, University Hospital of Düsseldorf, Moorenstraße 5, 40225, Düsseldorf, Germany.

Background: Since the introduction of sentinel node biopsy (SLNB) in unifocal vulvar cancer (diameter of < 4 cm) and unsuspicious groin lymph nodes, the morbidity rate of patients has significantly decreased globally. In contrast to SLNB, bilateral inguinofemoral lymphadenectomy (IFL) has been associated with increased risk of common morbidities. Current guidelines (NCCN, ESGO, RCOG, and German) recommend that in cases of unilaterally positive sentinel lymph node (SLN), bilateral IFL should be performed. However, two recent publications by Woelber et al. and Nica et al. contradict the current guideline, since a significant rate of positive non sentinel lymph nodes in IFL contralaterally was not observed [Woelber et al. 0% (p = 0/28) and Nica et al. 5.3% (p = 1/19)].

Methods: A retrospective single-center analysis conducted in the University Hospital of Dusseldorf, evaluating vulvar cancer patients treated with SLNB from 2002 to 2018.

Results: 22.2% of women (n = 4/18) were found to have contralateral IFL groin metastasis after an initial diagnosis of unilateral SLN metastasis. The depth of tumor infiltrating cells correlated significantly and positively with the rate of incidence of groin metastasis (p = 0.0038).

Conclusion: Current guideline for bilateral IFL should remain as the standard management. Therefore, this depth may be taken into account as an indication for bilateral IFL. The management of VC and SLNB should be performed in a high volume center with an experienced team in marking SLN and performing the adequate surgical procedure. Well conducted counseling of the patients outlining advantages but also potential oncological risks of this technique especially concerning rate of groin recurrence is critical.
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http://dx.doi.org/10.1186/s12905-020-01165-5DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7802357PMC
January 2021

Residual Axillary Burden After Neoadjuvant Chemotherapy (NACT) in Early Breast Cancer in Patients with a priori Clinically Occult Nodal Metastases - a transSENTINA Analysis.

Geburtshilfe Frauenheilkd 2020 Dec 3;80(12):1229-1236. Epub 2020 Dec 3.

Department of Gynecology and Obstetrics, University Hospital Essen, Essen, Germany.

Among patients with breast cancer undergoing neoadjuvant chemotherapy (NACT), the association between pathological complete remission (pCR) in the breast and clinical/pathological parameters is well established, whereas the association between these parameters and residual axillary involvement after NACT remains unclear. Patients with clinically occult nodal metastases (i.e. negative by clinical assessment but positive by SLNB prior to NACT, i.e. Arm B of the SENTINA trial) were included in the presented analysis. All patients received a second sentinel lymph node biopsy (SLNB) and axillary dissection after NACT. Univariate and multivariate analyses were carried out to evaluate the association between clinical/pathological parameters and axillary involvement after NACT. Arm B of the SENTINA study contained 360 patients, 318 of which were evaluable for this analysis. After NACT, 71/318 (22.3%) patients had involved SLNs or non-SLNs after NACT. Overall, 71/318 (22.3%) patients achieved a pCR in the breast. Associations of extranodal spread, lack of multifocality and pCR in the breast with residual axillary burden were statistically significant. In a descriptive analysis including all patients with clinically negative axilla before NACT in the SENTINA trial 1.2% of triple negative (TN) patients and 0.5% of HER/2 positive patients had residual axillary disease in case of a breast pCR. Patients in the SENTINA trial with clinically negative axilla and involved SLNs still carried a significant risk of nodal metastases after NACT. However, the risk of residual axillary burden was particularly low in TN and HER/2 positive tumors in case of a breast pCR.
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http://dx.doi.org/10.1055/a-1298-3453DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7714621PMC
December 2020
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