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2. Risk factors and outcome of COVID-19 in patients with hematological malignancies
- Author
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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
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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
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- 2020
3. Real-World Outcomes of Belantamab Mafodotin for Relapsed/Refractory Multiple Myeloma (RRMM): Preliminary Results of a Spanish Expanded Access Program (EAP).
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Alegre A, Benzo G, Alonso R, Martínez-López J, Jimenez-Ubieto A, Cuéllar C, Askari E, Prieto E, Aláez C, Aguado B, Velasco A, Krsnik I, Bocanegra A, Llorente L, Muñoz-Linares C, Morales A, Giménez E, Iglesias R, Martínez-Chamorro C, Alonso A, Jiménez-Montes C, and Blanchard MJ
- Abstract
Introduction: Belantamab mafodotin (BM) is a new anti-BCMA antibody-drug conjugate, recently approved for triple-class relapsed and refractory multiple myeloma (RRMM). We assessed real-world outcomes with BM in patients under the Spanish Expanded Access Program (EAP)., Methods: We conducted an observational, retrospective, multicenter study including RRMM patients who received ≥ 1 dose of BM (Nov 2019 to Jun 2021). The primary endpoint was overall response rate (ORR). Secondary endpoints were progression-free survival (PFS), overall survival (OS), and incidence of treatment-emergent adverse events (TEAEs)., Results: Thirty-three patients were included with a median of 70 years of age (range, 46-79 years). Median time from diagnosis was 71 months (range, 10-858 months). Median prior lines was 5 (range, 3-8 lines); 90% of patients were triple-/quad-/penta-refractory; 48% showed high-risk cytogenetics. Median BM doses was 3 (range 1-16 doses), with a median follow-up of 11 months (6-15 months). ORR was 42.2% (≥ VGPR, 18.2%). Median PFS was 3 months (95% CI 0.92-5.08) in the overall population, and 11 months (HR 0.26; 95% CI 0.10-0.68) for patients who achieved ≥ PR. PFS was not significantly different according to age, cytogenetic risk, and prior therapy lines. OS was 424 days (95% CI 107-740). Non-hematological TEAEs (57.6% of patients; 30.3% ≥ G3) included keratopathy (51.5%; 21.2% ≥ G3) and patient-reported vision-related symptoms (45.5%). Keratopathy was resolved in 70.6% of patients. G3 hematological TEAEs was 18.2%, thrombocytopenia (21.2%). Dose reductions due to TEAEs: 30.3%; delays: 36.4%. Treatment discontinuation causes: progression (54.5%), toxicity (non-ocular; 6%/ocular; 6% /ocular + non-ocular toxicity; 3%), death (6%), and patient's decision (3%)., Conclusions: BM showed relevant anti-myeloma activity in RRMM with a manageable safety profile. These results corroborate those observed in the BM pivotal trial., (© 2022. The Author(s).)
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- 2023
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4. Growth of Fee-for-Service Medicare Home-Based Medical Care Within Private Residences and Domiciliary Care Settings in the U.S., 2012-2019.
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Liu B, Ritchie CS, Ankuda CK, Perez-Benzo G, Osakwe ZT, Reckrey JM, Salinger MR, Leff B, and Ornstein KA
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- Aged, Fee-for-Service Plans, House Calls, Humans, Medicaid, United States, Home Care Services, Medicare Part C
- Abstract
Objectives: Home-based medical care (HBMC) delivers physician or advanced practice provider-led medical services for patients in private residences and domiciliary settings (eg, assisted living facilities, group/boarding homes). We aimed to examine the time trends in HBMC utilization by care settings., Design: Analyses of HBMC utilization at the national and state levels during the years 2012-2019., Setting and Participants: With Medicare public use files, we calculated the state-level utilization rate of HBMC among fee-for-service (FFS) Medicare beneficiaries, measured by visits per 1000 FFS enrollees, in private residences and domiciliary settings, both separately and combined., Methods: We assessed the trend of HBMC utilization over time via linear mixed models with random intercept for state, adjusting for the following state-level markers of HBMC supply and demand: number of HBMC providers, state ranking of total assisted living and residential care capacity, and the proportion of FFS beneficiaries with dementia, dual eligibility for Medicaid, receiving home health services, and Medicare Advantage., Results: Total HBMC visits in the United States increased from 3,911,778 in 2012 to 5,524,939 in 2019. The median (interquartile range) state-level HBMC utilization rate per 1000 FFS population was 67.6 (34.1-151.3) visits overall, 17.3 (7.9-41.9) visits in private residences, and 47.7 (23.1-86.6) visits in domiciliary settings. The annual percentage increase of utilization rates was significant for all care settings in crude models (3%-8%), and remained significant for overall visits and visits in domiciliary settings (2%-4%), but not in private residences., Conclusions and Implications: The national-level growth in HBMC from 2012-2019 was largely driven by a growth of HBMC occurring in domiciliary settings. To meet the needs of a growing aging population, future studies should focus efforts on policy and payment issues to address inequities in access to HBMC services for homebound older adults, and examine drivers of HBMC growth at regional and local levels., (Copyright © 2022 AMDA – The Society for Post-Acute and Long-Term Care Medicine. Published by Elsevier Inc. All rights reserved.)
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- 2022
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5. Risk factors and outcome of COVID-19 in patients with hematological malignancies.
- Author
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Piñana JL, Martino R, García-García I, Parody R, Morales MD, Benzo G, Gómez-Catalan I, Coll R, De La Fuente I, Luna A, Merchán B, Chinea A, de Miguel D, Serrano A, Pérez C, Diaz C, Lopez JL, Saez AJ, Bailen R, Zudaire T, Martínez D, Jurado M, Calbacho M, Vázquez L, Garcia-Cadenas I, Fox L, Pimentel AI, Bautista G, Nieto A, Fernandez P, Vallejo JC, Solano C, Valero M, Espigado I, Saldaña R, Sisinni L, Ribera JM, Jimenez MJ, Trabazo M, Gonzalez-Vicent M, Fernández N, Talarn C, Montoya MC, Cedillo A, and Sureda A
- 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 < 0.0001); ECOG 3-4 (OR, 2.56, 95% CI 1.4-4.7, p = 0.003); neutropenia (< 0.5 × 10
9 /L) (OR 2.8, 95% CI 1.3-6.1, p = 0.01); and a C-reactive protein (CRP) > 20 mg/dL (OR 3.3, 95% CI 1.7-6.4, p < 0.0001). In multivariate analysis of 216 patients with very severe COVID-19, treatment with azithromycin or low dose corticosteroids was associated with lower OM (OR 0.42, 95% CI 0.2-0.89 and OR 0.31, 95% CI 0.11-0.87, respectively, p = 0.02) whereas the use of hidroxycloroquine did not show significant improvement in OM (OR 0.64, 95% CI 0.37-1.1, P = 0.1)., Conclusions: In most patients with hematological malignancies COVID-19 mortality was directly driven by older age, disease status, performance status, as well as by immune (neutropenia) parameters and level of inflammation (high CRP). Use of azithromycin and low dose corticosteroids may be of value in very severe COVID-19., Competing Interests: Competing interestsThe author(s) declare that they have no conflict of interests., (© The Author(s) 2020.)- Published
- 2020
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