Impacto de los sistemas de nefrometría renal en la valoración de las complicaciones en el tratamiento percutáneo guiado por imagen de las masas renales de pequeño tamaño / Usefulness of renal nephrometry scoring systems in the prediction of complications associated to percutaneous image-guided treatment for small renal masses

Introducción Los tumores renales son un desafío para los profesionales de la salud debido a su creciente prevalencia y complejidad de manejo. El estudio investiga la utilidad de los sistemas de nefrometría renal R.E.N.A.L. score y Padua en la predicción de complicaciones de la crioablación percutánea (CA). Material y métodos El estudio analiza de forma prospectiva a 90 pacientes con carcinoma de células renales (CCR) estadio T1a tratados con crioablación, totalizando 101 tumores. Resultados Se estudiaron 90 pacientes con 101 tumores renales de pequeño tamaño que recibieron terapia crioablativa. Los pacientes tenían una edad media de 68 años y mayoría eran hombres (74,4%). La mayoría de los tumores eran menores a 4 cm (89,1%) y la puntuación media del Padua y R.E.N.A.L. scores fue de 8,65 y 7,35, respectivamente. Se observaron complicaciones en 12 casos. El PADUA y R.E.N.A.L. scores demostraron un poder predictivo moderado (área bajo la curva [AUC] = 0,58 y AUC = 0,63, respectivamente) para las complicaciones poscrioablación. Conclusiones La CA es un tratamiento seguro y efectivo para los tumores renales de pequeño tamaño. Los sistemas de nefrometría renal R.E.N.A.L. y Padua scores tienen un poder predictivo moderado para las complicaciones asociadas a la CA de tumores renales. (AU)

Introduction Due to their increasing prevalence and complex management, renal tumors are challenging for health professionals. The study aims to evaluate the usefulness of R.E.N.A.L. and PADUA nephrometry scores in the prediction of complications after percutaneous cryoablation. Material and methods The study prospectively analyzed 90 patients with 101 stage T1a renal cell carcinoma (RCC) tumors treated with cryoablation. Results Ninety patients with 101 small renal tumors who received cryoablative therapy were investigated. The mean age of the patients was 68 years and 74.4% were male. Most tumors were smaller than 4 cm (89.1%) and the mean PADUA and R.E.N.A.L. scores were 8.65 and 7.35, respectively. Complications were observed in 12 cases. PADUA and R.E.N.A.L. scores demonstrated moderate predictive power (AUC = 0.58 and AUC = 0.63, respectively) for post-cryoablation complications. Conclusions Percutaneous cryoablation is a safe and effective treatment for small renal tumors. The R.E.N.A.L. and PADUA renal nephrometry scores have moderate predictive power for complications associated with percutaneous cryoablation of renal tumors. (AU)

Usefulness of renal nephrometry scoring systems in the prediction of complications associated to percutaneous image-guided treatment for small renal masses.

INTRODUCTION: Due to their increasing prevalence and complex management, renal tumors are challenging for health professionals. The study aims to evaluate the usefulness of R.E.N.A.L. and PADUA nephrometry scores in the prediction of complications after percutaneous cryoablation. MATERIAL AND METHODS: The study prospectively analyzed 90 patients with 101 stage T1a renal cell carcinoma (RCC) tumors treated with cryoablation. RESULTS: Ninety patients with 101 small renal tumors who received cryoablative therapy were investigated. The mean age of the patients was 68 years and 74.4% were male. Most tumors were smaller than 4 cm (89.1%) and the mean PADUA and R.E.N.A.L. scores were 8.65 and 7.35, respectively. Complications were observed in 12 cases. PADUA and R.E.N.A.L. scores demonstrated moderate predictive power (AUC = 0.58 and AUC = 0.63, respectively) for post-cryoablation complications. CONCLUSIONS: Percutaneous cryoablation is a safe and effective treatment for small renal tumors. The R.E.N.A.L. and PADUA renal nephrometry scores have moderate predictive power for complications associated with percutaneous cryoablation of renal tumors.

Coste evitado en medicamentos de ensayos clínicos en cáncer de próstata / Drug Cost Avoidance in Prostate Cancer Clinical Trials

Objetivos: El impacto económico del cáncer de próstata es cada vez mayor, teniendo en cuenta el incremento de su incidencia y la mayor supervivencia de los pacientes. Los ensayos clínicos son esenciales para la evaluación de la eficacia y seguridad de los nuevos tratamientos, pero también pueden suponer un beneficio económico al evitar el coste derivado del fármaco. Nuestro objetivo es determinar el coste evitado en medicamentos en investigación en los ensayos clínicos en cáncer de próstata realizados en un período de 18 años en un centro de tercer nivel. Material y métodos: Se realizó un estudio observacional de prevalencia, con recogida de datos retrospectiva de los ensayos clínicos realizados en los que se utilizaron medicamentos comercializados actualmente. Se calculó el coste evitado durante el periodo de estudio (1996-2013). Resultados: De los 18 ensayos clínicos realizados sobre cáncer de próstata se incluyeron en el presente trabajo 5 que cumplieron criterios de selección, todos ellos fase iii, multicéntricos e internacionales y con fármacos actualmente comercializados. Incluyeron 136 pacientes. Se obtuvo un coste evitado global de 696.002 Euros, un coste medio evitado por ensayo clínico de 139.200 Euros y un coste medio evitado por paciente de 5.118 Euros. Conclusiones: El coste evitado en medicamentos en investigación es un beneficio tangible de los ensayos clínicos, cuya realización supone una fuente de ingresos para el hospital, no solo por los generados directamente por cada ensayo. Los ensayos clínicos suponen un contexto excepcional para el avance en investigación clínica, así como un ahorro real para nuestro sistema sanitario

Objectives: Economic impact of prostate cancer is increasing in relation to its increased incidence and increased patient survival. Clinical trials are essential to evaluate the efficacy and safety of new treatments but may also result in economic benefits by avoiding the cost of the drug. Our objective is to determine the avoided cost in investigational drugs in clinical trials of prostate cancer conducted in a period of 18 years in a tertiary center. Material and methods: We carried out an observational of prevalence study with retrospective collected data of clinical trials involving currently marketed drugs and cost avoidance during the study period (1996-2013) was calculated. Results: We include in this review five clinical trials on prostate cancer that met selection criteria of 18 performed. All of them were phase III, multicenter, international and with current marketed drugs. 136 patients were included. Total cost avoidance of 696,002 Euros and an average cost avoidance by clinical trial of 139,200 Euros were obtained. Average cost avoidance per patient was 5,118 Euros. Conclusion: Cost avoidance in investigational drugs is a tangible benefit of clinical trials, whose realization is a source of economic benefits for the hospital, not only by directly generated by each trial. Clinical trials are an exceptional framework for progress in clinical research and real savings for the health system

Drug Cost Avoidance in Prostate Cancer Clinical Trials.

OBJECTIVES: Economic impact of prostate cancer is increasing in relation to its increased incidence and increased patient survival. Clinical trials are essential to evaluate the efficacy and safety of new treatments but may also result in economic benefits by avoiding the cost of the drug. Our objective is to determine the avoided cost in investigational drugs in clinical trials of prostate cancer conducted in a period of 18 years in a tertiary center. MATERIAL AND METHODS: We carried out an observational of prevalence study with retrospective collected data of clinical trials involving currently marketed drugs and cost avoidance during the study period (1996-2013) was calculated. RESULTS: We include in this review five clinical trials on prostate cancer that met selection criteria of 18 performed. All of them were phase III, multicenter, international and with current marketed drugs. 136 patients were included. Total cost avoidance of 696,002€ and an average cost avoidance by clinical trial of 139,200€ were obtained. Average cost avoidance per patient was 5,118€. CONCLUSION: Cost avoidance in investigational drugs is a tangible benefit of clinical trials, whose realization is a source of economic benefits for the hospital, not only by directly generated by each trial. Clinical trials are an exceptional framework for progress in clinical research and real savings for the health system.

MicroARN circulantes en sangre de pacientes con cáncer de próstata / Circulating MicroRNAs in Blood of Patients With Prostate Cancer

Introducción: Los microARN (miARN) son ARN reguladores de pequeño tamaño que no codifican para proteínas. La detección de células tumorales circulantes (CTC) proporcionaría información diagnóstica y pronóstica en los tumores de próstata (TP). En este sentido los miARN podrían constituir una nueva y prometedora clase de biomarcadores para la detección de CTC. Objetivos: Analizar miARN circulantes en sangre total como marcadores no invasivos en pacientes con cáncer de próstata localizado e individuos sanos. Material y métodos: Estudio preliminar con una N poblacional de 40 pacientes con una media de edad de 71 años y un PSA medio de 18, 9 ng/ml (rango). Respecto al grupo de riesgo (GR): un 33,3% bajo riesgo, un 30% riesgo intermedio y un 36,7% alto riesgo. Se realizó un estudio previo in silico que identificó 92 miARN candidatos seguido de otro in vivo para verificar los hallazgos del primero mediante tecnología de arrays de PCR a tiempo real. Resultados: El análisis estadístico de los resultados reveló 10 miARN candidatos con una expresión diferencial estadísticamente significativa entre los distintos grupos de riesgo y los controles sanos: hsa-miR-337-3p, hsa-miR-330-3p, hsa-miR-339-3p, hsa-miR-124, hsa-miR-218, hsa-miR-128, hsa-miR-10a, hsa-miR-199b-5p, hsa-miR-200b y hsa-miR-15b Conclusiones: Nuestros datos sugieren que los miARN circulantes pueden servir como biomarcadores para identificar grupos de riesgo en CaP

Introduction: MicroRNAs (miRNAs) are small regulatory RNAs that do not code for proteins. Detection of circulating tumor cells (CTC) would provide diagnostic and prognostic information in prostate tumors (PT). Thus, miRNAs could constitute a promising new class of biomarkers for CTC detection. Objectives: To analyze circulating microRNAs in whole blood as non-invasive markers in patients with localized prostate cancer and healthy individuals. Material and methods: A preliminary study including a population of 40 patients with mean age of 71 years and mean PSA of 18, 9ng/ml (range). Regarding the risk group (RG): 33.3% had low risk, 30% intermediate risk and 36.7% high risk. A previous in silico study identified 92 candidates and was followed by another in vivo to verify the findings of the former using array technology by real-time PCR. Results: Statistical analysis of the results revealed 10 microRNAs candidates with statistically significant differential expression between the different risk groups and healthy controls: hsa-miR-337-3p, hsa-miR-330-3p, hsa-miR-339-3p, hsa-miR-124, hsa-miR-218, hsa-miR-128, hsa-miR-10a, hsa-miR-199b-5p, hsa-miR-200b and hsa-miR-15b. Conclusions: Our data suggest that circulating microRNAs can act as biomarkers to identify risk groups in CaP

Terapia focal en cáncer de próstata. Alternativas de tratamiento / Focal therapy for prostate cancer. Alternative treatment

Contexto: Los tratamientos radicales o de seguimiento activo son alternativas en el manejo del cáncer de próstata localizado, ambos no exentos de riesgos y efectos secundarios. El objetivo de este trabajo es analizar las diferentes posibilidades de la terapia focal en sus diferentes opciones para tratar el cáncer de próstata localizado. Adquisición de evidencia: Realizamos una revisión en Medline de las diferentes posibilidades de tratamiento focal desde el punto de vista técnico, desarrolladas en la actualidad con atención a los estudios prospectivos aleatorizados, así como las formas de seguimiento y evolución de resultados. Síntesis de evidencia: Diferentes técnicas en este momento están disponibles para realizar terapia focal, básicamente aquellas mínimamente invasivas -terapia vascular fotodinámica (TVF), crioterapia, braquiterapia, ultrasonido focalizado de alta intensidad (HIFU), láser intersticial- que permiten acceso directo y dirigido a la glándula. Los resultados preliminares de los estudios actuales demuestran una buena aceptabilidad de las técnicas con escasos efectos secundarios y buenos resultados oncológicos. La biopsia junto con la resonancia magnética nuclear (RMN) son las guías de seguimiento en estos pacientes, siendo el papel del antígeno prostático específico (PSA) menos definido. Conclusiones: La terapia focal es en la actualidad una alternativa con técnicas disponibles para una buena ejecución. Los datos actuales apuntan a una escasa morbilidad y buenos resultados oncológicos que hacen de la terapia focal una posible alternativa de tratamiento en los tumores localizados, a la espera de los resultados de más estudios aleatorizados

Context: The great controversy surrounding the treatment of localized prostate cancer is related with its possibilities of radical treatment or active surveillance. The objective of this paper is to analyze the rationale selection among current focal therapy modalities regarding tumor and patient selection. Evidence acquisition: Current articles about advantages and disadvantages on the treatment of localized prostate cancer as well as information about focal therapy regarding tumor selection, characteristics and indications cited in MEDLINE search were reviewed. Summary of evidence: Focal therapy standardized criteria must be: low risk tumors, PSA < 10-15, Gleason score ≤ 6, and unilateral presentation all supported by image-guided biopsy and nuclear magnetic resonance (NMR). There are doubts about the suitability of focal therapy in cases of bilateralism or in those with Gleason score 3 + 4 or PSA > 15. Conclusions: Focal therapy is an alternative for localized prostate cancer treatment. However, some aspects of their diagnosis and selection criteria should be defined by prospective studies which should provide knowledge about the indication for focal therapy

Terapia focal en cáncer de próstata. Racionalidad, indicaciones y selección / Focal Therapy for Prostate Cancer. Rationale, Indications and Selection

Contexto: El tratamiento del cáncer de próstata localizado está sujeto a gran controversia en lo referente a sus posibilidades de tratamiento, radical o seguimiento activo. El objetivo de este trabajo es analizar la racionalidad de la terapia focal, selección de tumores y pacientes en el entorno de las alternativas existentes. Adquisición de evidencia: Revisamos la literatura actual en Medline, relacionada con las ventajas e inconvenientes sobre el tratamiento de cáncer de próstata localizado, así como la información publicada sobre la terapia focal en referencia a la selección de tumores, características e indicaciones para terapia focal. Síntesis de evidencia: Los tumores de bajo riesgo, PSA < 10-15, Gleason ≤ 6, junto con las biopsias guiadas apoyadas con la resonancia magnética nuclear (RMN) y la unilateralidad deben ser el estándar para dicha selección. Existen dudas sobre la conveniencia de la terapia focal en los casos de bilateridad o aquellos de Gleason 3 + 4 o PSA > 15. Conclusiones: La terapia focal puede ser una alternativa para tratar el cáncer de próstata localizado, si bien algunos de sus aspectos diagnósticos y de selección deberán ser definidos por estudios prospectivos, que esperamos nos puedan aportar conocimiento sobre la indicación de la terapia focal

Context: The great controversy surrounding the treatment of localized prostate cancer is related with its possibilities of radical treatment or active surveillance. The objective of this paper is to analyze the rationale selection among current focal therapy modalities regarding tumor and patient selection. Evidence acquisition: Current articles about advantages and disadvantages on the treatment of localized prostate cancer as well as information about focal therapy regarding tumor selection, characteristics and indications cited in MEDLINE search were reviewed. Summary of evidence: Focal therapy standardized criteria must be: low risk tumors, PSA < 10-15, Gleason score ≤ 6, and unilateral presentation all supported by image-guided biopsy and nuclear magnetic resonance (NMR). There are doubts about the suitability of focal therapy in cases of bilateralism or in those with Gleason score 3 + 4 or PSA > 15. Conclusions: Focal therapy is an alternative for localized prostate cancer treatment. However, some aspects of their diagnosis and selection criteria should be defined by prospective studies which should provide knowledge about the indication for focal therapy

Circulating MicroRNAs in blood of patients with prostate cancer.

INTRODUCTION: MicroRNAs (miRNAs) are small regulatory RNAs that do not code for proteins. Detection of circulating tumor cells (CTC) would provide diagnostic and prognostic information in prostate tumors (PT). Thus, miRNAs could constitute a promising new class of biomarkers for CTC detection. OBJECTIVES: To analyze circulating microRNAs in whole blood as non-invasive markers in patients with localized prostate cancer and healthy individuals. MATERIAL AND METHODS: A preliminary study including a population of 40 patients with mean age of 71 years and mean PSA of 18, 9 ng/ml (range). Regarding the risk group (RG): 33.3% had low risk, 30% intermediate risk and 36.7% high risk. A previous in silico study identified 92 candidates and was followed by another in vivo to verify the findings of the former using array technology by real-time PCR. RESULTS: Statistical analysis of the results revealed 10 microRNAs candidates with statistically significant differential expression between the different risk groups and healthy controls: hsa-miR-337-3p, hsa-miR-330-3p, hsa-miR-339-3p, hsa-miR-124, hsa-miR-218, hsa-miR-128, hsa-miR-10a, hsa-miR-199b-5p, hsa-miR-200b and hsa-miR-15b. CONCLUSIONS: Our data suggest that circulating microRNAs can act as biomarkers to identify risk groups in CaP.

Focal therapy for prostate cancer. Alternative treatment.

CONTEXT: The great controversy surrounding the treatment of localized prostate cancer is related with its possibilities of radical treatment or active surveillance. The objective of this paper is to analyze the rationale selection among current focal therapy modalities regarding tumor and patient selection. EVIDENCE ACQUISITION: Current articles about advantages and disadvantages on the treatment of localized prostate cancer as well as information about focal therapy regarding tumour selection, characteristics and indications cited in MEDLINE search were reviewed. SUMMARY OF EVIDENCE: Focal therapy standardized criteria must be: low risk tumors, PSA<10-15, Gleason score ≤ 6, and unilateral presentation all supported by image-guided biopsy and nuclear magnetic resonance (NMR). There are doubts about the suitability of focal therapy in cases of bilateralism or in those with Gleason score 3+4 or PSA>15. CONCLUSIONS: Focal therapy is an alternative for localized prostate cancer treatment. However, some aspects of their diagnosis and selection criteria should be defined by prospective studies which should provide knowledge about the indication for focal therapy.

Focal therapy for prostate cancer. Rationale, indications and selection.

CONTEXT: The great controversy surrounding the treatment of localized prostate cancer is related with its possibilities of radical treatment or active surveillance. The objective of this paper is to analyze the rationale selection among current focal therapy modalities regarding tumor and patient selection. EVIDENCE ACQUISITION: Current articles about advantages and disadvantages on the treatment of localized prostate cancer as well as information about focal therapy regarding tumour selection, characteristics and indications cited in MEDLINE search were reviewed. SUMMARY OF EVIDENCE: Focal therapy standardized criteria must be: low risk tumors, PSA<10-15, Gleason score ≤ 6, and unilateral presentation all supported by image-guided biopsy and nuclear magnetic resonance (NMR). There are doubts about the suitability of focal therapy in cases of bilateralism or in those with Gleason score 3+4 or PSA>15. CONCLUSIONS: Focal therapy is an alternative for localized prostate cancer treatment. However, some aspects of their diagnosis and selection criteria should be defined by prospective studies which should provide knowledge about the indication for focal therapy.