Una actualización en el protocolo en cáncer de próstata metastásico hormonosensible / Hormone sensitive protocol for metastatic prostate cancer, an update

Revisar y actualizar los últimos protocolos en cáncer de próstata metastásico hormonosensible para mejorar su manejo clínico en la práctica clínica. Realizar un análisis de los datos y los protocolos más recientes en el cáncer de próstata metastásico hormonosensible según paneles de expertos en este ámbito. Actualmente se necesita un grupo de consenso nominal para unificar y mejorar las recomendaciones para el manejo de pacientes sensibles con cáncer de próstata metastásico. Este documento unifica y mejora el manejo de los pacientes con cáncer de próstata metastásico hormonosensible, con una metodología que combina datos cuantitativos y cualitativos, y basada en la participación de un amplio comité científico designado por la Asociación Española de Urología (AU)

To review and update last protocols in hormone sensitive metastatic prostate cancer for improving clinical management in routine. Evidence analysis available about recent updates protocols in hormone sensitive metastatic prostate cancer according to expert panel of clinicians about this field. A nominal consensus group for unify and improve the recommendations to the management of sensitive metastatic prostate cancer patients is currently needed. This document unifies and improve the management of patients with hormone sensitive metastatic prostate cancer, with a methodology that combines data quantitative and qualitative and based on the participation of a broad scientific committee appointed by the Spanish Association of Urology (AU)

Identificación de parámetros pronósticos relativos a la técnica quirúrgica en pacientes tratados mediante prostatectomía radical robótica / Identifying prognostic parameters related to surgical technique in patients treated by robotic radical prostatectomy

Introducción y objetivo Los factores más estudiados en pacientes tratados mediante prostatectomía radical robótica son antígeno prostático específico (PSA) y las características patológicas de la biopsia y la pieza de prostatectomía. Los factores asociados a la técnica quirúrgica han sido poco estudiados y con resultados controvertidos. El objetivo es identificar todos los factores posibles de la cirugía y su relación con la supervivencia libre de enfermedad (SLE) y de metástasis. Pacientes y métodos Estudio prospectivo aprobado por el Comité de Ética, en pacientes intervenidos de prostatectomía radical robótica desde enero del 2009 con seguimiento mínimo de cinco años. Analizamos como posibles factores pronósticos: el cirujano, el tiempo quirúrgico, la pérdida sanguínea, el acceso fascial, las técnicas de continencia, la preservación de la fascia, las bandeletas neurovasculares, el cuello vesical, la uretra, la curva de aprendizaje y las complicaciones quirúrgicas. Realizamos comparaciones univariables y emparejadas de supervivencia mediante la estimación de Kaplan-Meier y long-rank tests. El nivel de significancia para comparaciones múltiples se estableció con ajuste False Discovery Rate (p ajustada [padj]). Resultados Cohorte de 667 pacientes con mediana de seguimiento de 69 meses. En el análisis univariante, el cirujano (padj = 0,018), la conservación de ligamentos puboprostáticos (padj = 0,02), la preservación de fascia endopélvica (padj = 0,001) y realizar suspensión parauretral (padj < 0,001) son factores de mal pronóstico para la SLE. La preservación de la fascia también afecta negativamente a la supervivencia libre de metástasis (SLM) (padj = 0,04). Las cirugías previas abdominales, la próstata, el tiempo de intervención, el sangrado, el tipo de uretra residual, el lóbulo medio, el acceso fascial, la conservación de bandeletas o cuello vesical, no tienen significancia estadística (AU)

Introduction and objective The most frequently studied factors in patients treated by robotic radical prostatectomy are PSA and pathological features of the biopsy and prostatectomy specimen. Studies on the factors associated with the surgical technique are scarce and with controversial results. The objective is to identify all possible surgical factors and their relationship with disease-free and metastasis-free survival. Patients and Method Prospective study approved by the Ethics Committee, including patients who underwent robotic radical prostatectomy since January 2009 with a minimum follow-up of 5 years. Surgeon, surgical time, blood loss, fascial access, continence techniques, preservation of the fascia, neurovascular bundles, bladder neck, urethra, learning curve and surgical complications, were analyzed as possible prognostic factors. We performed univariate and matched comparisons of survival using Kaplan-Meier estimation and long-rank tests. The significance level for multiple comparisons was established with False Discovery Rate-adjustment (adjusted p). Results Cohort of 667 patients with a median follow-up of 69 months. In univariate analysis, surgeon (adjp = 0.018), preservation of puboprostatic ligaments (adjp = 0.02), preservation of endopelvic fascia (adjp = 0.001) and performing periurethral suspension (adjp < 0.001) are poor prognostic factors for disease-free survival. Fascia preservation also negatively affects metastasis-free survival (adjp = 0.04). Previous abdominal surgeries, prostate, surgical time, blood loss, type of residual urethra, middle lobe, fascial access, fascia or bladder neck preservation, have no statistical significance. Conclusions The surgeon and specific aspects of the surgical technique are determining factors in disease-free survival. Preservation of the fascia is the only factor that negatively affects metastasis-free survival (AU)

Identifying prognostic parameters related to surgical technique in patients treated by robotic radical prostatectomy.

INTRODUCTION AND OBJECTIVE: The most frequently studied factors in patients treated by robotic radical prostatectomy are PSA and pathological features of the biopsy and prostatectomy specimen. Studies on the factors associated with the surgical technique are scarce and with controversial results. The objective is to identify all possible surgical factors and their relationship with disease-free and metastasis-free survival. PATIENTS AND METHOD: Prospective study approved by the Ethics Committee, including patients who underwent robotic radical prostatectomy since January 2009 with a minimum follow-up of 5 years. Surgeon, surgical time, blood loss, fascial access, continence techniques, preservation of the fascia, neurovascular bundles, bladder neck, urethra, learning curve and surgical complications, were analyzed as possible prognostic factors. We performed univariate and matched comparisons of survival using Kaplan-Meier estimation and long-rank tests. The significance level for multiple comparisons was established with False Discovery Rate-adjustment (adjusted p). RESULTS: Cohort of 667 patients with a median follow-up of 69 months. In univariate analysis, surgeon (adjp=0.018), preservation of puboprostatic ligaments (adjp=0.02), preservation of endopelvic fascia (adjp=0.001) and performing periurethral suspension (adjp<0.001) are poor prognostic factors for disease-free survival. Fascia preservation also negatively affects metastasis-free survival (adjp=0.04). Previous abdominal surgeries, prostate, surgical time, blood loss, type of residual urethra, middle lobe, fascial access, fascia or bladder neck preservation, have no statistical significance. CONCLUSIONS: The surgeon and specific aspects of the surgical technique are determining factors in disease-free survival. Preservation of the fascia is the only factor that negatively affects metastasis-free survival.

Hormone sensitive protocol for metastatic prostate cancer, an update.

To review and update last protocols in hormone sensitive metastatic prostate cancer for improving clinical management in routine. Evidence analysis available about recent updates protocols in hormone sensitive metastatic prostate cancer according to expert panel of clinicians about this field. A nominal consensus group for unify and improve the recommendations to the management of sensitive metastatic prostate cancer patients is currently needed. This document unifies and improve the management of patients with hormone sensitive metastatic prostate cancer, with a methodology that combines data quantitative and qualitative and based on the participation of a broad scientific committee appointed by the Spanish Association of Urology.

Cáncer de próstata resistente a la castración no metastásico: recomendaciones de manejo / Non-metastatic castration-resistant prostate cancer: management recommendations

Introducción y objetivo: La supervivencia y calidad de vida (QoL) de los pacientes con cáncer de próstata resistente a la castración no metastásico (CPRCnm) se deteriora de forma muy significativa cuando llegan a desarrollar metástasis. Los antiandrógenos de nueva generación (apalutamida, enzalutamida y darolutamida) pueden prolongar la supervivencia libre de metástasis (SLM) y la supervivencia global (SG) en estos pacientes, manteniendo su QoL.Material y método: Tras una revisión sistemática de la literatura, un comité científico alcanzó un consenso sobre recomendaciones sencillas y prácticas que unifiquen y mejoren el manejo de los pacientes con CPRCnm en las consultas de urología.Resultados: Se dan recomendaciones sobre la frecuencia de determinación de antígeno prostático específico (PSA) y pruebas de imagen en pacientes con CPRCnm. También se destaca la importancia de las comorbilidades en el paciente con CPRCnm y se ofrecen recomendaciones sobre la valoración funcional y de la QoL que se pueden llevar a cabo en la consulta de urología. Se revisa la eficacia, seguridad y efectos sobre la QoL de los antiandrógenos de nueva generación.Conclusiones: Para la evaluación del tratamiento de pacientes con CPRCnm, es necesario tener en cuenta no solo la edad, sino también las comorbilidades y la QoL. Los antiandrógenos de nueva generación son una opción de tratamiento segura y eficaz en los pacientes con CPRCnm. Las recomendaciones de trabajo pueden servir de ayuda para optimizar su manejo de los pacientes con CPRCnm en las consultas de urología. (AU)

Introduction and objective: Survival and quality of life (QoL) of patients with non-metastatic castration-resistant prostate cancer (nmCRPC) deteriorate significantly when they develop metastases. New generation antiandrogens (apalutamide, enzalutamide and darolutamide) can prolong metastasis-free survival (MFS) and overall survival (OS) in these patients, maintaining their QoL.Material and methods: After the performance of a systematic review of the literature, a scientific committee reached a consensus on simple and practical recommendations to consolidate and improve the management of patients with nmCRPC in urology consultations.Results: Recommendations are made on the frequency of PSA determination and imaging tests in patients with nmCRPC. The importance of co-morbidities in patients with nmCRPC is also highlighted, and recommendations are also made on functional and QoL assessment that can be carried out during urology consultations. The efficacy, safety, and effects on QoL of new generation antiandrogens are reviewed.Conclusions: To evaluate treatment of patients with nmCRPC, it is necessary to consider co-morbidities and QoL, in addition to age. New generation antiandrogens are a safe and effective treatment option for patients with nmCRPC. The recommendations of this review can be helpful in optimizing the management of nmCRPC patients in urology consultations. (AU)

Non-metastatic castration-resistant prostate cancer: management recommendations.

INTRODUCTION AND OBJECTIVE: Survival and quality of life (QoL) of patients with non-metastatic castration-resistant prostate cancer (nmCRPC) deteriorate significantly when they develop metastases. New generation antiandrogens (apalutamide, enzalutamide and darolutamide) can prolong metastasis-free survival (MFS) and overall survival (OS) in these patients, maintaining their QoL. MATERIAL AND METHODS: After the performance of a systematic review of the literature, a scientific committee reached a consensus on simple and practical recommendations to consolidate and improve the management of patients with nmCRPC in urology consultations. RESULTS: Recommendations are made on the frequency of PSA determination and imaging tests in patients with nmCRPC. The importance of co-morbidities in patients with nmCRPC is also highlighted, and recommendations are also made on functional and QoL assessment that can be carried out during urology consultations. The efficacy, safety, and effects on QoL of new generation antiandrogens are reviewed. CONCLUSIONS: To evaluate treatment of patients with nmCRPC, it is necessary to consider co-morbidities and QoL, in addition to age. New generation antiandrogens are a safe and effective treatment option for patients with nmCRPC. The recommendations of this review can be helpful in optimizing the management of nmCRPC patients in urology consultations.

Seguridad de nivolumab en pacientes con carcinoma de células renales metastásico: experiencia española en urología en la práctica clínica real / Safety of nivolumab in metastatic renal cell carcinoma patients: A real-life experience in a Spanish urology setting

Introducción y objetivo: Nivolumab es un agente inmunoterapéutico aprobado para el tratamiento de pacientes con carcinoma de células renales (CCR) avanzado tratados previamente. La experiencia en práctica clínica real, especialmente en lo referente a la aparición de reacciones adversas inmunorrelacionadas, es escasa. Presentamos la experiencia acerca de la seguridad de nivolumab en pacientes con CCR metastásico (CCRm) tratados en 9 hospitales de España. Material y métodos: Estudio retrospectivo, multicéntrico en pacientes con CCRm tratados con nivolumab entre 2016 y 2018. Se recogieron datos sociodemográficos y clínicos basales y las reacciones adversas relacionadas con el fármaco. Resultados: Los 26 pacientes incluidos presentaron una edad de 63,7 ± 11,5 años. El 96% presentaba ECOG 0-1 y el 78% un riesgo MKSCC favorable/intermedio. El 73% presentaba subtipo histológico de células claras y el 30%, metástasis de inicio. La mediana de seguimiento fue de 9 meses (rango: 1-14). El 100% de los pacientes presentó una reacción adversa de cualquier grado; las más frecuentes fueron la fatiga, la fiebre y la anemia (27%). El 23% presentó una reacción adversa de grado 3. Las reacciones adversas llevaron a la suspensión del tratamiento en 3 pacientes (11%). Conclusión: En la práctica clínica real, nivolumab presenta un perfil de seguridad favorable y manejable, similar al descrito en otros estudios

Introduction and objectives: Nivolumab is an immunotherapy agent that has been an approved treatment for previously treated patients with advanced renal cell carcinoma (RCC). Experience in real-life settings, especially regarding immune- related adverse events, is scarce. We present our experience with reference to the safety of nivolumab in patients with metastatic RCC (mRCC) treated in 9 hospitals in Spain. Material and methods: Retrospective, multicentre study of patients with mRCC treated with nivolumab between 2016 and 2018. Data on baseline socio-demographic and clinical characteristics and drug-related adverse events were collected. Results: The mean age of the 26 patients included was 63.7 ± 11.5 years; 96% were ECOG 0-1 and 78% had favourable or intermediate MSKCC risk scores; 73% had the clear cell histological subtype and 30% metastatic disease. Median follow-up was 9 months (range 1-14). All patients experienced an adverse event at different grades, with fatigue, fever and anaemia being the most common (27%). Grade 3 adverse events occurred in 23% of patients. Adverse reactions led to treatment suspension in 3 patients (11%). Conclusion: In the real-life clinical setting, nivolumab shows favourable outcomes, similar to those reported by other studies

Safety of nivolumab in metastatic renal cell carcinoma patients: A real-life experience in a Spanish urology setting. / Seguridad de nivolumab en pacientes con carcinoma de células renales metastásico: experiencia española en urología en la práctica clínica real.

INTRODUCTION AND OBJECTIVES: Nivolumab is an immunotherapy agent that has been an approved treatment for previously treated patients with advanced renal cell carcinoma (RCC). Experience in real-life settings, especially regarding immune- related adverse events, is scarce. We present our experience with reference to the safety of nivolumab in patients with metastatic RCC (mRCC) treated in 9 hospitals in Spain. MATERIAL AND METHODS: Retrospective, multicentre study of patients with mRCC treated with nivolumab between 2016 and 2018. Data on baseline socio-demographic and clinical characteristics and drug-related adverse events were collected. RESULTS: The mean age of the 26 patients included was 63.7±11.5 years; 96% were ECOG 0-1 and 78% had favourable or intermediate MSKCC risk scores; 73% had the clear cell histological subtype and 30% metastatic disease. Median follow-up was 9 months (range 1-14). All patients experienced an adverse event at different grades, with fatigue, fever and anaemia being the most common (27%). Grade 3 adverse events occurred in 23% of patients. Adverse reactions led to treatment suspension in 3 patients (11%). CONCLUSION: In the real-life clinical setting, nivolumab shows favourable outcomes, similar to those reported by other studies.

Revisión de la evidencia sobre el manejo de medicamentos y productos peligrosos en los servicios de Urología. Documento de consenso entre la Asociación Española de Urología y la Sociedad Española de Farmacia Hospitalaria / Review of the evidence on handling drugs and hazardous products in Urology Departments. Consensus document between the Spanish Urological Association and the Spanish Society of Hospital Pharmacy

Introducción: La administración intravesical de medicamentos peligrosos es una práctica habitual en el ámbito de la urología, con posible exposición del personal sanitario a dichos medicamentos. Se considera necesario disponer de un documento de consenso entre las sociedades científicas implicadas -Asociación Española de Urología y Sociedad Española de Farmacia Hospitalaria- que recoja la mejor evidencia disponible para el manejo, de la forma más segura posible, de medicamentos peligrosos en el ámbito de los servicios de Urología. Métodos: Se ha realizado una revisión de la legislación y de las recomendaciones sobre el manejo de medicamentos peligrosos tanto a nivel estatal como internacional. Resultados: Se dispone de legislación nacional y de normativas para la protección de los trabajadores que manipulen medicamentos y productos peligrosos, así como recomendaciones de manipulación para la protección tanto del producto, como de los trabajadores. Discusión: Siguiendo las líneas estratégicas del Parlamento Europeo para el período 2014-2020 en el capítulo de seguridad y salud laboral, la Asociación Española de Urología y la Sociedad Española de Farmacia Hospitalaria proponen una serie de actuaciones que hagan disminuir los riesgos de exposición a los profesionales y cuidadores implicados en su manejo. Conclusiones: Tras esta revisión se establecen 19 recomendaciones para el manejo de medicamentos peligrosos que pueden resumirse en la necesidad de formación de todas las personas implicadas (desde equipos directivos hasta los pacientes y cuidadores), adopción de sistemas que no permitan fugas contaminantes, programas de vigilancia de las exposiciones y optimización de los recursos disponibles

Background: The intravesical administration of hazardous drug products is a standard practice in the urology setting, which potentially exposing medical personnel to these drug products. It was deemed necessary to have a consensus document among the scientific societies involved (the Spanish Urological Association and the Spanish Society of Hospital Pharmacy) that collects the best available evidence on the safest handling possible of dangerous drug products in the setting of urology departments. Methods: We reviewed the legislation and recommendations on the handling of dangerous drug products, both at the national and international level. Results: There is national legislation and regulations for protecting workers who handle dangerous drugs and products, as well as recommendations for handling to protect both the product and workers. Discussion: Following the strategic lines of the European Parliament for 2014-2020 in the chapter on occupational safety and health, the Spanish Urological Association and the Spanish Society of Hospital Pharmacy proposed a series of actions that decrease the risks of exposure for practitioners and caregivers involved in the handling of these products. Conclusions: After this review, 19 recommendations were established for handling dangerous drug products, which can be summarised as the need to train all individuals involved (from management teams to patients and caregivers), adopt systems that prevent contaminating leaks, implement exposure surveillance programmes and optimise available resources

Radio-223 en la secuencia terapéutica del cáncer de próstata resistente a la castración metastásico / Radium-223 in the therapeutic sequence of metastatic castration-resistant prostate cancer

Contexto: El radio-223 es un emisor de partículas □ con acción específica sobre las metástasis óseas. El estudio ALSYMPCA demostró que el radio-223 prolonga la supervivencia global y retrasa la aparición de eventos óseos en pacientes con cáncer de próstata resistente a la castración con metástasis óseas (CPRCm) sintomáticas y sin metástasis viscerales, con un buen perfil de seguridad. Objetivo: Revisión de la nueva evidencia científica de radio-223 a partir de análisis preespecificados y post hoc del estudio ALSYMPCA y de programas de acceso precoz posteriores a la publicación del estudio ALSYMPCA, con el fin de aportar nuevos datos en el manejo de pacientes con CPRCm. Adquisición de la evidencia: Búsqueda de evidencia en PubMed y en abstracts de congresos de urología y oncología internacionales, así como ensayos clínicos en marcha (ClinicalTrials.gov). Síntesis de la evidencia: Los resultados de los estudios revisados ofrecen resultados prometedores que ampliarían el beneficio terapéutico de radio-223 a pacientes con síntomas leves e incluso asintomáticos. También aportan evidencia preliminar acerca del beneficio del tratamiento con radio-223 tras el fracaso a docetaxel o a enzalutamida o abiraterona o la combinación de radio-223 con estos u otros agentes terapéuticos como los dirigidos al hueso o inmunoterapia. Conclusión: El radio-223 puede ser una opción de tratamiento en pacientes con síntomas leves y aportar un beneficio terapéutico tras el fracaso a tratamientos disponibles en la actualidad o en combinación con estos. Esta evidencia ha de ser corroborada en ensayos clínicos antes de ser incorporados en la práctica clínica

Context: Radium-223 is an -particle transmitter with specific action on bone metastases. The Alpharadin in Symptomatic Prostate Cancer Patients (ALSYMPCA) study showed that radium-223 extended overall survival and delayed the onset of bone events in patients with symptomatic castration-resistant prostate cancer with bone metastases (mCRPC) and without visceral metastases, with a good safety profile. Objective: To review the new scientific evidence on radium-223 based on prespecified and post-hoc analyses of the ALSYMPCA study and on early-access programs after the publication of the ALSYMPCA study, thereby providing new data on the management of patients with mCRPC. Acquisition of evidence: We searched for evidence on PubMed and in the abstracts of international urology and oncology congresses, as well as ongoing clinical trials (ClinicalTrials.gov). Synthesis of the evidence: The results of the reviewed studies offer promising results that will broaden the therapeutic benefits of radium-223 to patients with mild symptoms and those with no symptoms. The results also provide preliminary evidence on the benefit of radium-223 treatment after the failure of docetaxel, enzalutamide or abiraterone or the combination of radium-223 with these agents or other therapeutic agents such as bone-targeted agents and immunotherapy. Conclusion: Radium-223 can be a treatment option for patients with mild symptoms and can provide a therapeutic benefit after failure of currently available treatments or in combination with these treatments. This evidence should be corroborated in clinical trials before being added to clinical practice

Eficacia y seguridad de distintas cepas de BCG en el tratamiento del tumor vesical en práctica clínica habitual / Safety and efficacy of various strains of bacille Calmette-Guérin in the treatment of bladder tumours in standard clinical practice

Introducción: La evolución natural del tumor vesical no músculo infiltrante (TVNMI) es la recidiva con elevado porcentaje de progresión. La BCG se ha demostrado eficaz para disminuir estos porcentajes, pero hay pocos estudios comparativos entre cepas. Material y métodos: Registro observacional, prospectivo y multicéntrico, estudiándose 433 pacientes con visita de seguimiento a 12 meses de 961 registrados y evaluado supervivencia libre de enfermedad (SLE), de progresión (SLP) cáncer-específica (SE) y efectos adversos. Se estudiaron las cepas Tice, Russian, Tokyo, Connaught y RIVM. Resultados: Los datos sociodemográficos, antecedentes de TVNMI, comorbilidades, tamaño, número, estadio, grado, CIS asociado y Re-RTU, están bien balanceados. SLE: 85 recidivas (19,6%). La mediana del tiempo de SLE fue 20 meses. Al comparar las diferentes cepas, no se detectaron diferencias estadísticamente significativas (Log-rank test, p = 0,93). SLP: 33 progresiones (7,62%). Al comparar las diferentes cepas, no se detectaron diferencias estadísticamente significativas (Log-rank test, p = 0,69). SE: fallecieron 7 pacientes (1,68%). Al comparar la SE entre las diferentes cepas, no se detectaron diferencias (Log-rank test, p = 0,93). En seguridad, el 33,3% habían presentado algún tipo de efecto adverso, mayoritariamente clínica urinaria baja no ITU < 48h, > 48h y hematuria. Según los Common Toxicity Criteria de la European Organisation for Research and Treatment of Cancer, el 92,7% eran grado 1. No se obtuvieron diferencias estadísticamente significativas relevantes entre cepas. Conclusiones: En este análisis intermedio, el riesgo de recidiva, progresión, muerte específica y seguridad es independiente de la cepa de BCG utilizada

Background: The natural progression of bladder tumours (nonmuscle-invasive bladder cancer [NMIBC]) is recurrence with a high rate of progression. Bacille Calmette-Guérin (BCG) has been shown effective in reducing these rates, but there are few comparative studies between strains. Material and methods: An observational, prospective and multicentre registry studied 433 patients with a 12-month follow-up visit from 961 registered patients, assessing disease-free survival (DFS), progression-free survival (PFS) cancer-specific survival (CSS) and adverse effects. We studied the Tice, Russian, Tokyo, Connaught and RIVM strains. Results: The sociodemographic data, NMIBC history, comorbidities, size, number, stage, grade, associated carcinoma in situ and transurethral resection were well balanced. DFS: There were 85 relapses (19.6%). The median DFS time was 20months. When comparing the various strains, we detected no statistically significant differences (log-rank test; P =.93). LPS: There were 33 cases of progression (7.62%). When comparing the various strains, we detected no statistically significant differences (log-rank test; P = .69). CSS: Seven patients died (1.68%). When comparing the various strains, we detected no statistically significant differences (log-rank test; P = .93). In terms of safety, 33.3% of the patients presented some type of adverse effect, mostly lower urinary symptoms (no urinary tract infections) < 48 h, > 48 h and haematuria. According to the Common Toxicity Criteria of the European Organisation for Research and Treatment of Cancer, 92.7% of the patients were grade 1. There were no statistically significant differences between the strains. Conclusions: In this intermediate analysis, the risk of recurrence, progression, specific death and safety were independent of the BCG strain employed

Review of the evidence on handling drugs and hazardous products in Urology Departments. Consensus document between the Spanish Urological Association and the Spanish Society of Hospital Pharmacy. / Revisión de la evidencia sobre el manejo de medicamentos y productos peligrosos en los servicios de Urología. Documento de consenso entre la Asociación Española de Urología y la Sociedad Española de Farmacia Hospitalaria.

BACKGROUND: The intravesical administration of hazardous drug products is a standard practice in the urology setting, which potentially exposing medical personnel to these drug products. It was deemed necessary to have a consensus document among the scientific societies involved (the Spanish Urological Association and the Spanish Society of Hospital Pharmacy) that collects the best available evidence on the safest handling possible of dangerous drug products in the setting of urology departments. METHODS: We reviewed the legislation and recommendations on the handling of dangerous drug products, both at the national and international level. RESULTS: There is national legislation and regulations for protecting workers who handle dangerous drugs and products, as well as recommendations for handling to protect both the product and workers. DISCUSSION: Following the strategic lines of the European Parliament for 2014-2020 in the chapter on occupational safety and health, the Spanish Urological Association and the Spanish Society of Hospital Pharmacy proposed a series of actions that decrease the risks of exposure for practitioners and caregivers involved in the handling of these products. CONCLUSIONS: After this review, 19 recommendations were established for handling dangerous drug products, which can be summarised as the need to train all individuals involved (from management teams to patients and caregivers), adopt systems that prevent contaminating leaks, implement exposure surveillance programmes and optimise available resources.

Actualización del papel de la quimioterapia endovesical en el cáncer de vejiga no músculo-invasivo / Update on the role of endovesical chemotherapy in nonmuscle-invasive bladder cancer

No disponible

Safety and efficacy of various strains of bacille Calmette-Guérin in the treatment of bladder tumours in standard clinical practice. / Eficacia y seguridad de distintas cepas de BCG en el tratamiento del tumor vesical en práctica clínica habitual.

BACKGROUND: The natural progression of bladder tumours (nonmuscle-invasive bladder cancer [NMIBC]) is recurrence with a high rate of progression. Bacille Calmette-Guérin (BCG) has been shown effective in reducing these rates, but there are few comparative studies between strains. MATERIAL AND METHODS: An observational, prospective and multicentre registry studied 433 patients with a 12-month follow-up visit from 961 registered patients, assessing disease-free survival (DFS), progression-free survival (PFS) cancer-specific survival (CSS) and adverse effects. We studied the Tice, Russian, Tokyo, Connaught and RIVM strains. RESULTS: The sociodemographic data, NMIBC history, comorbidities, size, number, stage, grade, associated carcinoma in situ and transurethral resection were well balanced. DFS: There were 85 relapses (19.6%). The median DFS time was 20months. When comparing the various strains, we detected no statistically significant differences (log-rank test; P=.93). LPS: There were 33 cases of progression (7.62%). When comparing the various strains, we detected no statistically significant differences (log-rank test; P=.69). CSS: Seven patients died (1.68%). When comparing the various strains, we detected no statistically significant differences (log-rank test; P=.93). In terms of safety, 33.3% of the patients presented some type of adverse effect, mostly lower urinary symptoms (no urinary tract infections) <48h, >48h and haematuria. According to the Common Toxicity Criteria of the European Organisation for Research and Treatment of Cancer, 92.7% of the patients were grade1. There were no statistically significant differences between the strains. CONCLUSIONS: In this intermediate analysis, the risk of recurrence, progression, specific death and safety were independent of the BCG strain employed.

Radium-223 in the therapeutic sequence of metastatic castration-resistant prostate cancer. / Radio-223 en la secuencia terapéutica del cáncer de próstata resistente a la castración metastásico.

CONTEXT: Radium-223 is an □ -particle transmitter with specific action on bone metastases. The Alpharadin in Symptomatic Prostate Cancer Patients (ALSYMPCA) study showed that radium-223 extended overall survival and delayed the onset of bone events in patients with symptomatic castration-resistant prostate cancer with bone metastases (mCRPC) and without visceral metastases, with a good safety profile. OBJECTIVE: To review the new scientific evidence on radium-223 based on prespecified and post-hoc analyses of the ALSYMPCA study and on early-access programs after the publication of the ALSYMPCA study, thereby providing new data on the management of patients with mCRPC. ACQUISITION OF EVIDENCE: We searched for evidence on PubMed and in the abstracts of international urology and oncology congresses, as well as ongoing clinical trials (ClinicalTrials.gov). SYNTHESIS OF THE EVIDENCE: The results of the reviewed studies offer promising results that will broaden the therapeutic benefits of radium-223 to patients with mild symptoms and those with no symptoms. The results also provide preliminary evidence on the benefit of radium-223 treatment after the failure of docetaxel, enzalutamide or abiraterone or the combination of radium-223 with these agents or other therapeutic agents such as bone-targeted agents and immunotherapy. CONCLUSION: Radium-223 can be a treatment option for patients with mild symptoms and can provide a therapeutic benefit after failure of currently available treatments or in combination with these treatments. This evidence should be corroborated in clinical trials before being added to clinical practice.

Cáncer de próstata resistente a la castración. Recomendaciones de consenso de la Asociación Española de Urología / Castrate resistant prostate cancer. Consensus recommendations of the Spanish Association of Urology

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Bladder cancer in Spain 2011: population based study.

PURPOSE: We estimate the annual incidence of bladder cancer in Spain and describe the clinical profile of patients with bladder cancer enrolled in a population based study. MATERIALS AND METHODS: Using the structure of the Spanish National Health System as a basis, in 2011 the AEU (Spanish Association of Urology) conducted this study with a representative sample from 26 public hospitals and a reference population of 10,146,534 inhabitants, comprising 21.5% of the Spanish population. RESULTS: A total of 4,285 episodes of bladder cancer were diagnosed, of which 2,476 (57.8%) were new cases and 1,809 (42.2%) were cases of recurrence, representing an estimated 11,539 new diagnoses annually in Spain. The incidence of bladder cancer in Spain, age adjusted to the standard European population, was 20.08 cases per 100,000 inhabitants (95% CI 13.9, 26.3). Of patients diagnosed with a first episode of bladder cancer 84.3% were male, generally older than 59 years (81.7%) with a mean ± SD age of 70.5 ± 11.4 years. Of these patients 87.5% presented with some type of clinical symptom, with macroscopic hematuria (90.8%) being the most commonly detected. The majority of primary tumors were nonmuscle invasive (76.7%) but included a high proportion of high grade tumors (43.7%). According to the ISUP (International Society of Urologic Pathology)/WHO (2004) classification 51.1% was papillary high grade carcinoma. Carcinoma in situ was found in 2.2% of primary and 5.8% of recurrent cases. CONCLUSIONS: The incidence of bladder cancer in Spain, age adjusted to the standard European population, confirms that Spain has one of the highest incidences in Europe. Most primary nonmuscle invasive bladder cancer corresponded to high risk patients but with a low detected incidence of carcinoma in situ.

Enucleación de quiste lateral de próstata con láser holmium: una excelente alternativa / Enucleation of a lateral prostatic cyst of the prostate with the holmium laser, an excellent therapeutical alternative

Presentar un caso de sintomatología del tracto urinario inferior provocada por obstrucción al fluido urinario por un quiste lateral de próstata y los resultados de la enucleación del mismo con láser Holmium. Presentamos el caso de un paciente joven con sintomatología miccional de 1 año de evolución. Diagnosticado mediante ecografía de quiste prostático. Ante el diagnóstico de quiste obstructivo, se plantea enucleación con láser holmium obteniendo resultadospost operatorios inmediatos y excelentes. Los quistes prostáticos simples son el tipo más frecuente, siendo asintomáticos en la mayoría de los casos y descubiertos incidentalmente. Dichos quistes adquieren importancia clínica si provocan sintomatología del tracto urinario inferior, infertilidad o son el asiento de neoplasia prostática. El tratamiento habitual es la resección transuretral. En este paciente planteamos enucleación del quiste con láser holmium. Esta técnica permite et alta hospitalaria sin sonda en menos de 24 horas, se evita el riesgo de síndrome de reabsorción, provoca un mínimo sangrado y rápida remisión de la sintomatología...

The purpose of this paper is to present a case of lower urinary tract symptomatology caused by flow obstruction due to a lateral cyst of the prostate and the results obtained by enucleating using the Holmium laser. We present the case of a young patient with one year of lower urinary-tract symptoms. The diagnosis of a prostatic cyst was confirmed by ultrasound examination. Having the finding of an obstructive prostatic cyst it was treated by means of Holmium laser enucleation with excellent postoperative results. Simple prostatic cysts are the most frequent type and are generally asymptomatic and are incidentally discovered during routine examination. These cysts become clinically relevant when they cause lower urinary tract symptoms, infertility or are associated with cancer. Usual treatment is endoscopic resection. ln this case we preformed an Holmium laser enuclation of the c yst, thus permitting the discharge of the patient without catheter in less than 24h. And minimizes reabsortion syndrome and bleeding, with a very fast resolution of the clinical symptomatology...