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21. Das internationale Endometriose-Evaluationsprogramm (IEEP) – eine Studie für Kliniker, Forscher und Patientinnen

Author

Blum, S, additional, Fasching, P A, additional, Hildebrandt, T, additional, Lermann, J, additional, Heindl, F, additional, Born, T, additional, Lubrich, H, additional, Antoniadis, S, additional, Becker, K, additional, Tchartchian, G, additional, Bojahr, B, additional, Jentschke, M, additional, Fehmd, T, additional, Janni, W, additional, Hartung, C-P, additional, Füger, T, additional, Renner, S P, additional, Germeyer, A, additional, Oppelt, P, additional, Enzelsberger, S-H, additional, Fleisch, M, additional, Hepp, P, additional, Lange, J, additional, Fahlbusch, C, additional, Heusinger, K, additional, Burghaus, S, additional, Beckmann, M W, additional, and Hein, A, additional

Published
2020
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24. Trebananib or placebo plus carboplatin and paclitaxel as first-line treatment for advanced ovarian cancer (TRINOVA-3/ENGOT-ov2/GOG-3001): a randomised, double-blind, phase 3 trial

Author

Vergote, I. Scambia, G. O'Malley, D.M. Van Calster, B. Park, S.-Y. del Campo, J.M. Meier, W. Bamias, A. Colombo, N. Wenham, R.M. Covens, A. Marth, C. Raza Mirza, M. Kroep, J.R. Ma, H. Pickett, C.A. Monk, B.J. Park, S.Y. Song, Y.S. Makarova, Y. Trinidad, J. Ngan, H.Y.S. Aravantinos, G. Nam, J.-H. Gorbunova, V. Krikunova, L. Bae, D.-S. Arija, J.A.A. Mirza, M.R. Zamagni, C. Papandreou, C. Raspagliesi, F. Lisyanskaya, A. Benzaquen, A.O. Tognon, G. Ortega, E. Herraez, A.C. Buscema, J. Green, A. Burger, R. Sakaeva, D. Sanchez, A.R. Ghamande, S. King, L. Petru, E. Peen, U. Takeuchi, S. Ushijima, K. Martin, A.G. Kamelle, S. Carney, M. Forget, F. Bentley, J. Sehouli, J. Zola, P. Kato, H. Fadeeva, N. Gotovkin, E. Vladimirov, V. Marin, M.R. Alia, E.G. Shahin, M. Bhoola, S. Tewari, K. Anderson, D. Honhon, B. Pelgrims, J.G. Oza, A. Jimenez, J.G.-D. Hansen, V. Benjamin, I. Renard, V. Van den Bulck, H. Haenle, C. Koumakis, G. Yokota, H. Popov, V. Bradley, W. Wenham, R. Reid, R. McNamara, D. Friedman, R. Barlin, J. Spirtos, N. Chapman, J. Sevelda, P. Huizing, M. Lamot, C. Goffin, F. Hondt, L.D. Covens, A. Spadafora, S. Rautenberg, B. Reimer, T. Möbus, V. Hilpert, F. Gropp-Meier, M. Savarese, A. Pignata, S. Verderame, F. Mizuno, M. Takano, H. Ottevanger, P. Velasco, A.P. Palacio-Vazquez, I. Law, A. McIntyre, K. Teneriello, M. Fields, A. Lentz, S. Street, D. Schwartz, B. Mannel, R. Lim, P. Pulaski, H. Janni, W. Zorr, A. Karck, U. Cheng, A.C.K. Sorio, R. Gridelli, C. Aoki, D. Oishi, T. Hirashima, Y. Boere, I. Ferrer, E.F. Braly, P. Wilks, S. Lee, C. Schilder, J. Veljovich, D. Secord, A. Davis, K. Rojas-Espaillat, L. Lele, S. DePasquale, S. Squatrito, R. Schauer, C. Dirix, L. Vuylsteke, P. Joosens, E. Provencher, D. Lueck, H.-J. Hein, A. Burges, A. Canzler, U. Park-Simon, T.-W. Griesinger, F. Gadducci, A. Alabiso, O. Okamoto, A. Sawasaki, T. Saito, T. Ibañez, A.H. Calomeni, C. Spillman, M. Choksi, J. Taylor, N. Muller, C. Moore, D. DiSilvestro, P. Cunningham, M. Rose, P. Oppelt, P. Verhoeven, D. Graas, M.-P. Ghatage, P. Tonkin, K. Kurzeder, C. Schnappauf, B. Müller, V. Schmalzrie, H. Kalofonos, H. Bruzzone, M. Kroep, J. Diaz, C.C. Garcia, J.M. Polo, S.H. Garrison, M. Rocconi, R. Andrews, S. Bristow, R. McHale, M. Basil, J. Houck III, W. Bell, M. Cosin, J. Modesitt, S. Kendrick, J. Wade III, J. Wong, C. Evans, A. Buekers, T. Vanderkwaak, T. Ferriss, J. Darus, C. DAndre, S. Higgins, R. Monk, B. Bakkum-Gamez, J. DeMars, L. Van Le, L. Puls, L. Trehan, S. LaPolla, J. Michelson, E.D. Merchant, J. Peterson, C. Reid, G. Seago, D. Zweizig, S. Gajewski, W. Panwalkar, A. Leikermoser, R. Bogner, G. Debruyne, P. D'hondt, R. Berteloot, P. Kerger, J. Biagi, J. Castonguay, V. Welch, S. Muhic, A. Heubner, M. Grischke, E.-M. Rack, B. Fleisch, M. Lordick, F. Pectasides, D. Ho, W.M. Selvaggi, L. Vasquez, F.M. Villanueva, W.O.B. Alavez, A.M. Kessels, L. Bertran, A.S. Fernandez, C.M. Fabregat, M.B. Del Prete, S. Elkas, J. Cecchi, G. Kumar, P. Huh, W. Messing, M. Karimi, M. Kelley, A. Edraki, B. Mutch, D. Leiserowitz, G. Anderson, J. Lentz, S. Chambers, S. Morris, R. Waggoner, S. Gordon, A. Method, M. Johnson, P. Lord, R. Drake, J. Sivarajan, K. Midathada, M. Rice, K. Wadsworth, T. Pavelka, J. Edwards, R. Miller, D.S. Ford, P.L. Hurteau, J. Bender, D. Schimp, V. Creasman, W. Lerner, R. Chamberlain, D. Kueck, A. McDonald, J. Malad, S. Robinson-Bennett, B. Davidson, S. Krivak, T. Lestingi, T. Arango, H. Berard, P. Finkelstein, K. Gaur, R. Krasner, C. Ueland, F. Talmage, L. Yamada, S. Sutton, G. Potkul, R. Prasad-Hayes, M. Osborne, J. Celano, P. Thigpen, J. Sharma, S. Schilder, R. Tammela, J. Kemeny, M. Brown, A. Eisenhauer, E. Williams, J. Rowland, K. Nahum, K. Burke, J. Dar, Z. Fleming, N. Gibb, R. Guirguis, A. Herzog, T. John, V. Kumar, S. Kamat, A. Kassar, M. Leitao, M. Levine, L. Mendez, L. Patel, D. Berry, E. Warshal, D. Wolf, J. Zarwan, C. Collins, Y. Spitzer, G. Miller, B. Einstein, M. TRINOVA-3/ENGOT-ov2/GOG-3001 investigators

Abstract

Background: Angiopoietin 1 and 2 regulate angiogenesis and vascular remodelling by interacting with the tyrosine kinase receptor Tie2, and inhibition of angiogenesis has shown promise in the treatment of ovarian cancer. We aimed to assess whether trebananib, a peptibody that inhibits binding of angiopoietin 1 and 2 to Tie2, improved progression-free survival when added to carboplatin and paclitaxel as first-line therapy in advanced epithelial ovarian, primary fallopian tube, or peritoneal cancer in a phase 3 clinical trial. Methods: TRINOVA-3, a multicentre, multinational, phase 3, double-blind study, was done at 206 investigational sites (hospitals and cancer centres)in 14 countries. Eligible patients were aged 18 years or older with biopsy-confirmed International Federation of Gynecology and Obstetrics (FIGO)stage III to IV epithelial ovarian, primary peritoneal, or fallopian tube cancers, and an ECOG performance status of 0 or 1. Eligible patients were randomly assigned (2:1)using a permuted block method (block size of six patients)to receive six cycles of paclitaxel (175 mg/m2)and carboplatin (area under the serum concentration-time curve 5 or 6)every 3 weeks, plus weekly intravenous trebananib 15 mg/kg or placebo. Maintenance therapy with trebananib or placebo continued for up to 18 additional months. The primary endpoint was progression-free survival, as assessed by the investigators, in the intention-to-treat population. Safety analyses included patients who received at least one dose of study treatment. This trial is registered with ClinicalTrials.gov, number NCT01493505, and is complete. Findings: Between Jan 30, 2012, and Feb 25, 2014, 1164 patients were screened and 1015 eligible patients were randomly allocated to treatment (678 to trebananib and 337 to placebo). After a median follow-up of 27·4 months (IQR 17·7–34·2), 626 patients had progression-free survival events (405 [60%]of 678 in the trebananib group and 221 [66%]of 337 in the placebo group). Median progression-free survival did not differ between the trebananib group (15·9 months [15·0–17·6])and the placebo group (15·0 months [12·6–16·1])groups (hazard ratio 0·93 [95% CI 0·79–1·09]; p=0·36). 512 (76%)of 675 patients in the trebananib group and 237 (71%)of 336 in the placebo group had grade 3 or worse treatment-emergent adverse events; of which the most common events were neutropenia (trebananib 238 [35%]vs placebo 126 [38%])anaemia (76 [11%]vs 40 [12%]), and leucopenia (81 [12%]vs 35 [10%]). 269 (40%)patients in the trebananib group and 104 (31%)in the placebo group had serious adverse events. Two fatal adverse events in the trebananib group were considered related to trebananib, paclitaxel, and carboplatin (lung infection and neutropenic colitis); two were considered to be related to paclitaxel and carboplatin (general physical health deterioration and platelet count decreased). No treatment-related fatal adverse events occurred in the placebo group. Interpretation: Trebananib plus carboplatin and paclitaxel did not improve progression-free survival as first-line treatment for advanced ovarian cancer. The combination of trebananib plus carboplatin and paclitaxel did not produce new safety signals. These results show that trebananib in combination with carboplatin and paclitaxel is minimally effective in this patient population. Funding: Amgen. © 2019 Elsevier Ltd

Published
2019

25. Magnetically tunable optical diffraction gratings based on a ferromagnetic liquid crystal

Author

Rupp, R. A., Fleisch, M., Gao, S., Bošnjaković, Dejan, Cmok, L., Medle-Rupnik, P., Mertelj, A., Lisjak, D., Zhang, X., and Drevenšek-Olenik, I.

Subjects
Physics::Optics, Liquid crystals, micropatterned alignment, magnetically tunable optical diffractive structures
Abstract

Transmission optical diffraction gratings composed of periodic slices of a ferromagnetic liquid crystal and a conventional photoresist polymer are demonstrated. Dependence of diffraction efficiencies of various diffraction orders on an in-plane external magnetic field is investigated. It is shown that diffraction properties can be effectively tuned by magnetic fields as low as a few mT. The tuning mechanism is explained in the framework of a simple empirical model and also by numerical simulations based on the rigorous coupled wave analysis (RCWA). The obtained results provide a proof of principle of operation of magnetically tunable liquid crystalline diffractive optical elements applicable in contactless schemes for control of optical signals.

Published
2019

32. Cancers in Patients with Endometriosis

Author

Blum, S, additional, Häberle, L, additional, Tchartchian, G, additional, Schippert, C, additional, Fehm, T, additional, Hartung, CP, additional, Widschwendter, P, additional, Reicke, S, additional, Füger, T, additional, Germeyer, A, additional, Oppelt, P, additional, Lange, J, additional, Fleisch, M, additional, Renner, SP, additional, Hein, A, additional, Fasching, PA, additional, Beckmann, MW, additional, and Burghaus, S, additional

Published
2018
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34. Results of the German part of OptiBIRTH (ISRCTN10612254) : a cluster randomised trial to increase vaginal birth after one previous caesarean section

Author

Gross, Mechthild Maria, Grylka, Susanne, Bahlmann, F, Fleisch, M, Hillemanns, P, Kaisenberg, C, Koch, F, Schild, RL, Clarke, M, Begley, C, Gross, Mechthild Maria, Grylka, Susanne, Bahlmann, F, Fleisch, M, Hillemanns, P, Kaisenberg, C, Koch, F, Schild, RL, Clarke, M, and Begley, C

Abstract

Objective: The OptiBIRTH intervention was developed to enhance women-centred care for pregnant women who had had one previous caesarean section. Firstly, systematic reviews and focus group interviews with clinicians and women were carried out. Another systematic review focused on computer-based behavioural change interventions informed the design of an online component of the OptiBIRTH intervention, which was then tested in the trial to assess its impact on the VBAC rate in the German sites, as well as on interventions and events during labour. Methods: A cluster randomised trial (ISRCTN10612254) was carried out in 15 sites in three European countries (Ireland, Italy, Germany). The German part of the study was led by the Midwifery Research and Education Unit at Hannover Medical School (MiREdU). The participating sites were Buergerhospital Frankfurt, Diakovere Krankenhaus Henriettenstift Hannover, Klinikum Dritter Orden Muenchen, University hospital Wuppertal, and Hannover Medical School. The sites were randomly allocated into three intervention and two control sites. Recruitment of women took place between May 2014 and October 2015. Main international analysis was performed by Queen's University Belfast. Intranational comparisons in Germany were performed by MiREdU using descriptive statistics. Data of the baseline rate came from 2012 compared with data from 2015, which is an interim analysis pending the final comparison to 2016. Results: Overall, there was no statistically significant difference in the change in the proportion of women having a VBAC between 2012 and 2015 in the intervention sites compared to the controls. Although there were significant changes in Italy and Ireland, there were none in Germany. The 2015 VBAC rates in the German sites showed an increase compared to baseline (2012) in one intervention site (+1.0%) and in one control site (+3.2%) but decreases in the three other sites (-0.1, -6.2 and -10.1%). Regarding German OptiBIRTH participants, th

Published
2018

37. Intra-hisian 2:1 atrioventricular block secondary to Lyme disease

Author

Rey, M.-J, Zimmermann, M., Adamec, R., Fleisch, M., Viquerat, C., de Freudenreich, J., Rey, M.-J, Zimmermann, M., Adamec, R., Fleisch, M., Viquerat, C., and de Freudenreich, J.

Abstract

We describe a case of Lyme carditis with intra-hisian 2:1 atrioventricular (AV) block documented by electrophysiological study. To our knowledge, only two cases of AV block at the level of the His bundle has been described in the literature. Sinus rhythm was restored after 4 days of i.v. ceftriaxone

Published
2017

39. Quantitatively assessed coronary collateral circulation and restenosis following percutaneous revascularization

Author

Wahl, A., Billinger, M., Fleisch, M., Meier, B., Seiler, C., Wahl, A., Billinger, M., Fleisch, M., Meier, B., and Seiler, C.

Abstract

Aims A high degree of collateral supply to a vascular area where a percutaneous transluminal coronary angioplasty (PTCA) has been performed represents a haemodynamic force competing with the antegrade flow through the dilated lesion. Therefore, our purpose was to determine whether patients with restenosis following PTCA have a higher collateral flow to the recipient vessel than patients without restenosis. Methods and Results In 200 consecutive PTCA patients, an intracoronary pressure-derived collateral flow index (CFI) was determined quantitatively during balloon occlusion, using simultaneous measurements of the mean aortic pressure (Pao) and of the intracoronary pressure distal to the occluded stenosis (Poccl), as well as the estimated central venous pressure (CVP=5mmHg): CFI=(Poccl−CVP)/(Pao−CVP). Sixty-four patients had an angiographic follow-up examination after at least 2 months, and were subdivided into patients with restenosis (>50% diameter stenosis, n=34) and patients without restenosis (n=30). Patients with restenosis had a significantly higher collateral flow index at the initial coronary angiography than patients without restenosis (0·26±0·14 vs 0·12±0·09;P<0·0001). Conclusions Patients with restenosis after PTCA show a more extended collateral supply to this recipient area than patients without restenosis. Well developed collaterals to a revascularized region are a risk factor for restenosis of the treated lesion

Published
2017

42. Das internationale Endometriose Evaluations-Programm (IEEP) – eine Studie für Kliniker, Forscher und Patientinnen

Author

Brodkorb, T, primary, Fehm, T, additional, Burghaus, S, additional, Blum, S, additional, Baier, F, additional, Renner, SK, additional, Häberle, L, additional, Heusinger, K, additional, Hildebrandt, T, additional, Lermann, J, additional, Tchartchian, G, additional, Bojahr, B, additional, Porn, A, additional, Fleisch, M, additional, Reicke, S, additional, Füger, T, additional, Hartung, CP, additional, Hackl, J, additional, Fasching, PA, additional, Beckmann, MW, additional, and Renner, SP, additional

Published
2016
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43. The International Endometriosis Evaluation Program (IEEP Study) – A Systematic Study for Physicians, Researchers and Patients

Author

Burghaus, S., additional, Fehm, T., additional, Fasching, P., additional, Blum, S., additional, Renner, S., additional, Baier, F., additional, Brodkorb, T., additional, Fahlbusch, C., additional, Findeklee, S., additional, Häberle, L., additional, Heusinger, K., additional, Hildebrandt, T., additional, Lermann, J., additional, Strahl, O., additional, Tchartchian, G., additional, Bojahr, B., additional, Porn, A., additional, Fleisch, M., additional, Reicke, S., additional, Füger, T., additional, Hartung, C.-P., additional, Hackl, J., additional, and Beckmann, M., additional

Published
2016
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46. The Prevention of Positioning Injuries during Gynecologic Operations. Guideline of DGGG (S1-Level, AWMF Registry No. 015/077, February 2015)

Author

Fleisch, M., additional, Bremerich, D., additional, Schulte-Mattler, W., additional, Tannen, A., additional, Teichmann, A., additional, Bader, W., additional, Balzer, K., additional, Renner, S., additional, Römer, T., additional, Roth, S., additional, Schütz, F., additional, Thill, M., additional, Tinneberg, H., additional, and Zarras, K., additional

Published
2015
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