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2. Anti-infective vaccination strategies in patients with hematologic malignancies or solid tumors—Guideline of the Infectious Diseases Working Party (AGIHO) of the German Society for Hematology and Medical Oncology (DGHO)

Author

Rieger, C.T., Liss, B., Mellinghoff, S., Buchheidt, D., Cornely, O.A., Egerer, G., Heinz, W.J., Hentrich, M., Maschmeyer, G., Mayer, K., Sandherr, M., Silling, G., Ullmann, A., Vehreschild, M.J.G.T., von Lilienfeld-Toal, M., Wolf, H.H., and Lehners, N.

Published
2018
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26. Effect of Recombinant Zoster Vaccine on Incidence of Herpes Zoster After Autologous Stem Cell Transplantation A Randomized Clinical Trial

Author

Bastidas, A, de la Serna, J, El Idrissi, M, Oostvogels, L, Quittet, P, Lopez-Jimenez, J, Vural, F, Pohlreich, D, Zuckerman, T, Issa, NC, Gaidano, G, Lee, JJ, Abhyankar, S, Solano, C, de Oteyza, JP, Satlin, MJ, Schwartz, S, Campins, M, Rocci, A, Llamas, CV, Lee, DG, Tan, SM, Johnston, AM, Grigg, A, Boeckh, MJ, Campora, L, Lopez-Fauqued, M, Heineman, TC, Stadtmauer, EA, Sullivan, KM, Alonso, AA, Anagnostopoulos, A, Andreadis, C, Angelopoulou, M, Anttila, VJ, Aoun, M, Barista, I, Berkahn, L, Bloor, AJC, Broady, R, Brossart, P, Buadi, FK, Bulabois, CE, Cantin, G, Cellini, C, Chandrasekar, PH, Chauncey, T, Cuneo, A, Dadwal, SS, Dickinson, M, Eom, H, Sanfeliu, AE, Coll, CF, Flomenberg, PR, Gonzalez-Rodriguez, AP, Gottlieb, DJ, Grisariu, S, Guenther, A, Gutman, J, Hahn, U, Heinz, WJ, Heras, I, Ikeda, T, Jarque, I, Karthaus, M, Kerre, T, Kiani, A, Klein, AK, Kofla, G, Kryuchkova, IV, Kuo, CY, Kuruvilla, J, Kuvshinov, A, Kwak, JY, Lee, JH, Lepretre, S, Lie, AKW, Lucchesi, A, Maertens, J, Marijt, EWA, Munoz, CM, Michieli, M, Milliken, ST, Milpied, N, Coll, JM, Mossad, SB, Murphy, J, Matilla, MBN, Novak, J, Olney, HJ, Navarrete, RO, Cascon, MJP, Peniket, A, Penka, G, Piatkowska-Jakubas, B, Zarzuela, MP, Quiel, D, Rowley, SD, Sabry, W, Salmi, TM, Selleslag, DLD, Shea, TC, Silling, G, Sinisalo, UM, Sohn, SK, Staib, P, Szer, J, Theunissen, K, Topcuoglu, P, Tyurina, NG, Uvarov, M, Wahid, FSA, San Segundo, LY, Yegin, ZA, Yeh, SP, Yip, SF, Yoon, SS, Young, JAH, Zachee, P, Zaja, F, and ZOE-HSCT Study Grp Collaborators

Abstract

IMPORTANCE Herpes zoster, a frequent complication following autologous hematopoietic stem cell transplantation (HSCT), is associated with significant morbidity. A nonlive adjuvanted recombinant zoster vaccine has been developed to prevent posttransplantation zoster. OBJECTIVE To assess the efficacy and adverse event profile of the recombinant zoster vaccine in immunocompromised autologous HSCT recipients. DESIGN, SETTING, AND PARTICIPANTS Phase 3, randomized, observer-blinded study conducted in 167 centers in 28 countries between July 13, 2012, and February 1, 2017, among 1846 patients aged 18 years or older who had undergone recent autologous HSCT. INTERVENTIONS Participants were randomized to receive 2 doses of either recombinant zoster vaccine (n=922) or placebo (n=924) administered into the deltoid muscle; the first dose was given 50 to 70 days after transplantation and the second dose 1 to 2 months thereafter. MAIN OUTCOMES AND MEASURES The primary end point was occurrence of confirmed herpes zoster cases. RESULTS Among 1846 autologous HSCT recipients (mean age, 55 years; 688 [37%] women) who received 1 vaccine or placebo dose, 1735 (94%) received a second dose and 1366 (74%) completed the study. During the 21-month median follow-up, at least 1 herpes zoster episode was confirmed in 49 vaccine and 135 placebo recipients (incidence, 30 and 94 per 1000 person-years, respectively), an incidence rate ratio (IRR) of 0.32 (95% CI, 0.22-0.44; P

Published
2019

31. Healthcare burden of probable and proven invasive mucormycosis: a multi-centre cost-of-illness analysis of patients treated in tertiary care hospitals between 2003 and 2016

Author

Heimann, S. M., Vehreschild, M. J. G. T., Cornely, O. A., Heinz, W. J., Gruener, B., Silling, G., Kessel, J., Seidel, D., Vehreschild, J. J., Heimann, S. M., Vehreschild, M. J. G. T., Cornely, O. A., Heinz, W. J., Gruener, B., Silling, G., Kessel, J., Seidel, D., and Vehreschild, J. J.

Abstract

Background: Invasive mucormycosis (IM) is a rare invasive fungal infection with a high mortality rate. However, data concerning the clinical and economic burden of IM are scarce. Aim: To evaluate the direct treatment costs and additional expenditures of patients with IM. Methods: A retrospective cost-of-illness analysis of cases with IM extracted from Fungi-Scope - Global Registry for Emerging Fungal Infections, accessible through the epidemiological research platform www.ClinicalSurveys.net, was undertaken. Results of patients with IM were compared with those of matched patients with similar underlying conditions based on the German Diagnosis Related Group (G-DRG) coding. Findings: Out of 46 patients with probable/proven IM, 31 (67%) patients were male and the median age was 53 years (range 11-88 years). Forty-two patients (92%) had haematological diseases as the most common risk factor. Analysis of cost factors identified antifungal treatment due to IM as the primary cost driver [(sic)22,816, 95% confidence interval (CI) (sic)15,036-32,346], with mean overall direct treatment costs of (sic)53,261 (95% CI (sic)39,660-68,825). Compared with matched patients, patients with IM were treated in hospital for 26.5 additional days (standard deviation 31.8 days; P < 0.001), resulting in mean additional costs of (sic)32,991 (95% CI (sic)21,558-46,613; P < 0.001). Probable IM, as well as absence of chemotherapy, surgical measures due to IM, and antifungal prophylaxis were associated with lower overall costs. Nineteen patients (41.3%) died during hospitalization. Conclusion: This study demonstrates the considerable healthcare burden of IM. The choice of antifungal agent for treatment of IM had no impact on overall cost. (C) 2018 The Healthcare Infection Society. Published by Elsevier Ltd. All rights reserved.

Published
2019

36. Secondary antifungal prophylaxis: 953

Author

Cornely, O. A., Sieniawski, M., Böhme, A., Maschmeyer, G., Reichert, D., Karthaus, M., Buchheidt, D., Martino, R., Einsele, H., Silling, G., Öhler, L., Schiel, X., Ullmann, A. J., Glasmacher, A., Krüger, W., Gratwohl, A., Lövenich, H., and Fätkenheuer, G.

Published
2002

40. Anti-infective vaccination strategies in patients with hematologic malignancies or solid tumors-Guideline of the Infectious Diseases Working Party (AGIHO) of the German Society for Hematology and Medical Oncology (DGHO)

Author

Rieger, C. T., Liss, B., Mellinghoff, S., Buchheidt, D., Cornely, O. A., Egerer, G., Heinz, W. J., Hentrich, M., Maschmeyer, G., Mayer, K., Sandherr, M., Silling, G., Ullmann, A., Vehreschild, M. J. G. T., von Lilienfeld-Toal, M., Wolf, H. H., Lehners, N., Rieger, C. T., Liss, B., Mellinghoff, S., Buchheidt, D., Cornely, O. A., Egerer, G., Heinz, W. J., Hentrich, M., Maschmeyer, G., Mayer, K., Sandherr, M., Silling, G., Ullmann, A., Vehreschild, M. J. G. T., von Lilienfeld-Toal, M., Wolf, H. H., and Lehners, N.

Abstract

Infectious complications are a significant cause of morbidity and mortality in patients with malignancies specifically when receiving anticancer treatments. Prevention of infection through vaccines is an important aspect of clinical care of cancer patients. Immunocompromising effects of the underlying disease as well as of antineoplastic therapies need to be considered when devising vaccination strategies. This guideline provides clinical recommendations on vaccine use in cancer patients including autologous stem cell transplant recipients, while allogeneic stem cell transplantation is subject of a separate guideline. The document was prepared by the Infectious Diseases Working Party (AGIHO) of the German Society for Hematology and Medical Oncology (DGHO) by reviewing currently available data and applying evidence-based medicine criteria.

Published
2018

41. Randomized comparison of liposomal amphotericin B versus placebo to prevent invasive mycoses in acute lymphoblastic leukaemia

Author

Cornely, O. A., Leguay, T., Maertens, J., Vehreschild, M. J. G. T., Anagnostopoulos, A., Castagnola, C., Verga, L., Rieger, C., Kondakci, M., Harter, G., Duarte, R. F., Allione, B., Cordonnier, C., Heussel, C. P., Morrissey, C. O., Agrawal, S. G., Peter Donnelly, J., Bresnik, M., Hawkins, M. J., Garner, W., Gokbuget, N., Jarchum, G., Dictar, M., Ramirez Borga, S., Valledor, A., Knoebl, P., Greil, R., Linkesch, W., Sill, H., De Prijck, B., Sonet, A., Theunissen, K., Selleslag, D., Vargas Schwarzbold, A., Nucci, M. L. M., Lopes de Castro Lobo, C., Fogliatto, L., Bonmati, C., Turlure, P., Herbrecht, R., Thiebaut, A., Michallet, M., Egerer, G., Silling, G., Pfreundschuh, M., Hasenkamp, J., Kraemer, D. M., Topp, M., Heinz, W., Junghanss, C., Schaich, M. A., Parmentier, S., Roellig, C., Beck, H. J., Huttmann, A., Mousset, S., Duenzinger, U. N., Schwartz, S., Haerter, G., Ostermann, H., Tsirigotis, P., Matsouka, P., Angelopoulou, M. K., Karakantza, M., Spyridonidis, A., Kolomansky, A., Moses, A., Horowitz, N., Rahav, G., Aversa, F., Velardi, A., Pagano, Livio, Gentile, Giuseppe, Gobbi, M., Luppi, M., Nosari, A. M., Rambaldi, A., Candoni, A., Marbello, L., Rossi, G., Pogliani, E., Moreira, I., Nunes, A., Botelho de Sousa, A., Rubio Tejero, A. I., Vallejo, C., Vazquez, L., Besalduch Vidal, J., Gomez-Garcia de Soria, V., Jurado Chacon, M., Gonzalez Campos, J., Olavarria, E., Barba, P., de la Serna Torroba, J., Duarte, R., Heim, D., Zimmerli, S., Gerber, B., Akova, M., Bolaman, A. Z., Tabak, F., Akan, H., Senol, E., and Gilead Sciences

Subjects
0301 basic medicine, Male, Antifungal Agents, Administration, Intravenous, Adolescent, Adult, Aged, Aged, 80 and over, Amphotericin B, Chemoprevention, Double-Blind Method, Europe, Female, Humans, Invasive Fungal Infections, Middle Aged, Placebos, Precursor Cell Lymphoblastic Leukemia-Lymphoma, South America, Treatment Outcome, Young Adult, Medizin, law.invention, Randomized controlled trial, law, hemic and lymphatic diseases, Clinical endpoint, 80 and over, Pharmacology (medical), Original Research, hemic and immune systems, Chemotherapy regimen, Infectious Diseases, Tolerability, Administration, Intravenous, Inflammatory diseases Radboud Institute for Molecular Life Sciences [Radboudumc 5], Microbiology (medical), medicine.medical_specialty, 030106 microbiology, Neutropenia, Placebo, 03 medical and health sciences, Internal medicine, medicine, Pharmacology, Surrogate endpoint, business.industry, medicine.disease, Surgery, Regimen, Settore MED/15 - MALATTIE DEL SANGUE, business
Abstract

[Objectives] To prevent invasive fungal disease (IFD) in adult patients undergoing remission-induction chemotherapy for newly diagnosed acute lymphoblastic leukaemia (ALL)., [Patients and methods] In a double-blind multicentre Phase 3 study, patients received prophylactic liposomal amphotericin B (L-AMB) at 5 mg/kg intravenously or placebo twice weekly in a 2:1 random allocation during remission-induction treatment. The primary endpoint was the development of proven or probable IFD. Secondary endpoints included those focused on the safety and tolerability of prophylactic L-AMB., [Results] Three hundred and fifty-five patients from 86 centres in Europe and South America received at least one dose of L-AMB (n = 237) or placebo (n = 118). Rates of proven and probable IFD assessed independently were 7.9% (18/228) in the L-AMB group and 11.7% (13/111) in the placebo group (P = 0.24). Rates of possible IFD were 4.8% (11/228) in the L-AMB and 5.4% (6/111) in the placebo group (P = 0.82). The remission-induction phase was a median of 22 days for both groups. Overall mortality was similar between the groups: 7.2% (17/237) for L-AMB and 6.8% (8/118) for placebo (P = 1.00). Hypokalaemia and creatinine increase were significantly more frequent with L-AMB., [Conclusions] The IFD rate among adult patients undergoing remission-induction chemotherapy for newly diagnosed ALL was 11.7% in the placebo group, and was not significantly different in patients receiving L-AMB, suggesting that the L-AMB regimen studied is not effective as prophylaxis against IFD. The IFD rate appears higher than previously reported, warranting further investigation. Tolerability of L-AMB was what might be expected. Further studies are needed to determine the optimal antifungal strategy during remission-induction chemotherapy of ALL., This study was funded by Gilead Sciences, Inc. M. B., W. G. and M. J. H. are employees of Gilead Sciences. All other authors or their institutions have received compensation for study participation from Gilead Sciences International Ltd.

Published
2017

43. The Epidemiology of Invasive Aspergillosis and Resistance Patterns of Aspergillus spp. in Germany - Interim Analysis of a Multicenter Observational Study

Author

Vehreschild, MJ, Hamprecht, A, Adam, T, Bader, O, Becker, C, Bekerdijan-Ding, I, Buchheidt, D, Doelken, G, Elias, J, Haase, G, Hahn-Ast, C, Karthaus, M, Kekulé, A, Krause, S, Neumann, S, Keller, P, Kiehl, M, Rohde, H, La Rosée, P, Ruhnke, M, Schalk, E, Schafhausen, P, Schwartz, S, Silling, G, Schulz, K, Staib, P, Ullmann, A, Weber, T, Cornely, OA, Vehreschild, MJ, Hamprecht, A, Adam, T, Bader, O, Becker, C, Bekerdijan-Ding, I, Buchheidt, D, Doelken, G, Elias, J, Haase, G, Hahn-Ast, C, Karthaus, M, Kekulé, A, Krause, S, Neumann, S, Keller, P, Kiehl, M, Rohde, H, La Rosée, P, Ruhnke, M, Schalk, E, Schafhausen, P, Schwartz, S, Silling, G, Schulz, K, Staib, P, Ullmann, A, Weber, T, and Cornely, OA

Published
2014

44. Phase II Dose Escalation Study of Caspofungin for Invasive Aspergillosis

Author

Cornely, O. A., Vehreschild, J. J., Vehreschild, M. J. G. T., Wuerthwein, G., Arenz, D., Schwartz, S., Heussel, C. P., Silling, G., Mahne, M., Franklin, J., Harnischmacher, U., Wilkens, A., Farowski, F., Karthaus, M., Lehrnbecher, T., Ullmann, A. J., Hallek, M., Groll, A. H., Cornely, O. A., Vehreschild, J. J., Vehreschild, M. J. G. T., Wuerthwein, G., Arenz, D., Schwartz, S., Heussel, C. P., Silling, G., Mahne, M., Franklin, J., Harnischmacher, U., Wilkens, A., Farowski, F., Karthaus, M., Lehrnbecher, T., Ullmann, A. J., Hallek, M., and Groll, A. H.

Abstract

Our objective was to evaluate the maximum tolerated dose of caspofungin for invasive aspergillosis (IA). The safety and pharmacokinetics of escalating dosages of caspofungin were investigated in IA. Eight patients each received caspofungin 70, 100, 150, or 200 mg once a day (QD). Dose-limiting toxicity (DLT) was defined as the same non-hematological treatment-related adverse event of grade >= 4 in 2 of 8 patients or >= 3 in 4 of 8 patients in a cohort. A total of 46 patients (median age, 61 years; 21 female; 89% with hematological malignancies) received caspofungin (9, 8, 9, and 20 patients in the 70-, 100-, 150-, and 200-mg cohorts) for a median of 24.5 days. Plasma pharmacokinetics were linear across the investigated dosages and followed a two-compartment model, with weight as the covariate on clearance and sex as the covariate on central volume of distribution. Simulated peak plasma concentrations at steady state ranged from 14.2 to 40.6 mg/liter (28%), trough concentrations from 4.1 to 11.8 mg/liter (58%), and area under the concentration-time curve from 175 to 500 mg/liter/h (32%) (geometric mean, geometric coefficient of variation). Treatment was well tolerated without dose-limiting toxicity. The rate of complete or partial responses was 54.3%, and the overall mortality at 12-week follow-up was 28.3%. In first-line treatment of invasive aspergillosis, daily doses of up to 200 mg caspofungin were well tolerated and the maximum tolerated dose was not reached. Pharmacokinetics was linear. Response rates were similar to those previously reported for voriconazole and liposomal amphotericin.

Published
2011

46. Phase II Dose Escalation Study of Caspofungin for Invasive Aspergillosis

Author

Cornely, O. A., primary, Vehreschild, J. J., additional, Vehreschild, M. J. G. T., additional, Würthwein, G., additional, Arenz, D., additional, Schwartz, S., additional, Heussel, C. P., additional, Silling, G., additional, Mahne, M., additional, Franklin, J., additional, Harnischmacher, U., additional, Wilkens, A., additional, Farowski, F., additional, Karthaus, M., additional, Lehrnbecher, T., additional, Ullmann, A. J., additional, Hallek, M., additional, and Groll, A. H., additional

Published
2011
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47. Viral encephalitis after allogeneic stem cell transplantation: a rare complication with distinct characteristics of different causative agents

Author

Schmidt-Hieber, M., primary, Schwender, J., additional, Heinz, W. J., additional, Zabelina, T., additional, Kuhl, J. S., additional, Mousset, S., additional, Schuttrumpf, S., additional, Junghanss, C., additional, Silling, G., additional, Basara, N., additional, Neuburger, S., additional, Thiel, E., additional, and Blau, I. W., additional

Published
2010
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48. Forty-one recent cases of invasive zygomycosis from a global clinical registry

Author

Ruping, M. J. G. T., primary, Heinz, W. J., additional, Kindo, A. J., additional, Rickerts, V., additional, Lass-Florl, C., additional, Beisel, C., additional, Herbrecht, R., additional, Roth, Y., additional, Silling, G., additional, Ullmann, A. J., additional, Borchert, K., additional, Egerer, G., additional, Maertens, J., additional, Maschmeyer, G., additional, Simon, A., additional, Wattad, M., additional, Fischer, G., additional, Vehreschild, J. J., additional, and Cornely, O. A., additional

Published
2009
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50. Caspofungin treatment in severely ill, immunocompromised patients: a case-documentation study of 118 patients

Author

Glasmacher, A., primary, Cornely, O. A., additional, Orlopp, K., additional, Reuter, S., additional, Blaschke, S., additional, Eichel, M., additional, Silling, G., additional, Simons, B., additional, Egerer, G., additional, Siemann, M., additional, Florek, M., additional, Schnitzler, R., additional, Ebeling, P., additional, Ritter, J., additional, Reinel, H., additional, Schütt, P., additional, Fischer, H., additional, Hahn, C., additional, and Just-Nuebling, G., additional

Published
2005
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