Efectividad de un programa de instilación de quimioterapia precoz en pacientes con cáncer de vejiga / Effectiveness of a program of early instillation single chemotherapy in patients with bladder cancer

Objetivo. Determinar la efectividad de un programa de tratamiento con quimioterapia precoz para pacientes con cáncer vesical no músculo infiltrante antes y después de un plan de formación y comunicación dirigido a los profesionales que intervienen en el mismo. Método. Estudio longitudinal prospectivo, no experimental, de una cohorte de 349 pacientes con diagnóstico endoscópico de tumor vesical no músculo infiltrante en el AGS norte de Cádiz, entre 2010 y 2013, subsidiarios de tratamiento con mitomicina C posoperatoria. Resultados. La tasa media de pacientes incluidos en el programa fue del 53,9%. Esta tasa aumentó un 79,3% a los 3 años. La reducción absoluta del riesgo de recidiva para los pacientes que recibieron QTp fue del 18,1% (IC 95%: 8,8-27,4, p < 0,001), y el número de pacientes necesario a tratar de 5,5 (IC 95%: 3,6-11,3, p < 0,001). Conclusiones. Un programa de quimioterapia precoz postoperatoria que contemple un plan de evaluación y difusión de resultados ha conseguido un adecuado nivel de adherencia entre los profesionales, obteniendo el impacto esperado en la disminución de la recidiva precoz del cáncer de vejiga no músculo infiltrante (AU)

Objective. To determine the effectiveness of early intravesical chemotherapy intervention for patients with non-muscle invasive bladder cancer, before and after a training and inter-professional communication plan. Method. Non-experimental prospective longitudinal study of a cohort of 349 patients with endoscopic diagnosis of a non-muscle invasive bladder tumour in Northern Area Health Management of Cadiz between 2010 and 2013 and amenable to postoperative treatment with mitomycin C. Results. The mean rate of patients included in the program was 53.9%. The inclusion rate rose by 79.3% at 3 years. The absolute risk reduction of recurrence for patients receiving treatment is 18.1% (95% CI; 8.81% - 27.48%, p<.001), and the number of patients needed to treat was 5.5 (95% CI; 3.6 - 11.3, p<.001). Conclusions. A program of early postoperative chemotherapy that includes a plan for evaluation and dissemination of results has achieved a good level of adherence among professionals, obtaining the expected impact on the reduction of early recurrence of non-muscle invasive bladder cancer (AU)

[Effectiveness of a program of early instillation single chemotherapy in patients with bladder cancer]. / Efectividad de un programa de instilación de quimioterapia precoz en pacientes con cáncer de vejiga.

OBJECTIVE: To determine the effectiveness of early intravesical chemotherapy intervention for patients with non-muscle invasive bladder cancer, before and after a training and inter-professional communication plan. METHOD: Non-experimental prospective longitudinal study of a cohort of 349 patients with endoscopic diagnosis of a non-muscle invasive bladder tumour in Northern Area Health Management of Cadiz between 2010 and 2013 and amenable to postoperative treatment with mitomycin C. RESULTS: The mean rate of patients included in the program was 53.9%. The inclusion rate rose by 79.3% at 3 years. The absolute risk reduction of recurrence for patients receiving treatment is 18.1% (95% CI; 8.81% - 27.48%, p<.001), and the number of patients needed to treat was 5.5 (95% CI; 3.6 - 11.3, p<.001). CONCLUSIONS: A program of early postoperative chemotherapy that includes a plan for evaluation and dissemination of results has achieved a good level of adherence among professionals, obtaining the expected impact on the reduction of early recurrence of non-muscle invasive bladder cancer.

[Toxicity of intravesical gemcitabine in superficial bladder cancer treatment]. / Toxicidad de la gemcitabina intravesical en el tratamiento del cáncer de vejiga superficial.

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Toxicidad de la gemcitabina intravesical en el tratamiento del cáncer de vejiga superficial / Toxicity of intravesical gemcitabine in superficial bladder cancer treatment

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Experiencia inicial con acetato de abiraterona en pacientes con cáncer de próstata resistente a la castración / Initial experience with abiraterone acetate in patients with castration-resistant prostate cancer

Objetivo: Describir los resultados obtenidos de la experiencia en el tratamiento con acetato de abiraterona (AA) en 25 hombres con cáncer de próstata metastásico resistente a la castración (CPMRC). Realizamos el análisis comparativo de la eficacia y seguridad de este fármaco en relación con la literatura existente. Material y método: Estudio biinstitucional prospectivo de una cohorte de 25 pacientes consecutivos que reciben tratamiento con AA por CPMRC, con un seguimiento medio 7,9 (3-15) meses. Análisis de la seguridad y eficacia del tratamiento en relación con las características basales de los pacientes (edad, tratamientos previos, PSA basal, performance status, dolor, metástasis). Resultados: La supervivencia global es del 80% a los 13,6 meses de seguimiento (IC 95%: 11,8-15,4). La supervivencia libre de progresión clínico-radiológica de la serie es de 9,5 ± 1 meses (IC 95%: 7,7-11,3) y el de respuesta bioquímica de 6,8 ± 1 meses (IC 95%: 5-8,7). Solo el tratamiento previo con quimioterapia empeora significativamente el tiempo de respuesta a AA (supervivencia libre de progresión radiológica 6,4 meses [IC 95%: 4,2-8,6] y bioquímica de 4,3 meses [IC 95%: 2,6-6]). La incidencia de efectos adversos fue del 36%, todos grado 1-2/4, y en ningún caso requiere suspender o disminuir la dosis de AA. Conclusiones: El tratamiento con AA ha sido eficaz en nuestra serie, con una tolerabilidad considerablemente mayor a lo publicado en otros estudios

Objective: To describe the results obtained in 25 men with metastatic castration-resistant prostate cancer (MCRPC) treated with abiraterone (AA). A comparative analysis of abiraterone effectiveness and safety between our results and data published in the literature was conducted. Materials and method: Bi-institutional prospective analysis of 25 consecutive patients with MCRPC undergoing treatment with abiraterone, with a mean follow-up 7.9 (3-15) months was carried out. Treatment effectiveness and safety analyses regarding baseline characteristics of patients (age, prior treatments, basal PSA, performance status, pain, and metastasis) were conducted. Results: At 13.6 months of follow-up, the overall survival is 80% (CI 95%: 11.8-15.4). Clinical and radiological-free progression survival is 9.5 ± 1 months (CI 95%: 7.7-11.3) and biochemical response is 6.8 ± 1 months (CI 95%: 5-8.7). Only the treatment with chemotherapy impaired significantly the response time to AA [6.4 months for radiological-free progression survival (CI 95%: 4.2-8.6) and 4.3 months for biochemical-free progression survival (CI 95%: 2.6-6)]. The incidence of adverse drug events was 36%; all of them were of grade 1-2/4 and, in no case, suspension or reduction of the dose of AA was needed. Conclusions: The treatment with AA has been effective in our series, with a tolerability considerably higher than what other studies published

Initial experience with abiraterone acetate in patients with castration-resistant prostate cancer.

OBJECTIVE: To describe the results obtained in 25 males with metastatic castration-resistant prostate cancer (MCRPC) treated with abiraterone (AA). A comparative analysis of abiraterone effectiveness and safety between our results and data published in the literature was conducted. MATERIAL AND METHOD: Bi-institutional prospective analysis of 25 consecutive patients with MCRPC undergoing treatment with abiraterone, with a mean follow-up 7.9 (3-15) months was carried out. Treatment effectiveness and safety analyses regarding baseline characteristics of patients (age, prior treatments, basal PSA, performance status, pain, metastasis) were conducted. RESULTS: At 13.6 months of follow-up, the overall survival is 80% (CI 95%: 11.8-15.4). Clinical and radiological-free progression survival is 9.5 ± 1 months (CI 95%: 7.7-11.3) and biochemical response is 6.8 ± 1 months (CI 95%: 5-8.7). Only the treatment with chemotherapy impaired significantly the response time to AA [6.4 months for radiological-free progression survival (CI 95%: 4.2-8,6) and 4.3 months for biochemical-free progression survival (CI 95%: 2.6-6)]. The incidence of adverse drug events was 36%, all of them grade 1-2/4 and, in no case, suspension or reduction of the dose of AA was needed. CONCLUSIONS: The treatment with AA has been effective in our series, with a tolerability considerably higher than what other studies published.

Adherencia y toxicidad de los inhibidores de la tirosinquinasa en leucemia mieloide crónica / Adherence and toxicity to tyrosine kinase inhibitor therapy in chronic myeloid leukemia

Objetivo: Analizar la adherencia y la toxicidad del tratamiento con inhibidores de tirosinquinasa (TKIs) en pacientes diagnosticados de Leucemia Mieloide Crónica (LMC). Método: Estudio observacional retrospectivo de 18 meses de duración (enero 2011-junio 2012) en el que se incluyeron todos los pacientes diagnosticados de LMC en un hospital de segundo nivel (550 camas) en tratamiento con imatinib, dasatinib o nilotinib. Las variables recogidas fueron sexo, edad de diagnóstico, años de tratamiento y reacciones adversas. La adherencia se valoró mediante un sistema combinado basado en el autocuestionario SMAQ y el registro de dispensaciones. Resultados: Se incluyeron un total de 25 pacientes. El 92,0% experimentaron reacciones adversas a imatinib; 83,3% a dasatinib y 66,7% a nilotinib. La adherencia media fue de 71,3%. Se identificaron como posibles parámetros de falta de adherencia el sexo femenino (55,6% vs. 66,7%, p = 0,586), mayores de 50 años (55,6% vs. 83,3%, p = 0,125), más de cuatro años de duración de tratamiento (70,0% vs. 57,1%, p = 0,521) y la presencia de determinados efectos adversos (trastornos gastrointestinales y dolor musculoesquelético). Conclusiones: Casi un tercio de los pacientes en tratamiento fueron considerados no adherentes. A pesar de que el tamaño muestral no nos ha permitido establecer relaciones estadísticamente significativos entre la adherencia y las variables analizadas, la relevancia clínica de estos resultados muestran la importancia de realizar futuros estudios con poblaciones mayores que confirmen las tendencias establecidas en este estudio (AU)

Objective: To analyze adherence and toxicity of tyrosine kinase inhibitor (TKIs) therapy in patients diagnosed with chronic myeloid leukemia (CML). Method: A 18-months retrospective observational study (January 2011-June 2012) which included all patients diagnosed with CML in a secondary hospital (550 beds) and were treated with imatinib, dasatinib or nilotinib. It was collected the following variables: sex, age at diagnosis, years of treatment and side effects. Adherence was evaluated using SMAQ questionnaire and recording dispensations. Results: 25 patients were included and all but two (92.0%) experienced side effects to imatinib,83.3% to dasatinib and 66.7% to nilotinib. The average adherence was 71.3%. There was identified as possible parameters of lack of adherence the female patients (55.6 % vs. 66.7%, p = 0.586), older than 50 (55.6 % vs. 83.3 %, p = 0.125), more than four years of treatment (70.0 % vs. 57.1 %, p = 0.521) and the presence of certain side effects (gastrointestinal disorders and musculoeskeletal pain) (AU)

[Adherence and toxicity to tyrosine kinase inhibitor therapy in chronic myeloid leukemia]. / Adherencia y toxicidad de los inhibidores de la tirosinquinasa en leucemia mieloide crónica.

OBJECTIVE: To analyze adherence and toxicity of tyrosine kinase inhibitor (TKIs) therapy in patients diagnosed with chronic myeloid leukemia (CML). METHOD: A 18-months retrospective observational study (January 2011-June 2012) which included all patients diagnosed with CML in a secondary hospital (550 beds) and were treated with imatinib, dasatinib or nilotinib. It was collected the following variables: sex, age at diagnosis, years of treatment and side effects. Adherence was evaluated using SMAQ questionnaire and recording dispensations. RESULTS: 25 patients were included and all but two (92.0%) experienced side effects to imatinib,83.3% to dasatinib and 66.7% to nilotinib. The average adherence was 71.3%. There was identified as possible parameters of lack of adherence the female patients (55.6 % vs. 66.7%, p = 0.586), older than 50 (55.6 % vs. 83.3 %, p = 0.125), more than four years of treatment (70.0 % vs. 57.1 %, p = 0.521) and the presence of certain side effects (gastrointestinal disorders and musculoeskeletal pain). CONCLUSIONS: Almost one third of patients were considered nonadherent to therapy. Although the sample size did not allow us to establish a statistically significant relation between adherence and the variables analyzed, the clinical relevance of these results show the importance of future studies with larger populations to confirm the trends established in this study.

Objetivo: Analizar la adherencia y la toxicidad del tratamiento con inhibidores de tirosinquinasa (TKIs) en pacientes diagnosticados de Leucemia Mieloide Crónica (LMC). Método: Estudio observacional retrospectivo de 18 meses de duración (enero 2011-junio 2012) en el que se incluyeron todos los pacientes diagnosticados de LMC en un hospital de se - gundo nivel (550 camas) en tratamiento con imatinib, dasatinib o nilotinib. Las variables recogidas fueron sexo, edad de diagnóstico, años de tratamiento y reacciones adversas. La adherencia se valoró mediante un sistema combinado basado en el autocuestionario SMAQ y el registro de dispensaciones. Resultados: Se incluyeron un total de 25 pacientes. El 92,0% experimentaron reacciones adversas a imatinib; 83,3% a dasatinib y 66,7% a nilotinib. La adherencia media fue de 71,3%. Se identificaron como posibles parámetros de falta de adherencia el sexo femenino (55,6% vs. 66,7%, p = 0,586), mayores de 50 años (55,6% vs. 83,3%, p = 0,125), más de cuatro años de duración de tratamiento (70,0% vs. 57,1%, p = 0,521) y la presencia de determinados efectos adversos (trastornos gastrointestinales y dolor musculoesquelético). Conclusiones: Casi un tercio de los pacientes en tratamiento fueron considerados no adherentes. A pesar de que el tamaño muestral no nos ha permitido establecer relaciones estadísticamente significativos entre la adherencia y las variables analizadas, la relevancia clínica de estos resultados muestran la importancia de realizar futuros estudios con poblaciones mayores que confirmen las tendencias establecidas en este estudio.