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1. Cellular and humoral immunogenicity of the mRNA-1273 SARS-CoV-2 vaccine in patients with hematologic malignancies

Author

Marta Crespo, Eva Catalá, Isabel Ruiz-Camps, Maria Laura Fox, Guillermo Villacampa, Mónica Martínez-Gallo, Gemma Pujadas, Pau Abrisqueta, Candela Fernández-Naval, Soraya Peralta-Garzón, David Valcárcel, Tomás Pumarola, Moraima Jiménez, Magda Campins, Daniel Medina-Gil, Pere Barba, Alba Cabirta, Cristina Hernández, M. Hernández, Alberto Orfao, Francesc Bosch, Ana Marín-Niebla, Guillermo Ortí, Mercedes Valentín, Marcos González, Juliana Esperalba, Elisa Roldán, Mercedes Gironella, Carlota Pagès Geli, Generalitat de Catalunya, Institut Català de la Salut, [Jiménez M, Roldán E, Gironella M, Fox L, Orti G, Barba P, Valcárcel D, Bosch F, Abrisqueta P] Servei d’Hematologia, Vall d’Hebron Hospital Universitari, Barcelona, Spain. Experimental Hematology, Vall d’Hebron Institute of Oncology (VHIO), Barcelona, Spain. Departament de Medicina, Universitat Autònoma de Barcelona, Bellaterra, Spain. [Fernández-Naval C, Pumarola T, Esperalba J] Servei de Microbiologia, Vall d’Hebron Hospital Universitari, Barcelona, Spain. Vall d’Hebron Institut de Recerca (VHIR), Barcelona, Spain. [Villacampa G] Oncology Data Science (ODysSey) Group, Vall d’Hebron Institute of Oncology (VHIO), Barcelona, Spain. [Martinez-Gallo M, Hernández M] Servei d’Immunologia, Vall d’Hebron Hospital Universitari, Barcelona, Spain. Vall d’Hebron Institut de Recerca (VHIR), Barcelona, Spain. Departament de Biologia Cel·lular, Fisiologia i Immunologia, Universitat Autònoma de Barcelona, Bellaterra, Spain. [Medina-Gil D, Peralta-Garzón S, Pujadas G, Hernández C, Pagès C, Crespo M] Departament de Medicina, Universitat Autònoma de Barcelona, Bellaterra, Spain. Experimental Hematology, Vall d’Hebron Institute of Oncology (VHIO), Barcelona, Spain. [Cabirta A, Catalá E, Valentín M, Marín-Niebla A] Servei d’Hematologia, Vall d’Hebron Hospital Universitari, Barcelona, Spain. Experimental Hematology, Vall d’Hebron Institute of Oncology (VHIO), Barcelona, Spain. [Orfao A] Department of Medicine and Cytometry General ServiceNucleus, Cancer Research Centre (IBMCC/CSIC/USAL/IBSAL), Salamanca, Spain. [González M] Department of Hematology, University Hospital of Salamanca (HUS/IBSAL), CIBERONC–CB16/12/00233 and Center for Cancer Research–IBMCC (USAL-CSIC), Salamanca, Spain. [Campins M] Servei de Medicina Preventiva i Epidemiologia, Vall d’Hebron Hospital Universitari, Barcelona, Spain. [Ruiz-Camps I] Servei de Malalties Infeccioses, Vall d’Hebron Hospital Universitari, Barcelona, Spain. Vall d’Hebron Institut de Recerca (VHIR), Barcelona, Spain, and Vall d'Hebron Barcelona Hospital Campus

Subjects
COVID-19 Vaccines, Immunobiology and Immunotherapy, Clinical Trials and Observations, T cell, Antibodies, Viral, Hypogammaglobulinemia, Immunogenicity, Vaccine, medicine, virosis::infecciones por virus ARN::infecciones por Nidovirales::infecciones por Coronaviridae::infecciones por Coronavirus [ENFERMEDADES], Humans, RNA, Messenger, Immune System Phenomena::Antibody Formation::Immunogenicity, Vaccine [PHENOMENA AND PROCESSES], neoplasias::neoplasias por localización::neoplasias hematológicas [ENFERMEDADES], BNT162 Vaccine, Aged, Response rate (survey), Messenger RNA, business.industry, SARS-CoV-2, Immunogenicity, Antibody titer, COVID-19, Virus Diseases::RNA Virus Infections::Nidovirales Infections::Coronaviridae Infections::Coronavirus Infections [DISEASES], Regular Article, Hematology, Aplasia, Neoplasms::Neoplasms by Site::Hematologic Neoplasms [DISEASES], medicine.disease, Antibodies, Neutralizing, medicine.anatomical_structure, Hematologic Neoplasms, Immunology, Humoral immunity, Sang - Malalties, fenómenos del sistema inmunitario::formación de anticuerpos::inmunogenicidad vacunal [FENÓMENOS Y PROCESOS], business, Immunoglobulines, COVID-19 (Malaltia) - Vacunació, 2019-nCoV Vaccine mRNA-1273
Abstract

Recent studies have shown a suboptimal humoral response to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) messenger RNA (mRNA) vaccines in patients diagnosed with hematologic malignancies; however, data about cellular immunogenicity are scarce. The aim of this study was to evaluate both the humoral and cellular immunogenicity 1 month after the second dose of the mRNA-1273 vaccine. Antibody titers were measured by using the Elecsys and LIAISON anti–SARS-CoV-2 S assays, and T-cell response was assessed by using interferon-γ release immunoassay technology. Overall, 76.3% (184 of 241) of patients developed humoral immunity, and the cellular response rate was 79% (184 of 233). Hypogammaglobulinemia, lymphopenia, active hematologic treatment, and anti-CD20 therapy during the previous 6 months were associated with an inferior humoral response. Conversely, age >65 years, active disease, lymphopenia, and immunosuppressive treatment of graft-versus-host disease (GVHD) were associated with an impaired cellular response. A significant dissociation between the humoral and cellular responses was observed in patients treated with anti-CD20 therapy (the humoral response was 17.5%, whereas the cellular response was 71.1%). In these patients, B-cell aplasia was confirmed while T-cell counts were preserved. In contrast, humoral response was observed in 77.3% of patients undergoing immunosuppressive treatment of GVHD, whereas only 52.4% had a cellular response. The cellular and humoral responses to the SARS-CoV-2 mRNA-1273 vaccine in patients with hematologic malignancies are highly influenced by the presence of treatments such as anti-CD20 therapy and immunosuppressive agents. This observation has implications for the further management of these patients., The authors also thank the Cellex Foundation for providing research facilities and equipment and the CERCA Programme/Generalitat de Catalunya for institutional support.

Published
2021

2. Supportive Care During Pediatric Hematopoietic Stem Cell Transplantation : Prevention of Infections. A Report From Workshops on Supportive Care of the Paediatric Diseases Working Party (PDWP) of the European Society for Blood and Marrow Transplantation (EBMT)

Author

Marianne Ifversen, Roland Meisel, Petr Sedlacek, Krzysztof Kalwak, Luisa Sisinni, Daphna Hutt, Thomas Lehrnbecher, Adriana Balduzzi, Tamara Diesch, Andrea Jarisch, Tayfun Güngör, Jerry Stein, Isaac Yaniv, Halvard Bonig, Michaela Kuhlen, Marc Ansari, Tiago Nava, Jean-Hugues Dalle, Cristina Diaz-de-Heredia, Eugenia Trigoso, Ulrike Falkenberg, Mihaela Hartmann, Marco Deiana, Marta Canesi, Chiara Broggi, Alice Bertaina, Brenda Gibson, Gergely Krivan, Kim Vettenranta, Toni Matic, Jochen Buechner, Anita Lawitschka, Christina Peters, Akif Yesilipek, Koray Yalçin, Giovanna Lucchini, Shahrzad Bakhtiar, Dominik Turkiewicz, Riitta Niinimäki, Jacek Wachowiak, Simone Cesaro, Arnaud Dalissier, Selim Corbacioglu, Andre Manfred Willasch, Peter Bader, Children's Hospital, Lastentautien yksikkö, HUS Children and Adolescents, Ifversen, M, Meisel, R, Sedlacek, P, Kalwak, K, Sisinni, L, Hutt, D, Lehrnbecher, T, Balduzzi, A, Diesch, T, Jarisch, A, Gungor, T, Stein, J, Yaniv, I, Bonig, H, Kuhlen, M, Ansari, M, Nava, T, Dalle, J, Diaz-de-Heredia, C, Trigoso, E, Falkenberg, U, Hartmann, M, Deiana, M, Canesi, M, Broggi, C, Bertaina, A, Gibson, B, Krivan, G, Vettenranta, K, Matic, T, Buechner, J, Lawitschka, A, Peters, C, Yesilipek, A, Yalcin, K, Lucchini, G, Bakhtiar, S, Turkiewicz, D, Niinimaki, R, Wachowiak, J, Cesaro, S, Dalissier, A, Corbacioglu, S, Willasch, A, Bader, P, Institut Català de la Salut, [Ifversen M] Department of Paediatrics and Adolescent Medicine, Copenhagen University Hospital Rigshospitalet, Copenhagen, Denmark. [Meisel R] Division of Pediatric Stem Cell Therapy, Department of Pediatric Oncology, Hematology and Clinical Immunology, Medical Faculty, Heinrich-Heine-University, Duesseldorf, Germany. [Sedlacek P] Department of Pediatric Hematology and Oncology, Hospital Motol, Charles University, Prague, Czechia. [Kalwak K] Department of Pediatric Hematology, Oncology and Bone Marrow Transplantation, Wroclaw Medical University, Wroclaw, Poland. [Sisinni L] Pediatric Hematology, Oncology and Hematopoietic Stem Cell Transplantation Unit, Hospital Santa Creu i Sant Pau, Barcelona, Spain. [Hutt D] Division of Pediatric Hematology, Oncology and Bone Marrow Transplantation, The Edmond and Lily Safra Children's Hospital, Tel Aviv, Israel. [Diaz-de-Heredia C] Servei d’Oncologia i Hematologia Pediàtriques, Vall d'Hebron Hospital Universitari, Barcelona, Spain, and Vall d'Hebron Barcelona Hospital Campus

Subjects
medicine.medical_treatment, allogeneic hematological stem cell transplantation, CHILDREN, Hematopoietic stem cell transplantation, Otros calificadores::Otros calificadores::/efectos adversos [Otros calificadores], GUIDELINES, Pediatrics, PROPHYLAXIS, 0302 clinical medicine, 3123 Gynaecology and paediatrics, Antibiotic prophylactic therapy, Young adult, Children, antibiotic prophylactic therapy, Original Research, COMPLICATIONS, Hematology, ddc:618, Therapeutics::Biological Therapy::Immunomodulation::Immunotherapy::Immunosuppression::Transplantation Conditioning [ANALYTICAL, DIAGNOSTIC AND THERAPEUTIC TECHNIQUES, AND EQUIPMENT], terapéutica::terapia biológica::inmunomodulación::inmunoterapia::inmunosupresión::acondicionamiento para el trasplante [TÉCNICAS Y EQUIPOS ANALÍTICOS, DIAGNÓSTICOS Y TERAPÉUTICOS], Vaccination, Hematopoietic stem cell, allogeneic hematological stem cell transplantation, antibiotic prophylactic therapy, children, infection precaution, vaccination, CHEMOTHERAPY, CANCER, 3. Good health, Leukemia, medicine.anatomical_structure, surgical procedures, operative, 030220 oncology & carcinogenesis, Cohort, terapéutica::terapia biológica::tratamientos basados en células y tejidos::trasplante de células::trasplante de células madre::trasplante de células madre hematopoyéticas [TÉCNICAS Y EQUIPOS ANALÍTICOS, DIAGNÓSTICOS Y TERAPÉUTICOS], medicine.medical_specialty, Cirurgia - Complicacions, Isolation (health care), Pathological Conditions, Signs and Symptoms::Pathologic Processes::Postoperative Complications [DISEASES], RJ1-570, 03 medical and health sciences, Internal medicine, medicine, Other subheadings::Other subheadings::/adverse effects [Other subheadings], PARTICULATE AIR FILTRATION, infection precaution, ddc:610, NEUTROPENIC DIET, Intensive care medicine, Donor selection, business.industry, Cèl·lules mare hematopoètiques - Trasplantació, medicine.disease, vaccination, afecciones patológicas, signos y síntomas::procesos patológicos::complicaciones posoperatorias [ENFERMEDADES], RECIPIENTS, Infection precaution, Pediatrics, Perinatology and Child Health, Sang - Malalties, Therapeutics::Biological Therapy::Cell- and Tissue-Based Therapy::Cell Transplantation::Stem Cell Transplantation::Hematopoietic Stem Cell Transplantation [ANALYTICAL, DIAGNOSTIC AND THERAPEUTIC TECHNIQUES, AND EQUIPMENT], business, Allogeneic hematological stem cell transplantation, LEUKEMIA, 030215 immunology
Abstract

Terapia profiláctica antibiótica; Niños; Vacunación Teràpia profilàctica antibiòtica; Nens; Vacunació Antibiotic prophylactic therapy; Children; Vaccination Specific protocols define eligibility, conditioning, donor selection, graft composition and prophylaxis of graft vs. host disease for children and young adults undergoing hematopoietic stem cell transplant (HSCT). However, international protocols rarely, if ever, detail supportive care, including pharmaceutical infection prophylaxis, physical protection with face masks and cohort isolation or food restrictions. Supportive care suffers from a lack of scientific evidence and implementation of practices in the transplant centers brings extensive restrictions to the child's and family's daily life after HSCT. Therefore, the Board of the Pediatric Diseases Working Party (PDWP) of the European Society for Blood and Marrow Transplantation (EBMT) held a series of dedicated workshops since 2017 with the aim of initiating the production of a set of minimal recommendations. The present paper describes the consensus reached within the field of infection prophylaxis.

Published
2021

3. Glofitamab, a novel, bivalent CD20-targeting T-cell-engaging bispecific antibody, induces durable complete remissions in relapsed or refractory B-cell lymphoma : a phase I trial

Author

Martin Weisser, Michael Dickinson, Gilles Salles, Michael Crump, Ann-Marie E Bröske, Peter N. Morcos, Carmelo Carlo-Stella, David Perez-Callejo, Natalie Dimier, Marina Bacac, Tom Moore, Franck Morschhauser, David Carlile, Denise Thomas, Cristiano Ferlini, Fritz Offner, Pablo Umana, Linda Lundberg, Martin Hutchings, Anton Belousov, Joaquin Martinez-Lopez, Gloria Iacoboni, Anna Sureda, Institut Català de la Salut, [Hutchings M] Department of Hematology and Phase 1 Unit, Rigshospitalet, Copenhagen, Denmark. [Morschhauser F] Université de Lille, CHU Lille, ULR 7365 - GRITA - Groupe de Recherche sur les formes Injectables et les Technologies Associées, Lille, France. [Iacoboni G] Servei d’Hematologia, Vall d’Hebron Hospital Universitari, Barcelona, Spain. Experimental Hematology, Vall d’Hebron Institute of Oncology (VHIO), Barcelona, Spain. Departament de Medicina, Universitat Autònoma de Barcelona, Bellaterra, Spain. [Carlo-Stella C] Humanitas Clinical and Research Center—IRCCS and Humanitas University, Rozzano, Italy. [Offner FC] Ghent University, Ghent, Belgium. [Sureda A] Institut Català d’Oncologia-Hospitalet, Institut d’Investigació Biomèdica de Bellvitge, Universitat de Barcelona, Barcelona, Spain, and Vall d'Hebron Barcelona Hospital Campus

Subjects
Adult, Male, Cancer Research, medicine.medical_specialty, Lymphoma, B-Cell, Neoplasms::Neoplasms by Histologic Type::Lymphoma::Lymphoma, Non-Hodgkin::Lymphoma, B-Cell [DISEASES], T-Lymphocytes, T cell, CD3, Cèl·lules B - Tumors - Tractament, aminoácidos, péptidos y proteínas::proteínas::proteínas sanguíneas::inmunoproteínas::inmunoglobulinas::anticuerpos::anticuerpos biespecíficos [COMPUESTOS QUÍMICOS Y DROGAS], neoplasias::neoplasias por tipo histológico::linfoma::linfoma no Hodgkin::linfoma de células B [ENFERMEDADES], Bivalent (genetics), Young Adult, Antineoplastic Agents, Immunological, Internal medicine, Antibodies, Bispecific, Lymphatic diseases, medicine, Medicine and Health Sciences, Humans, Otros calificadores::/terapia [Otros calificadores], Aged, Aged, 80 and over, CD20, Otros calificadores::Otros calificadores::/administración & dosificación [Otros calificadores], Hematology, biology, Malalties del sistema limfàtic, business.industry, Cancer, Other subheadings::/therapy [Other subheadings], Middle Aged, Antigens, CD20, medicine.disease, Immunoglobulines - Ús terapèutic, Lymphoma, medicine.anatomical_structure, Oncology, Sang - Malalties, biology.protein, Cancer research, Other subheadings::Other subheadings::/administration & dosage [Other subheadings], Female, Monoclonal antibodies, Antibody, Amino Acids, Peptides, and Proteins::Proteins::Blood Proteins::Immunoproteins::Immunoglobulins::Antibodies::Antibodies, Bispecific [CHEMICALS AND DRUGS], business, Anticossos monoclonals
Abstract

PURPOSE Glofitamab is a T-cell–engaging bispecific antibody possessing a novel 2:1 structure with bivalency for CD20 on B cells and monovalency for CD3 on T cells. This phase I study evaluated glofitamab in relapsed or refractory (R/R) B-cell non-Hodgkin lymphoma (B-NHL). Data for single-agent glofitamab, with obinutuzumab pretreatment ( Gpt) to reduce toxicity, are presented. METHODS Seven days before the first dose of glofitamab (0.005-30 mg), all patients received 1,000 mg Gpt. Dose-escalation steps were determined using a Bayesian continuous reassessment method with overdose control. Primary end points were safety, pharmacokinetics, and the maximum tolerated dose of glofitamab. RESULTS Following initial single-patient cohorts, 171 patients were treated within conventional multipatient cohorts and received at least one dose of glofitamab. This trial included heavily pretreated patients with R/R B-NHL; most were refractory to prior therapy (155; 90.6%) and had received a median of three prior therapies. One hundred and twenty-seven patients (74.3%) had diffuse large B-cell lymphoma, transformed follicular lymphoma, or other aggressive histology, and the remainder had indolent lymphoma subtypes. Five (2.9%) patients withdrew from treatment because of adverse events. Cytokine release syndrome occurred in 86 of 171 (50.3%) patients (grade 3 or 4: 3.5%); two (1.2%) patients experienced grade 3, transient immune effector cell–associated neurotoxicity syndrome-like symptoms. The overall response rate was 53.8% (complete response [CR], 36.8%) among all doses and 65.7% (CR, 57.1%) in those dosed at the recommended phase II dose. Of 63 patients with CR, 53 (84.1%) have ongoing CR with a maximum of 27.4 months observation. CONCLUSION In patients with predominantly refractory, aggressive B-NHL, glofitamab showed favorable activity with frequent and durable CRs and a predictable and manageable safety profile.

Published
2021

4. COVID-19 and stem cell transplantation; results from an EBMT and GETH multicenter prospective survey

Author

Carlos Vallejo Llamas, Mohsen Al Zahrani, Per Ljungman, Kim Orchard, María J. Jiménez, María Calbacho, Beatriz Aguado, Jose Luis Lopez Lorenzo, Safiye Koçulu Demir, Rafael de la Cámara, Aliénor Xhaard, Rocio Parody Porras, Maria Laura Fox, Rodrigo Martino Bofarull, Daniele Vallisa, José Luis Piñana, Gloria Tridello, Mi Kwon, Angel Cedillo, Anna De Grassi, Nina Knelange, Jane F. Apperley, Malgorzata Mikulska, Jan Styczyński, Stephan Mielke, Nicolaus Kröger, Lucía López-Corral, Fabio Ciceri, Claudia Crippa, Ana Berceanu, National Institute for Health Research (UK), Ljungman, P., de la Camara, R., Mikulska, M., Tridello, G., Aguado, B., Zahrani, M. A., Apperley, J., Berceanu, A., Bofarull, R. M., Calbacho, M., Ciceri, F., Lopez-Corral, L., Crippa, C., Fox, M. L., Grassi, A., Jimenez, M. -J., Demir, S. K., Kwon, M., Llamas, C. V., Lorenzo, J. L. L., Mielke, S., Orchard, K., Porras, R. P., Vallisa, D., Xhaard, A., Knelange, N. S., Cedillo, A., Kroger, N., Pinana, J. L., Styczynski, J., Institut Català de la Salut, [Ljungman P] Department of Cellular Therapy and Allogeneic Stem Cell Transplantation, Karolinska Comprehensive Cancer Center, Karolinska University Hospital Huddinge, Stockholm, Sweden. Division of Hematology, Department of Medicine Huddinge, Karolinska Institutet, Stockholm, Sweden. [de la Camara R] Department of Hematology, Hospital de la Princesa, Madrid, Spain. [Mikulska M] Division of Infectious Diseases, University of Genoa and Ospedale Policlinico San Martino, Genova, Italy. [Tridello G] Pediatric Hematology Oncology, Verona, Italy. [Aguado B] Department of Hematology, Hospital de la Princesa, Madrid, Spain. [Zahrani MA] King Abdul – Aziz Medical City, Riyadh, Saudi Arabia. [Fox ML] Servei d’Hematologia, Vall d’Hebron Hospital Universitari, Barcelona, Spain. Experimental Hematology Group, Vall d’Hebron Institute of Oncology (VHIO), Barcelona, Spain, and Vall d'Hebron Barcelona Hospital Campus

Subjects
Investigative Techniques::Epidemiologic Methods::Data Collection::Surveys and Questionnaires [ANALYTICAL, DIAGNOSTIC AND THERAPEUTIC TECHNIQUES, AND EQUIPMENT], Male, Cancer Research, medicine.medical_treatment, Hematopoietic stem cell transplantation, Stem cells, virosis::infecciones por virus ARN::infecciones por Nidovirales::infecciones por Coronaviridae::infecciones por Coronavirus [ENFERMEDADES], Medicine, Prospective Studies, Young adult, Prospective cohort study, Child, Immunodeficiency, COVID-19 (Malaltia) - Complicacions, Aged, 80 and over, Hematopoietic Stem Cell Transplantation, Virus Diseases::RNA Virus Infections::Nidovirales Infections::Coronaviridae Infections::Coronavirus Infections [DISEASES], Immunosuppression, Hematology, Middle Aged, Prognosis, Survival Rate, Oncology, Child, Preschool, Hematologic Neoplasms, Infectious diseases, Female, Cèl·lules mare, terapéutica::terapia biológica::tratamientos basados en células y tejidos::trasplante de células::trasplante de células madre::trasplante de células madre hematopoyéticas [TÉCNICAS Y EQUIPOS ANALÍTICOS, DIAGNÓSTICOS Y TERAPÉUTICOS], Haematological diseases, Adult, medicine.medical_specialty, Adolescent, Article, Young Adult, Internal medicine, Mortalitat, Humans, Transplantation, Homologous, Mortality, Survival rate, Aged, Performance status, Cèl·lules mare hematopoètiques - Trasplantació, business.industry, SARS-CoV-2, Infant, COVID-19, técnicas de investigación::métodos epidemiológicos::recopilación de datos::encuestas y cuestionarios [TÉCNICAS Y EQUIPOS ANALÍTICOS, DIAGNÓSTICOS Y TERAPÉUTICOS], medicine.disease, Transplantation, Sang - Malalties, Therapeutics::Biological Therapy::Cell- and Tissue-Based Therapy::Cell Transplantation::Stem Cell Transplantation::Hematopoietic Stem Cell Transplantation [ANALYTICAL, DIAGNOSTIC AND THERAPEUTIC TECHNIQUES, AND EQUIPMENT], business, Follow-Up Studies
Abstract

© The Author(s) 2021., This study reports on 382 COVID-19 patients having undergone allogeneic (n = 236) or autologous (n = 146) hematopoietic cell transplantation (HCT) reported to the European Society for Blood and Marrow Transplantation (EBMT) or to the Spanish Group of Hematopoietic Stem Cell Transplantation (GETH). The median age was 54.1 years (1.0–80.3) for allogeneic, and 60.6 years (7.7–81.6) for autologous HCT patients. The median time from HCT to COVID-19 was 15.8 months (0.2–292.7) in allogeneic and 24.6 months (−0.9 to 350.3) in autologous recipients. 83.5% developed lower respiratory tract disease and 22.5% were admitted to an ICU. Overall survival at 6 weeks from diagnosis was 77.9% and 72.1% in allogeneic and autologous recipients, respectively. Children had a survival of 93.4%. In multivariate analysis, older age (p = 0.02), need for ICU (p < 0.0001) and moderate/high immunodeficiency index (p = 0.04) increased the risk while better performance status (p = 0.001) decreased the risk for mortality. Other factors such as underlying diagnosis, time from HCT, GVHD, or ongoing immunosuppression did not significantly impact overall survival. We conclude that HCT patients are at high risk of developing LRTD, require admission to ICU, and have increased mortality in COVID-19., JA acknowledges the support of the UK NIHR Imperial College Biomedical Research Centre.

Published
2021

5. An electronic alert system increases screening for hepatitis B and C and improves management of patients with haematological disorders

Author

Paula Gubern, Luisa Roade, Maria Buti, Francesc Bosch, María José Carreras, Anna Farriols, Rafael Esteban, Pau Abrisqueta, Mar Riveiro-Barciela, Institut Català de la Salut, [Riveiro-Barciela M, Esteban R, Buti M] Unitat del Fetge, Servei de Medicina Interna, Vall d’Hebron Hospital Universitari, Barcelona, Spain. Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBERehd), Barcelona, Spain. [Gubern P, Roade L] Unitat del Fetge, Servei de Medicina Interna, Vall d’Hebron Hospital Universitari, Barcelona, Spain. [Abrisqueta P, Bosch F] Servei d’Hematologia, Vall d’Hebron Hospital Universitari, Barcelona, Spain. [Carreras MJ, Farriols A] Servei de Farmàcia, Vall d’Hebron Hospital Universitari, Barcelona, Spain, and Vall d'Hebron Barcelona Hospital Campus

Subjects
Male, HBsAg, medicine.medical_specialty, Population, lcsh:Medicine, Article, enfermedades hematológicas y linfáticas::enfermedades hematológicas [ENFERMEDADES], 03 medical and health sciences, 0302 clinical medicine, Electrònica mèdica, Diagnòstic, Internal medicine, Prevalence, medicine, Humans, Mass Screening, disciplinas de las ciencias naturales::física::electrónica::electrónica médica [DISCIPLINAS Y OCUPACIONES], Diagnosis [ANALYTICAL, DIAGNOSTIC AND THERAPEUTIC TECHNIQUES, AND EQUIPMENT], Medical prescription, lcsh:Science, education, Alert system, Mass screening, education.field_of_study, Multidisciplinary, business.industry, lcsh:R, Hemic and Lymphatic Diseases::Hematologic Diseases [DISEASES], virus diseases, Natural Science Disciplines::Physics::Electronics::Electronics, Medical [DISCIPLINES AND OCCUPATIONS], diagnóstico [TÉCNICAS Y EQUIPOS ANALÍTICOS, DIAGNÓSTICOS Y TERAPÉUTICOS], Middle Aged, Hepatitis B, medicine.disease, Hepatitis C, Hematologic Diseases, digestive system diseases, Electronics, Medical, 030220 oncology & carcinogenesis, Sang - Malalties, lcsh:Q, Female, Virus Activation, 030211 gastroenterology & hepatology, Viral hepatitis, business, Biomarkers, Haematological disorders
Abstract

Hepatitis B; Hepatitis C Hepatitis B; Hepatitis C Hepatitis B; Hepatitis C Treatment of haematological disorders in patients with chronic hepatitis B or resolved infection (anti-HBc-positive) is associated with a risk of hepatitis B reactivation. Moreover, patients with chronic hepatitis C have a higher risk of haematological malignancies than general population. An electronic alert system was developed to promote screening of hepatitis B (HBV) and C (HCV) in patients starting haematological therapies. The system included screening and linkage to care and a request for testing in those without data. From March, 2017 to March, 2018 data from 420 consecutive patients with haematological diseases were included. At first prescription before the alerts, the HCV and HBV screening rate was 60.5%. Following the alerts, an additional 115 were screened, increasing the overall screening rate to 87.9%. Anti-HBc alone was detected in 57, anti-HCV in 13, and HBsAg in 2 patients. Overall, 68% of patients with any viral hepatitis markers were previously not know, and the impact was particularly important for anti-HBc detection (47/57 unknown). Nucleoside analogues were prescribed in 28 (49.1%) anti-HBc-positive and the 2 HBsAg-positive patients. Prospective follow-up with HBV DNA and HBsAg testing showed no cases of HBV reactivation. An estimated 1.2 HBV reactivations were avoided as consequence of the alert system. In summary, an electronic alert system increased viral hepatitis screening in patients receiving haematological treatment and led to improvements in the management of these patients, including avoided HBV reactivation. This work was supported by a GoSHAPE European programme grant (Gilead Sciences Europe 2015).English language support was provided by Celine Cavallo.

Published
2020

6. Risk factors and outcome of COVID-19 in patients with hematological malignancies

Author

Carmen Eva Perez, Maria Trabazo, Diana Martínez, Irene Garcia-Garcia, Carola Diaz, Rocío Parody, Rosa Coll, José Luis Piñana, Rebeca Bailén, Ignacio De La Fuente, Marta Valero, María-José Jiménez, Irene García-Cadenas, Teresa Zudaire, I Espigado, Agustin Nieto, Ana Serrano, Angel Cedillo, Noemí Fernández, Guiomar Bautista, Adolfo Saez, María Dolores Morales, Luisa Sisinni, Beatriz Merchán, Lourdes Vázquez, Anna Sureda, Laura Fox, Josep-Maria Ribera, Rodrigo Martino, Alejandro Luna, Ana I. Pimentel, Juan Carlos Vallejo, Gonzalo Benzo, Jose Lopez, Carme Talarn, Raquel Saldaña, María Calbacho, Anabelle Chinea, Dunia de Miguel, Maria Carmen Montoya, Manuel Jurado, Irene Gómez-Catalan, Carlos Solano, Marta González-Vicent, Pascual Fernández, Piñana, José Luis, Piñana, José Luis [0000-0001-8533-2562], Infectious Complications Subcommittee of the Spanish Hematopoietic Stem Cell Transplantation and Cell Therapy Group (GETH), [Piñana,JL] Hematology División, Hospital Universitario y Politécnico La Fe, Instituto de Investigación Sanitaria La Fe, Valencia, Spain. [Piñana,JL] CIBERONC, Instituto Carlos III, Madrid, Spain. [Martino,R, Garcia‑Cadenas,I] Hematology División, Hospital de la Santa Creu i Sant Pau, Barcelona, Spain. [García-García,I, Luna,A, Chinea,A, Saez,AJ] Hematology División, Hospital Ramon y Cajal, Madrid, Spain. [Parody,R, Sureda,A] Hematology División, Institut Català Oncologia-Hospital Duran i Reynals, Barcelona, Spain. [Morales,MD, Merchán,B, de Miguel,D] Hematology División, Hospital de Guadalajara, Guadalajara, Spain. [Benzo,G] Hematology División, Hospital La Princesa, Madrid, Spain. [Gómez-Catalan,I, Serrano,A, Montoya,MC] Hematology División, Hospital de Albacete, Albacete, Spain. [Coll,R] Hematology División, Institut Català Oncologia-Hospital Josep Trueta, Girona, Spain. [De La Fuente,I, Pérez,C] Hematology División, Hospital Clínico de Valladolid, Valladolid, Spain. [Diaz,C] Hematology División, Hospital Carlos Haya, Malaga, Spain. [Lopez, JL] Hematology División, Hospital Fundación Jiménez Díaz, Madrid, Spain. [Bailen,R] Hematology División, Hospital Gregorio Marañon, Madrid, Spain. [Zudaire,T] Hematology División, Hospital de Navarra, Navarra, Spain. [Martínez,D] Hematology División, Hospital a Coruña, Coruña, Spain. [Jurado,M] Hematology División, Hospital Virgen de la Nieves, Granada, Spain. [Calbacho,M] Hematology División, Hospital 12 de Octubre, Madrid, Spain. [Vázquez,L] Hematology División, Hospital Universitario de Salamanca, Salamanca, Spain. [Fox,L] Hematology División, Hospital Vall d`Hebron, Barcelona, Spain. [Pimentel,AI] Hematology División, Hospital Clínico Universitario Lozano Blesa, IIS Aragon, Zaragoza, Spain. [Bautista,G] Hematology División, Hospital Puerta de Hierro, Madrid, Spain. [Nieto,A] Hematology División, Hospital de Vigo, Vigo, Spain. [Fernandez,P] Hematology División, Hospital General de Alicante, Alicante, Spain. [Vallejo,JC] Hematology División, Hospital de Donostia, Donostia, Spain. [Solano,C] Hematology División, Hospital Clínico Universitario de Valencia, Valencia, Spain. [Valero,M] Hematology División, Hospital Arnau de Vilanova, Valencia, Spain.[Espigado,I] Department of Hematology, University Hospital Virgen del Rocío/ University of Sevilla, CSIC/ Institute of Biomedicine of Sevilla, Sevilla, Spain. [Saldaña,R] Hematology División, Hospital de Jerez, Jerez, Spain. [Sisinni,L] Pediatric Hematology-Oncology División, Hospital la Paz, Madrid, Spain. [Ribera,JM, Jimenez,MJ] Hematology División, ICO-Hospital Germans Trias i Pujol, Josep Carreras Research Institute, Badalona, Spain. [Trabazo,M] Pediatric División, Hospital de la Santa Creu i Sant Pau, Barcelona, Spain. [Gonzalez-Vicent,M] Pediatric División, Hospital niño Jesús, Madrid, Spain. [Fernández,N] Hematology División, Hospital Marqués de Valdecilla, Santander, Spain. [Talarn,C] Hematology División, Hospital Joan XXIII, Tarragona, Spain. [Cedillo,A] Hematopoietic Stem Cell Transplantation and Cell Therapy Group (GETH), Madrid, Spain. [Piñana,JL] Division of Clinical Hematology, Hospital Universitario la Fe de Valencia, Valencia, Spain., Institut Català de la Salut, [Piñana JL] Hematology División, Hospital Universitario y Politécnico La Fe, Instituto de Investigación Sanitaria La Fe, Valencia, Spain. CIBERONC, Instituto Carlos III, Madrid, Spain. Division of Clinical Hematology, Hospital Universitario la Fe de Valencia, Avda Fernando Abril Martorell, 106 CP 46026 Valencia, Spain. [Martino R] Hematology División, Hospital de la Santa Creu i Sant Pau, Barcelona, Spain. [García-García I] Hematology División, Hospital Ramon y Cajal, Madrid, Spain. [Parody R] Hematology División, Institut Català Oncologia-Hospital Duran i Reynals, Barcelona, Spain. [Morales MD] Hematology División, Hospital de Guadalajara, Guadalajara, Spain. [Benzo G] Hematology División, Hospital La Princesa, Madrid, Spain. [Fox L] Servei d’Hematologia, Vall d’Hebron Hospital Universitari, Barcelona, Spain, and Vall d'Hebron Barcelona Hospital Campus

Subjects
0301 basic medicine, Cancer Research, Diseases::Neoplasms::Neoplasms by Site::Hematologic Neoplasms [Medical Subject Headings], COVID-19 (Malaltia) - Mortalitat, Coronavirus infections, Azithromycin, Analytical, Diagnostic and Therapeutic Techniques and Equipment::Investigative Techniques::Epidemiologic Methods::Statistics as Topic::Probability::Risk::Risk Factors [Medical Subject Headings], Organisms::Eukaryota::Animals::Chordata::Vertebrates::Mammals::Primates::Haplorhini::Catarrhini::Hominidae::Humans [Medical Subject Headings], 0302 clinical medicine, Analytical, Diagnostic and Therapeutic Techniques and Equipment::Investigative Techniques::Epidemiologic Methods::Epidemiologic Study Characteristics as Topic::Epidemiologic Studies::Cohort Studies::Retrospective Studies [Medical Subject Headings], Reacción en cadena de la polimerasa, virosis::infecciones por virus ARN::infecciones por Nidovirales::infecciones por Coronaviridae::infecciones por Coronavirus [ENFERMEDADES], Hematologic neoplasms, Persons::Persons::Age Groups::Adult::Aged [Medical Subject Headings], Hematology, Factors de risc en les malalties, Stem cell transplantation, Analytical, Diagnostic and Therapeutic Techniques and Equipment::Surgical Procedures, Operative::Transplantation::Cell Transplantation::Stem Cell Transplantation::Hematopoietic Stem Cell Transplantation [Medical Subject Headings], Virus Diseases::RNA Virus Infections::Nidovirales Infections::Coronaviridae Infections::Coronavirus Infections [DISEASES], lcsh:Diseases of the blood and blood-forming organs, lcsh:Neoplasms. Tumors. Oncology. Including cancer and carcinogens, Prognosis, Multicenter study, Polymerase chain reaction, Oncology, Analytical, Diagnostic and Therapeutic Techniques and Equipment::Surgical Procedures, Operative::Transplantation::Cell Transplantation::Stem Cell Transplantation [Medical Subject Headings], 030220 oncology & carcinogenesis, Malalties hematològiques, Factores de riesgo, medicine.drug, medicine.medical_specialty, Pronòstic mèdic, Risk factors in diseases, Infecciones por coronavirus, Analytical, Diagnostic and Therapeutic Techniques and Equipment::Investigative Techniques::Epidemiologic Methods::Statistics as Topic::Analysis of Variance::Multivariate Analysis [Medical Subject Headings], Chemicals and Drugs::Amino Acids, Peptides, and Proteins::Proteins::Blood Proteins::Immunoproteins::C-Reactive Protein [Medical Subject Headings], Neutropenia, Hematologia oncològica, lcsh:RC254-282, Trasplante de células madre, 03 medical and health sciences, Other subheadings::Other subheadings::Other subheadings::/mortality [Other subheadings], Internal medicine, medicine, Persons::Persons::Age Groups::Child [Medical Subject Headings], Mortality, neoplasias::neoplasias por localización::neoplasias hematológicas [ENFERMEDADES], Persons::Persons::Age Groups::Adult [Medical Subject Headings], Estudio multicéntrico, Estudio restrospectivo, Geographical Locations::Geographic Locations::Europe::Spain [Medical Subject Headings], Otros calificadores::Otros calificadores::Otros calificadores::/mortalidad [Otros calificadores], Performance status, lcsh:RC633-647.5, business.industry, SARS-CoV-2, Research, Neoplasias hemtaológicas, Hematologic diseases, Analytical, Diagnostic and Therapeutic Techniques and Equipment::Investigative Techniques::Epidemiologic Methods::Data Collection::Vital Statistics::Mortality [Medical Subject Headings], COVID-19, Retrospective cohort study, Odds ratio, Neoplasms::Neoplasms by Site::Hematologic Neoplasms [DISEASES], medicine.disease, Diseases::Virus Diseases::RNA Virus Infections::Nidovirales Infections::Coronaviridae Infections::Coronavirus Infections [Medical Subject Headings], Confidence interval, Retrospective studies, Transplantation, 030104 developmental biology, Sang - Malalties, Mortalidad, Risk factor, business
Abstract

Background Prognostic factors of poor outcome in patients with hematological malignancies and COVID-19 are poorly defined. Patients and methods This was a Spanish transplant group and cell therapy (GETH) multicenter retrospective observational study, which included a large cohort of blood cancer patients with laboratory-confirmed SARS-CoV-2 infection through PCR assays from March 1st 2020 to May 15th 2020. Results We included 367 pediatric and adult patients with hematological malignancies, including recipients of autologous (ASCT) (n = 58) or allogeneic stem cell transplantation (allo-SCT) (n = 65) from 41 hospitals in Spain. Median age of patients was 64 years (range 1–93.8). Recipients of ASCT and allo-SCT showed lower mortality rates (17% and 18%, respectively) compared to non-SCT patients (31%) (p = 0.02). Prognostic factors identified for day 45 overall mortality (OM) by logistic regression multivariate analysis included age > 70 years [odds ratio (OR) 2.1, 95% confidence interval (CI) 1.2–3.8, p = 0.011]; uncontrolled hematological malignancy (OR 2.9, 95% CI 1.6–5.2, p 20 mg/dL (OR 3.3, 95% CI 1.7–6.4, p

Published
2020

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

Author

Grau, Santiago, Azanza Perea, José Ramón, Ruiz, Isabel, Vallejo, Carlos, Mensa, Josep, Maertens, Johan, Heinz, Werner J., Barrueta, Jon Andoni, Peral, Carmen, Mesa, Francisco Jesús, Barrado, Miguel, Charbonneau, Claudie, Rubio-Rodríguez, Darío, Rubio-Terrés, Carlos, Universitat Autònoma de Barcelona, Institut Català de la Salut, [Grau S] Pharmacy Department, Hospital del Mar, Universitat Autònoma de Barcelona, Bellaterra, Spain. [Azanza JR] Clinical Pharmacology Department, Clínica Universidad de Navarra, Pamplona. [Ruiz I] Servei de Malalties Infeccioses, Vall d’Hebron Hospital Universitari, Barcelona, Spain. [Vallejo C] Hematology Department, Hospital Universitario Donostia, San Sebastián. [Mensa J] Infectious Diseases Department, Hospital Clínic de Barcelona, Barcelona, Spain. [Maertens J] Hematology Department, University Hospital Gasthuisberg, Leuven, Belgium, and Vall d'Hebron Barcelona Hospital Campus

Subjects
0301 basic medicine, Hematologia -- Malalties, medicine.medical_specialty, Combination therapy, genetic structures, Cost effectiveness, 030106 microbiology, Economics, Econometrics and Finance (miscellaneous), Otros calificadores::Otros calificadores::/farmacoterapia [Otros calificadores], Other subheadings::Other subheadings::/drug therapy [Other subheadings], Anidulafungin, anidulafungin, enfermedades hematológicas y linfáticas::enfermedades hematológicas [ENFERMEDADES], 03 medical and health sciences, Internal medicine, voriconazole, medicine, Adverse effect, cost-effectiveness, Original Research, Voriconazole, invasive aspergillosis, localizaciones geográficas::Europa (continente)::España [DENOMINACIONES GEOGRÁFICAS], Health Care Economics and Organizations::Economics::Costs and Cost Analysis [HEALTH CARE], business.industry, Assistència sanitària - Cost - Catalunya, Health Policy, Hemic and Lymphatic Diseases::Hematologic Diseases [DISEASES], Cost-effectiveness analysis, medicine.disease, Confidence interval, Surgery, ClinicoEconomics and Outcomes Research, body regions, Geographic Locations::Europe::Spain [GEOGRAPHICALS], economía y organizaciones para la atención de la salud::economía::costes y análisis de costes [ATENCIÓN DE SALUD], Hematologic disease, galactomannan, Galactomannan, Sang - Malalties, Invasive aspergillosis, Cost-effectiveness, sense organs, business, Medicaments, medicine.drug
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

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