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1. Effectiveness of real-time continuous glucose monitoring to improve glycaemic control and pregnancy outcome in patients with gestational diabetes mellitus: a study protocol for a randomised controlled trial

Author

Andrea Icks, T Fehm, Irene Hoesli, Michael Roden, Christian S Göbl, Evelyn Annegret Huhn, Tina Linder, Daniel Eppel, Karen Weißhaupt, Christine Klapp, Karen Schellong, Wolfgang Henrich, Gülen Yerlikaya-Schatten, Ingo Rosicky, Peter Husslein, Kinga Chalubinski, Martina Mittlböck, Petra Rust, Bettina Winzeler, Johan Jendle, Markus Vomhof, Gregory Gordon Greiner, Julia Szendrödi, and Andrea Tura

Subjects
Medicine
Abstract

Introduction Real-time continuous glucose monitoring (rt-CGM) informs users about current interstitial glucose levels and allows early detection of glycaemic excursions and timely adaptation by behavioural change or pharmacological intervention. Randomised controlled studies adequately powered to evaluate the impact of long-term application of rt-CGM systems on the reduction of adverse obstetric outcomes in women with gestational diabetes (GDM) are missing. We aim to assess differences in the proportion of large for gestational age newborns in women using rt-CGM as compared with women with self-monitored blood glucose (primary outcome). Rates of neonatal hypoglycaemia, caesarean section and shoulder dystocia are secondary outcomes. A comparison of glucose metabolism and quality of life during and after pregnancy completes the scope of this study.Methods and analysis Open-label multicentre randomised controlled trial with two parallel groups including 372 female patients with a recent diagnosis of GDM (between 24+0 until 31+6 weeks of gestation): 186 with rt-CGM (Dexcom G6) and 186 with self-monitored blood glucose (SMBG). Women with GDM will be consecutively recruited and randomised to rt-CGM or control (SMBG) group after a run-in period of 6–8 days. The third visit will be scheduled 8–10 days later and then every 2 weeks. At every visit, glucose measurements will be evaluated and all patients will be treated according to the standard care. The control group will receive a blinded CGM for 10 days between the second and third visit and between week 36+0 and 38+6. Cord blood will be sampled immediately after delivery. 48 hours after delivery neonatal biometry and maternal glycosylated haemoglobin A1c (HbA1c) will be assessed, and between weeks 8 and 16 after delivery all patients receive a re-examination of glucose metabolism including blinded CGM for 8–10 days.Ethics and dissemination This study received ethical approval from the main ethic committee in Vienna. Data will be presented at international conferences and published in peer-reviewed journals.Trial registration number NCT03981328; Pre-results.

Published
2020
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2. The HER2 phenotype of circulating tumor cells in HER2-positive early breast cancer: A translational research project of a prospective randomized phase III trial.

Author

B A S Jaeger, J Neugebauer, U Andergassen, C Melcher, F Schochter, D Mouarrawy, G Ziemendorff, M Clemens, E V Abel, G Heinrich, K Schueller, A Schneeweiss, P Fasching, M W Beckmann, Ch Scholz, T W P Friedl, K Friese, K Pantel, T Fehm, W Janni, and B Rack

Subjects
Medicine, Science
Abstract

HER2 is one of the predominant therapeutic targets in breast cancer. The metastatic selection process may lead to discrepancies between the HER2 status of the primary tumor and circulating tumor cells (CTCs). This study analyzed the HER2 status of CTCs in patients with HER2-positive primary breast cancer at the time of diagnosis. Aim of the study was to assess potential discordance of HER2 status between primary tumor and CTCs, as this may have important implications for the use of HER2-targeted therapy.The number and HER2 status of CTCs out of 30ml peripheral blood were assessed in 642 patients using the CellSearch System (Janssen Diagnostics, USA). The cutoff for CTC positivity was the presence of at least 1 CTC, and the cutoff for HER2 positivity of CTCs was the presence of at least 1 CTC with a strong HER2 staining.258 (40.2%) of the 642 patients were positive for CTCs (median 2; range 1-1,689). 149 (57.8%) of these 258 patients had at least 1 CTC with strong HER2 staining. The presence of HER2-positive CTCs was not associated with tumor size (p = 0.335), histopathological grading (p = 0.976), hormone receptor status (ER: p = 0.626, PR: p = 0.263) or axillary lymph node involvement (p = 0.430). Overall, 83 (32.2%) of the CTC-positive patients exclusively had CTCs with strong HER2 staining, whereas 31 (12.0%) had only CTCs with negative HER2 staining. Within-sample variation in the HER2 status of CTCs was found in 86 (57.8%) of the 149 patients with more than 1 CTC.This study demonstrated that discordance between the HER2 expression of CTCs and that of the primary tumor frequently occurs in early breast cancer. Future follow-up evaluation will assess whether this discrepancy may contribute to trastuzumab resistance.

Published
2017
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4. Therapiealgorithmen für das Mammakarzinom

Author

J.-U. Blohmer, A. Schneeweiss, I. Bauerfeind, T. Fehm, V. Müller, C. Thomssen, I. Witzel, A. Wöckel, and W. Janni

Subjects
Oncology, Hematology
Published
2021

5. Das Zertifizierungssystem der Deutschen Krebsgesellschaft

Author

T. Fehm, J. Rückher, Simone Wesselmann, Carsten Bokemeyer, and U. Graeven

Subjects
Gynecology, medicine.medical_specialty, Oncology, business.industry, medicine, Hematology, business
Abstract

Seit den Anfangen im Jahr 2003 hat sich das Zertifizierungssystem der Deutschen Krebsgesellschaft (DKG) zur masgeblichen Qualitatssicherungsinitiative in der Onkologie weiterentwickelt. Auf Basis der Erfahrungen der letzten Jahre sollen der Nutzen und das Weiterentwicklungspotenzial des Zertifizierungssystems aufgezeigt werden. Das Prinzip der kontinuierlichen Qualitatsverbesserung gilt sowohl fur das Zertifizierungssystem selbst als auch fur die zertifizierten Zentren. Die uber viele Jahre zusammengetragenen Daten der zertifizierten Zentren ermoglichen umfangreiche Einblicke in die Entwicklung der onkologischen Versorgungsstrukturen in Deutschland. Bisher fehlen Instrumente zur systematischen Risikoadjustierung und Integration von „patient-reported outcomes“ (PRO). Die mit der Zertifizierung verbundenen Anstrengungen der Zentren (z. B. fur die Dokumentation) werden bisher kaum finanziell honoriert. Der nicht unerhebliche Aufwand fur die Zentren im Dienste der Behandlungsqualitat sollte seitens der Politik und der Kostentrager starker berucksichtigt werden.

Published
2021

33. Characteristics of patients with brain metastases from HER2-positive breast cancer

Author

Arkadius Polasik, J. Puppe, TW Park-Simon, K Lübbe, M Thill, Julia Rey, C Denkert, V Müller, S Loibl, E Laakmann, I Witzel, Rudolf Weide, Valentina Nekljudova, K Riecke, D. M. Zahm, C Mundhenke, T Hesse, T Fehm, and T Neunhöffer

Subjects
Oncology, medicine.medical_specialty, business.industry, HER2 Positive Breast Cancer, Internal medicine, medicine, business
Published
2021

37. Die intravenöse Leiomyomatose

Author

H. Aubin, J. Drusenheimer, H. Schelzig, F. Kommoss, A. Lichtenberg, T. Fehm, and T. Ebel

Subjects
0301 basic medicine, Gynecology, 03 medical and health sciences, medicine.medical_specialty, 030104 developmental biology, 0302 clinical medicine, business.industry, 030220 oncology & carcinogenesis, medicine, business, Pathology and Forensic Medicine
Abstract

Die intravenose Leiomyomatose (IVLM) stellt eine ungewohnliche Neoplasie glatter Muskelzellen im Uterus dar, welche bei Patientinnen mit Uterus myomatosus auftreten kann. Sie weist eine charakteristische Histomorphologie mit Vordringen benigner glatter Muskelzellen in venose Blutgefase der Uteruswandung auf und kann durch intravaskulare und intrakardiale Ausbreitung zu lebensbedrohlichen klinischen Konsequenzen fuhren. Die klinischen und morphologischen Aspekte dieser seltenen, feingeweblich an gynakopathologischen Routinepraparaten bei meist kardiologisch noch asymptomatischen Patientinnen diagnostizierten Erkrankung sind nicht hinreichend bekannt und werden im vorliegenden Fall prasentiert und diskutiert.

Published
2019

38. Characteristics of patients with brain metastases from human epidermal growth factor receptor 2-positive breast cancer: subanalysis of Brain Metastases in Breast Cancer Registry

Author

E, Laakmann, I, Witzel, T, Neunhöffer, T-W, Park-Simon, R, Weide, K, Riecke, A, Polasik, M, Schmidt, J, Puppe, C, Mundhenke, K, Lübbe, T, Hesse, M, Thill, D-M, Zahm, C, Denkert, T, Fehm, V, Nekljudova, J, Rey, S, Loibl, and V, Müller

Subjects
Cancer Research, Oncology, Brain Neoplasms, Receptor, ErbB-2, Humans, Breast Neoplasms, Female, Registries
Abstract

Up to 40% of patients with metastatic human epidermal growth factor receptor 2 (HER2)-positive breast cancer develop brain metastases (BMs). Understanding of clinical features of these patients with HER2-positive breast cancer and BMs is vital.A total of 2948 patients from the Brain Metastases in Breast Cancer registry were available for this analysis, of whom 1311 had primary tumors with the HER2-positive subtype.Patients with HER2-positive breast cancer and BMs were-when compared with HER2-negative patients-slightly younger at the time of breast cancer and BM diagnosis, had a higher pathologic complete response rate after neoadjuvant chemotherapy and a higher tumor grade. Furthermore, extracranial metastases at the time of BM diagnosis were less common in HER2-positive patients, when compared with HER2-negative patients. HER2-positive patients had more often BMs in the posterior fossa, but less commonly leptomeningeal metastases. The median overall survival (OS) in all HER2-positive patients was 13.2 months (95% confidence interval 11.4-14.4). The following factors were associated with shorter OS (multivariate analysis): older age at BM diagnosis [≥60 versus60 years: hazard ratio (HR) 1.63, P0.001], lower Eastern Cooperative Oncology Group status (2-4 versus 0-1: HR 1.59, P0.001), higher number of BMs (2-3 versus 1: HR 1.30, P = 0.082; ≥4 versus 1: HR 1.51, P = 0.004; global P = 0.015), BMs in the fossa anterior (HR 1.71, P0.001), leptomeningeal metastases (HR 1.63, P = 0.012), symptomatic BMs at diagnosis (HR 1.35, P = 0.033) and extracranial metastases at diagnosis of BMs (HR 1.43, P = 0.020). The application of targeted therapy after the BM diagnosis (HR 0.62, P0.001) was associated with longer OS. HER2-positive/hormone receptor-positive patients showed longer OS than HER2-positive/hormone receptor-negative patients (median 14.3 versus 10.9 months; HR 0.86, P = 0.03), but no differences in progression-free survival were seen between both groups.We identified factors associated with the prognosis of HER2-positive patients with BMs. Further research is needed to understand the factors determining the longer survival of HER2-positive/hormone receptor-positive patients.

Published
2022

39. GestDina – Untersuchung der aktuellen Situation der Nachsorge von Frauen mit GDM

Author

Andrea Icks, I Schmitz-Losem, Regina Ensenauer, O Kuß, B Westerhoff, Verena Leve, Veronika Lappe, M Neuenschwander, S Schellhammer, F Meier-Stiegen, Anja Viehmann, M Schneider, T Kerres, U Jüngling, G Bizjak, F Meyer, U Linnenkamp, D Müller-Bößmann, T Fehm, F Borgmeier, U Lange, O Dortmann, V Gräfe, Gregory Gordon Greiner, H Adamczewski, C Rupprecht, M Kaltheuner, E Ruckhäberle, L Schumacher, M Tamayo, Stefan Wilm, T Hollmann, and Peter Ihle

Published
2020

49. GestDina – Analysis of the current aftercare situation for gestational diabetes

Author

Anja Viehmann, E Ruckhäberle, L Schumacher, G Bizjak, V Gräfe, Verena Leve, Peter Ihle, I Schmitz-Losem, S Schellhammer, C Rupprecht, Stefan Wilm, M Schneider, T Fehm, O Dortmann, D Müller-Bößmann, T Kerres, M Tamayo, M Neuenschwander, U Jüngling, Regina Ensenauer, Gregory Gordon Greiner, F Meier-Stiegen, O Kuß, H Adamczewski, U Lange, F Borgmeier, T Hollmann, Veronika Lappe, F Meyer, U Linnenkamp, M Kaltheuner, Andrea Icks, and B Westerhoff

Subjects
Gestational diabetes, medicine.medical_specialty, business.industry, Obstetrics, Medicine, Current (fluid), business, medicine.disease
Published
2020

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