Clinical and histological predictive factors of reclassification of prostate cancer patients on active surveillance.

INTRODUCTION AND OBJECTIVE: Active surveillance (AS) has been established as a therapeutic strategy in patients with low-risk prostate cancer. Demographic and anatomopathological factors that increase the probability of reclassifying patients have been identified. MATERIALS AND METHODS: Laboratory and histopathological data were collected from 116 patients included on AS since 2014. Univariate analysis was performed with Chi-square, t-student and Kendall's Tau, multivariate analysis according to logistic regression and Kaplan-Meier curves were calculated. RESULTS: Of the 116 patients in AS, the median age at diagnosis was 66 years and the median follow-up was 13 months (2-72). Of these, 61 (52.6%) are still on surveillance, while 55 (47.4%) have left the program, mostly due to histological progression (52 patients (45.2%)); radical prostatectomy was performed in 27 (49.1%). Prostate volume (PV)≤60cc and the number of positive cylinders >1 in diagnostic biopsy (P=.05) were associated with higher reclassification rate in univariate analysis (P<.05). Multivariate analysis showed that these two variables significantly correlated with higher reclassification rate (PV 60 cc: OR 4.39, P=.04; >1 positive cylinder at diagnostic biopsy: OR 2.48, P=.03). CONCLUSIONS: It has been shown that initial ultrasound volume and the number of positive cylinders in the diagnostic biopsy are independent risk factors for reclassification. Initial PSA, laterality of the affected cylinders and PSA density were not predictive factors of progression in our series.

Factores clínicos e histológicos predictores de reclasificación en pacientes incluidos en programa de vigilancia activa de cáncer de próstata / Clinical and histological predictive factors of reclassification of prostate cancer patients on active surveillance

Introducción y objetivo La vigilancia activa (VA) se ha establecido como estrategia terapéutica en pacientes con cáncer de próstata de bajo riesgo. Se han identificado factores demográficos y anatomopatológicos que aumentan la probabilidad de reclasificar a los enfermos. Materiales y métodos Se han recogido datos analíticos e histopatológicos de 116 pacientes incluidos en VA desde 2014. Se ha realizado un análisis univariante con X2, t de Student y Tau de Kendall, un análisis multivariante según regresión logística y se han calculado las curvas de Kaplan-Meier. Resultados De los 116 pacientes en VA, la mediana de edad al diagnóstico fue 66 años y la mediana de seguimiento fueron 13 meses (2-72). De todos ellos, 61 (52,6%) siguen en vigilancia mientras que 55 (47,4%) han salido del programa, la mayoría por progresión histológica (52 pacientes [45,2%]), realizándose prostatectomía radical en 27 (49,1%). El volumen prostático (Vp) ≤ 60cc y el número de cilindros positivos >1 en la biopsia diagnóstica (p = 0,05) se asociaron con mayor tasa de reclasificación en el análisis univariante (p < 0,05). En el análisis multivariante, estas dos variables se correlacionaron significativamente con una mayor tasa de reclasificación (Vp ≤ 60 cc: OR 4,39, p = 0,04; >1 cilindro positivo en la biopsia diagnóstica: OR 2,48, p = 0,03). Conclusiones Se ha objetivado que el volumen ecográfico inicial y el número de cilindros positivos en la biopsia diagnóstica son factores de riesgo independientes para la reclasificación. El antígeno prostático específico (PSA) inicial, la lateralidad de los cilindros afectos y la densidad de PSA no fueron elementos predictores de progresión en nuestra serie (AU)

Introduction and Objective Active surveillance (AS) has been established as a therapeutic strategy in patients with low-risk prostate cancer. Demographic and anatomopathological factors that increase the probability of reclassifying patients have been identified. Materials and Methods Laboratory and histopathological data were collected from 116 patients included on AS since 2014. Univariate analysis was performed with Chi-square, t-student and Kendall's Tau, multivariate analysis according to logistic regression and Kaplan-Meier curves were calculated. Results Of the 116 patients in AS, the median age at diagnosis was 66 years and the median follow-up was 13 months (2-72). Of these, 61 (52.6%) are still on surveillance, while 55 (47.4%) have left the program, mostly due to histological progression (52 patients (45.2%)); radical prostatectomy was performed in 27 (49.1%). Prostate volume (PV) ≤ 60cc and the number of positive cylinders > 1 in diagnostic biopsy (p = 0.05) were associated with higher reclassification rate in univariate analysis (p < 0.05). Multivariate analysis showed that these two variables significantly correlated with higher reclassification rate (PV 60 cc: OR 4.39, p = 0.04; > 1 positive cylinder at diagnostic biopsy: OR 2.48, p = 0.03). Conclusions It has been shown that initial ultrasound volume and the number of positive cylinders in the diagnostic biopsy are independent risk factors for reclassification. Initial PSA, laterality of the affected cylinders and PSA density were not predictive factors of progression in our series (AU)

Desarrollo e implementación de una unidad de inmunoterapia en un servicio de urología / Development and implementation of an immunotherapy unit in a urology department

Introducción La inmunoterapia está revolucionando el tratamiento del cáncer, siendo los anticuerpos monoclonales dirigidos contra moléculas reguladoras del punto de control la terapia más ampliamente utilizada en la actualidad. Un total de seis fármacos inhibidores del punto de control inmunitario (CPI) han sido aprobados por la U.S. Food and Drug Administration (FDA) y por la European Medicines Agency (EMA) para su uso en diversos tumores sólidos del aparato genitourinario. Material y métodos Se revisó la literatura y se analizó la metodología y experiencia propia adquirida para instaurar el tratamiento con CPI en un servicio de Urología. Resultados Se describen los requisitos recomendables desde el punto de vista formativo, logístico y procedimental para implementar una unidad de inmunoterapia en un servicio de Urología que permita ofrecer con seguridad el tratamiento experto con CPI a los pacientes con tumores genitourinarios. Conclusiones El cumplimiento del programa propuesto garantiza la administración segura de CPI en un entorno hospitalario (AU)

Introduction Immunotherapy is revolutionizing cancer treatment, with monoclonal antibodies directed against checkpoint regulatory molecules currently being the most widely used therapy. A total of six immune checkpoint inhibitor (CPI) drugs have been approved by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for use in various solid tumors of the genitourinary tract. Material and methods the literature is reviewed and the methodology, as well as our own experience, are analyzed to establish treatment with CPI in a urology department. Results The requirements recommended in terms of training, logistics and procedure are described in order to safely offer expert treatment with CPI to patients with genitourinary tumors. Conclusions Compliance with the proposed program ensures safe administration of immune checkpoint inhibitors in a hospital setting (AU)

Development and implementation of an immunotherapy unit in a urology department.

INTRODUCTION: Immunotherapy is revolutionizing cancer treatment, with monoclonal antibodies directed against checkpoint regulatory molecules currently being the most widely used therapy. A total of six immune checkpoint inhibitor (CPI) drugs have been approved by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for use in various solid tumors of the genitourinary tract. MATERIAL AND METHODS: The literature is reviewed and the methodology, as well as our own experience, are analyzed to establish treatment with CPIs in a urology department. RESULTS: The requirements recommended in terms of training, logistics and procedure are described in order to safely offer expert treatment with CPIs to patients with genitourinary tumors. CONCLUSIONS: Compliance with the proposed program ensures safe administration of immune checkpoint inhibitors in a hospital setting.

Topical EMLA for pain control during extracorporeal shock wave lithotripsy: prospective, comparative, randomized, double-blind study.

Patient collaboration in external shock wave lithotripsy (ESWL) is critical for its correct application, making proper analgesic selection indispensable. The aim of this study was to evaluate the efficacy of combined application of EMLA and intravenous (i.v.) pethidine compared with pethidine plus placebo cream in patients undergoing ESWL for ureteral and/or renal lithiasis. Prospective, controlled, randomized, double-blind study was conducted in patients receiving ESWL for renal and/or ureterolithiasis. The patients were randomly assigned to receive i.v. pethidine plus either EMLA cream (group A) or placebo hydrating cream (group B). Evaluated were type, location, and size of lithiasis, patient's sex, age, body mass index, comorbidity, Visual Analogue Scale (VAS) score of pain, and degree of lithiasis fragmentation. EMLA cream provided significantly better pain relief and lithiasis fragmentation and more completed ESWL treatment. Topical application of EMLA cream combined with i.v. pethidine improved VAS scores and lithiasis fragmentation and decreased the rate of withdrawal from ESWL procedure versus i.v. pethidine plus placebo therapy.

[Radiofrequency ablation as an alternative treatment for organ confined renal tumor]. / Ablación con radiofrecuencia como alternativa de tratamiento para el tumor renal localizado.

INTRODUCTION: We report our early clinical experience associated with radiofrequency (RF) ablation in patients with renal cell carcinoma (RCC) and evaluate the efficacy, tolerability and complications. MATERIAL AND METHODS: Retrospective review of patients treated in our hospital with kidney ecoguide RF. All of them diagnosed with renal tumor and not candidates for surgery because of bilateral tumor, significant comorbidity or refusal to surgical treatment. We use an Amitech® 220 Watts generator with an electrode tip 3 cm. Straight knitting needles and hooks. Controls were performed with axial tomography at 24h, 7 days, 1, 3 and 6 months and every 6 months thereafter. RESULTS: 11 tumors, 9 patients. The mean age was 76 years (63-85 years). The average tumor size was 3.5 cm (2.2-5.8 cm). In 2 tumors was needed prior chemoembolization. In other two new RF session was needed. 9 tumors with treatment considered effective. Mean follow-up was 17.5 months (3-52 months). One patient had local recurrence at 14 months and needed a laparoscopic radical nephrectomy and two patients developed lung metastases 41.5 months after RF. There were no clinically relevant complications. CONCLUSIONS: In our experience, we believe that RF is considered an alternative treatment for renal tumors with clinical stage T1 or T2 very symptomatic in patients in whom surgery is not possible, with acceptable results in the medium term, a good tolerance, reduced consumption of hospital resources and low complication rate.

Ablación con radiofrecuencia como alternativa de tratamiento para el tumor renal localizado / Radiofrequency ablation as an alternative treatment for organ confined renal tumor

Introducción: Presentamos nuestra serie inicial de tumores renales tratados mediante radiofrecuencia (RF) continua percutánea y evaluamos la eficacia, la tolerabilidad y las complicaciones de la técnica. Material y métodos: Revisión retrospectiva de los pacientes tratados en nuestro hospital con RF renal ecoguiada. Todos diagnosticados de tumor renal y no candidatos a cirugía por tumor bilateral, comorbilidad importante o rechazo al tratamiento quirúrgico. Utilizamos un generador Amitech® de 220W con una punta de electrodo de 3 cm, agujas de punta recta y en gancho. Los controles fueron realizados mediante una tomografía computarizada toracoabdominopélvica a las 24h, a los 7 días, al mes, a los 3 meses y a los 6 meses, y cada 6 meses después. Resultados: Se hallaron 11 tumores en 9 pacientes. La media de edad fue de 76 años (63–85). La media de tamaño tumoral fue de 3,5cm (2,2–5,8). En 2 tumores se necesitó de quimioembolización previa y en otros dos se necesitó una nueva sesión de RF. Hubo 9 tumores con tratamiento considerado como eficaz. La media de seguimiento fue de 17,5 meses (3–52). Un paciente tuvo persistencia de enfermedad a los 3 meses con necesidad de nefrectomía radical laparoscópica y otros dos tuvieron metástasis pulmonares a los 26,5 meses de media. No hubo complicaciones relevantes clínicamente. Conclusiones: En nuestra experiencia, estimamos que la RF es un tratamiento considerado como una alternativa para los tumores renales de estadio clínico T1 o T2 muy sintomáticos, en pacientes en los que no es posible la cirugía, con unos resultados aceptables a medio plazo, una buena tolerancia, un escaso consumo de recursos hospitalarios y un bajo índice de complicaciones (AU)

Introduction: We report our early clinical experience associated with radiofrequency (RF) ablation in patients with renal cell carcinoma (RCC) and evaluate the efficacy, tolerability and complicactions. Material and methods: Retrospective review of patients treated in our hospital with kidney ecoguide RF. All of them diagnosed with renal tumor and not candidates for surgery because of bilateral tumor, significant comorbidity or refusal to surgical treatment. We use an Amitech® 220 Watts generator with an electrode tip 3cm. Straight knitting needles and hooks. Controls were performed with axial tomography at 24h, 7 days, 1, 3 and 6 months and every 6 months thereafter.Results11 tumors, 9 patients. The mean age was 76 years (63–85 years). The average tumor size was 3.5cm (2,2–5,8cm). In 2 tumors was needed prior chemoembolization. In other two new RF session was needed. 9 tumors with treatment considered effective. Mean follow-up was 17.5 months (3–52 months). One patient had local recurrence at 14 months and needed a laparoscopic radical nephrectomy and two patients developed lung metastases 41.5 months after RF. There were no clinically relevant complications. Conclusions: In our experience, we believe that RF is considered an alternative treatment for renal tumors with clinical stage T1 or T2 very symptomatic in patients in whom surgery is not possible, with acceptable results in the medium term, a good tolerance, reduced consumption of hospital resources and low complication rate (AU)