[Effectiveness and tolerability of zoledronic acid in the treatment of metastatic prostate cancer]. / Efectividad y tolerabilidad del acido zoledrónico en el tratamiento del cancer de próstata metastásico.

OBJECTIVES: 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. MATERIALS AND METHODS: 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. 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. 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. RESULTS: 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. 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. Osteolysis markers (N-telopeptide) decreased significantly with the treatment across both the HS and HI groups. 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. CONCLUSIONS: 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.

Efectividad y tolerabilidad del ácido zoledrónico en el tratamiento del cancer de próstata metastásico / Effectiveness and tolerability oz zoledronic acid in the treatment of metastatic prostate cancer

Objetivos: Evaluar la efectividad y tolerabilidad del ácido zoledrónico en pacientes con cáncer de próstata y metástasis óseas en fase hormono sensible (HS) y hormono independiente (HI). Material y Métodos: 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). 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. La tolerabilidad se estudió registrando el número y tipo de efectos adversos. Se realizó una encuesta de satisfacción al paciente tras finalizar el tratamiento. Resultados: 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. 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. 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).Un 66% de los pacientes contestaron sentirse satisfechos o muy satisfechos. Conclusiones: El ácido zoledrónico se mostró eficaz para aliviar el dolor, mejorar la movilidad y aumentar la calidad de vida y reducir o retrasarlos eventos esqueléticos en los pacientes con cáncer de próstata con enfermedad ósea metastásica sintomática, independientemente de la fase, HSo HI en que se encuentren. La tolerabilidad y la satisfacción de los pacientes fue buena (AU)

Objetives: 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. Materials and Methods: 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. 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. 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. Results: 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. 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. Osteolysis markers (N-telopeptide) decreased significantly with the treatment across both the HS and HI groups. 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. Conclusions: 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 (AU)