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"apellidos" => "Gil Salom" ] ] ] ] ] "idiomaDefecto" => "es" "EPUB" => "https://multimedia.elsevier.es/PublicationsMultimediaV1/item/epub/S0210480608738725?idApp=UINPBA00004N" "url" => "/02104806/0000003200000005/v1_201304251907/S0210480608738725/v1_201304251907/es/main.assets" ] "es" => array:12 [ "idiomaDefecto" => true "titulo" => "Efectividad y tolerabilidad del ácido zoledrónico en el tratamiento del cancer de próstata metastásico" "tieneTextoCompleto" => 0 "paginas" => array:1 [ 0 => array:2 [ "paginaInicial" => "492" "paginaFinal" => "501" ] ] "autores" => array:1 [ 0 => array:4 [ "autoresLista" => "J.M. Cózar Olmo, J. Carballido Rodríguez, P. Luque Galvez, A.G. Tabernero Gómez, A. Barreiro Mouro, E. Sánchez Sánchez, C. González Enguita, J. Alcover García, E. García-Galisteo, J.M. Abascal García, M. Sánchez Chapado, F. GómezVeiga, R.J. Minguez Martínez, A. Rodríguez Antolín, R.A. Medina López, M. Rico Morales, F.J. Regadera Sejas, S. Búcar Terrades, D. Jamardo González, R. 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"apellidos" => "Jamardo González" "referencia" => array:1 [ 0 => array:2 [ "etiqueta" => "<span class="elsevierStyleSup">18</span>" "identificador" => "aff0090" ] ] ] 19 => array:3 [ "nombre" => "R." "apellidos" => "Gálvez" "referencia" => array:1 [ 0 => array:2 [ "etiqueta" => "<span class="elsevierStyleSup">19</span>" "identificador" => "aff0095" ] ] ] ] "afiliaciones" => array:19 [ 0 => array:3 [ "entidad" => "Servicio de Urología H. Universitario Virgen de las Nieves, Granada" "etiqueta" => "<span class="elsevierStyleSup">1</span>" "identificador" => "aff0005" ] 1 => array:3 [ "entidad" => "Unidad de Urología H. Puerta de Hierro, Madrid" "etiqueta" => "<span class="elsevierStyleSup">2</span>" "identificador" => "aff0010" ] 2 => array:3 [ "entidad" => "Servicio de Urología H. Clínico Provincial de Barcelona" "etiqueta" => "<span class="elsevierStyleSup">3</span>" "identificador" => "aff0015" ] 3 => array:3 [ "entidad" => "Unidad de Urología H. La Paz, Madrid" "etiqueta" => "<span class="elsevierStyleSup">4</span>" "identificador" => "aff0020" ] 4 => array:3 [ "entidad" => "Servicio de Urología Complejo Hospitalario de Ourense (H. Cristal), Ourense" "etiqueta" => "<span class="elsevierStyleSup">5</span>" "identificador" => "aff0025" ] 5 => array:3 [ "entidad" => "Servicio de Urología H. Virgen de la Macarena, Sevilla" "etiqueta" => "<span class="elsevierStyleSup">6</span>" "identificador" => "aff0030" ] 6 => array:3 [ "entidad" => "Servicio de Urología Fundación Jiménez Díaz, Madrid" "etiqueta" => "<span class="elsevierStyleSup">7</span>" "identificador" => "aff0035" ] 7 => array:3 [ "entidad" => "División de Urología, Universidad Estatal de Campinas - Unicamp, São Paulo, Brazil" "etiqueta" => "<span class="elsevierStyleSup">8</span>" "identificador" => "aff0040" ] 8 => array:3 [ "entidad" => "Servicio de Urología H. Central de Asturias, Oviedo" "etiqueta" => "<span class="elsevierStyleSup">9</span>" "identificador" => "aff0045" ] 9 => array:3 [ "entidad" => "Servicio de Urología H. Príncipe de Asturias, Alcalá de Henares" "etiqueta" => "<span class="elsevierStyleSup">10</span>" "identificador" => "aff0050" ] 10 => array:3 [ "entidad" => "Servicio de Urología H. Juan Canalejo, A Coruña" "etiqueta" => "<span class="elsevierStyleSup">11</span>" "identificador" => "aff0055" ] 11 => array:3 [ "entidad" => "Servicio de Urología H. La Princesa, Madrid" "etiqueta" => "<span class="elsevierStyleSup">12</span>" "identificador" => "aff0060" ] 12 => array:3 [ "entidad" => "Servicio de Urología H. Universitario 12 de Octubre, Madrid" "etiqueta" => "<span class="elsevierStyleSup">13</span>" "identificador" => "aff0065" ] 13 => array:3 [ "entidad" => "Servicio de Urología H. Virgen del Rocío, Sevilla" "etiqueta" => "<span class="elsevierStyleSup">14</span>" "identificador" => "aff0070" ] 14 => array:3 [ "entidad" => "Servicio de Urología H. Xeral-Calde, Lu" "etiqueta" => "<span class="elsevierStyleSup">15</span>" "identificador" => "aff0075" ] 15 => array:3 [ "entidad" => "Servicio de Urología H. Central de Asturias, Oviedo" "etiqueta" => "<span class="elsevierStyleSup">16</span>" "identificador" => "aff0080" ] 16 => array:3 [ "entidad" => "Servicio de Urología H. Municipal de Badalona" "etiqueta" => "<span class="elsevierStyleSup">17</span>" "identificador" => "aff0085" ] 17 => array:3 [ "entidad" => "Servicio de Urología H. Meixoeiro de Vigo" "etiqueta" => "<span class="elsevierStyleSup">18</span>" "identificador" => "aff0090" ] 18 => array:3 [ "entidad" => "Servicio de Unidad del Dolor H. Universitario Virgen de las Nieves, Granada" "etiqueta" => "<span class="elsevierStyleSup">19</span>" "identificador" => "aff0095" ] ] "correspondencia" => array:1 [ 0 => array:3 [ "identificador" => "cor0005" "etiqueta" => "20" "correspondencia" => "Correspondencia autor: Dr. J.M. Cózar Olmo Servicio de Urología. Hospital Universitario Virgen de las Nieves. Avda. Fuerzas Armadas, nº2 - 18014 Granada Tel: 686873340/Fax: 958020145" ] ] ] ] "titulosAlternativos" => array:1 [ "en" => array:1 [ "titulo" => "Effectiveness and tolerability of zoledronic acid in the treatment of metastatic prostate cancer" ] ] "pdfFichero" => "main.pdf" "tienePdf" => true "PalabrasClave" => array:2 [ "es" => array:1 [ 0 => array:4 [ "clase" => "keyword" "titulo" => "Palabras clave" "identificador" => "xpalclavsec88599" "palabras" => array:4 [ 0 => "Cáncer de próstata metastásico" 1 => "Ácido Zoledrónico" 2 => "Eventos óseos" 3 => "Calidad de vida" ] ] ] "en" => array:1 [ 0 => array:4 [ "clase" => "keyword" "titulo" => "Key words" "identificador" => "xpalclavsec88600" "palabras" => array:4 [ 0 => "Metastatic prostate cancer" 1 => "Zoledronic acid" 2 => "Skeletal events" 3 => "Quality of life" ] ] ] ] "tieneResumen" => true "resumen" => array:2 [ "es" => array:2 [ "titulo" => "Resumen" "resumen" => "<span class="elsevierStyleSectionTitle">Objetivos</span><p id="spar0005" class="elsevierStyleSimplePara elsevierViewall">Evaluar la efectividad y tolerabilidad del ácido zoledrónico en pacientes con cáncer de próstata y metástasis óseas en fase hormonosensible (HS) y hormonoindependiente (HI)</p> <span class="elsevierStyleSectionTitle">Material y Métodos</span><p id="spar0010" class="elsevierStyleSimplePara elsevierViewall">Se diseñó un estudio de ámbito nacional, observacional, prospectivo, abierto, y multicéntrico, Se incluyeron un total de 218 varones diagnosticados de cáncer de próstata en fase HS (36%) o HI (64%) que recibieron, además del tratamiento oncológico específico, ácido zoledrónico (4 mg/IV/mes durante 6 meses)</p><p id="spar0015" class="elsevierStyleSimplePara elsevierViewall">Se evaluó la efectividad mediante: 1) Evaluación de la mejoría del dolor y movilidad; 2) Incidencia y tiempo de aparición de eventos esqueléticos (TEE); y 3) Análisis de marcadores óseos</p><p id="spar0020" class="elsevierStyleSimplePara elsevierViewall">La tolerabilidad se estudió registrando el número y tipo de efectos adversos. Se realizó una encuesta de satisfacción al paciente tras finalizar el tratamiento</p> <span class="elsevierStyleSectionTitle">Resultados</span><p id="spar0025" class="elsevierStyleSimplePara elsevierViewall">De los 218 pacientes, 170 (78%) fueron evaluables para efectividad. En todos ellos, ya fueran del grupo HS o HI, se observó una disminución de la puntuación del dolor en reposo y en movimiento (p>0,0001), una mejora en la movilidad (p=0,005), y en la calidad de vida</p><p id="spar0030" class="elsevierStyleSimplePara elsevierViewall">La incidencia global de eventos esqueléticos fue del 11,2%, con un TEE de 10,7 meses. No hubo diferencias significativas entre los pacientes HS respecto a los HI. Los marcadores de osteolisis (N-telopéptido) descendieron significativamente con el tratamiento, tanto en los HS como HI</p><p id="spar0035" class="elsevierStyleSimplePara elsevierViewall">Para seguridad fueron evaluables 212 pacientes (97,2%). La incidencia de las reacciones adversas fue del 16% (34/212), siendo significativamente mayor en los pacientes HS (22,4%) con respecto a los HI (11,9%). Globalmente la tolerabilidad al ácido zoledrónico fue buena, sin morbilidad significativa entre ambos grupos (HS y HI)</p><p id="spar0040" class="elsevierStyleSimplePara elsevierViewall">Un 66% de los pacientes contestaron sentirse satisfechos o muy satisfechos</p> <span class="elsevierStyleSectionTitle">Conclusiones</span><p id="spar0045" class="elsevierStyleSimplePara elsevierViewall">El ácido zoledrónico se mostró eficaz para aliviar el dolor, mejorar la movilidad y aumentar la calidad de vida y reducir o retrasar los eventos esqueléticos en los pacientes con cáncer de próstata con enfermedad ósea metastásica sintomática, independientemente de la fase, HS o HI en que se encuentren. La tolerabilidad y la satisfacción de los pacientes fue buena</p>" ] "en" => array:2 [ "titulo" => "Abstract" "resumen" => "<span class="elsevierStyleSectionTitle">Objetives</span><p id="spar0050" class="elsevierStyleSimplePara elsevierViewall">To assess the effectiveness and tolerability of zoledronic acid in prostate cancer patients with bone metastases at the hormone-sensitive (HS) and hormone-independent (HI) stages</p> <span class="elsevierStyleSectionTitle">Materials and Methods</span><p id="spar0055" class="elsevierStyleSimplePara elsevierViewall">A nationwide, observational, prospective, open and multi-centre trial was devised, with a total of 218 male patients diagnosed with prostate cancer at the HS stage (36%) or HI stage (64%) who were administered zoledronic acid (4 mg/IV/month for 6 months) in addition to their specific oncological treatment</p><p id="spar0060" class="elsevierStyleSimplePara elsevierViewall">Effectiveness was assessed by the following means: 1) Assessment of the improvement in pain and mobility; 2) Incidence and time to onset of skeletal-related events (SREs) and 3) Analysis of bone markers</p><p id="spar0065" class="elsevierStyleSimplePara elsevierViewall">Tolerability was assessed by means of registering the number and type of adverse effects. A satisfaction survey was carried out amongst the patients after the end of the trial</p> <span class="elsevierStyleSectionTitle">Results</span><p id="spar0070" class="elsevierStyleSimplePara elsevierViewall">Out of the 218 patients, 170 (78%) were evaluable for effectiveness. A decrease in pain ratings at rest and during movement was observed in all patients, whether in the HS or HI groups (p<0,0001). Improved mobility was observed likewise (p=0,005), as was quality of life</p><p id="spar0075" class="elsevierStyleSimplePara elsevierViewall">The global incidence of skeletal events was 11.2%, with a time to onset of SREs of 10.7 months. There were no significant differences observed between HS vs. HI patients</p><p id="spar0080" class="elsevierStyleSimplePara elsevierViewall">Osteolysis markers (N-telopeptide) decreased significantly with the treatment across both the HS and HI groups</p><p id="spar0085" class="elsevierStyleSimplePara elsevierViewall">For safety reasons, 212 patients were evaluable (97.2%). The incidence of adverse drug reactions was 16% (34/212) and was found to be significantly higher in HS patients (22.4%) compared with HI patients (11.9%). Overall, the tolerability of zoledronic acid was good, with no significant morbidity in either group (HS and HI). 66% of the patients reported feeling satisfied or very satisfied</p> <span class="elsevierStyleSectionTitle">Conclusions</span><p id="spar0090" class="elsevierStyleSimplePara elsevierViewall">Zoledronic acid proved effective in the relief of pain, improving mobility and quality of life as well as reducing or delaying the occurrence of skeletal-related events in prostate cancer patients presenting metastatic bone disease, regardless of the phase, whether HS or HI, they found themselves in. Tolerability and patient satisfaction were rates as good</p>" ] ] "bibliografia" => array:2 [ "titulo" => "Referencias" "seccion" => array:1 [ 0 => array:2 [ "identificador" => "bibs0005" "bibliografiaReferencia" => array:18 [ 0 => array:3 [ "identificador" => "bib0005" "etiqueta" => "1." 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Efectividad y tolerabilidad del ácido zoledrónico en el tratamiento del cancer de próstata metastásico
Effectiveness and tolerability of zoledronic acid in the treatment of metastatic prostate cancer
J.M. Cózar Olmo1,20
, J. Carballido Rodríguez2, P. Luque Galvez3, A.G. Tabernero Gómez4, A. Barreiro Mouro5, E. Sánchez Sánchez6, C. González Enguita7, J. Alcover García3, E. García-Galisteo8, J.M. Abascal García9, M. Sánchez Chapado10, F. GómezVeiga11, R.J. Minguez Martínez12, A. Rodríguez Antolín13, R.A. Medina López14, M. Rico Morales15, F.J. Regadera Sejas16, S. Búcar Terrades17, D. Jamardo González18, R. Gálvez19
Autor para correspondencia
cozarjm@yahoo.es
Correspondencia autor: Dr. J.M. Cózar Olmo Servicio de Urología. Hospital Universitario Virgen de las Nieves. Avda. Fuerzas Armadas, nº2 - 18014 Granada Tel: 686873340/Fax: 958020145
Correspondencia autor: Dr. J.M. Cózar Olmo Servicio de Urología. Hospital Universitario Virgen de las Nieves. Avda. Fuerzas Armadas, nº2 - 18014 Granada Tel: 686873340/Fax: 958020145
1 Servicio de Urología H. Universitario Virgen de las Nieves, Granada
2 Unidad de Urología H. Puerta de Hierro, Madrid
3 Servicio de Urología H. Clínico Provincial de Barcelona
4 Unidad de Urología H. La Paz, Madrid
5 Servicio de Urología Complejo Hospitalario de Ourense (H. Cristal), Ourense
6 Servicio de Urología H. Virgen de la Macarena, Sevilla
7 Servicio de Urología Fundación Jiménez Díaz, Madrid
8 División de Urología, Universidad Estatal de Campinas - Unicamp, São Paulo, Brazil
9 Servicio de Urología H. Central de Asturias, Oviedo
10 Servicio de Urología H. Príncipe de Asturias, Alcalá de Henares
11 Servicio de Urología H. Juan Canalejo, A Coruña
12 Servicio de Urología H. La Princesa, Madrid
13 Servicio de Urología H. Universitario 12 de Octubre, Madrid
14 Servicio de Urología H. Virgen del Rocío, Sevilla
15 Servicio de Urología H. Xeral-Calde, Lu
16 Servicio de Urología H. Central de Asturias, Oviedo
17 Servicio de Urología H. Municipal de Badalona
18 Servicio de Urología H. Meixoeiro de Vigo
19 Servicio de Unidad del Dolor H. Universitario Virgen de las Nieves, Granada
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Efectividad y tolerabilidad del ácido zoledrónico en el tratamiento del cancer de próstata metastásico
J.M. Cózar Olmo, J. Carballido Rodríguez, P. Luque Galvez, A.G. Tabernero Gómez, A. Barreiro Mouro, E. Sánchez Sánchez, C. González Enguita, J. Alcover García, E. García-Galisteo, J.M. Abascal García, M. Sánchez Chapado, F. GómezVeiga, R.J. Minguez Martínez, A. Rodríguez Antolín, R.A. Medina López, M. Rico Morales, F.J. Regadera Sejas, S. Búcar Terrades, D. Jamardo González, R. Gálvez
10.1016/S0210-4806(08)73873-7Actas Urol Esp. 2008;32:492-501