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1. Cost-effectiveness analysis of combination antifungal therapy with voriconazole and anidulafungin versus voriconazole monotherapy for primary treatment of invasive aspergillosis in Spain

Author

Grau S, Azanza JR, Ruiz I, Vallejo C, Mensa J, Maertens J, Heinz WJ, Barrueta JA, Peral C, Mesa FJ, Barrado M, Charbonneau C, Rubio-Rodríguez D, and Rubio-Terrés C

Subjects
Anidulafungin, cost-effectiveness, galactomannan, invasive aspergillosis, voriconazole, Medicine (General), R5-920, Therapeutics. Pharmacology, RM1-950
Abstract

Santiago Grau,1 Jose Ramon Azanza,2 Isabel Ruiz,3 Carlos Vallejo,4 Josep Mensa,5 Johan Maertens,6 Werner J Heinz,7 Jon Andoni Barrueta,8 Carmen Peral,9 Francisco Jesús Mesa,8 Miguel Barrado,10 Claudie Charbonneau,11 Darío Rubio-Rodríguez,12 Carlos Rubio-Terrés12 1Pharmacy Department, Hospital del Mar, Universitat Autònoma de Barcelona, Barcelona, 2Clinical Pharmacology Department, Clínica Universidad de Navarra, Pamplona, 3Infectious Diseases Department, Hospital Universitari Vall d’Hebron, Barcelona, 4Hematology Department, Hospital Universitario Donostia, San Sebastián, 5Infectious Diseases Department, Hospital Clínic de Barcelona, Barcelona, Spain; 6Hematology Department, University Hospital Gasthuisberg, Leuven, Belgium; 7Hematology/Oncology Department, Medizinische Klinik und Poliklinik II, Universitätsklinikum, Würzburg, Germany; 8Medical Department, 9Economics and Outcomes Research Department, Pfizer S.L.U, Alcobendas, 10Clinical Trials Department, Trial Form Support, Madrid, Spain; 11Pharmacoeconomics Department, Pfizer International Operations, Paris, France; 12Pharmacoeconomics Department, Health Value, Madrid, Spain Objective: According to a recent randomized, double-blind clinical trial comparing the combination of voriconazole and anidulafungin (VOR+ANI) with VOR monotherapy for invasive aspergillosis (IA) in patients with hematologic disease or with hematopoietic stem cell transplant, mortality was lower after 6 weeks with VOR+ANI than with VOR monotherapy in a post hoc analysis of patients with galactomannan-based IA. The objective of this study was to compare the cost-effectiveness of VOR+ANI with VOR, from the perspective of hospitals in the Spanish National Health System.Methods: An economic model with deterministic and probabilistic analyses was used to determine costs per life-year gained (LYG) for VOR+ANI versus VOR in patients with galactomannan-based IA. Mortality, adverse event rates, and life expectancy were obtained from clinical trial data. The costs (in 2015 euros [€]) of the drugs and the adverse event-related costs were obtained from Spanish sources. A Tornado plot and a Monte Carlo simulation (1,000 iterations) were used to assess uncertainty of all model variables.Results: According to the deterministic analysis, for each patient treated with VOR+ANI compared with VOR monotherapy, there would be a total of 0.348 LYG (2.529 vs 2.181 years, respectively) at an incremental cost of €5,493 (€17,902 vs €12,409, respectively). Consequently, the additional cost per LYG with VOR+ANI compared with VOR would be €15,785. Deterministic sensitivity analyses confirmed the robustness of these findings. In the probabilistic analysis, the cost per LYG with VOR+ANI was €15,774 (95% confidence interval: €15,763–16,692). The probability of VOR+ANI being cost-effective compared with VOR was estimated at 82.5% and 91.9%, based on local cost-effectiveness thresholds of €30,000 and €45,000, respectively.Conclusion: According to the present economic study, combination therapy with VOR+ANI is cost-effective as primary therapy of IA in galactomannan-positive patients in Spain who have hematologic disease or hematopoietic stem cell transplant, compared with VOR monotherapy. Keywords: anidulafungin, cost-effectiveness, galactomannan, invasive aspergillosis, voriconazole

Published
2016

3. Outcomes of CMML patients undergoing allo-HCT are significantly worse compared to MDS-a study of the CMWP of the EBMT

Author

Rovó, A, Gras, L, Piepenbroek, B, Kroeger, N, Reinhardt, HC, Radujkovic, A, Blaise, D, Kobbe, G, Niityvuopio, R, Platzbecker, U, Sockel, K, Hunault-Berger, M, Cornelissen, JJ, Forcade, E, Bourhis, JH, Chalandon, Y, Kinsella, F, Nguyen-Quoc, S, Maertens, J, Elmaagacli, A, Mordini, N, Hayden, P, Raj, K, Drozd-Sokolowska, J, de Wreede, LC, Mclornan, DP, Robin, M, Yakoub-Agha, I, Onida, F, Rovó, A, Gras, L, Piepenbroek, B, Kroeger, N, Reinhardt, HC, Radujkovic, A, Blaise, D, Kobbe, G, Niityvuopio, R, Platzbecker, U, Sockel, K, Hunault-Berger, M, Cornelissen, JJ, Forcade, E, Bourhis, JH, Chalandon, Y, Kinsella, F, Nguyen-Quoc, S, Maertens, J, Elmaagacli, A, Mordini, N, Hayden, P, Raj, K, Drozd-Sokolowska, J, de Wreede, LC, Mclornan, DP, Robin, M, Yakoub-Agha, I, and Onida, F

Abstract

Although CMML since long has been separated from MDS, many studies continue to evaluate the outcomes of both diseases after hematopoietic cell transplantation (allo-HCT) together. Data evaluating outcomes of a large CMML cohort after allo-HCT compared to MDS are limited. We aim to compare outcomes of CMML to MDS patients who underwent allo-HCT between 2010 and 2018. Patients ≥18 years with CMML and MDS undergoing allo-HCT reported to the EBMT registry were analyzed. Progression to AML before allo-HCT was an exclusion criterion. Overall survival (OS), progression/relapse-free survival (PFS), relapse incidence (including progression) (REL), and non-relapse mortality (NRM) were evaluated in univariable and multivariable (MVA) Cox proportional hazard models including interaction terms between disease and confounders. In total, 10832 patients who underwent allo-HCT were included in the study, there were a total of 1466 CMML, and 9366 MDS. The median age at time of allo-HCT in CMML (median 60.5, IQR 54.3–65.2 years) was significantly higher than in the MDS cohort (median 58.8, IQR 50.2–64.5 years; p < .001). A significantly higher percentage of CMML patients were male (69.4%) compared to MDS (61.2%; p < .001). There were no clinically meaningful differences in the distribution of Karnofsky score, Sorror HCT-CI score at allo-HCT, and donor type, between the CMML and MDS patients. RIC platforms were utilized in 63.9% of CMML allo-HCT, and in 61.4% of MDS patients (p = .08). In univariable analyses, we found that OS, PFS, and REL were significantly worse in CMML when compared with MDS (all p < .0001), whereas no significant difference was observed in NRM (p = .77). In multivariable analyses, the HR comparing MDS versus CMML for OS was 0.81 (95% CI, 0.74–0.88, p < .001), PFS 0.76 (95% CI 0.70–0.82, p < .001), relapse 0.66 (95% CI 0.59–0.74, p < .001), and NRM 0.87 (95% CI 0.78–0.98, p = .02), respectively. The association between baseline variables and outco

Published
2024

4. Upper and/or Lower Respiratory Tract Infection Caused by Human Metapneumovirus After Allogeneic Hematopoietic Stem Cell Transplantation

Author

Piñana, J.L., Tridello, G., Xhaard, A., Wendel, L., Montoro, J., Vazquez, L., Heras, I., Ljungman, P., Mikulska, M., Salmenniemi, U., Perez, A., Kröger, N., Cornelissen, J, Sala, E., Martino, R., Geurten, C., Byrne, J., Maertens, J., Kerre, T., Martin, M, Pascual, M.J., Yeshurun, M., Finke, J., Groll, A.H., Shaw, P.J., Blijlevens, N.M.A., Arcese, W., Ganser, A., Suarez-Lledo, M., Alzahrani, M., Choi, G., Forcade, E., Paviglianiti, A., Solano, C., Wachowiak, J., Zuckerman, T., Bader, P., Clausen, J., Mayer, J., Schroyens, W., Metafuni, E., Knelange, N., Averbuch, D., Camara, R. de la, Piñana, J.L., Tridello, G., Xhaard, A., Wendel, L., Montoro, J., Vazquez, L., Heras, I., Ljungman, P., Mikulska, M., Salmenniemi, U., Perez, A., Kröger, N., Cornelissen, J, Sala, E., Martino, R., Geurten, C., Byrne, J., Maertens, J., Kerre, T., Martin, M, Pascual, M.J., Yeshurun, M., Finke, J., Groll, A.H., Shaw, P.J., Blijlevens, N.M.A., Arcese, W., Ganser, A., Suarez-Lledo, M., Alzahrani, M., Choi, G., Forcade, E., Paviglianiti, A., Solano, C., Wachowiak, J., Zuckerman, T., Bader, P., Clausen, J., Mayer, J., Schroyens, W., Metafuni, E., Knelange, N., Averbuch, D., and Camara, R. de la

Abstract

Contains fulltext : 304925.pdf (Publisher’s version ) (Closed access), BACKGROUND: Human metapneumovirus (hMPV) epidemiology, clinical characteristics and risk factors for poor outcome after allogeneic stem cell transplantation (allo-HCT) remain a poorly investigated area. METHODS: This retrospective multicenter cohort study examined the epidemiology, clinical characteristics, and risk factors for poor outcomes associated with human metapneumovirus (hMPV) infections in recipients of allo-HCT. RESULTS: We included 428 allo-HCT recipients who developed 438 hMPV infection episodes between January 2012 and January 2019. Most recipients were adults (93%). hMPV infections were diagnosed at a median of 373 days after allo-HCT. The infections were categorized as upper respiratory tract disease (URTD) or lower respiratory tract disease (LRTD), with 60% and 40% of cases, respectively. Patients with hMPV LRTD experienced the infection earlier in the transplant course and had higher rates of lymphopenia, neutropenia, corticosteroid use, and ribavirin therapy. Multivariate analysis identified lymphopenia and corticosteroid use (>30 mg/d) as independent risk factors for LRTD occurrence. The overall mortality at day 30 after hMPV detection was 2% for URTD, 12% for possible LRTD, and 21% for proven LRTD. Lymphopenia was the only independent risk factor associated with day 30 mortality in LRTD cases. CONCLUSIONS: These findings highlight the significance of lymphopenia and corticosteroid use in the development and severity of hMPV infections after allo-HCT, with lymphopenia being a predictor of higher mortality in LRTD cases.

Published
2024

5. Decoding the historical tale: COVID-19 impact on haematological malignancy patients—EPICOVIDEHA insights from 2020 to 2022

Author

Salmanton-Garcia, J., Marchesi, F., Farina, F., Weinbergerova, B., Itri, F., Davila-Valls, J., Martin-Perez, S., Glenthoj, A., Hersby, D. S., Gomes da Silva, M., Nunes Rodrigues, R., Lopez-Garcia, A., Cordoba, R., Bilgin, Y. M., Falces-Romero, I., El-Ashwah, S., Emarah, Z., Besson, C., Kohn, M., Van Doesum, J., Ammatuna, E., Marchetti, M., Labrador, J., Zambrotta, G. P. M., Verga, L., Jaksic, O., Nucci, M., Piukovics, K., Cabirta-Touzon, A., Jimenez, M., Arellano, E., Espigado, I., Blennow, O., Nordlander, A., Meers, S., van Praet, J., Aiello, T. F., Garcia-Vidal, C., Fracchiolla, N., Sciume, M., Seval, G. C., Zak, P., Buquicchio, C., Tascini, C., Grafe, S. K., Schonlein, M., Adzic-Vukicevic, T., Bonuomo, V., Cattaneo, C., Nizamuddin, S., Cernan, M., Plantefeve, G., Prin, R., Szotkovski, T., Collins, G. P., Dargenio, M., Petzer, V., Wolf, D., Colovic, N., Prezioso, L., Valkovic, T., Passamonti, F., Mendez, G. -A., Sili, U., Vena, A., Bavastro, M., Limongelli, A., Duarte, R. F., Ledoux, M. -P., Cvetanoski, M., Stojanoski, Z., Machado, M., Batinic, J., Magliano, G., Biernat, M. M., Pantic, N., Poulsen, C. B., Cuccaro, A., Del Principe, M. I., Kulasekararaj, A., Ormazabal-Velez, I., Busca, A., Demirkan, F., Ijaz, M., Klimko, N., Stoma, I., Khostelidi, S., Fernandez, N., Omrani, A. S., Bergantim, R., De Jonge, N., Fouquet, G., Navratil, M., Abu-Zeinah, G., Samarkos, M., Maertens, J., De Ramon, C., Guidetti, A., Magyari, F., Gonzalez-Lopez, T. J., Lahmer, T., Finizio, O., Ali, N., Pinczes, L. I., Lavilla-Rubira, E., Romano, A., Merelli, M., Delia, M., Calbacho, M., Meletiadis, J., Antic, D., Hernandez-Rivas, J. -A., Marques de Almeida, J., Al-Khabori, M., Hoenigl, M., Tisi, M. C., Khanna, N., Barac, A., Eisa, N., Di Blasi, R., Lievin, R., Miranda-Castillo, C., Bahr, N. C., Lamure, S., Papa, M. V., Yahya, A., Aujayeb, A., Novak, J., Erben, N., Fernandez-Galan, M., Ribera-Santa Susana, J. -M., Rinaldi, I., Fazzi, R., Piedimonte, M., Dulery, R., Gonzaga, Y., Soto-Silva, A., Sapienza, G., Serris, A., Drgona, Groh, A., Serrano, L., Gavriilaki, E., Tragiannidis, A., Prattes, J., Coppola, N., Otasevic, V., Mladenovic, M., Mitrovic, M., Miskovic, B., Jindra, P., Zompi, S., Sacchi, M. V., Krekeler, C., Infante, M. S., Garcia-Bordallo, D., Colak, G. M., Mayer, J., Nygaard, M., Hanakova, M., Racil, Z., Bonanni, Matteo, Koehler, P., Rahimli, L., Cornely, O. A., Pagano, Livio, Martin-Vallejo, F. J., Zdziarski, P., Zarrinfer, H., Wittig, J., Win, S., Wai-Man, V., Visek, B., Vinh, D. C., Vehreschild, M., Varricchio, G., Tsirigotis, P., Torres-Tienza, A., Tanase, A. D., Tafuri, A., Stamouli, M., Sramek, J., Soussain, C., Shirinova, A., Schubert, J., Schalk, E., Salehi, M. R., Saleh, M., Rosati, G., Roldan, E., Reizine, F., Rego, M., Regalado-Artamendi, I., Popova, M., Pinto, F., Philippe, L., Orth, H. M., Ommen, H. -B., Obr, A., Nunez-Martin-Buitrago, L., Noel, N., Neuhann, J., Nadali, G., Nacov, J. A., Munhoz Alburquerque, A. M., Mitra, M. E., Mikulska, M., Mellinghoff, S., Mechtel, B., Martin-Gonzalez, J. -A., Malak, S., Loureiro-Amigo, J., Lorenzo De La Pena, L., Liberti, G., Landau, M., Lacej, I., Kolditz, M., Kho, C. S., Khedr, R. A., Karthaus, M., Karlsson, L. K., Jimenez-Lorenzo, M. -J., Izuzquiza, M., Hoell-Neugebauer, B., Herbrecht, R., Heath, C. H., Guolo, F., Grothe, J., Giordano, A., Gerasymchuk, S., Garcia-Sanz, R., Garcia-Pouton, N., Funke, V. A. M., Fung, M., Flasshove, C., Fianchi, Luana, Essame, J., Egger, M., Drenou, B., Dragonetti, G., Desole, M., Della Pepa, R., Deau Fischer, B., De Kort, E., De Cabo, E., Danion, F., Daguindau, E., Cushion, T., Cremer, L., Criscuolo, Marianna, Cordini, G., Cingolani, Antonella, Ciceri, F., Chowdhury, F. R., Chelysheva, E., Chauchet, A., Chai, L. Y. A., Ceesay, M. M., Busch, E., Brehon, M., Borducchi, D. M. M., Booth, S., Bologna, S., Berg Venemyr, C., Bailen-Almorox, R., Antoniadou, A., Anastasopoulou, A. N., Altuntas, F., Bonanni M., Pagano L. (ORCID:0000-0001-8287-928X), Fianchi L., Criscuolo M., Cingolani A. (ORCID:0000-0002-3793-2755), Salmanton-Garcia, J., Marchesi, F., Farina, F., Weinbergerova, B., Itri, F., Davila-Valls, J., Martin-Perez, S., Glenthoj, A., Hersby, D. S., Gomes da Silva, M., Nunes Rodrigues, R., Lopez-Garcia, A., Cordoba, R., Bilgin, Y. M., Falces-Romero, I., El-Ashwah, S., Emarah, Z., Besson, C., Kohn, M., Van Doesum, J., Ammatuna, E., Marchetti, M., Labrador, J., Zambrotta, G. P. M., Verga, L., Jaksic, O., Nucci, M., Piukovics, K., Cabirta-Touzon, A., Jimenez, M., Arellano, E., Espigado, I., Blennow, O., Nordlander, A., Meers, S., van Praet, J., Aiello, T. F., Garcia-Vidal, C., Fracchiolla, N., Sciume, M., Seval, G. C., Zak, P., Buquicchio, C., Tascini, C., Grafe, S. K., Schonlein, M., Adzic-Vukicevic, T., Bonuomo, V., Cattaneo, C., Nizamuddin, S., Cernan, M., Plantefeve, G., Prin, R., Szotkovski, T., Collins, G. P., Dargenio, M., Petzer, V., Wolf, D., Colovic, N., Prezioso, L., Valkovic, T., Passamonti, F., Mendez, G. -A., Sili, U., Vena, A., Bavastro, M., Limongelli, A., Duarte, R. F., Ledoux, M. -P., Cvetanoski, M., Stojanoski, Z., Machado, M., Batinic, J., Magliano, G., Biernat, M. M., Pantic, N., Poulsen, C. B., Cuccaro, A., Del Principe, M. I., Kulasekararaj, A., Ormazabal-Velez, I., Busca, A., Demirkan, F., Ijaz, M., Klimko, N., Stoma, I., Khostelidi, S., Fernandez, N., Omrani, A. S., Bergantim, R., De Jonge, N., Fouquet, G., Navratil, M., Abu-Zeinah, G., Samarkos, M., Maertens, J., De Ramon, C., Guidetti, A., Magyari, F., Gonzalez-Lopez, T. J., Lahmer, T., Finizio, O., Ali, N., Pinczes, L. I., Lavilla-Rubira, E., Romano, A., Merelli, M., Delia, M., Calbacho, M., Meletiadis, J., Antic, D., Hernandez-Rivas, J. -A., Marques de Almeida, J., Al-Khabori, M., Hoenigl, M., Tisi, M. C., Khanna, N., Barac, A., Eisa, N., Di Blasi, R., Lievin, R., Miranda-Castillo, C., Bahr, N. C., Lamure, S., Papa, M. V., Yahya, A., Aujayeb, A., Novak, J., Erben, N., Fernandez-Galan, M., Ribera-Santa Susana, J. -M., Rinaldi, I., Fazzi, R., Piedimonte, M., Dulery, R., Gonzaga, Y., Soto-Silva, A., Sapienza, G., Serris, A., Drgona, Groh, A., Serrano, L., Gavriilaki, E., Tragiannidis, A., Prattes, J., Coppola, N., Otasevic, V., Mladenovic, M., Mitrovic, M., Miskovic, B., Jindra, P., Zompi, S., Sacchi, M. V., Krekeler, C., Infante, M. S., Garcia-Bordallo, D., Colak, G. M., Mayer, J., Nygaard, M., Hanakova, M., Racil, Z., Bonanni, Matteo, Koehler, P., Rahimli, L., Cornely, O. A., Pagano, Livio, Martin-Vallejo, F. J., Zdziarski, P., Zarrinfer, H., Wittig, J., Win, S., Wai-Man, V., Visek, B., Vinh, D. C., Vehreschild, M., Varricchio, G., Tsirigotis, P., Torres-Tienza, A., Tanase, A. D., Tafuri, A., Stamouli, M., Sramek, J., Soussain, C., Shirinova, A., Schubert, J., Schalk, E., Salehi, M. R., Saleh, M., Rosati, G., Roldan, E., Reizine, F., Rego, M., Regalado-Artamendi, I., Popova, M., Pinto, F., Philippe, L., Orth, H. M., Ommen, H. -B., Obr, A., Nunez-Martin-Buitrago, L., Noel, N., Neuhann, J., Nadali, G., Nacov, J. A., Munhoz Alburquerque, A. M., Mitra, M. E., Mikulska, M., Mellinghoff, S., Mechtel, B., Martin-Gonzalez, J. -A., Malak, S., Loureiro-Amigo, J., Lorenzo De La Pena, L., Liberti, G., Landau, M., Lacej, I., Kolditz, M., Kho, C. S., Khedr, R. A., Karthaus, M., Karlsson, L. K., Jimenez-Lorenzo, M. -J., Izuzquiza, M., Hoell-Neugebauer, B., Herbrecht, R., Heath, C. H., Guolo, F., Grothe, J., Giordano, A., Gerasymchuk, S., Garcia-Sanz, R., Garcia-Pouton, N., Funke, V. A. M., Fung, M., Flasshove, C., Fianchi, Luana, Essame, J., Egger, M., Drenou, B., Dragonetti, G., Desole, M., Della Pepa, R., Deau Fischer, B., De Kort, E., De Cabo, E., Danion, F., Daguindau, E., Cushion, T., Cremer, L., Criscuolo, Marianna, Cordini, G., Cingolani, Antonella, Ciceri, F., Chowdhury, F. R., Chelysheva, E., Chauchet, A., Chai, L. Y. A., Ceesay, M. M., Busch, E., Brehon, M., Borducchi, D. M. M., Booth, S., Bologna, S., Berg Venemyr, C., Bailen-Almorox, R., Antoniadou, A., Anastasopoulou, A. N., Altuntas, F., Bonanni M., Pagano L. (ORCID:0000-0001-8287-928X), Fianchi L., Criscuolo M., and Cingolani A. (ORCID:0000-0002-3793-2755)

Abstract

Background: The COVID-19 pandemic heightened risks for individuals with hematological malignancies due to compromised immune systems, leading to more severe outcomes and increased mortality. While interventions like vaccines, targeted antivirals, and monoclonal antibodies have been effective for the general population, their benefits for these patients may not be as pronounced. Methods: The EPICOVIDEHA registry (National Clinical Trials Identifier, NCT04733729) gathers COVID-19 data from hematological malignancy patients since the pandemic's start worldwide. It spans various global locations, allowing comprehensive analysis over the first three years (2020–2022). Findings: The EPICOVIDEHA registry collected data from January 2020 to December 2022, involving 8767 COVID-19 cases in hematological malignancy patients from 152 centers across 41 countries, with 42% being female. Over this period, there was a significant reduction in critical infections and an overall decrease in mortality from 29% to 4%. However, hospitalization, particularly in the ICU, remained associated with higher mortality rates. Factors contributing to increased mortality included age, multiple comorbidities, active malignancy at COVID-19 onset, pulmonary symptoms, and hospitalization. On the positive side, vaccination with one to two doses or three or more doses, as well as encountering COVID-19 in 2022, were associated with improved survival. Interpretation: Patients with hematological malignancies still face elevated risks, despite reductions in critical infections and overall mortality rates over time. Hospitalization, especially in ICUs, remains a significant concern. The study underscores the importance of vaccination and the timing of COVID-19 exposure in 2022 for enhanced survival in this patient group. Ongoing monitoring and targeted interventions are essential to support this vulnerable population, emphasizing the critical role of timely diagnosis and prompt treatment in preventing severe

Published
2024

6. Impact of post-transplant cyclophosphamide (PTCy)-based prophylaxis in matched sibling donor allogeneic haematopoietic cell transplantation for patients with myelodysplastic syndrome: a retrospective study on behalf of the Chronic Malignancies Working Party of the EBMT

Author

Salas, M. Q., Eikema, D. -J., Koster, L., Maertens, J., Passweg, J., Finke, J., Broers, A. E. C., Koc, Y., Kroger, N., Ozkurt, Z. N., Pascual-Cascon, M. J., Platzbecker, U., Van Gorkom, G., Schroeder, T., Lopez-Lorenzo, J. L., Martino, Michelangelo, Chiusolo, Patrizia, Kaufmann, M., Onida, F., Gurnari, C., Scheid, C., Drozd-Sokolowska, J., Raj, K., Robin, M., Mclornan, D. P., Martino M., Chiusolo P. (ORCID:0000-0002-1355-1587), Salas, M. Q., Eikema, D. -J., Koster, L., Maertens, J., Passweg, J., Finke, J., Broers, A. E. C., Koc, Y., Kroger, N., Ozkurt, Z. N., Pascual-Cascon, M. J., Platzbecker, U., Van Gorkom, G., Schroeder, T., Lopez-Lorenzo, J. L., Martino, Michelangelo, Chiusolo, Patrizia, Kaufmann, M., Onida, F., Gurnari, C., Scheid, C., Drozd-Sokolowska, J., Raj, K., Robin, M., Mclornan, D. P., Martino M., and Chiusolo P. (ORCID:0000-0002-1355-1587)

Abstract

We retrospectively compared outcomes of 404 MDS patients undergoing 1st matched sibling donor allo-HCT receiving either PTCy-based (n = 66) or other “conventional prophylaxis” (n = 338; mostly calcineurin inhibitor + methotrexate or MMF). Baseline characteristics were balanced, except for higher use of myeloablative regimens in the PTCy group (52.3% vs. 38.2%, p = 0.047). Incidences of neutrophil (Day +28: 89% vs. 97%, p = 0.011) and platelet (Day +100: 89% vs. 97%, p < 0.001) engraftment were lower for PTCy-based. Day +100 cumulative incidences of grade II–IV and III–IV aGVHD, and 5-year CI of extensive cGVHD were 32%, 18% and 18% for PTCy-based and 25% (p = 0.3), 13% (p = 0.4) and 31% (p = 0.09) for the conventional cohort. Five-year OS (51% vs. 52%, p = 0.6) and GRFS (33% vs. 25%, p = 0.6) were similar between groups. Patients receiving PTCy had a trend to a lower cumulative incidence of relapse (20% vs. 33%, p = 0.06), not confirmed on multivariable analysis (p = 0.3). Although higher NRM rates were observed in patients receiving PTCy (32% vs. 21%, p = 0.02) on univariate analysis, this was not confirmed on multivariate analysis (HR 1.46, p = 0.18), and there was no resultant effect on OS (HR 1.20, p = 0.5). Based on these data, PTCy prophylaxis appears to be an attractive option for patients with MDS undergoing MSD allo-HCT.

Published
2024

7. The mortality of COVID-19 in CML patients from 2020 until 2022: results from the EPICOVIDEHA survey

Author

El-Ashwah, S., Salmanton-Garcia, J., Bilgin, Y. M., Itri, F., Zak, P., Weinbergerova, B., Verga, L., Omrani, A. S., Silva, M. G. D., Szotkowski, T., Marchetti, M., Buquicchio, C., Nucci, M., Schonlein, M., Farina, F., Besson, C., Prezioso, L., Nizamuddin, S., Davila-Valls, J., Martin-Perez, S., Bonuomo, V., Van Doesum, J., Tisi, M. C., Passamonti, F., Mendez, G. -A., Meers, S., Maertens, J., Lopez-Garcia, A., Glenthoj, A., Bonnani, M., Rinaldi, I., Ormazabal-Velez, I., Labrador, J., Kulasekararaj, A., Espigado, I., Demirkan, F., De Jonge, N., Collins, G. P., Calbacho, M., Blennow, O., Al-Khabori, M., Adzic-Vukicevic, T., Arellano, E., Miskovic, B., Mladenovic, M., Nordlander, A., Racil, Z., Ammatuna, E., Cordoba, R., Hersby, D. S., Grafe, S., Emarah, Z., Hanakova, M., Sacchi, M. V., Ijaz, M., Rahimli, L., Nunes Rodrigues, R., Zambrotta, G. P. M., Marchesi, F., Cornely, O. A., Pagano, Livio, Pagano L. (ORCID:0000-0001-8287-928X), El-Ashwah, S., Salmanton-Garcia, J., Bilgin, Y. M., Itri, F., Zak, P., Weinbergerova, B., Verga, L., Omrani, A. S., Silva, M. G. D., Szotkowski, T., Marchetti, M., Buquicchio, C., Nucci, M., Schonlein, M., Farina, F., Besson, C., Prezioso, L., Nizamuddin, S., Davila-Valls, J., Martin-Perez, S., Bonuomo, V., Van Doesum, J., Tisi, M. C., Passamonti, F., Mendez, G. -A., Meers, S., Maertens, J., Lopez-Garcia, A., Glenthoj, A., Bonnani, M., Rinaldi, I., Ormazabal-Velez, I., Labrador, J., Kulasekararaj, A., Espigado, I., Demirkan, F., De Jonge, N., Collins, G. P., Calbacho, M., Blennow, O., Al-Khabori, M., Adzic-Vukicevic, T., Arellano, E., Miskovic, B., Mladenovic, M., Nordlander, A., Racil, Z., Ammatuna, E., Cordoba, R., Hersby, D. S., Grafe, S., Emarah, Z., Hanakova, M., Sacchi, M. V., Ijaz, M., Rahimli, L., Nunes Rodrigues, R., Zambrotta, G. P. M., Marchesi, F., Cornely, O. A., Pagano, Livio, and Pagano L. (ORCID:0000-0001-8287-928X)

Abstract

Since the beginning of the COVID-19 pandemic, there has been an overall improvement in patient mortality. However, haematological malignancy patients continue to experience significant impacts from COVID-19, including high rates of hospitalization, intensive care unit (ICU) admissions, and mortality. In comparison to other haematological malignancy patients, individuals with chronic myeloid leukemia (CML) generally have better prognosis. This study, conducted using a large haematological malignancy patient database (EPICOVIDEHA), demonstrated that the majority of CML patients experienced mild infections. The decline in severe and critical infections over the years can largely be attributed to the widespread administration of vaccinations and the positive response they elicited. Notably, the mortality rate among CML patients was low and exhibited a downward trend in subsequent years. Importantly, our analysis provided confirmation of the effectiveness of vaccinations in CML patients.

Published
2024

9. Outcome in patients with diffuse large B-cell lymphoma who relapse after autologous stem cell transplantation and receive active therapy. A retrospective analysis of the Lymphoma Working Party of the European Society for Blood and Marrow Transplantation (EBMT)

Author

González-Barca, E., Boumendil, A., Blaise, D., Trněný, M., Masszi, T., Finel, H., Michieli, M. G., Bittenbring, J. T., Gritti, G., Snowden, J. A., Bishton, M., Bruno, B., de Villambrosia, S. González, Janikova, A., Leleu, X., Anagnostopoulos, A., Poiré, X., Crysandt, M., Özkurt, Z. N., Vandenberghe, E., Itälä-Remes, M., Cahn, J. Y., Jantunen, E., Schroyens, W., Maertens, J., Esquirol, A., Dreger, P., Montoto, S., and Sureda, A.

Published
2020
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14. Diagnosis and management of Aspergillus diseases: executive summary of the 2017 ESCMID-ECMM-ERS guideline

Author

Ullmann, A.J., Aguado, J.M., Arikan-Akdagli, S., Denning, D.W., Groll, A.H., Lagrou, K., Lass-Flörl, C., Lewis, R.E., Munoz, P., Verweij, P.E., Warris, A., Ader, F., Akova, M., Arendrup, M.C., Barnes, R.A., Beigelman-Aubry, C., Blot, S., Bouza, E., Brüggemann, R.J.M., Buchheidt, D., Cadranel, J., Castagnola, E., Chakrabarti, A., Cuenca-Estrella, M., Dimopoulos, G., Fortun, J., Gangneux, J.-P., Garbino, J., Heinz, W.J., Herbrecht, R., Heussel, C.P., Kibbler, C.C., Klimko, N., Kullberg, B.J., Lange, C., Lehrnbecher, T., Löffler, J., Lortholary, O., Maertens, J., Marchetti, O., Meis, J.F., Pagano, L., Ribaud, P., Richardson, M., Roilides, E., Ruhnke, M., Sanguinetti, M., Sheppard, D.C., Sinkó, J., Skiada, A., Vehreschild, M.J.G.T., Viscoli, C., and Cornely, O.A.

Published
2018
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16. Liposomal amphotericin B—the present

Author

Maertens, J., Pagano, Livio, Azoulay, E., and Warris, A.

Subjects
Azoles, Microbiology (medical), Antifungal Agents, Neutropenia, INFECTIOUS-DISEASES SOCIETY, Microbiology, PERSISTENT FEVER, Echinocandins, Amphotericin B, Humans, Pharmacology (medical), Pharmacology & Pharmacy, EMPIRICAL ANTIFUNGAL THERAPY, Pharmacology, Science & Technology, PEDIATRIC-PATIENTS, ESCMID-ASTERISK GUIDELINE, INTRAABDOMINAL CANDIDIASIS, SEPTIC SHOCK, POPULATION PHARMACOKINETICS, INVASIVE FUNGAL DISEASES, Settore MED/15 - MALATTIE DEL SANGUE, Infectious Diseases, Infection, Life Sciences & Biomedicine, CRITICALLY-ILL PATIENTS, Invasive Fungal Infections
Abstract

Most invasive fungal infections are opportunistic in nature but the epidemiology is constantly changing, with new risk groups being identified. Neutropenia is a classical risk factor for fungal infections, while critically ill patients in the ICU are now increasingly at risk of yeast and mould infections. Factors to be considered when choosing antifungal treatment include the emergence of rarer fungal pathogens, the risk of resistance to azoles and echinocandins and the possibility of drug-drug interactions. Liposomal amphotericin B has retained its place in the therapeutic armamentarium based on its clinical profile: a broad spectrum of antifungal activity with a low risk of resistance, predictable pharmacokinetics with a rapid accumulation at the infection site (including biofilms), a low potential for drug-drug interactions and a low risk of acute and chronic treatment-limiting toxicities versus other formulations of amphotericin B. It is a suitable choice for the first-line empirical or pre-emptive treatment of suspected fungal infections in neutropenic haematology patients and is an excellent alternative for patients with documented fungal disease who can no longer tolerate or continue their first-line azole or echinocandin therapy, both in the haematology setting and in the ICU. Moreover, it is the first-line drug of choice for the treatment of invasive mucormycosis. Finally, liposomal amphotericin B is one of the few antifungal agents approved for use in children of all ages over 1 month and is included in paediatric-specific guidelines for the management of fungal disease. ispartof: JOURNAL OF ANTIMICROBIAL CHEMOTHERAPY vol:77 issue:Suppl_2 pages:11-20 ispartof: location:England status: published

Published
2022

19. Investigation Of The Gut Microbiota Composition And Activity In Acute Myeloid Leukemic Patients: First Results Of The Microaml Study

Author

Pötgens, S.A., primary, Bindels, F., additional, Havelange, V., additional, Li, F., additional, Lecop, S., additional, Neyrinck, A.M., additional, Neveux, N., additional, Demoulin, J.-B., additional, Moors, I., additional, Kerre, T., additional, Maertens, J., additional, Walter, J., additional, Schoemans, H., additional, Delzenne, N.M., additional, and Bindels, L.B., additional

Published
2023
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20. Outcome of COVID-19 in allogeneic stem cell transplant recipients: Results from the EPICOVIDEHA registry.

Author

Busca, A., Salmanton-García, J., Marchesi, F., Farina, F., Seval, G.C., Doesum, J. Van, Jonge, N. de, Bahr, N.C., Maertens, J., Meletiadis, J., Fracchiolla, N.S., Weinbergerová, B., Verga, L., Ráčil, Z., Jiménez, M., Glenthøj, A., Blennow, O., Tanase, A.D., Schönlein, M., Prezioso, L., Khanna, N., Duarte, R.F., Žák, P., Nucci, M., Machado, M., Kulasekararaj, A., Espigado, I., Kort, E.A. de, Ribera-Santa Susana, J.M., Marchetti, M., Magliano, G., Falces-Romero, I., Ilhan, O., Ammatuna, E., Zompi, S., Tsirigotis, P., Antoniadou, A., Zambrotta, G.P.M., Nordlander, A., Karlsson, L.K., Hanakova, M., Dragonetti, G., Cabirta, A., Berg Venemyr, C., Gräfe, S., Praet, J. Van, Tragiannidis, A., Petzer, V., López-García, A., Itri, F., Groh, A., Gavriilaki, E., Dargenio, M., Rahimli, L., Cornely, O.A., Pagano, L., Busca, A., Salmanton-García, J., Marchesi, F., Farina, F., Seval, G.C., Doesum, J. Van, Jonge, N. de, Bahr, N.C., Maertens, J., Meletiadis, J., Fracchiolla, N.S., Weinbergerová, B., Verga, L., Ráčil, Z., Jiménez, M., Glenthøj, A., Blennow, O., Tanase, A.D., Schönlein, M., Prezioso, L., Khanna, N., Duarte, R.F., Žák, P., Nucci, M., Machado, M., Kulasekararaj, A., Espigado, I., Kort, E.A. de, Ribera-Santa Susana, J.M., Marchetti, M., Magliano, G., Falces-Romero, I., Ilhan, O., Ammatuna, E., Zompi, S., Tsirigotis, P., Antoniadou, A., Zambrotta, G.P.M., Nordlander, A., Karlsson, L.K., Hanakova, M., Dragonetti, G., Cabirta, A., Berg Venemyr, C., Gräfe, S., Praet, J. Van, Tragiannidis, A., Petzer, V., López-García, A., Itri, F., Groh, A., Gavriilaki, E., Dargenio, M., Rahimli, L., Cornely, O.A., and Pagano, L.

Abstract

Item does not contain fulltext, BACKGROUND: The outcome of COVID-19 in allogeneic hematopoietic stem cell transplantation (HSCT) recipients is almost uniformely considered poor. The aim of present study was to retrospectively analyse the outcome and risk factors for mortality in a large series of patients who developed COVID-19 infection after an allogeneic HSCT. METHODS: This multicenter retrospective study promoted by the European Hematology Association - Infections in Hematology Study Working Group, included 326 adult HSCT patients who had COVID-19 between January 2020 and March 2022. RESULTS: The median time from HSCT to the diagnosis of COVID-19 was 268 days (IQR 86-713; range 0-185 days). COVID-19 severity was mild in 21% of the patients, severe in 39% and critical in 16% of the patients. In multivariable analysis factors associated with a higher risk of mortality were, age above 50 years, presence of 3 or more comorbidities, active hematologic disease at time of COVID-19 infection, development of COVID-19 within 12 months of HSCT, and severe/critical infections. Overall mortality rate was 21% (n=68): COVID-19 was the main or secondary cause of death in 16% of the patients (n=53). CONCLUSIONS: Mortality in HSCT recipients who develop COVID-19 is high and largely dependent on age, comorbidities, active hematologic disease, timing from transplant and severity of the infection.

Published
2023

21. Empiric vs Preemptive Antifungal Strategy in High-Risk Neutropenic Patients on Fluconazole Prophylaxis: A Randomized Trial of the European Organization for Research and Treatment of Cancer.

Author

Maertens, J., Lodewyck, T., Donnelly, J.P., Chantepie, S., Robin, C., Blijlevens, N.M., Turlure, P., Selleslag, D., Baron, F., Aoun, M., Heinz, W.J., Bertz, H., Ráčil, Z., Vandercam, B., Drgona, L., Coiteux, V., Llorente, C.C., Schaefer-Prokop, C.M., Paesmans, M., Ameye, L., Meert, L., Cheung, K.J., Hepler, D.A., Loeffler, J., Barnes, R., Marchetti, O., Verweij, P.E., Lamoth, F., Bochud, P.Y., Schwarzinger, M., Cordonnier, C., Maertens, J., Lodewyck, T., Donnelly, J.P., Chantepie, S., Robin, C., Blijlevens, N.M., Turlure, P., Selleslag, D., Baron, F., Aoun, M., Heinz, W.J., Bertz, H., Ráčil, Z., Vandercam, B., Drgona, L., Coiteux, V., Llorente, C.C., Schaefer-Prokop, C.M., Paesmans, M., Ameye, L., Meert, L., Cheung, K.J., Hepler, D.A., Loeffler, J., Barnes, R., Marchetti, O., Verweij, P.E., Lamoth, F., Bochud, P.Y., Schwarzinger, M., and Cordonnier, C.

Abstract

Item does not contain fulltext, BACKGROUND: Empiric antifungal therapy is considered the standard of care for high-risk neutropenic patients with persistent fever. The impact of a preemptive, diagnostic-driven approach based on galactomannan screening and chest computed tomography scan on demand on survival and on the risk of invasive fungal disease (IFD) during the first weeks of high-risk neutropenia is unknown. METHODS: Patients with acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) and allogeneic hematopoietic cell transplant recipients were randomly assigned to receive caspofungin empirically (arm A) or preemptively (arm B), while receiving fluconazole 400 mg daily prophylactically. The primary end point of this noninferiority study was overall survival (OS) 42 days after randomization. RESULTS: Of 556 patients recruited, 549 were eligible: 275 in arm A and 274 in arm B. Eighty percent of the patients had AML or MDS requiring high-dose chemotherapy, and 93% of them were in the first induction phase. At day 42, the OS was not inferior in arm B (96.7%; 95% confidence interval [CI], 93.8%-98.3%) when compared with arm A (93.1%; 95% CI, 89.3%-95.5%). The rates of IFDs at day 84 were not significantly different, 7.7% (95% CI, 4.5%-10.8%) in arm B vs 6.6% (95% CI, 3.6%-9.5%) in arm A. The rate of patients who received caspofungin was significantly lower in arm B (27%) than in arm A (63%; P < .001). CONCLUSIONS: The preemptive antifungal strategy was safe for high-risk neutropenic patients given fluconazole as prophylaxis, halving the number of patients receiving antifungals without excess mortality or IFDs. Clinical Trials Registration. NCT01288378; EudraCT 2010-020814-27.

Published
2023

22. Clinical Impact of Polymerase Chain Reaction-Based Aspergillus and Azole Resistance Detection in Invasive Aspergillosis: A Prospective Multicenter Study

Author

Huygens, S., Dunbar, A., Buil, J.B., Klaassen, C.H.W., Verweij, P.E., Dijk, K van, Jonge, N. de, Janssen, J, Velden, W.J.F.M. van der, Biemond, B.J., Bart, A., Bruns, A.H.W., Haas, P.A., Demandt, A.M.P., Oudhuis, G., Borne, P. von dem, Beek, M.T. van der, Klein, S.K., Godschalk, P., Span, L.F.R., Postma, D.F., Kampinga, G.A., Maertens, J., Lagrou, K., Mercier, T., Moors, I., Boelens, J. Jan, Selleslag, D., Reynders, M., Zandijk, W., Doorduijn, J.K., Cornelissen, J.J., Schauwvlieghe, A., Rijnders, B.J.A., Huygens, S., Dunbar, A., Buil, J.B., Klaassen, C.H.W., Verweij, P.E., Dijk, K van, Jonge, N. de, Janssen, J, Velden, W.J.F.M. van der, Biemond, B.J., Bart, A., Bruns, A.H.W., Haas, P.A., Demandt, A.M.P., Oudhuis, G., Borne, P. von dem, Beek, M.T. van der, Klein, S.K., Godschalk, P., Span, L.F.R., Postma, D.F., Kampinga, G.A., Maertens, J., Lagrou, K., Mercier, T., Moors, I., Boelens, J. Jan, Selleslag, D., Reynders, M., Zandijk, W., Doorduijn, J.K., Cornelissen, J.J., Schauwvlieghe, A., and Rijnders, B.J.A.

Abstract

Item does not contain fulltext, BACKGROUND: Invasive aspergillosis (IA) by a triazole-resistant Aspergillus fumigatus is associated with high mortality. Real-time resistance detection will result in earlier initiation of appropriate therapy. METHODS: In a prospective study, we evaluated the clinical value of the AsperGenius polymerase chain reaction (PCR) assay in hematology patients from 12 centers. This PCR assay detects the most frequent cyp51A mutations in A. fumigatus conferring azole resistance. Patients were included when a computed tomography scan showed a pulmonary infiltrate and bronchoalveolar fluid (BALf) sampling was performed. The primary end point was antifungal treatment failure in patients with azole-resistant IA. RESULTS: Of 323 patients enrolled, complete mycological and radiological information was available for 276 (94%), and probable IA was diagnosed in 99/276 (36%). Sufficient BALf for PCR testing was available for 293/323 (91%). Aspergillus DNA was detected in 116/293 (40%) and A. fumigatus DNA in 89/293 (30%). The resistance PCR was conclusive in 58/89 (65%) and resistance detected in 8/58 (14%). Two had a mixed azole-susceptible/azole-resistant infection. In the 6 remaining patients, treatment failure was observed in 1. Galactomannan positivity was associated with mortality (P = .004) while an isolated positive Aspergillus PCR was not (P = .83). CONCLUSIONS: Real-time PCR-based resistance testing may help to limit the clinical impact of triazole resistance. In contrast, the clinical impact of an isolated positive Aspergillus PCR on BALf seems limited. The interpretation of the EORTC/MSGERC PCR criterion for BALf may need further specification (eg, minimum cycle threshold value and/or PCR positive on >1 BALf sample).

Published
2023

23. Etoposide plus cytarabine versus cyclophosphamide or melphalan in busulfan-based preparative regimens for autologous stem cell transplantation in adults with acute myeloid leukemia in first complete remission: a study from the Acute Leukemia Working Party of the EBMT.

Author

Sanz, J., Labopin, M., Pabst, T., Versluis, J., Gorkom, G. van, Meijer, E., Gedde-Dahl, T., Montoro, J., Arcese, W., Pérez-Simón, J.A., Schaap, N.P.M., Maertens, J., Vrhovac, R., Lanza, F., Gorin, N.C., Mohty, M., Ciceri, F., Sanz, J., Labopin, M., Pabst, T., Versluis, J., Gorkom, G. van, Meijer, E., Gedde-Dahl, T., Montoro, J., Arcese, W., Pérez-Simón, J.A., Schaap, N.P.M., Maertens, J., Vrhovac, R., Lanza, F., Gorin, N.C., Mohty, M., and Ciceri, F.

Abstract

Contains fulltext : 299983.pdf (Publisher’s version ) (Closed access), We retrospectively compared the impact of the conditioning regimen in adult patients with acute myeloid leukemia (AML) in first complete remission (CR1) that received high-dose myeloablative chemotherapy followed by autologous stem cell transplantation (ASCT) from 2010 to 2021 with either high-dose cytarabine, etoposide and busulfan (BEA), busulfan with cyclophosphamide (BUCY) or busulfan and high-dose melphalan (BUMEL) registered in the EBMT database. Overall 1560 patients underwent ASCT, of which 156, 1143 and 261 received BEA, BUCY and BUMEL, respectively. Compared to BUCY and BUMEL, BEA patients were younger (p < 0.001) and less frequently had NPM1 mutations (p = 0.03). Transplant outcomes at 5 years with BEA, BUCY and BUMEL were: cumulative incidence of relapse 41.8%, 46.6% and 51.6%; non-relapse mortality (NRM) 1.5%, 5.2% and 7.3%; probability of leukemia-free survival (LFS) 56.7%, 48.2% and 41.1%; and overall survival (OS) 71.3%, 62.3% and 56%, respectively. In multivariable analysis the BEA regimen showed significant improvement in OS compared to BUCY (hazard ratio [HR] 0.65; 95% CI, 0.42-0.83; p = 0.048) and BUMEL (HR 0.59; 95% CI, 0.37-0.94; p = 0.029). In conclusion, high-dose myeloablative combination chemotherapy with BEA offered improved outcomes compared to classical BUCY or BUMEL in patients with AML in CR1 undergoing ASCT., 01 november 2023

Published
2023

24. Defibrotide plus best standard of care compared with best standard of care alone for the prevention of sinusoidal obstruction syndrome (HARMONY): a randomised, multicentre, phase 3 trial

Author

Grupp, S. A., Corbacioglu, S., Kang, H. J., Teshima, T., Khaw, S. L., Locatelli, Franco, Maertens, J., Stelljes, M., Stepensky, P., Lopez, P., Amber, V., Pagliuca, A., Richardson, P. G., Mohty, M., Locatelli F. (ORCID:0000-0002-7976-3654), Grupp, S. A., Corbacioglu, S., Kang, H. J., Teshima, T., Khaw, S. L., Locatelli, Franco, Maertens, J., Stelljes, M., Stepensky, P., Lopez, P., Amber, V., Pagliuca, A., Richardson, P. G., Mohty, M., and Locatelli F. (ORCID:0000-0002-7976-3654)

Abstract

Background: Sinusoidal obstruction syndrome, also known as veno-occlusive disease, is a potentially life-threatening complication of haematopoietic stem-cell transplantation (HSCT). We aimed to compare defibrotide prophylaxis plus best supportive care versus best supportive care alone for sinusoidal obstruction syndrome prevention after HSCT. Methods: This open-label, randomised, multicentre, phase 3 trial was done in 104 centres in 14 countries. Patients who were at least 1 month old, were scheduled to receive allogeneic HSCT (adult [aged >16 years] or paediatric [aged >1 month to ≤16 years] patients) or autologous HSCT (paediatric patients only), and were at high risk or very high risk of developing sinusoidal obstruction syndrome were eligible for inclusion. Patients were randomly assigned (1:1) by an interactive web response system to receive intravenous defibrotide 25 mg/kg per day (four equal doses [6·25 mg/kg per dose]) and best supportive care (determined by individual institutional guidelines; defibrotide prophylaxis group) or best supportive care only (best supportive care group). Randomisation was stratified by sinusoidal obstruction syndrome risk, age, and country. The primary endpoint, sinusoidal obstruction syndrome-free survival at day 30 after HSCT, was assessed by an independent Endpoint Adjudication Committee in the intention-to-treat (ITT) population. Safety was assessed in all patients who received protocol treatment. The trial is registered with ClinicalTrials.gov, NCT02851407. Findings: Between Jan 11, 2017, and Oct 20, 2020, 372 patients (172 [46%] women and 200 [54%] men; median age 14·0 years [IQR 4·0–41·0] were randomly assigned to the defibrotide prophylaxis group (n=190) or best supportive care group (n=182; ITT population). On the basis of recommendations from the Independent Data Monitoring Committee following completion of the planned interim analysis in the first 280 recruited patients on April 29, 2020, enrolment was prematurel

Published
2023

25. Update of recommendations for the management of COVID-19 in patients with haematological malignancies, haematopoietic cell transplantation and CAR T therapy, from the 2022 European Conference on Infections in Leukaemia (ECIL 9)

Author

Cesaro, S., Mikulska, M., Hirsch, H. H., Styczynski, J., Meylan, S., Cordonnier, C., Navarro, D., von Lilienfeld-Toal, M., Mehra, V., Marchesi, F., Besson, C., Masculano, R. C., Beutel, G., Einsele, H., Maertens, J., de la Camara, R., Ljungman, P., Pagano, Livio, Pagano L. (ORCID:0000-0001-8287-928X), Cesaro, S., Mikulska, M., Hirsch, H. H., Styczynski, J., Meylan, S., Cordonnier, C., Navarro, D., von Lilienfeld-Toal, M., Mehra, V., Marchesi, F., Besson, C., Masculano, R. C., Beutel, G., Einsele, H., Maertens, J., de la Camara, R., Ljungman, P., Pagano, Livio, and Pagano L. (ORCID:0000-0001-8287-928X)

Abstract

N/A

Published
2023

26. Impact of SARS-CoV-2 vaccination and monoclonal antibodies on outcome post–CD19-directed CAR T-cell therapy: an EPICOVIDEHA survey

Author

van Doesum, J. A., Salmanton-Garcia, J., Marchesi, F., Blasi, R. D., Falces-Romero, I., Cabirta, A., Farina, F., Besson, C., Weinbergerova, B., Van Praet, J., Schonlein, M., Lopez-Garcia, A., Lamure, S., Guidetti, A., De Ramon-Sanchez, C., Batinic, J., Gavriilaki, E., Tragiannidis, A., Tisi, M. C., Plantefeve, G., Petzer, V., Ormazabal-Velez, I., Almeida, J. M. D., Marchetti, M., Maertens, J., Machado, M., Kulasekararaj, A., Hernandez-Rivas, J. -A., Silva, M. G. D., Fernandez, N., Espigado, I., Drgona, L., Dragonetti, Giulia, Metafuni, Elisabetta, Calbacho, M., Blennow, O., Wolf, D., van Anrooij, B., Rodrigues, R. N., Nordlander, A., Martin-Gonzalez, J. -A., Lievin, R., Jimenez, M., Grafe, S. K., Garcia-Sanz, R., Cordoba, R., Rahimli, L., van Meerten, T., Cornely, O. A., Pagano, Livio, Dragonetti G., Metafuni E., Pagano L. (ORCID:0000-0001-8287-928X), van Doesum, J. A., Salmanton-Garcia, J., Marchesi, F., Blasi, R. D., Falces-Romero, I., Cabirta, A., Farina, F., Besson, C., Weinbergerova, B., Van Praet, J., Schonlein, M., Lopez-Garcia, A., Lamure, S., Guidetti, A., De Ramon-Sanchez, C., Batinic, J., Gavriilaki, E., Tragiannidis, A., Tisi, M. C., Plantefeve, G., Petzer, V., Ormazabal-Velez, I., Almeida, J. M. D., Marchetti, M., Maertens, J., Machado, M., Kulasekararaj, A., Hernandez-Rivas, J. -A., Silva, M. G. D., Fernandez, N., Espigado, I., Drgona, L., Dragonetti, Giulia, Metafuni, Elisabetta, Calbacho, M., Blennow, O., Wolf, D., van Anrooij, B., Rodrigues, R. N., Nordlander, A., Martin-Gonzalez, J. -A., Lievin, R., Jimenez, M., Grafe, S. K., Garcia-Sanz, R., Cordoba, R., Rahimli, L., van Meerten, T., Cornely, O. A., Pagano, Livio, Dragonetti G., Metafuni E., and Pagano L. (ORCID:0000-0001-8287-928X)

Abstract

Patients with previous CD19-directed chimeric antigen receptor (CAR) T-cell therapy have a prolonged vulnerability to viral infections. Coronavirus disease 2019 (COVID-19) has a great impact and has previously been shown to cause high mortality in this population. Until now, real-world data on the impact of vaccination and treatment on patients with COVID-19 after CD19-directed CAR T-cell therapy are lacking. Therefore, this multicenter, retrospective study was conducted with data from the EPICOVIDEHA survey. Sixty-four patients were identified. The overall mortality caused by COVID-19 was 31%. Patients infected with the Omicron variant had a significantly lower risk of death due to COVID-19 compared with patients infected with previous variants (7% vs 58% [P = .012]). Twenty-six patients were vaccinated at the time of the COVID-19 diagnosis. Two vaccinations showed a marked but unsignificant reduction in the risk of COVID-19–caused mortality (33.3% vs 14.2% [P = .379]). In addition, the course of the disease appears milder with less frequent intensive care unit admissions (39% vs 14% [P = .054]) and a shorter duration of hospitalization (7 vs 27.5 days [P = .022]). Of the available treatment options, only monoclonal antibodies seemed to be effective at reducing mortality from 32% to 0% (P = .036). We conclude that survival rates of CAR T-cell recipients with COVID-19 improved over time and that the combination of prior vaccination and monoclonal antibody treatment significantly reduces their risk of death. This trial was registered at www.clinicaltrials.gov as #NCT04733729.

Published
2023

27. Age, successive waves, immunization, and mortality in elderly COVID-19 hematological patients: EPICOVIDEHA findings

Author

Rossi, G., Salmanton-Garcia, J., Cattaneo, C., Marchesi, F., Davila-Valls, J., Martin-Perez, S., Itri, F., Lopez-Garcia, A., Glenthoj, A., Da Silva, M. G., Besson, C., Marchetti, M., Weinbergerova, B., Jaksic, O., Jimenez, M., Bilgin, Y. M., Van Doesum, J., Farina, F., Ak, P., Verga, L., Collins, G. P., Bonuomo, V., Praet, J. V., Nucci, M., Meers, S., Espigado, I., Fracchiolla, N. S., Valkovic, T., Poulsen, C. B., Colovic, N., Dragonetti, Giulia, Ledoux, M. -P., Tascini, C., Buquicchio, C., Blennow, O., Passamonti, F., Machado, M., Labrador, J., Duarte, R. F., Schonlein, M., Prezioso, L., Falces-Romero, I., Kulasekararaj, A., Garcia-Vidal, C., Fernandez, N., Abu-Zeinah, G., Ormazabal-Velez, I., Ad ic-Vukicevic, T., Piukovics, K., Stoma, I., Cuccaro, A., Magliano, G., Szotkowski, T., Gonzalez-Lopez, T. -J., El-Ashwah, S., Bergantim, R., Sili, U., Maertens, J., Demirkan, F., De Ramon, C., Petzer, V., Del Principe, M. I., Navratil, M., Dargenio, M., Seval, G. C., Samarkos, M., Racil, Z., Pinczes, L. I., Lahmer, T., Busca, A., Mendez, G. -A., Vena, A., Biernat, M. M., Merelli, M., Calbacho, M., Barac, A., Bavastro, M., Limongelli, A., Ilhan, O., Wolf, D., Colak, G. M., Garcia-Sanz, R., Emarah, Z., Mi kovic, B., Grafe, S. K., Mladenovic, M., Aiello, T. F., Nunez-Martin-Buitrago, L., Nordlander, A., Arellano, E., Zambrotta, G. P. M., Ammatuna, E., Cabirta, A., Sacchi, M. V., Rodrigues, R. N., Hersby, D. S., Hanakova, M., Rahimli, L., Cordoba, R., Cornely, O. A., Pagano, Livio, Marques De, Almeida, Hernandez-Rivas, Marques De Almeida, J., Hernandez-Rivas, J. A., Guidetti, A., Finizio, O., Stojanoski, Z., Cvetanoski, M., Meletiadis, J., De Jonge, N., Antic, D., Ali, N., Tisi, M. C., Serrano, L., Plantefeve, G., Khanna, N., Hoenigl, M., Cernan, M., Miranda-Castillo, C., Fernandez-Galan, M., Serris, A., Erben, N., Dulery, R., Aujayeb, A., Papa, M. V., Novak, J., Delia, M., Sapienza, G., Reizine, F., Omrani, A. S., Di Blasi, R., Lamure, S., Drgona, L., Coppola, N., Batinic, J., Al-Khabori, M., Ribera-Santa Susana, J. -M., Piedimonte, M., Loureiro-Amigo, J., Fouquet, G., Fazzi, R., Danion, F., Schubert, J., Hoell-Neugebauer, B., Bahr, N. C., Yahia, A. O., Torres-Atienza, A., Rinaldi, I., Popova, M., Ommen, H. -B., Mitra, M. E., Mikulska, M., Lacej, I., Khostelidi, S., Win, S., Vinh, D., Saleh, M., Prattes, J., Jindra, P., Guolo, F., Della Pepa, R., Chelysheva, E., Zdziarski, P., Wai-Man, V., Soto-Silva, A., Orth, H. M., Malak, S., Lorenzo De La Pena, L., Kolditz, M., Kho, C. S., Heath, C. H., Groh, A., Gavriilaki, E., Fung, M., Egger, M., De Kort, E., De Cabo, E., Cushion, T., Chowdhury, F. R., Ceesay, M. M., Brehon, M., Varricchio, G., Tafuri, A., Jimenez-Lorenzo, M. -J., Klimko, N., Tsirigotis, P., Antoniadou, A., Vehreschild, M., Dragonetti G., Pagano L. (ORCID:0000-0001-8287-928X), Rossi, G., Salmanton-Garcia, J., Cattaneo, C., Marchesi, F., Davila-Valls, J., Martin-Perez, S., Itri, F., Lopez-Garcia, A., Glenthoj, A., Da Silva, M. G., Besson, C., Marchetti, M., Weinbergerova, B., Jaksic, O., Jimenez, M., Bilgin, Y. M., Van Doesum, J., Farina, F., Ak, P., Verga, L., Collins, G. P., Bonuomo, V., Praet, J. V., Nucci, M., Meers, S., Espigado, I., Fracchiolla, N. S., Valkovic, T., Poulsen, C. B., Colovic, N., Dragonetti, Giulia, Ledoux, M. -P., Tascini, C., Buquicchio, C., Blennow, O., Passamonti, F., Machado, M., Labrador, J., Duarte, R. F., Schonlein, M., Prezioso, L., Falces-Romero, I., Kulasekararaj, A., Garcia-Vidal, C., Fernandez, N., Abu-Zeinah, G., Ormazabal-Velez, I., Ad ic-Vukicevic, T., Piukovics, K., Stoma, I., Cuccaro, A., Magliano, G., Szotkowski, T., Gonzalez-Lopez, T. -J., El-Ashwah, S., Bergantim, R., Sili, U., Maertens, J., Demirkan, F., De Ramon, C., Petzer, V., Del Principe, M. I., Navratil, M., Dargenio, M., Seval, G. C., Samarkos, M., Racil, Z., Pinczes, L. I., Lahmer, T., Busca, A., Mendez, G. -A., Vena, A., Biernat, M. M., Merelli, M., Calbacho, M., Barac, A., Bavastro, M., Limongelli, A., Ilhan, O., Wolf, D., Colak, G. M., Garcia-Sanz, R., Emarah, Z., Mi kovic, B., Grafe, S. K., Mladenovic, M., Aiello, T. F., Nunez-Martin-Buitrago, L., Nordlander, A., Arellano, E., Zambrotta, G. P. M., Ammatuna, E., Cabirta, A., Sacchi, M. V., Rodrigues, R. N., Hersby, D. S., Hanakova, M., Rahimli, L., Cordoba, R., Cornely, O. A., Pagano, Livio, Marques De, Almeida, Hernandez-Rivas, Marques De Almeida, J., Hernandez-Rivas, J. A., Guidetti, A., Finizio, O., Stojanoski, Z., Cvetanoski, M., Meletiadis, J., De Jonge, N., Antic, D., Ali, N., Tisi, M. C., Serrano, L., Plantefeve, G., Khanna, N., Hoenigl, M., Cernan, M., Miranda-Castillo, C., Fernandez-Galan, M., Serris, A., Erben, N., Dulery, R., Aujayeb, A., Papa, M. V., Novak, J., Delia, M., Sapienza, G., Reizine, F., Omrani, A. S., Di Blasi, R., Lamure, S., Drgona, L., Coppola, N., Batinic, J., Al-Khabori, M., Ribera-Santa Susana, J. -M., Piedimonte, M., Loureiro-Amigo, J., Fouquet, G., Fazzi, R., Danion, F., Schubert, J., Hoell-Neugebauer, B., Bahr, N. C., Yahia, A. O., Torres-Atienza, A., Rinaldi, I., Popova, M., Ommen, H. -B., Mitra, M. E., Mikulska, M., Lacej, I., Khostelidi, S., Win, S., Vinh, D., Saleh, M., Prattes, J., Jindra, P., Guolo, F., Della Pepa, R., Chelysheva, E., Zdziarski, P., Wai-Man, V., Soto-Silva, A., Orth, H. M., Malak, S., Lorenzo De La Pena, L., Kolditz, M., Kho, C. S., Heath, C. H., Groh, A., Gavriilaki, E., Fung, M., Egger, M., De Kort, E., De Cabo, E., Cushion, T., Chowdhury, F. R., Ceesay, M. M., Brehon, M., Varricchio, G., Tafuri, A., Jimenez-Lorenzo, M. -J., Klimko, N., Tsirigotis, P., Antoniadou, A., Vehreschild, M., Dragonetti G., and Pagano L. (ORCID:0000-0001-8287-928X)

Abstract

Objectives: Elderly patients with hematologic malignancies face the highest risk of severe COVID-19 outcomes. The infection's impact on different age groups remains unstudied in detail. Methods: We analyzed elderly patients (age groups: 65-70, 71-75, 76-80, and >80 years old) with hematologic malignancies included in the EPICOVIDEHA registry between January 2020 and July 2022. Univariable and multivariable Cox regression models were conducted to identify factors influencing death in COVID-19 patients with hematological malignancy. Results: The study included data from 3,603 elderly patients (aged 65 or older) with hematological malignancy, with a majority being male (58.1%) and a significant proportion having comorbidities. The patients were divided into four age groups, and the analysis assessed COVID-19 outcomes, vaccination status, and other variables in relation to age and pandemic waves. The 90-day survival rate for patients with COVID-19 was 71.2%, with significant differences between groups. The pandemic waves had varying impacts, with the first wave affecting patients over 80 years old, the second being more severe in 65-70, and the third being the least severe in all age groups. Factors contributing to 90-day mortality included age, comorbidities, lymphopenia, active malignancy, acute leukemia, less than three vaccine doses, severe COVID-19, and using only corticosteroids as treatment. Conclusion: These data underscore the heterogeneity of elderly hematological patients, highlight the different impacts of COVID-19 waves and the pivotal importance of vaccination, and may help in planning future healthcare efforts.

Published
2023

28. Reduced intensity allogeneic stem cell transplantation for follicular lymphoma relapsing after an autologous transplant achieves durable long-term disease control: an analysis from the Lymphoma Working Party of the EBMT

Author

Robinson, S.P., Boumendil, A., Finel, H., Schouten, H., Ehninger, G., Maertens, J., Crawley, C., Rambaldi, A., Russell, N., Anders, W., Blaise, D., Yakoub-Agha, I., Ganser, A., Castagna, L., Volin, L., Cahn, J.-Y., Montoto, S., and Dreger, P.

Published
2016
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29. COVID-19 in adult acute myeloid leukemia patients: a long-term follow-up study from the European Hematology Association survey (EPICOVIDEHA)

Author

Marchesi F, Salmanton-García J, Emarah Z, Piukovics K, Nucci M, López-García A, Ráčil Z, Farina F, Popova M, Zompi S, Audisio E, Ledoux MP, Verga L, Weinbergerová B, Szotkovski T, Da Silva MG, Fracchiolla N, De Jonge N, Collins G, Marchetti M, Magliano G, García-Vidal C, Biernat MM, Van Doesum J, Machado M, Demirkan F, Al- Khabori M, Žák P, Víšek B, Stoma I, Méndez GA, Maertens J, Khanna N, Espigado I, Dragonetti G, Fianchi L, Del Principe MI, Cabirta A, Ormazabal- Vélez I, Jaksic O, Buquicchio C, Bonuomo V, Batinić J, Omrani AS, Lamure S, Finizio O, Fernández N, Falces-Romero I, Blennow O, Bergantim R, Ali N, Win S, Van Praet J, Tisi MC, Shirinova A, Schönlein M, Prattes J, Piedimonte M, Petzer V, Navrátil M, Kulasekararaj A, Jindra P, Sramek J, Glenthøj A, Fazzi R, De Ramón-Sánchez C, Cattaneo C, Calbacho M, Bahr NC, El-Ashwah S, Cordoba R, Hanakova M, Zambrotta G, Sciumè M, Booth S, Rodrigues RN, Sacchi MV, García-Poutón N, Martín- González JA, Khostelidi S, Gräfe S, Rahimli L, Ammatuna E, Busca A, Corradini P, Hoenigl M, Klimko N, Koehler P, Pagliuca A, Passamonti F, Cornely OA, Pagano L and EPICOVIDEHA working group.

Subjects
AML Covid 19
Abstract

Patients with acute myeloid leukemia (AML) are at high risk of dying from coronavirus disease 2019 (COVID-19). The optimal management of AML patients with COVID-19 has not been established. Our multicenter study included 388 adult AML patients diagnosed with COVID-19 between February 2020 and October 2021. The vast majority were receiving or had received AML treatment in the preceding 3 months. COVID-19 was severe in 41.2% and critical in 21.1% of cases. The chemotherapeutic schedule was modified in 174 patients (44.8%), delayed in 68 and permanently discontinued in 106. After a median follow-up of 325 days, 180 patients (46.4%) had died ; death was attributed to COVID-19 (43.3%), AML (26.1%) or to a combination of both (26.7%), whereas in 3.9% of cases the reason was unknown. Active disease, older age, and treatment discontinuation were associated with death, whereas AML treatment delay was protective. Seventy-nine patients had a simultaneous AML and COVID-19 diagnosis, with better survival when AML treatment could be delayed (80% ; P

Published
2023

30. Long-term follow-up of a retrospective comparison of reduced-intensity conditioning and conventional high-dose conditioning for allogeneic transplantation from matched related donors in myelodysplastic syndromes

Author

Martino, R, Henseler, A, van Lint, M, Schaap, N, Finke, J, Beelen, D, Vigouroux, S, Alessandrino, E P, Mufti, G J, Veelken, J H, Bruno, B, Yakoub-Agha, I, Volin, L, Maertens, J, Or, R, Leblond, V, Rovira, M, Kalhs, P, Alvarez, A F, Vitek, A, Sierra, J, Wagner, E, Robin, M, de Witte, T, and Kröger, N

Published
2017
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31. Allogeneic haematopoietic stem cell transplant in patients with lower risk myelodysplastic syndrome: a retrospective analysis on behalf of the Chronic Malignancy Working Party of the EBMT

Author

Robin, M, Porcher, R, Zinke-Cerwenka, W, van Biezen, A, Volin, L, Mufti, G, Craddock, C, Finke, J, Richard, C, Passweg, J, Peniket, A, Maertens, J, Sucak, G, Gedde-Dahl, T, Vitek, A, Nagler, A, Blaise, D, Beelen, D, Maillard, N, Schwerdtfeger, R, de Witte, T, and Kroger, N

Published
2017
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32. Comparative value of post-remission treatment in cytogenetically normal AML subclassified by NPM1 and FLT3-ITD allelic ratio

Author

Versluis, J, in ‘t Hout, F E M, Devillier, R, van Putten, W L J, Manz, M G, Vekemans, M -C, Legdeur, M -C, Passweg, J R, Maertens, J, Kuball, J, Biemond, B J, Valk, P J M, van der Reijden, B A, Meloni, G, Schouten, H C, Vellenga, E, Pabst, T, Willemze, R, Löwenberg, B, Ossenkoppele, G, Baron, F, Huls, G, and Cornelissen, J J

Published
2017
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33. Correction: Lenalidomide added to standard intensive treatment for older patients with AML and high-risk MDS

Author

Ossenkoppele, G. J., Breems, D. A., Stuessi, G., van Norden, Y., Bargetzi, M., Biemond, B. J., A von dem Borne, P., Chalandon, Y., Cloos, J., Deeren, D., Fehr, M., Gjertsen, B., Graux, C., Huls, G., Janssen, J. J. J. W., Jaspers, A., Jongen-Lavrencic, M., de Jongh, E., Klein, S. K., van der Klift, M., van Marwijk Kooy, M., Maertens, J., Michaux, L., van der Poel, M. W. M., van Rhenen, A., Tick, L., Valk, P., Vekemans, M. C., van der Velden, W. J. F. M., de Weerdt, O., Pabst, T., Manz, M., and Löwenberg, B.

Published
2020
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34. Allogeneic stem cell transplantation for acute myeloid leukemia with normal cytogenetics (CN-AML): outcome, risk factors and role of molecular subgroups in 1006 patients - a report from the Acute Leukemia Working Party of EBMT [Abstract]

Author

Schmid, Christoph, Labopin, M., Socie, G., Rambaldi, A., Schwerdtfeger, R., Deconinck, E., Vigouroux, S., Huynh, A., Volin, L., Bourhis, J.-H., Maertens, J., Chevalier, P., Jindra, P., Schlimok, G., Cornelissen, J., Ifrah, N., Nagler, A., Polge, E., Esteve, J., and Mohty, M.

Published
2022

36. A phase 1b study of glasdegib + azacitidine in patients with untreated acute myeloid leukemia and higher-risk myelodysplastic syndromes

Author

Sekeres, MA, Schuster, M, Joris, M, Krauter, J, Maertens, J, Breems, D, Gyan, E, Kovacsovics, T, Verma, A, Vyas, P, Wang, ES, Ching, K, O'Brien, T, Gallo Stampino, C, Ma, WW, Kudla, A, Chan, G, and Zeidan, AM

Subjects
Adult, Leukemia, Myeloid, Acute, Treatment Outcome, Myelodysplastic Syndromes, Phenylurea Compounds, Azacitidine, Humans, Benzimidazoles, Drug Therapy, Combination, Hematology, General Medicine, Risk Assessment
Abstract

This phase 1b study evaluated glasdegib (100mg once daily) + azacitidine in adults with newly diagnosed acute myeloid leukemia (AML), higher-risk myelodysplastic syndromes (MDS), or chronic myelomonocytic leukemia (CMML) who were ineligible for intensive chemotherapy. Of 72 patients enrolled, 12 were in a lead-in safety cohort (LIC) and 60 were in the AML and MDS (including CMML) expansion cohorts. In the LIC, the safety profile of glasdegib + azacitidine was determined to be consistent with those of glasdegib or azacitidine alone, with no evidence of drug–drug interaction. In the expansion cohort, the most frequently (≥ 10%) reported non-hematologic Grade ≥ 3 treatment-emergent adverse events were decreased appetite, electrocardiogram QT prolongation, and hypertension in the AML cohort and sepsis, diarrhea, hypotension, pneumonia, and hyperglycemia in the MDS cohort. Overall response rates in the AML and MDS cohorts were 30.0% and 33.3%, respectively; 47.4% and 46.7% of patients who were transfusion dependent at baseline achieved independence. Median overall survival (95% confidence interval) was 9.2 (6.2–14.0) months and 15.8 (9.3–21.9) months, respectively, and response was associated with molecular mutation clearance. Glasdegib + azacitidine in patients with newly diagnosed AML or MDS demonstrated an acceptable safety profile and preliminary evidence of clinical benefits. Trial registration: ClinicalTrials.gov NCT02367456.

Published
2022

37. Performance of existing definitions and tests for the diagnosis of invasive aspergillosis in critically ill, non-neutropenic, adult patients: An update including COVID-19 data

Author

Bassetti, Matteo, primary, Zuccaro, Valentina, additional, Asperges, Erika, additional, Scudeller, Luigia, additional, Giacobbe, Daniele Roberto, additional, Akova, M., additional, Alastruey-Izquierdo, A., additional, Arikan-Akdagli, S., additional, Azoulay, E., additional, Blot, S., additional, Cortegiani, A., additional, Cornely, O.A., additional, Grecchi, C., additional, Lass-Flörl, C., additional, Koehler, P., additional, Cuenca-Estrella, M., additional, de Lange, D.W., additional, De Rosa, F.G., additional, De Waele, J.J., additional, Dimopoulos, G., additional, Garnacho-Montero, J., additional, Hoenigl, M., additional, Kanj, S.S., additional, Lamoth, F., additional, Maertens, J., additional, Martin-Loeches, I., additional, Muñoz, P., additional, Kullberg, B.J., additional, Agvald-Ohman, C., additional, Poulakou, G., additional, Rebuffi, C., additional, Rello, J., additional, Sanguinetti, M., additional, Taccone, F.S., additional, Timsit, J-F., additional, Torres, A., additional, Vazquez, J.A., additional, Wauters, J., additional, Calandra, T., additional, Tejada, S., additional, Karaiskos, I., additional, Peghin, M., additional, Vena, A., additional, Mortensen, K.L., additional, Lebihan, C., additional, and Mercier, T., additional

Published
2022
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43. The Joint European Working Group of the ISSMGE, ISRM and IAEG for the Definition of Professional Tasks, Responsibilities and Co-operation in Ground Engineering

Author

Bock, Helmut, Broch, E., Chartres, R., Gambin, M., Maertens, J., Maertens, L., Norbury, D., Pinto, P., Schubert, W., Stille, H., Bhattacharji, S., editor, Neugebauer, H.J., editor, Reitner, J., editor, Stüwe, K., editor, Friedman, G.M., editor, Seilacher, A., editor, Hack, Robert, editor, Azzam, Rafig, editor, and Charlier, Robert, editor

Published
2004
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44. Extracorporeal membrane oxygenation support in COVID-19: an international cohort study of the Extracorporeal Life Support Organization registry

Author

Barbaro, R, Maclaren, G, Boonstra, P, Iwashyna, T, Slutsky, A, Fan, E, Bartlett, R, Tonna, J, Hyslop, R, Fanning, J, Rycus, P, Hyer, S, Anders, M, Agerstrand, C, Hryniewicz, K, Diaz, R, Lorusso, R, Combes, A, Brodie, D, Alexander, P, Barrett, N, Belohlavek, J, Fisher, D, Fraser, J, Hssain, A, Jung, J, Mcmullan, M, Mehta, Y, Ogino, M, Paden, M, Shekar, K, Stead, C, Abu-Omar, Y, Agnoletti, V, Akbar, A, Alfoudri, H, Alviar, C, Aronsky, V, August, E, Auzinger, G, Aveja, H, Bakken, R, Balcells, J, Bangalore, S, Barnes, B, Bautista, A, Bellows, L, Beltran, F, Benharash, P, Benni, M, Berg, J, Bertini, P, Blanco-Schweizer, P, Brunsvold, M, Budd, J, Camp, D, Caridi-Scheible, M, Carton, E, Casanova-Ghosh, E, Castleberry, A, Chipongian, C, Choi, C, Circelli, A, Cohen, E, Collins, M, Copus, S, Coy, J, Crist, B, Cruz, L, Czuczwar, M, Daneshmand, M, Davis II, D, De la Cruz, K, Devers, C, Duculan, T, Durham, L, Elapavaluru, S, Elzo Kraemer, C, Filho, E, Fitzgerald, J, Foti, G, Fox, M, Fritschen, D, Fullerton, D, Gelandt, E, Gerle, S, Giani, M, Goh, S, Govener, S, Grone, J, Guber, M, Gudzenko, V, Gutteridge, D, Guy, J, Haft, J, Hall, C, Hassan, I, Herran, R, Hirose, H, Ibrahim, A, Igielski, D, Ivascu, F, Izquierdo Blasco, J, Jackson, J, Jain, H, Jaiswal, B, Johnson, A, Jurynec, J, Kellter, N, Kohl, A, Kon, Z, Kredel, M, Kriska, K, Kunavarapu, C, Lansink-Hartgring, O, Larocque, J, Larson, S, Layne, T, Ledot, S, Lena, N, Lillie, J, Lotz, G, Lucas, M, Ludwigson, L, Maas, J, Maertens, J, Mast, D, Mccardle, S, Mcdonald, B, Mclarty, A, Mcmahon, C, Meybohm, P, Meyns, B, Miller, C, Moraes Neto, F, Morris, K, Muellenbach, R, Nicholson, M, O'Brien, S, O'Keefe, K, Ogston, T, Oldenburg, G, Oliveira, F, Oppel, E, Pardo, D, Parker, S, Pedersen, F, Pellecchia, C, Pelligrini, J, Pham, T, Phillips, A, Pirani, T, Piwowarczyk, P, Plambeck, R, Pruett, W, Quandt, B, Ramanathan, K, Rey, A, Reyher, C, Riera del Brio, J, Roberts, R, Roe, D, Roeleveld, P, Rudy, J, Rueda, L, Russo, E, Sanchez Ballesteros, J, Satou, N, Saueressig, M, Saunders, P, Schlotterbeck, M, Schwarz, P, Scriven, N, Serra, A, Shamsah, M, Sim, L, Smart, A, Smith, A, Smith, D, Smith, M, Sodha, N, Sonntagbauer, M, Sorenson, M, Stallkamp, E, Stewart, A, Swartz, K, Takeda, K, Thompson, S, Toy, B, Tuazon, D, Uchiyama, M, Udeozo, O, van Poppel, S, Ventetuolo, C, Vercaemst, L, Vinh Chau, N, Wang, I, Williamson, C, Wilson, B, Winkels, H, Barbaro R. P., MacLaren G., Boonstra P. S., Iwashyna T. J., Slutsky A. S., Fan E., Bartlett R. H., Tonna J. E., Hyslop R., Fanning J. J., Rycus P. T., Hyer S. J., Anders M. M., Agerstrand C. L., Hryniewicz K., Diaz R., Lorusso R., Combes A., Brodie D., Alexander P., Barrett N., Belohlavek J., Fisher D., Fraser J., Hssain A. A., Jung J. S., McMullan M., Mehta Y., Ogino M. T., Paden M. L., Shekar K., Stead C., Abu-Omar Y., Agnoletti V., Akbar A., Alfoudri H., Alviar C., Aronsky V., August E., Auzinger G., Aveja H., Bakken R., Balcells J., Bangalore S., Barnes B. W., Bautista A., Bellows L. L., Beltran F., Benharash P., Benni M., Berg J., Bertini P., Blanco-Schweizer P., Brunsvold M., Budd J., Camp D., Caridi-Scheible M., Carton E., Casanova-Ghosh E., Castleberry A., Chipongian C. T., Choi C. W., Circelli A., Cohen E., Collins M., Copus S., Coy J., Crist B., Cruz L., Czuczwar M., Daneshmand M., Davis II D., De la Cruz K., Devers C., Duculan T., Durham L., Elapavaluru S., Elzo Kraemer C. V., Filho E. C., Fitzgerald J., Foti G., Fox M., Fritschen D., Fullerton D., Gelandt E., Gerle S., Giani M., Goh S. G., Govener S., Grone J., Guber M., Gudzenko V., Gutteridge D., Guy J., Haft J., Hall C., Hassan I. F., Herran R., Hirose H., Ibrahim A. S., Igielski D., Ivascu F. A., Izquierdo Blasco J., Jackson J., Jain H., Jaiswal B., Johnson A. C., Jurynec J. A., Kellter N. M., Kohl A., Kon Z., Kredel M., Kriska K., Kunavarapu C., Lansink-Hartgring O., LaRocque J., Larson S. B., Layne T., Ledot S., Lena N., Lillie J., Lotz G., Lucas M., Ludwigson L., Maas J. J., Maertens J., Mast D., McCardle S., McDonald B., McLarty A., McMahon C., Meybohm P., Meyns B., Miller C., Moraes Neto F., Morris K., Muellenbach R., Nicholson M., O'Brien S., O'Keefe K., Ogston T., Oldenburg G., Oliveira F. M., Oppel E., Pardo D., Parker S. J., Pedersen F. M., Pellecchia C., Pelligrini J. A. S., Pham T. T. N., Phillips A. R., Pirani T., Piwowarczyk P., Plambeck R., Pruett W., Quandt B., Ramanathan K., Rey A., Reyher C., Riera del Brio J., Roberts R., Roe D., Roeleveld P. P., Rudy J., Rueda L. F., Russo E., Sanchez Ballesteros J., Satou N., Saueressig M. G., Saunders P. C., Schlotterbeck M., Schwarz P., Scriven N., Serra A., Shamsah M., Sim L., Smart A., Smith A., Smith D., Smith M., Sodha N., Sonntagbauer M., Sorenson M., Stallkamp E. B., Stewart A., Swartz K., Takeda K., Thompson S., Toy B., Tuazon D., Uchiyama M., Udeozo O. I., van Poppel S., Ventetuolo C., Vercaemst L., Vinh Chau N. V., Wang I. -W., Williamson C., Wilson B., Winkels H., Barbaro, R, Maclaren, G, Boonstra, P, Iwashyna, T, Slutsky, A, Fan, E, Bartlett, R, Tonna, J, Hyslop, R, Fanning, J, Rycus, P, Hyer, S, Anders, M, Agerstrand, C, Hryniewicz, K, Diaz, R, Lorusso, R, Combes, A, Brodie, D, Alexander, P, Barrett, N, Belohlavek, J, Fisher, D, Fraser, J, Hssain, A, Jung, J, Mcmullan, M, Mehta, Y, Ogino, M, Paden, M, Shekar, K, Stead, C, Abu-Omar, Y, Agnoletti, V, Akbar, A, Alfoudri, H, Alviar, C, Aronsky, V, August, E, Auzinger, G, Aveja, H, Bakken, R, Balcells, J, Bangalore, S, Barnes, B, Bautista, A, Bellows, L, Beltran, F, Benharash, P, Benni, M, Berg, J, Bertini, P, Blanco-Schweizer, P, Brunsvold, M, Budd, J, Camp, D, Caridi-Scheible, M, Carton, E, Casanova-Ghosh, E, Castleberry, A, Chipongian, C, Choi, C, Circelli, A, Cohen, E, Collins, M, Copus, S, Coy, J, Crist, B, Cruz, L, Czuczwar, M, Daneshmand, M, Davis II, D, De la Cruz, K, Devers, C, Duculan, T, Durham, L, Elapavaluru, S, Elzo Kraemer, C, Filho, E, Fitzgerald, J, Foti, G, Fox, M, Fritschen, D, Fullerton, D, Gelandt, E, Gerle, S, Giani, M, Goh, S, Govener, S, Grone, J, Guber, M, Gudzenko, V, Gutteridge, D, Guy, J, Haft, J, Hall, C, Hassan, I, Herran, R, Hirose, H, Ibrahim, A, Igielski, D, Ivascu, F, Izquierdo Blasco, J, Jackson, J, Jain, H, Jaiswal, B, Johnson, A, Jurynec, J, Kellter, N, Kohl, A, Kon, Z, Kredel, M, Kriska, K, Kunavarapu, C, Lansink-Hartgring, O, Larocque, J, Larson, S, Layne, T, Ledot, S, Lena, N, Lillie, J, Lotz, G, Lucas, M, Ludwigson, L, Maas, J, Maertens, J, Mast, D, Mccardle, S, Mcdonald, B, Mclarty, A, Mcmahon, C, Meybohm, P, Meyns, B, Miller, C, Moraes Neto, F, Morris, K, Muellenbach, R, Nicholson, M, O'Brien, S, O'Keefe, K, Ogston, T, Oldenburg, G, Oliveira, F, Oppel, E, Pardo, D, Parker, S, Pedersen, F, Pellecchia, C, Pelligrini, J, Pham, T, Phillips, A, Pirani, T, Piwowarczyk, P, Plambeck, R, Pruett, W, Quandt, B, Ramanathan, K, Rey, A, Reyher, C, Riera del Brio, J, Roberts, R, Roe, D, Roeleveld, P, Rudy, J, Rueda, L, Russo, E, Sanchez Ballesteros, J, Satou, N, Saueressig, M, Saunders, P, Schlotterbeck, M, Schwarz, P, Scriven, N, Serra, A, Shamsah, M, Sim, L, Smart, A, Smith, A, Smith, D, Smith, M, Sodha, N, Sonntagbauer, M, Sorenson, M, Stallkamp, E, Stewart, A, Swartz, K, Takeda, K, Thompson, S, Toy, B, Tuazon, D, Uchiyama, M, Udeozo, O, van Poppel, S, Ventetuolo, C, Vercaemst, L, Vinh Chau, N, Wang, I, Williamson, C, Wilson, B, Winkels, H, Barbaro R. P., MacLaren G., Boonstra P. S., Iwashyna T. J., Slutsky A. S., Fan E., Bartlett R. H., Tonna J. E., Hyslop R., Fanning J. J., Rycus P. T., Hyer S. J., Anders M. M., Agerstrand C. L., Hryniewicz K., Diaz R., Lorusso R., Combes A., Brodie D., Alexander P., Barrett N., Belohlavek J., Fisher D., Fraser J., Hssain A. A., Jung J. S., McMullan M., Mehta Y., Ogino M. T., Paden M. L., Shekar K., Stead C., Abu-Omar Y., Agnoletti V., Akbar A., Alfoudri H., Alviar C., Aronsky V., August E., Auzinger G., Aveja H., Bakken R., Balcells J., Bangalore S., Barnes B. W., Bautista A., Bellows L. L., Beltran F., Benharash P., Benni M., Berg J., Bertini P., Blanco-Schweizer P., Brunsvold M., Budd J., Camp D., Caridi-Scheible M., Carton E., Casanova-Ghosh E., Castleberry A., Chipongian C. T., Choi C. W., Circelli A., Cohen E., Collins M., Copus S., Coy J., Crist B., Cruz L., Czuczwar M., Daneshmand M., Davis II D., De la Cruz K., Devers C., Duculan T., Durham L., Elapavaluru S., Elzo Kraemer C. V., Filho E. C., Fitzgerald J., Foti G., Fox M., Fritschen D., Fullerton D., Gelandt E., Gerle S., Giani M., Goh S. G., Govener S., Grone J., Guber M., Gudzenko V., Gutteridge D., Guy J., Haft J., Hall C., Hassan I. F., Herran R., Hirose H., Ibrahim A. S., Igielski D., Ivascu F. A., Izquierdo Blasco J., Jackson J., Jain H., Jaiswal B., Johnson A. C., Jurynec J. A., Kellter N. M., Kohl A., Kon Z., Kredel M., Kriska K., Kunavarapu C., Lansink-Hartgring O., LaRocque J., Larson S. B., Layne T., Ledot S., Lena N., Lillie J., Lotz G., Lucas M., Ludwigson L., Maas J. J., Maertens J., Mast D., McCardle S., McDonald B., McLarty A., McMahon C., Meybohm P., Meyns B., Miller C., Moraes Neto F., Morris K., Muellenbach R., Nicholson M., O'Brien S., O'Keefe K., Ogston T., Oldenburg G., Oliveira F. M., Oppel E., Pardo D., Parker S. J., Pedersen F. M., Pellecchia C., Pelligrini J. A. S., Pham T. T. N., Phillips A. R., Pirani T., Piwowarczyk P., Plambeck R., Pruett W., Quandt B., Ramanathan K., Rey A., Reyher C., Riera del Brio J., Roberts R., Roe D., Roeleveld P. P., Rudy J., Rueda L. F., Russo E., Sanchez Ballesteros J., Satou N., Saueressig M. G., Saunders P. C., Schlotterbeck M., Schwarz P., Scriven N., Serra A., Shamsah M., Sim L., Smart A., Smith A., Smith D., Smith M., Sodha N., Sonntagbauer M., Sorenson M., Stallkamp E. B., Stewart A., Swartz K., Takeda K., Thompson S., Toy B., Tuazon D., Uchiyama M., Udeozo O. I., van Poppel S., Ventetuolo C., Vercaemst L., Vinh Chau N. V., Wang I. -W., Williamson C., Wilson B., and Winkels H.

Abstract

Background: Multiple major health organisations recommend the use of extracorporeal membrane oxygenation (ECMO) support for COVID-19-related acute hypoxaemic respiratory failure. However, initial reports of ECMO use in patients with COVID-19 described very high mortality and there have been no large, international cohort studies of ECMO for COVID-19 reported to date. Methods: We used data from the Extracorporeal Life Support Organization (ELSO) Registry to characterise the epidemiology, hospital course, and outcomes of patients aged 16 years or older with confirmed COVID-19 who had ECMO support initiated between Jan 16 and May 1, 2020, at 213 hospitals in 36 countries. The primary outcome was in-hospital death in a time-to-event analysis assessed at 90 days after ECMO initiation. We applied a multivariable Cox model to examine whether patient and hospital factors were associated with in-hospital mortality. Findings: Data for 1035 patients with COVID-19 who received ECMO support were included in this study. Of these, 67 (6%) remained hospitalised, 311 (30%) were discharged home or to an acute rehabilitation centre, 101 (10%) were discharged to a long-term acute care centre or unspecified location, 176 (17%) were discharged to another hospital, and 380 (37%) died. The estimated cumulative incidence of in-hospital mortality 90 days after the initiation of ECMO was 37·4% (95% CI 34·4–40·4). Mortality was 39% (380 of 968) in patients with a final disposition of death or hospital discharge. The use of ECMO for circulatory support was independently associated with higher in-hospital mortality (hazard ratio 1·89, 95% CI 1·20–2·97). In the subset of patients with COVID-19 receiving respiratory (venovenous) ECMO and characterised as having acute respiratory distress syndrome, the estimated cumulative incidence of in-hospital mortality 90 days after the initiation of ECMO was 38·0% (95% CI 34·6–41·5). Interpretation: In patients with COVID-19 who received ECMO, both estimated

Published
2020

46. The impact of anti-mould prophylaxis on Aspergillus PCR blood testing for the diagnosis of invasive aspergillosis

Author

Cruciani, M., White, P. L., Mengoli, C., Löffler, J., Morton, C. O., Klingspor, L., Buchheidt, D., Maertens, J., Heinz, W. J., Rogers, T. R., Weinbergerova, B., Warris, A., Lockhart, D. E. A., Jones, B., Cordonnier, C., Donnelly, J. P., and Barnes, R. A.

Subjects
0301 basic medicine, Microbiology (medical), medicine.medical_specialty, 030106 microbiology, Subgroup analysis, Aspergillosis, Polymerase Chain Reaction, Sensitivity and Specificity, Gastroenterology, law.invention, Mannans, 03 medical and health sciences, Galactomannan, chemistry.chemical_compound, 0302 clinical medicine, Meta-Analysis as Topic, law, Internal medicine, medicine, Humans, Pharmacology (medical), 030212 general & internal medicine, Polymerase chain reaction, Pharmacology, Aspergillus, medicine.diagnostic_test, biology, business.industry, Incidence (epidemiology), medicine.disease, biology.organism_classification, 3. Good health, Infectious Diseases, chemistry, Immunoassay, business, Invasive Fungal Infections, Cohort study
Abstract

Background The performance of the galactomannan enzyme immunoassay (GM-EIA) is impaired in patients receiving mould-active antifungal therapy. The impact of mould-active antifungal therapy on Aspergillus PCR testing needs to be determined. Objectives To determine the influence of anti-mould prophylaxis (AMP) on the performance of PCR blood testing to aid the diagnosis of proven/probable invasive aspergillosis (IA). Methods As part of the systematic review and meta-analysis of 22 cohort studies investigating Aspergillus PCR blood testing in 2912 patients at risk of IA, subgroup analysis was performed to determine the impact of AMP on the accuracy of Aspergillus PCR. The incidence of IA was calculated in patients receiving and not receiving AMP. The impact of two different positivity thresholds (requiring either a single PCR positive test result or ≥2 consecutive PCR positive test results) on accuracy was evaluated. Meta-analytical pooling of sensitivity and specificity was performed by logistic mixed-model regression. Results In total, 1661 (57%) patients received prophylaxis. The incidence of IA was 14.2%, significantly lower in the prophylaxis group (11%–12%) compared with the non-prophylaxis group (18%–19%) (P Conclusions Contrary to its influence on GM-EIA, AMP significantly decreases Aspergillus PCR specificity, without affecting sensitivity, possibly as a consequence of AMP limiting the clinical progression of IA and/or leading to false-negative GM-EIA results, preventing the classification of probable IA using the EORTC/MSGERC definitions.

Published
2020

47. Infectious complications of targeted drugs and biotherapies in acute leukemia. Clinical practice guidelines by the European Conference on Infections in Leukemia (ECIL), a joint venture of the European Group for Blood and Marrow Transplantation (EBMT), the European Organization for Research and Treatment of Cancer (EORTC), the International Immunocompromised Host Society (ICHS) and the European Leukemia Net (ELN)

Author

Maschmeyer, G., Bullinger, L., Garcia-Vidal, C., Herbrecht, R., Maertens, J., Menna, P., Pagano, L., Thiebaut-Bertrand, A., and Calandra, T.

Subjects
Cancer Research, hemic and lymphatic diseases
Abstract

The 9th web-based European Conference on Infections in Leukemia (ECIL-9), held September 16-17, 2021, reviewed the risk of infections and febrile neutropenia associated with more recently approved immunotherapeutic agents and molecular targeted drugs for the treatment of acute myeloid leukemia (AML) and acute lymphoblastic leukemia (ALL). Novel antibody based treatment approaches (inotuzumab ozogamicin, gemtuzumab ozogamicin, flotetuzumab), isocitrate dehydrogenases inhibitors (ivosidenib, enasidenib, olutasidenib), FLT3 kinase inhibitors (gilteritinib, midostaurin, quizartinib), a hedgehog inhibitor (glasdegib) as well as a BCL2 inhibitor (venetoclax) were reviewed with respect to their mode of action, their immunosuppressive potential, their current approval and the infectious complications and febrile neutropenia reported from clinical studies. Evidence-based recommendations for prevention and management of infectious complications and specific alerts regarding the potential for drug-drug interactions were developed and discussed in a plenary session with the panel of experts until consensus was reached. The set of recommendations was posted on the ECIL website for a month for comments from members of EBMT, EORTC, ICHS and ELN before final approval by the panelists. While a majority of these agents are not associated with a significantly increased risk when used as monotherapy, caution is required with combination therapy such as venetoclax plus hypomethylating agents, gemtuzumab ozogamicin plus cytotoxic drugs or midostaurin added to conventional AML chemotherapy.

Published
2022

49. Liposomal amphotericin B exposure in critically ill patients: a prospective pharmacokinetic study

Author

Daele, R. Van, Wauters, J., Elkayal, O., Dreesen, E., Debaveye, Y., Lagrou, K., Beer, Y. de, Maertens, J., Brüggemann, R.J.M., Spriet, I., Daele, R. Van, Wauters, J., Elkayal, O., Dreesen, E., Debaveye, Y., Lagrou, K., Beer, Y. de, Maertens, J., Brüggemann, R.J.M., and Spriet, I.

Abstract

Item does not contain fulltext, Liposomal amphotericin B (L-AmB) is a broad-spectrum antifungal drug. Little is known about its pharmacokinetics (PK) in critically ill patients. The aim of this study was to document the PK of L-AmB in this population. It was also explored if covariates may be identified that influence its exposure. All adult, critically ill patients (at the intensive care unit or hematology ward) treated with L-AmB between October 2016 and January 2020 were eligible for this study. The administered dose was left at the discretion of the treating clinician. Plasma samples were collected at predose and 1, 2, 4, 8, 12, 16, 20 and 24 h postdose at an early (day 2-3) and/or later (≥ day 6) treatment day. Additionally, daily trough concentrations were collected until day 14. Of 33 included patients, 31 were evaluable; their median [IQR] age and body weight was 59 [54-64] years and 68 [59-77] kg, respectively. L-AmB was administered at doses between 2.7 mg/kg and 12.3 mg/kg, with a median [IQR] trough concentration of 3.1 [2.0-4.7] mg/l. The overall median area under the 24 h concentration-time curve (AUC0-24) and peak plasma concentration (Cmax) were 169.0 [117.0-253.0] mg h/l and 23.2 [16.9-33.7] mg/l, respectively. A considerable intra- and interpatient PK variability for Cmax and AUC0-24 was observed but no explaining variables, except the administered dose, could be identified. The PK of L-AmB in critically ill patients was documented. A considerable variability in exposure was observed between and within patients; however, it was not associated with a multitude of patient-related characteristics.

Published
2022

50. Nocardia Infections in Hematopoietic Cell Transplant Recipients: A Multicenter International Retrospective Study of the Infectious Diseases Working Party of the European Society for Blood and Marrow Transplantation

Author

Averbuch, D., Greef, J. van der, Duréault, A., Wendel, L., Tridello, G., Lebeaux, D., Mikulska, M., Gil, L., Knelange, N., Zuckerman, T., Roussel, X., Robin, C., Xhaard, A., Aljurf, M., Beguin, Y., Bourgeois, A. Le, Botella-Garcia, C., Khanna, N., Praet, J. Van, Kröger, N., Blijlevens, N.M.A., Ducastelle Leprêtre, S., Ho, A., Roos-Weil, D., Yeshurun, M., Lortholary, O., Fontanet, A., Camara, R. de la, Coussement, J., Maertens, J., Styczynski, J., Averbuch, D., Greef, J. van der, Duréault, A., Wendel, L., Tridello, G., Lebeaux, D., Mikulska, M., Gil, L., Knelange, N., Zuckerman, T., Roussel, X., Robin, C., Xhaard, A., Aljurf, M., Beguin, Y., Bourgeois, A. Le, Botella-Garcia, C., Khanna, N., Praet, J. Van, Kröger, N., Blijlevens, N.M.A., Ducastelle Leprêtre, S., Ho, A., Roos-Weil, D., Yeshurun, M., Lortholary, O., Fontanet, A., Camara, R. de la, Coussement, J., Maertens, J., and Styczynski, J.

Abstract

Item does not contain fulltext, BACKGROUND: Nocardiosis is rare after hematopoietic cell transplantation (HCT). Little is known regarding its presentation, management, and outcome in this population. METHODS: This retrospective international study reviewed nocardiosis episodes in HCT recipients (1/1/2000-31/12/2018; 135 transplant centers; 33 countries) and described their clinical, microbiological, radiological, and outcome characteristics. RESULTS: We identified 81 nocardiosis episodes in 74 allo- and 7 auto-HCT recipients. Nocardiosis occurred a median of 8 (IQR: 4-18) months post-HCT. The most frequently involved organs were lungs (70/81; 86%) and brain (30/81; 37%); 29 (36%) patients were afebrile; 46/81 (57%) had disseminated infections. The most common lung imaging findings were consolidations (33/68; 49%) or nodules (32/68; 47%); brain imaging findings were multiple brain abscesses (19/30; 63%). Ten of 30 (33%) patients with brain involvement lacked neurological symptoms. Fourteen of 48 (29%) patients were bacteremic. Nocardia farcinica was the most common among molecularly identified species (27%; 12/44). Highest susceptibility rates were reported to linezolid (45/45; 100%), amikacin (56/57; 98%), trimethoprim-sulfamethoxazole (57/63; 90%), and imipenem (49/57; 86%). One-year and last follow-up (IQR: 4-42.5 months) all-cause mortality were 40% (32/81) and 52% (42/81), respectively. In the multivariable analysis, underlying disease not in complete remission (HR: 2.81; 95% CI: 1.32-5.95) and prior bacterial infection (HR: 3.42; 95% CI: 1.62-7.22) were associated with higher 1-year all-cause mortality. CONCLUSIONS: Nocardiosis is a late post-HCT infection usually manifesting as a pulmonary disease with frequent dissemination, brain infection, and bacteremia. Brain imaging should be performed in HCT recipients with nocardiosis regardless of neurological symptoms. Overall mortality is high.

Published
2022

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