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L., Barcelona, Spain" "etiqueta" => "c" "identificador" => "aff0010" ] 3 => array:3 [ "entidad" => "Hospital de la Santa Creu i Sant Pau, Barcelona, Spain" "etiqueta" => "d" "identificador" => "aff0015" ] ] "correspondencia" => array:1 [ 0 => array:3 [ "identificador" => "cor0005" "etiqueta" => "⁎" "correspondencia" => "Corresponding author." ] ] ] ] "titulosAlternativos" => array:1 [ "es" => array:1 [ "titulo" => "Estado actual de la leucemia mieloide aguda en España: Resultados de un estudio Delphi sobre su epidemiología, manejo de la enfermedad y necesidades clínicas no cubiertas" ] ] "resumenGrafico" => array:2 [ "original" => 0 "multimedia" => array:7 [ "identificador" => "fig0005" "etiqueta" => "Fig. 1" "tipo" => "MULTIMEDIAFIGURA" "mostrarFloat" => true "mostrarDisplay" => false "figura" => array:1 [ 0 => array:4 [ "imagen" => "gr1.jpeg" "Alto" => 1482 "Ancho" => 2175 "Tamanyo" => 245625 ] ] "descripcion" => array:1 [ "en" => "<p id="spar0005" class="elsevierStyleSimplePara elsevierViewall">Treatment algorithm of AML patients in Spain.</p>" ] ] ] "textoCompleto" => "<span class="elsevierStyleSections"><p id="par0005" class="elsevierStylePara elsevierViewall">Acute myeloid leukaemia (AML) is a rapidly progressing and life-threatening malignant disease. Unfortunately, this disease remains incurable in a majority of patients, particularly in the elderly.<a class="elsevierStyleCrossRef" href="#bib0030"><span class="elsevierStyleSup">1</span></a></p><p id="par0010" class="elsevierStylePara elsevierViewall">Information about AML in Spain is limited; to assess its epidemiology, management, impact on patient-reported outcomes, use of resources and key unmet needs in our country, we conducted a two-round Delphi study with 17 haematologists from 11 Spanish regions. The Delphi technique allows obtaining information based on the opinion of experts who know the disease and treat patients with AML in real clinical practice.</p><p id="par0015" class="elsevierStylePara elsevierViewall">Estimated prevalence in Spain in the last five years is 12,493. Every year, there are approximately 1903 incident patients with AML in Spain (overall incidence rate: 3.7 cases/100,000; 13.7 cases/100,000 in patients ≥65 years), in line with that reported in Europe.<a class="elsevierStyleCrossRef" href="#bib0035"><span class="elsevierStyleSup">2</span></a> Most patients have <span class="elsevierStyleItalic">de novo</span> AML and are ≥65 years old. AML is associated with marrow infiltration and insufficient haematopoiesis leading to severe symptoms and high mortality rate (67% at 5 years).</p><p id="par0020" class="elsevierStylePara elsevierViewall">Clinical guidelines used in Spain are from the Programa Español de Tratamientos en Hematología (PETHEMA) Group and the CETLAM group (Grupo Cooperativo de Estudio y Tratamiento de las Leucemias Agudas y Mielodisplasias). Standard treatment involves repeated courses of induction with the ‘7<span class="elsevierStyleHsp" style=""></span>+<span class="elsevierStyleHsp" style=""></span>3’regimen [cytarabine (7 days) and daunorubicin/idarubicin (3 days)] followed by post-remission therapy [consolidation with/without haematopoietic stem cell transplantation (HSCT)] (<a class="elsevierStyleCrossRef" href="#fig0005">Fig. 1</a>). Patient hospitalisation for up to 1 month per cycle is required involving transfusions and antibacterial agents representing a substantial burden for patients and the healthcare system.<a class="elsevierStyleCrossRef" href="#bib0040"><span class="elsevierStyleSup">3</span></a> Standard therapies have not consistently improved over the last 20 years. The exception is the higher accessibility to allogeneic HSCT, due to higher access to alternative donors and the increase of the upper age limit for the procedure with the introduction of reduced-intensity conditioning regimens. Persistent mortality rates in AML are mostly due to resistance to and the sometimes lethal complications of therapy. Recent incorporation of midostaurin or gemtuzumab ozogamicin to standard combination chemotherapy, as well as the liposomal cytarabine/daunorubicin formulation lead to improved survival of certain subsets of AML (e.g. sAML).<a class="elsevierStyleCrossRefs" href="#bib0045"><span class="elsevierStyleSup">4,5</span></a></p><elsevierMultimedia ident="fig0005"></elsevierMultimedia><p id="par0025" class="elsevierStylePara elsevierViewall">Prior to treatment selection, patients are classified according to features such as patient age, medical comorbidities, performance status and underlying genetic features including cytogenetic and molecular aberrations. Therapy allocation is based on probability of response and expected tolerability to intensive chemotherapy, as well as potential curability of the disease with consolidation therapy with or without subsequent HSCT. Patients with the best prognosis are those with <span class="elsevierStyleItalic">de novo</span> AML and <65 years (estimated median survival of 16.5 months and long-term survival in remission of 45% of patients). In this group, prognosis improves in the presence of favourable genetic features with curability rates >60%. Patients with the worst prognosis are those ≥65 years diagnosed with secondary AML (estimated average survival time 6.8 months and long-term survival <10%). It is estimated that in patients up to the age of 70, 50% of AML patients will reach the HSCT phase, remaining practically anecdotal above that age.</p><p id="par0030" class="elsevierStylePara elsevierViewall">The estimated overall cost of treating a patient with AML in Spain ranges between 92,934€ and 108,228€, including pharmacological costs of intensive chemotherapy (induction and consolidation phases), hospitalisation costs plus healthcare resources utilisation and allogeneic HSCT. For patients undergoing autologous HSCT, the cost could range between 59,879€ and 75,173€ per patient.<a class="elsevierStyleCrossRef" href="#bib0040"><span class="elsevierStyleSup">3</span></a> Hospitalisation and use of healthcare resources account for approximately 95% of the total costs of treating a patient with AML.<a class="elsevierStyleCrossRef" href="#bib0040"><span class="elsevierStyleSup">3</span></a></p><p id="par0035" class="elsevierStylePara elsevierViewall">Key unmet needs in Spain were identified and proposed actions included: (1) encourage participation in a national epidemiological registry for AML in Spain supported by the healthcare administration; (2) need for new therapies with increased efficacy and safety; (3) inclusion of HRQoL data in clinical trials; (4) promote information exchange among collaborative groups and centralise complex diagnostic tests in certain centres; (5) need for cost-effectiveness studies; (6) provide training by experts in the pathology to all healthcare personnel involved in the management of AML patients.</p><p id="par0040" class="elsevierStylePara elsevierViewall">The study provides current estimates on epidemiology, patient flow, disease management and main unmet needs for AML patients in Spain. Data reported would benefit from further ratification by a larger number of experts and the analyses of data from existing national AML registries.</p><span id="sec0005" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0005">Funding</span><p id="par0055" class="elsevierStylePara elsevierViewall">The study and the writing of this letter was sponsored by Jazz Pharmaceuticals.</p></span></span>" "textoCompletoSecciones" => array:1 [ "secciones" => array:3 [ 0 => array:2 [ "identificador" => "sec0005" "titulo" => "Funding" ] 1 => array:2 [ "identificador" => "xack532961" "titulo" => "Acknowledgements" ] 2 => array:1 [ "titulo" => "References" ] ] ] "pdfFichero" => "main.pdf" "tienePdf" => true "multimedia" => array:1 [ 0 => array:7 [ "identificador" => "fig0005" "etiqueta" => "Fig. 1" "tipo" => "MULTIMEDIAFIGURA" "mostrarFloat" => true "mostrarDisplay" => false "figura" => array:1 [ 0 => array:4 [ "imagen" => "gr1.jpeg" "Alto" => 1482 "Ancho" => 2175 "Tamanyo" => 245625 ] ] "descripcion" => array:1 [ "en" => "<p id="spar0005" class="elsevierStyleSimplePara elsevierViewall">Treatment algorithm of AML patients in Spain.</p>" ] ] ] "bibliografia" => array:2 [ "titulo" => "References" "seccion" => array:1 [ 0 => array:2 [ "identificador" => "bibs0015" "bibliografiaReferencia" => array:5 [ 0 => array:3 [ "identificador" => "bib0030" "etiqueta" => "1" "referencia" => array:1 [ 0 => array:2 [ "contribucion" => array:1 [ 0 => array:2 [ "titulo" => "Sequential administration of gemtuzumab ozogamicin and conventional chemotherapy as first line therapy in elderly patients with acute myeloid leukemia: a Phase II study (AML-15) of the EORTC and GIMEMA leukemia groups" "autores" => array:1 [ 0 => array:2 [ "etal" => true "autores" => array:6 [ 0 => "S. Amadori" 1 => "S. Suciu" 2 => "R. Willemze" 3 => "F. Mandelli" 4 => "D. Selleslag" 5 => "R. Stauder" ] ] ] ] ] "host" => array:1 [ 0 => array:1 [ "Revista" => array:3 [ "tituloSerie" => "Haematologica" "fecha" => "2004" "paginaInicial" => "89" ] ] ] ] ] ] 1 => array:3 [ "identificador" => "bib0035" "etiqueta" => "2" "referencia" => array:1 [ 0 => array:2 [ "contribucion" => array:1 [ 0 => array:2 [ "titulo" => "Incidence, survival and prevalence of myeloid malignancies in Europe" "autores" => array:1 [ 0 => array:2 [ "etal" => true "autores" => array:6 [ 0 => "O. Visser" 1 => "A. Trama" 2 => "M. Maynadié" 3 => "C. Stiller" 4 => "R. Marcos-Gragera" 5 => "R. 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Value Health. 2018;21:S447 ISPOR 21st Annual Congress." ] ] ] 3 => array:3 [ "identificador" => "bib0045" "etiqueta" => "4" "referencia" => array:1 [ 0 => array:2 [ "contribucion" => array:1 [ 0 => array:2 [ "titulo" => "Midostaurin, enasidenib, CPX-351, gemtuzumab ozogamicin, and venetoclax bring new hope to AML" "autores" => array:1 [ 0 => array:2 [ "etal" => false "autores" => array:2 [ 0 => "A.H. Wei" 1 => "I.S. Tiong" ] ] ] ] ] "host" => array:1 [ 0 => array:2 [ "doi" => "10.1182/blood-2017-08-784066" "Revista" => array:6 [ "tituloSerie" => "Blood" "fecha" => "2017" "volumen" => "130" "paginaInicial" => "2469" "paginaFinal" => "2474" "link" => array:1 [ 0 => array:2 [ "url" => "https://www.ncbi.nlm.nih.gov/pubmed/29051180" "web" => "Medline" ] ] ] ] ] ] ] ] 4 => array:3 [ "identificador" => "bib0050" "etiqueta" => "5" "referencia" => array:1 [ 0 => array:2 [ "contribucion" => array:1 [ 0 => array:2 [ "titulo" => "Reformulating acute myeloid leukemia: liposomal cytarabine and daunorubicin (CPX-351) as an emerging therapy for secondary AML" "autores" => array:1 [ 0 => array:2 [ "etal" => false "autores" => array:3 [ 0 => "E.C. Chen" 1 => "A.T. Fathi" 2 => "A.M. Brunner" ] ] ] ] ] "host" => array:1 [ 0 => array:2 [ "doi" => "10.2147/OTT.S141212" "Revista" => array:6 [ "tituloSerie" => "Onco Targets Ther" "fecha" => "2018" "volumen" => "11" "paginaInicial" => "3425" "paginaFinal" => "3434" "link" => array:1 [ 0 => array:2 [ "url" => "https://www.ncbi.nlm.nih.gov/pubmed/29928134" "web" => "Medline" ] ] ] ] ] ] ] ] ] ] ] ] "agradecimientos" => array:1 [ 0 => array:4 [ "identificador" => "xack532961" "titulo" => "Acknowledgements" "texto" => "<p id="par0045" class="elsevierStylePara elsevierViewall">We thank the participation of doctors L. Algarra, C. Barrenetxea, M. Cervera, M. Colorado, L. Costilla, J. Esteve, A. Garrido, S. Jiménez, J. Labrador, E. Lavilla, J.L. López, M. Olave, P. Martínez, A. Novo, C. Pedro, J.A. Pérez-Simón,</p><p id="par0050" class="elsevierStylePara elsevierViewall">M.A. Sanz, J. Serrano, M.R. Varela, B. Vidriales, and M.A. Cebollero and V. Ortiz for their contribution to this study. The study and the writing of this letter was sponsored by Jazz Pharmaceuticals.</p>" "vista" => "all" ] ] ] "idiomaDefecto" => "en" "url" => "/00257753/0000015600000011/v1_202105290524/S0025775320303559/v1_202105290524/en/main.assets" "Apartado" => array:4 [ "identificador" => "66447" "tipo" => "SECCION" "es" => array:2 [ "titulo" => "Cartas científicas" "idiomaDefecto" => true ] "idiomaDefecto" => "es" ] "PDF" => "https://static.elsevier.es/multimedia/00257753/0000015600000011/v1_202105290524/S0025775320303559/v1_202105290524/en/main.pdf?idApp=UINPBA00004N&text.app=https://www.elsevier.es/" "EPUB" => "https://multimedia.elsevier.es/PublicationsMultimediaV1/item/epub/S0025775320303559?idApp=UINPBA00004N" ]
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Current status of acute myeloid leukaemia in Spain: Results from a Delphi study on its epidemiology, disease management and unmet clinical needs
Estado actual de la leucemia mieloide aguda en España: Resultados de un estudio Delphi sobre su epidemiología, manejo de la enfermedad y necesidades clínicas no cubiertas
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Current status of acute myeloid leukaemia in Spain: Results from a Delphi study on its epidemiology, disease management and unmet clinical needs
Pau Montesinos, Alicia Gil, Jorge Sierra
10.1016/j.medcle.2021.05.001Med Clin. 2021;156:573-4