Control oncológico en cáncer de próstata de alto riesgo tras prostatectomía radical y radioterapia de rescate en comparación con radioterapia más hormonoterapia primaria / Oncological control in high-risk prostate cancer after radical prostatectomy and salvage radiotherapy compared to radiotherapy plus primary hormone therapy

Introducción: En pacientes con cáncer de próstata localizado de alto riesgo (CPAR) el tratamiento multimodal juega un papel fundamental. Objetivo: Comparar la supervivencia libre de recidiva (SLR) en pacientes con CPAR tratados de forma primaria con radioterapia (RT)+hormonoterapia (HT) frente a prostatectomía radical (PR) rescatados con RT de rescate (RTR) con o sin HT tras recidiva bioquímica (RB). Material y métodos: Análisis retrospectivo de 226 pacientes con CPAR (1996-2008), tratados de forma primaria con RT+HT (n = 137) o PR (n = 89). Utilizamos el método de Kaplan-Meier para evaluar la supervivencia y el test de log-rank para evaluar las diferencias entre las distintas categorías de las variables. Se realiza análisis multivariante mediante regresión de Cox para determinar variables con impacto en la SLR con significación estadística (p < 0,05). Resultados: La mediana de seguimiento de la serie fue de 111 (RIC 85-137,5) meses. Tras RT+HT recidivaron 32 (23,4%) pacientes, y 41 (46,1%) tras PR (p = 0,0001). Al comparar los tratamientos primarios, la SLR a los 5 y 10 años fue mayor tras RT+HT frente a PR en monoterapia (p = 0,001). El tratamiento primario con RT+HT redujo a más de la mitad el riesgo de RB al compararse con la PR (HR=0,41, p = 0,002). La estimación de la SLR a los 5 y 10 años después de PR+RTR±HT fue de 89,7 y 87,1%, mientras que tras RT+HT primaria fue de 91,6 y 71,1%, respectivamente (p = 0,01). El único factor que se comportó como predictor independiente de SLR fue el tratamiento multimodal mediante PR+RTR±HT cuando se presentó la RB (HR = 2,39, p = 0,01). Conclusión: En CPAR el tratamiento multimodal con PR + RTR ± HT si RB mejora significativamente la SLR con respecto al tratamiento con RT + HT

Introduction: In patients with high-risk localized prostate cancer (HRPCa), multimodal treatment plays a fundamental role. Objective: To compare relapse-free survival (RFS) in patients with HRPCa, treated primarily with radiotherapy (RT) + hormone therapy (HT) versus radical prostatectomy (RP) and salvage RT (sRT) ± HT when biochemical recurrence (BCR) appears. Material and methods: Retrospective analysis of 226 patients with HRPCa (1996-2008), treated primarily with RT+HT (n = 137) or RP (n = 89). The Kaplan-Meier method has been used to evaluate survival and the log-rank test has been used to evaluate the contrast between the different categories of the variables. Multivariate analysis has been performed using Cox regression to determine variables with an impact on RFS with statistical significance (P < 0.05). Results: The median follow-up of the series was 111 (IQR 85-137.5) months. After RT+HT, 32 (23.4%) patients relapsed, and after RP (P = 0.0001), 41 (46.1%) cases. When comparing the primary treatments, the RFS at 5 and 10 years was higher after RT+HT versus RP in monotherapy (P = 0.001). The primary treatment with RT+HT reduced the risk of BCR when compared to the RP (HR = 0.41, P = 0.002). The estimation of the RFS at 5 and 10 years after RP + sRT ± HT was 89.7 and 87.1%, while after primary RT + HT was 91.6 and 71.1%, respectively (P = 0.01). The only factor that behaved as an independent predictor of RFS was the multimodal treatment with RP + sRT ± HT when BCR showed up (HR = 2.39, P = 0.01). Conclusion: In HRPCa, multimodal treatment with RP + sRT ± HT if BCR, significantly improves RFS with respect to treatment with R RT + HT

Oncological control in high-risk prostate cancer after radical prostatectomy and salvage radiotherapy compared to radiotherapy plus primary hormone therapy. / Control oncológico en cáncer de próstata de alto riesgo tras prostatectomía radical y radioterapia de rescate en comparación con radioterapia más hormonoterapia primaria.

INTRODUCTION: In patients with high-risk localized prostate cancer (HRPCa), multimodal treatment plays a fundamental role. OBJECTIVE: To compare relapse-free survival (RFS) in patients with HRPCa, treated primarily with radiotherapy (RT)+hormone therapy (HT) versus radical prostatectomy (RP) and salvage RT (sRT)±HT when biochemical recurrence (BCR) appears. MATERIAL AND METHODS: Retrospective analysis of 226 patients with HRPCa (1996-2008), treated primarily with RT+HT (n=137) or RP (n=89). The Kaplan-Meier method has been used to evaluate survival and the log-rank test has been used to evaluate the contrast between the different categories of the variables. Multivariate analysis has been performed using Cox regression to determine variables with an impact on RFS with statistical significance (P<0.05). RESULTS: The median follow-up of the series was 111 (IQR 85-137.5) months. After RT+HT, 32 (23.4%) patients relapsed, and after RP (P=0.0001), 41 (46.1%) cases. When comparing the primary treatments, the RFS at 5 and 10 years was higher after RT+HT versus RP in monotherapy (P=0.001). The primary treatment with RT+HT reduced the risk of BCR when compared to the RP (HR=0.41, P=0.002). The estimation of the RFS at 5 and 10 years after RP+sRT±HT was 89.7 and 87.1%, while after primary RT+HT was 91.6 and 71.1%, respectively (P=0.01). The only factor that behaved as an independent predictor of RFS was the multimodal treatment with RP+sRT±HT when BCR showed up (HR=2.39, P=0.01). CONCLUSION: In HRPCa, multimodal treatment with RP+sRT±HT if BCR, significantly improves RFS with respect to treatment with RT+HT.

Predicción de recidiva bioquímica tras prostatectomía radical. Nueva herramienta para la selección de candidatos a radioterapia adyuvante / Prediction of biochemical recurrence after radical prostatectomy. New tool for selecting candidates for adjuvant radiation therapy

Objetivo: Diseñar un sumatorio de riesgo para la selección de pacientes para radioterapia adyuvante después de prostatectomía. Material y método: Estudio retrospectivo de 629 pacientes con cáncer de próstata localizado y pN0-pNx tratados con prostatectomía y con un PSA a los 2-3 meses < 0,2 ng/ml. Recidiva bioquímica si PSA > 0,4 ng/ml. Análisis multivariante mediante regresión de Cox. Asignación de puntuación (0-2) en función del HR de las variables significativas. El sumatorio de las puntuaciones definió el sumatorio de riesgo. Resultados: El 19,7% pT3, 24,2% Gleason ≥ 8 y el 26,3% de márgenes quirúrgicos positivos. Mediana de seguimiento de 82 meses. Recidiva bioquímica el 26,6%. El Gleason = 7 (4 + 3) (HR = 2,01, p = 0,008), el Gleason ≥ 8 (HR = 3,07, p < 0,001), el estadio pT3b (HR = 1,93, p = 0,008) y el margen quirúrgico positivo (HR = 2,20, p < 0,001) se identificaron como variables pronosticas independientes de recidiva bioquímica. Se asignó 0 puntos a los pacientes sin variables pronósticas de riesgo, un punto a los pacientes con Gleason = 7 (4 + 3), pT3b o márgenes quirúrgicos positivos y 2 puntos si Gleason ≥ 8. Los pacientes con un sumatorio de riesgo ≤ 2 tuvieron una supervivencia libre de recidiva bioquímica a los 5 y 8 años superior al 50%, en cambio, los pacientes con un sumatorio de riesgo ≥ 3 tuvieron una supervivencia libre de recidiva bioquímica inferior al 44%. Conclusión: Los pacientes con un sumatorio de riesgo ≤ 2 no se beneficiarían de radioterapia adyuvante, mientras que los pacientes con un sumatorio de riesgo ≥ 3 pudieran beneficiarse de radioterapia adyuvante

Objective: To design a risk summation to select patients for adjuvant radiation therapy after prostatectomy. Materials and method: A retrospective study was conducted on 629 patients with localised prostate cancer (pN0–pNx) who were treated with prostatectomy and with a prostate-specific antigen (PSA) value < 0.2 ng/mL at 2–3 months. Biochemical recurrence was defined as a PSA > 0.4 ng/mL. A multivariate Cox regression analysis was performed. A score (0–2) was assigned according to the hazard ratio of the significant variables. The score summation defined the risk summation. Results: A total of 19.7% of the patients were pT3, 24.2% had a Gleason score ≥8, and 26.3% had positive surgical margins. The median follow-up was 82 months. Some 26.6% of the patients experienced biochemical recurrence. The identified prognostic variables independent of biochemical recurrence were a Gleason score = 7 (4 + 3) (HR, 2.01; P = .008), a Gleason score ≥ 8 (HR, 3.07; P < .001), a pT3b stage (HR, 1.93; p = .008) and a positive surgical margin (HR, 2.20; P < .001). We assigned 0 points to patients without risk prognosis variables; 1 point to patients with Gleason scores = 7 (4 + 3), pT3b or positive surgical margins; and 2 points to patients with Gleason scores ≥ 8. The patients with a risk summation ≤ 2 had > 50% survival free of biochemical recurrence at 5 and 8 years. In contrast, the patients with a risk summation ≥ 3 had <44% survival free of biochemical recurrence. Conclusion: The patients with a risk summation ≤ 2 did not benefit from adjuvant radiation therapy, while the patients with a risk summation ≥ 3 might benefit from adjuvant radiation therapy

Prediction of biochemical recurrence after radical prostatectomy. New tool for selecting candidates for adjuvant radiation therapy.

OBJECTIVE: To design a risk summation to select patients for adjuvant radiation therapy after prostatectomy. MATERIALS AND METHOD: A retrospective study was conducted on 629 patients with localised prostate cancer (pN0-pNx) who were treated with prostatectomy and with a prostate-specific antigen (PSA) value <0.2ng/mL at 2-3 months. Biochemical recurrence was defined as a PSA >0.4ng/mL. A multivariate Cox regression analysis was performed. A score (0-2) was assigned according to the hazard ratio of the significant variables. The score summation defined the risk summation. RESULTS: A total of 19.7% of the patients were pT3, 24.2% had a Gleason score ≥ 8, and 26.3% had positive surgical margins. The median follow-up was 82 months. Some 26.6% of the patients experienced biochemical recurrence. The identified prognostic variables independent of biochemical recurrence were a Gleason score =7 (4+3) (HR, 2.01; P=.008), a Gleason score ≥ 8 (HR, 3.07; P <.001), a pT3b stage (HR, 1.93; p=.008) and a positive surgical margin (HR, 2.20; P<.001). We assigned 0 points to patients without risk prognosis variables; 1 point to patients with Gleason scores =7 (4+3), pT3b or positive surgical margins; and 2 points to patients with Gleason scores ≥ 8. The patients with a risk summation ≤ 2 had >50% survival free of biochemical recurrence at 5 and 8 years. In contrast, the patients with a risk summation ≥ 3 had <44% survival free of biochemical recurrence. CONCLUSION: The patients with a risk summation ≤ 2 did not benefit from adjuvant radiation therapy, while the patients with a risk summation ≥ 3 might benefit from adjuvant radiation therapy.

Valor de los márgenes quirúrgicos de resección positivos en los pacientes con cáncer de próstata pT2. Implicaciones en el tratamiento adyuvante / Value of Positive Resection Margins in Patients with pT2 Prostate Cancer. Implicationsfor Adjuvant Treatment

Objetivo: Analizar el impacto sobre la supervivencia libre de recidiva bioquímica de la afectación tumoral de los márgenes quirúrgicos de resección en los pacientes con cáncer de próstata en estadio localizado (pT2) en la pieza de prostatectomía y su implicación en el tratamiento adyuvante. Material y método: Estudio retrospectivo de 536 pacientes con cáncer de próstata en un estadiopT2 tratados con prostatectomía radical entre 1996 y 2007. Posteriormente a la prostatectomía se recogieron las siguientes variables: score de Gleason, estadio patológico, invasión capsular ,márgenes quirúrgicos e invasión perineural. Se realizó un análisis univariante y posteriormente se ajustó mediante un modelo de riesgos proporcionales de Cox (método enter).Resultados: El 21,7% presentó márgenes quirúrgicos positivos y el 20,9% desarrolló recidiva bioquímica con una mediana de seguimiento de 57 meses. El 37,9% de los pacientes con afectación patológica de los márgenes quirúrgicos de resección presentó recidiva bioquímica, frente al 16% de los que no la tenían (p < 0,001). En el análisis multivariante solo el margen quirúrgico (p < 0,001), y el score de Gleason mayor o igual a 8 (p < 0,001) se comportaron como factores independientes de recidiva bioquímica. Al estratificar la serie según estas dos variables encontramos que los pacientes con márgenes quirúrgicos positivos y score de Gleason ≤ 7 tienen una probabilidad de recidiva a los 5 y 10 años del 35 y del 50%, frente al 74 y 87% en el grupo con márgenes quirúrgicos positivos y score de Gleason ≥ 8 (p = 0,002). Conclusión: Los pacientes con cáncer de próstata pT2, márgenes quirúrgicos positivos y score de Gleason ≥ 8 se beneficiarán de una radioterapia adyuvante. El 50% de los pacientes con márgenes positivos y un score de Gleason ≤ 7 no presentarán recidiva, por lo que la indicación de radioterapia adyuvante sigue siendo controvertida (AU)

Objective: To analyse the impact on the recurrence-free biochemical survival of tumour involvement of surgical resection margins in patients with localized prostate cancer (pT2) in the prostatectomy specimen and its implications for adjuvant treatment. Materials and method: Retrospective study of 536 patients with stage pT2 prostate cancer, treated with radical prostatectomy between 1996 and 2007. Subsequent to the prostatectomy, the following variables were collected: Gleason score, pathological stage, capsular invasion, surgical margins and perineural invasion. We performed a univariate analysis and subsequently adjusted it by means of a Cox proportional hazard model (enter method). Results: 21.7% presented positive surgical margins and 20.9% developed biochemical recurrence after a mean follow-up of 57 months. 37.9% of the patients with pathological involvement of the resection surgical margins presented biochemical recurrence against 16% that did not have it (p < 0.001). In the multivariate analysis, only the surgical margin (p < 0.001) and the Gleason score greater or equal to 8 (p < 0.001) behaved as independent biochemical recurrence factors. On stratifying the series according to these two variables, we found that the patients with positive surgical margins and a Gleason score of ≤ 7 have a recurrence probability at 5 and10 years of 35% and 50% against 74% and 87% in the group with positive surgical margins and a Gleason score of ≥ 8 (p = 0.002).Conclusion: Patients with pT2 prostate cancer, positive surgical margins and a Gleason score of ≥ 8 will benefit from adjuvant radiotherapy. 50% of the patients with positive margins and a Gleason score of ≤ 7 will not recur, which means that the indication of adjuvant radiotherapy continues to be controversial (AU)

[Value of positive resection margins in patients with pT2 prostate cancer. Implications for adjuvant treatment]. / Valor de los márgenes quirúrgicos de resección positivos en lospacientes con cáncer de próstata pT2. Implicaciones en eltratamiento adyuvante.

OBJECTIVE: To analyse the impact on the recurrence-free biochemical survival of tumour involvement of surgical resection margins in patients with localized prostate cancer (pT2) in the prostatectomy specimen and its implications for adjuvant treatment. MATERIALS AND METHOD: Retrospective study of 536 patients with stage pT2 prostate cancer, treated with radical prostatectomy between 1996 and 2007. Subsequent to the prostatectomy, the following variables were collected: Gleason score, pathological stage, capsular invasion, surgical margins and perineural invasion. We performed a univariate analysis and subsequently adjusted it by means of a Cox proportional hazard model (enter method). RESULTS: 21.7% presented positive surgical margins and 20.9% developed biochemical recurrence after a mean follow-up of 57 months. 37.9% of the patients with pathological involvement of the resection surgical margins presented biochemical recurrence against 16% that did not have it (p<0.001). In the multivariate analysis, only the surgical margin (p<0.001) and the Gleason score greater or equal to 8 (p<0.001) behaved as independent biochemical recurrence factors. On stratifying the series according to these two variables, we found that the patients with positive surgical margins and a Gleason score of ≤ 7 have a recurrence probability at 5 and 10 years of 35% and 50% against 74% and 87% in the group with positive surgical margins and a Gleason score of ≥ 8 (p=0.002). CONCLUSION: Patients with pT2 prostate cancer, positive surgical margins and a Gleason score of ≥ 8 will benefit from adjuvant radiotherapy. 50% of the patients with positive margins and a Gleason score of ≤ 7 will not recur, which means that the indication of adjuvant radiotherapy continues to be controversial.

[Urinary calculi in myelomeningocele adults]. / Litiasis urinaria en adultos con mielomeningocele.

INTRODUCTION AND OBJECTIVES: The improvements in the management of newborns with myelomeningocele (MMC) have obtained a big increase in survival, allowing them to get longevity like never before, but data regarding urologic diseases during adult age are still missing. We herein evaluate the features of urinary lithiasis in adults born with MMC and the therapies used for its treatment. MATERIAL AND METHOD: We review 52 patients diagnosed at birth of MMC, between 18 and 40 years old, treated in our institution, with a mean follow-up of 6.7 years. RESULTS: 10 patients (19.2%) were diagnosed of urolithiasis. Three developed kidney calculi and one of them, with 7 more patients, developed bladder calculi (15.3%). The neurological level was < or = L2 in 3 cases, L2-S1 in 5, and > or = S1 in the other two. The type of neurogenic dysfunction of inferior urinary tract was multiple lesion of lower motor neurone in 6 cases, upper motor neurone in 1 case, multiple mixed lesion in 1 case and in case it was impossible to determine. Two patients had a bladder augmentation procedure and one of these with other 3 patients had a non-functional AMS-800 artificial urinary sphincter. Bladder stones were treated endoscopically in 14 procedures and by suprapubic cystolithotomy in 4 procedures, combined with removal of AMS-800 in 3 of them. One patient spontaneously passed a small stone. In one case, 2 ESWL and 2 percutaneous nephrolithotomies were needed. Three patients developed multiple recurrences during follow-up. CONCLUSIONS: Urinary lithiasis is common in adults with MMC. Some distinct features of these patients, together with their anatomical configuration and some therapies used in them, cause diagnostic, therapeutic and prophylaxis issues for the calculi they may develop.

Litiasis urinaria en adultos con mielomeningocele / Urinary calculi in myelomeningocele adults

Introducción y objetivos: Los avances en el tratamiento de los nacidos con mielomeningocele (MMC) han logrado un gran aumento en su supervivencia, permitiéndoles una longevidad nunca antes alcanzada, pero todavía son escasos los datos concernientes a los problemas urológicos que estos enfermos plantean durante su vida adulta. Hemos evaluado las características de la litiasis urinaria en adultos nacidos con MMC así como los tratamientos empleados en la misma. Material y métodos: Revisamos 52 pacientes nacidos con MMC de entre 18 y 40 años, atendidos durante los últimos 14 años en nuestro hospital, con una media de seguimiento de 6,7 años. Resultados: Se diagnosticaron de litiasis urinaria 10 pacientes (19,2%). Tres formaron cálculos renales (5,7%), y uno de ellos, junto con 7 pacientes más, desarrollaron cálculos vesicales (15,3%). El nivel neurológico fue ≤ L2 en 3 casos, L2- S1 en 5, y >= S1 en otros dos. El tipo de disfunción neurógena del tracto urinario inferior fue de lesión múltiple pura de neurona motora inferior en 6 casos, de neurona motora superior en 1, lesión múltiple mixta en otro, no pudiéndose valorar en el restante. Dos pacientes tenían una ampliación vesical y uno de estos junto con otros 3 pacientes era portador de AMS-800 no funcionantes. La litiasis vesical se trató endoscopicamente en 14 ocasiones y mediante cistolitotomía suprapúbica en 4, junto a la retirada de AMS-800 en 3 de ellas. Un paciente expulsó un pequeño cálculo. En un paciente fueron necesarias 2 litotricias extracorpóreas y 2 nefrolitotomías percutáneas. Tres pacientes tuvieron múltiples recidivas. Conclusiones: La litiasis urinaria es frecuente en los adultos con MMC. Determinadas características de estos pacientes, junto con su configuración anatómica y algunos tratamientos empleados en ellos, ocasionan problemas de diagnostico, tratamiento y prevención de los cálculos que forman

Introduction and objectives: the improvements in the management of newborns with myelomeningocele (MMC) have obtained a big increase in survival, allowing them to get longevity like never before, but data regarding urologic diseases during adult age are still missing. We herein evaluate the features of urinary lithiasis in adults born with MMC and the therapies used for its treatment. Material and method: we review 52 patients diagnosed at birth of MMC, between 18 and 40 years old, treated in our institution, with a mean follow-up of 6.7 years. Results: 10 patients (19.2%) were diagnosed of urolithiasis. Three developed kidney calculi and one of them, with 7 more patients, developed bladder calculi (15.3%). The neurological level was >= L2 in 3 cases, L2-S1 in 5, and >= S1 in the other two. The type of neurogenic dysfunction of inferior urinary tract was multiple lesion of lower motor neurone in 6 cases, upper motor neurone in 1 case, multiple mixed lesion in 1 case and in case it was impossible to determine. Two patients had a bladder augmentation procedure and one of these with other 3 patients had a non-functional AMS-800 artificial urinary sphincter. Bladder stones were treated endoscopically in 14 procedures and by suprapubic cystolithotomy in 4 procedures, combined with removal of AMS-800 in 3 of them. One patient spontaneously passed a small stone. In one case, 2 ESWL and 2 percutaneous nephrolithotomies were needed. Three patients developed multiple recurrences during follow-up. Conclusions: urinary lithiasis is common in adults with MMC. Some distinct features of these patients, together with their anatomical configuration and some therapies used in them, cause diagnostic, therapeutic and prophylaxis issues for the calculi they may develop

[Evolution of the clinical, echographic and pathological characteristics of patients with indication of transrectal ultrasound and prostate biopsy between 1994 and 2003]. / Evolución de las características clínicas, ecográficas y patológicas de los pacientes con indicación de ecografía transrectal y biopsia de próstata entre 1994 y 2003.

OBJECTIVE: The aim of this paper is to evaluate the evolution in the clinical, echographic and pathological characteristics of patients undergoing transrectal ultrasound and prostate biopsy over a 10 year period (1994-2003). MATERIAL AND METHODS: Patients undergoing a first biopsy of the prostate between 1994-2003 were studied retrospectively. Since the biopsy criteria have changed several times over this period, results were analysed for four different periods: 1994-1997, 1998, 1999-2003 (the latter was further divided into two periods--1999-2001 and 2002-2003--to observe the temporal evolution with the same biopsy criteria). Patients were assigned to risk groups according to D'Amico. RESULTS: We observed that individuals referred for biopsy and those diagnosed with prostate cancer (PC) had a lower mean age (p=0.0001 and p=0.01), there were more patients with a PSA from 4.1-10 ng/ml (p=0.0001 and p=0.0001), more patients had no significant DRE findings (p=0.0001 and p=0.0001) or ultrasound findings (p=0.0001 and p=0.0001). The incidence of cancer diagnosis has decreased from 39.4% to 34.3% (p=0.03). There was an increased incidence of score 7, at the expense of a decline in scores 5-6 and 8-10 and disappearance of score 2-4 (p=0.0001). Patients assigned to the low risk group increased from 9% to 18.1%, those assigned to the intermediate risk group from 20.2% to 43.1% and there was a reduction in those assigned to the high risk group from 70.7% to 38.7% (p=0.0001). Analysis of the final two time periods revealed that the evolution of the series remained the same except for a decrease in age at biopsy and diagnosis of cancer. CONCLUSIONS: Nowadays, the risk factors of patients with an indication of biopsy have less weight than ten years ago. We currently diagnose patients with PC with more favourable prognostic factors. However, the price we pay for this earlier diagnosis is reflected in a less effective biopsy, a larger proportion of the population without PC having to experience the physical complications and psychological stress of a biopsy, a greater number of patients having to undergo a second biopsy and, therefore, a greater and more costly use of resources to diagnose PC.

Evolución de las características clínicas, ecográficas y patológicas de los pacientes con indicación de ecografía transrectal y biopsia de próstata entre 1994 Y 2003 / Evolution of the clinical, echographic and pathological characteristics of patients with indication of transrectal ultrasound and prostate biopsy between 1994 and 2003

Objetivo: El objetivo de este artículo es evaluar los cambios en el tiempo que se han producido en las características clínicas, ecográficas, bioquímicas y patológicas de los pacientes sometidos a ecografía transrectal y biopsia de próstata en un periodo 10 años(1994-2003). Material y método: Se ha analizado de forma retrospectiva los pacientes sometidos a una primera biopsia de próstata en el periodo 1994-2003. Durante el mismo se ha modificado en varias ocasiones los criterios de biopsia, por lo que el análisis de los resultados se realizará en 4 periodos de tiempo: 1994-1997, 1998, 1999- 2003 (este último se desdobla en dos - 1999-2001 y 2002- 2003 - para observar la evolución en el tiempo con los mismos criterios de biopsia). Los pacientes son asignados a grupos de riesgo según D´Amico. Resultados: Hemos observado tanto en los sujetos remitidos para biopsia como en los diagnosticados de cáncer de próstata (CP) una disminución de la edad media (p=0,0001 y p=0,01), un aumento de los pacientes con PSA entre 4,1-10 ng/ml (p=0,0001 y p=0,0001), un aumento de los sujetos sin alteraciones al tacto rectal (p=0,0001 y p=0,0001) ni ecográficas (p=0,0001 y p=0,0001). La incidencia de diagnósticos de cáncer ha disminuido del 39,4% al 34,3% (p=0,03). Se observa un aumento del score 7 con disminución del 5-6, 8-10 y desaparición del 2-4 (p=0,0001). Los pacientes asignados al grupo de bajo riesgo aumentan del 9% al 18,1%, del 20,2% al 43,1% los asignados al grupo de riesgo intermedio y disminuyen los asignados al grupo de riesgo alto del 70,7% al 38,7% (p=0,0001). Al analizar los dos últimos periodos de tiempo se mantiene la evolución de la serie excepto en la disminución de la edad de biopsia y de diagnostico de cáncer. Conclusiones: Los pacientes con indicación de biopsia tienen actualmente unos factores de riesgo con menor peso que hace una década. Actualmente diagnosticamos a los pacientes de CP con unos factores pronósticos más favorables. Pero el precio que tenemos que pagar por esta anticipación diagnóstica se traduce en: una menor efectividad de la biopsia, un aumento de la población sin CP sometida a las complicaciones físicas y el estrés psicológico que implica la realización de la biopsia, un aumento de pacientes sometidos a re-biopsia y por lo tanto, un incremento en la utilización de los recursos y de los costes necesarios para el diagnostico de CP

Objective: The aim of this paper is to evaluate the evolution in the clinical, echographic and pathological characteristics of patients undergoing transrectal ultrasound and prostate biopsy over a 10 year period (1994-2003). Material and methods: Patients undergoing a first biopsy of the prostate between 1994-2003 were studied retrospectively. Since the biopsy criteria have changed several times over this period, results were analysed for four different periods: 1994-1997, 1998, 1999-2003 (the latter was further divided into two periods - 1999-2001 and 2002-2003 – to observe the temporal evolution with the same biopsy criteria). Patients were assigned to risk groups according to D´Amico. Results: We observed that individuals referred for biopsy and those diagnosed with prostate cancer (PC) had a lower mean age (p=0.0001 and p=0.01), there were more patients with a PSA from 4.1-10 ng/ml (p=0.0001 and p=0.0001), more patients had no significant DRE findings (p=0.0001 and p=0.0001) or ultrasound findings (p=0.0001 and p=0.0001). The incidence of cancer diagnosis has decreased from 39.4% to 34.3% (p=0,03). There was an increased incidence of score 7, at the expense of a decline in scores 5-6 and 8-10 and disappearance of score 2-4 (p=0.0001). Patients assigned to the low risk group increased from 9% to 18.1%, those assigned to the intermediate risk group from 20.2% to 43.1% and there was a reduction in those assigned to the high risk group from 70.7% to 38.7% (p=0.0001). Analysis of the final two time periods revealed that the evolution of the series remained the same except for a decrease in age at biopsy and diagnosis of cancer. Conclusions: Nowadays, the risk factors of patients with an indication of biopsy have less weight than ten years ago. We currently diagnose patients with PC with more favourable prognostic factors. However, the price we pay for this earlier diagnosis is reflected in a less effective biopsy, a larger proportion of the population without PC having to experience the physical complications and psychological stress of a biopsy, a greater number of patients having to undergo a second biopsy and, therefore, a greater and more costly use of resources to diagnose PC

[Giant bizarre scrotal leiomyoma]. / Leiomioma escrotal bizarro gigante: a propósito de un caso.

OBJECTIVES: To review the diagnosis and therapeutic management of scrotal wall smooth muscle tumors by reporting an illustrative case. To emphasize that despite their histological characteristics on presentation, compatible with malignancy, these tumors have a benign behaviour, even when their size is much bigger than the ones found in the review bibliography. METHODS: 75-year-old male who presented a big, very slowly growing, painless, mobile, hard, not adhered to deep layers, non transilluminating scrotal tumor. RESULTS: Pathology reported a giant bizarre scrotal leiomyoma. CONCLUSIONS: We emphasize the atypical characteristics of this case, which despite its compliance with almost all classical criteria establishing the malignant character of tumor lesions has a benign behaviour. It complies with the criterion that, accordingly to reviewed bibliography, seems to be the most important to determine it: the absence of mitosis. We also insist on the importance of an adequate diagnostic approach which guarantees a proper surgical approach, for which we think ultrasound is essential.

[Incidence and significance of "atypical acinar proliferation" in transrectal prostatic biopsies]. / Incidencia y significación de la "proliferación acinar atípica" en las biopsias transrectales de próstata.

OBJECTIVE: To determine the incidence of atypical acini in our series, the percentage of prostate cancer and other suspicious or preneoplastic lesions in the successive biopsies and to establish a follow up strategy in these patients. MATERIAL AND METHOD: A total of 117 patients diagnosed with isolated atypical acini or associated with high grade PIN were obtained from our database, 75 (64%) of these were submitted to at least a second biopsy of the gland. The age, PSA, digital rectal examination (DRE), prostate volume, ultrasound nodule and previous pathological diagnosis were compared with the pathology results of the successive biopsies of the gland. RESULTS: Incidence of atypical acini was 4%. A total of 46.7% of patients undergoing a repeat biopsy presented prostate cancer. We did not find significant differences in the clinical variables studied between patients with or without a definite cancer diagnosis. Patients initially diagnosed with acinar atypia with associated high grade PIN presented a higher incidence of cancer in the repeat biopsy than patients with isolated acinar atypia (p=0.007). A total of 94.3% of all neoplasms diagnosed were detected in the 2nd and 3rd biopsy. CONCLUSIONS: Patients with atypical acini are at high risk of having prostate cancer not detected in the first biopsy. They should, therefore, undergo a second biopsy as soon as possible. There is only a very small probability of detecting cancer after the 3rd biopsy.

Incidencia y significación de la “proliferación acinar atípica” en las biopsias transrectales de próstata / Incidence and significance of “atypical acinar proliferation” in transrectal prostatic biopsies

OBJETIVO: Evaluar la incidencia de atipia acinar en nuestra serie, el porcentaje de cáncer de próstata y otras lesiones sospechosas o preneoplásicas en las biopsias sucesivas y establecer una estrategia de seguimiento en estos pacientes. MATERIAL Y MÉTODO: Se han extraído de nuestra base de datos 117 pacientes con el diagnóstico de atipia acinar aislada o asociada a PIN de alto grado, 75 (64%) fueron sometidos al menos a una segunda biopsia de la glándula. La edad, PSA, tacto rectal, volumen prostático, nódulo ecográfico y diagnóstico patológico previo se compararon con el resultado patológico de las sucesivas biopsias de la glándula. RESULTADOS: La incidencia de atipia acinar fue del 4%. El 46,7% de los pacientes sometidos a rebiopsia presentaron cáncer de próstata. No encontramos diferencias significativas en las variables clínicas analizadas entre los pacientes con diagnóstico final de cáncer o no. Los pacientes con diagnóstico inicial de atipia acinar con PIN de alto grado asociado presentaron una mayor incidencia de cáncer en la rebiopsia que los pacientes con atipia acinar aislada (p=0,007). El 94,3% de las neoplasias diagnosticadas se detectaron en la 2ª y 3ª biopsia. CONCLUSIONES: Los pacientes con atipia acinar tienen un riesgo elevado de tener un cáncer de próstata no detectado en la 1ª biopsia, por lo tanto deben de ser sometidos a rebiopsia en el menor plazo posible. La probabilidad de diagnosticar un cáncer después de una 3ª biopsia es muy pequeña

OBJECTIVE: To determine the incidence of atypical acini in our series, the percentage of prostate cancer and other suspicious or preneoplastic lesions in the successive biopsies and to establish a follow up strategy in these patients. MATERIAL AND METHOD: A total of 117 patients diagnosed with isolated atypical acini or associated with high grade PIN were obtained from our database, 75 (64%) of these were submitted to at least a second biopsy of the gland. The age, PSA, digital rectal examination (DRE), prostate volume, ultrasound nodule and previous pathological diagnosis were compared with the pathology results of the successive biopsies of the gland.RESULTS: Incidence of atypical acini was 4%. A total of 46.7% of patients under going a repeat biopsy presented prostate cancer. We did not find significant differences in the clinical variables studied between patients with or without a definite cancer diagnosis. Patients initially diagnosed with acinar atypia with associated high grade PIN presented a higher incidence of cancer in the repeat biopsy than patients with isolated acinar atypia (p=0.007). A total of 94.3% of all neoplasms diagnosed were detected in the 2nd and 3rd biopsy. CONCLUSIONS: Patients with atypical acini are at high risk of having prostate cancer not detected in the first biopsy. They should, therefore, undergo a second biopsy as soon as possible. There is only a very small probability of detecting cancer after the 3rd biopsy

[Incidence of high grade prostatic intraepithelial neoplasm in transrectal biopsy of the prostate]. / Incidencia de la neoplasia intraepitelial prostática de alto grado en las biopsias transrectales de la próstata.

OBJECTIVE: To analyze the incidence of high grade prostatic intraepithelial neoplasia (PIN) in the transrectal prostate biopsies of patients from the Urology department. METHODS: From 1995 to 1999, 2018 patients aged 46-92 years (mean 68 +/- 10) had a transrectal biopsy. Thirty-six percent had a suspicious DRE and the mean serum PSA was 31.7 +/- 152.9 ng/ml. The anatomopathological diagnoses were: a) cancer, b) benign pathology, c) high grade PIN and d) glandular atypia. Statistical analysis using the chi square and Mann-Whitney tests was performed to compare the following variables: age, DRE, PSA, PSAf/PSAt ratio and the finding of a suspicious node on ultrasound. RESULTS: The incidence of high grade PIN in this series was 8% and the incidence of prostate cancer was 38.6%, PIN grade 3 was diagnosed in 94 patients and PIN grade 2 in 67, and was associated with glandular atypia in 13 patients. Patients with prostate cancer were older and showed statistically significant higher PSA, percentage of suspicious DRE, sonographically suspicious nodes, and a lower PSAf/PSAt ratio than the other diagnoses (p < 0.001). Comparison of patients with high grade PIN and those with benign pathology showed no differences for age, DRE, PSA levels and PSAf/PSAt ratio. However, a significantly lower incidence of sonographically suspicious nodes was found (p < 0.001). CONCLUSIONS: The incidence of high grade PIN was 8%. High grade PIN does not cause sufficient changes in the clinical variables analyzed to suspect this lesion before it is confirmed by the pathological findings.

[Differences in survival of patients with bladder cancer depending on depth of muscle infiltration]. / Diferencias en la supervivencia de los pacientes con cáncer de vejiga según la profundidad de la infiltración muscular.

OBJECTIVE: To study the survival of patients with bladder cancer and infiltration into the muscle who undergo radical cystectomy, documenting any survival difference based on the depth of muscle infiltration (pT2a vs. pT2b). MATERIAL AND METHOD: 109 patients with infiltration into the muscle (T2) in the TUR were treated with radical cystectomy between 1986 and 1996; 39 patients were excluded due to infra-staging and 2 died in the immediate postoperative: 68 patients were eligible for the study. Median follow-up was 51 months. At the time of analysis 44 were alive (2 with tumoral disease and one with a second non-urological tumour), 21 had died (4 for causes other than vesical tumour) and 3 patients were considered lost to follow-up at 3, 31 and 111 months. Survival analysis was performed using the Kaplan-Meier method, and the variables were compared with the log-rank test. RESULTS: The 3- and 5-year overall survival of our series was 76% and 62%, while cancer specific survival was 80% and 70% respectively. Cancer specific survival at 5 years by stages was: pT0-83%, pT1-80%, pT2a-66% and pT2b-60% (p = 0.52). The cystectomy specimen (pT0) showed no residual tumour in 15 (22%) patients, and 5-year cancer specific survival in this group was 83% vs. 66% in patients with residual cancer (p = 0.24). CONCLUSIONS: Patients with pT2a and pT2b bladder cancer showed no differences in survival and we believe they should be all included in the same prognostic group (pT2). pT0 patients are a subgroup of patients with significant survival rates in which radical cystectomy should be considered as overtreatment, and a more conservative protocol should be preferred.

Diferencias en la supervivencia de los pacientes con cáncer de vejiga según la profundidad de la infiltración muscular / Differences in survival of patients with bladde cancer based on depth of infiltration into the muscle

OBJETIVO: Analizar la supervivencia de los pacientes con cáncer de vejiga e infiltración de la capa muscular tratados mediante cistectomía radical comprobando la existencia o no de diferencias en la supervivencia según la profundidad de la infiltración muscular (pT2a frente a pT2b). MATERIAL Y MÉTODO: Entre 1986 y 1996, 109 pacientes con infiltración de la muscular (T2) en la RTU fueron tratados mediante cistectomía radical, 39 pacientes fueron excluidos por infraestadiaje y 2 por exitus en el postoperatorio inmediato, quedando 68 pacientes válidos para el estudio. La mediana de seguimiento fue de 51 meses y en el momento de la revisión 44 pacientes estaban vivos (2 con enfermedad tumoral y otro con un segundo tumor no urológico), 21 pacientes habían fallecido (4 por causas distintas al tumor vesical) y 3 pacientes se consideraron perdidos a los 3,31 y 11 meses de seguimiento. El análisis de la supervivencia se ha realizado mediante el método de Kaplan-Meier, comparando las variables analizadas mediante el test de long-rank. RESULTADOS: La supervivencia global de la serie fue a los 3 y 5 años del 76 por ciento y del 62 por ciento y la cáncer específica del 80 por ciento y del 70 por ciento respectivamente. La supervivencia cáncer específica a los 5 años por estadios patológicos fue: pT0-83 por ciento, pT180 por ciento, pT2a-66 por ciento y pT2b-60 por ciento (p=0,52). En 15 (22 por ciento) pacientes no se encontraron restos tumorales en la pieza de cistectomía (pT0), la supervivencia cáncer específica a los 5 años en este grupo fue del 83 por ciento frente al 66 por ciento en los pacientes con cáncer residual (p=0,24). CONCLUSIONES: No hemos encontrado diferencias en la supervivencia entre los pacientes con cáncer vesical pT2a y pT2b por lo que creemos que se deberían de clasificar dentro de un mismo grupo pronóstico (pT2). Los pacientes pT0 representan un subgrupo de pacientes con una supervivencia importante en los cuales la cistectomía radical se podría considerar como un sobretratamiento, pudiendo ser candidatos a protocolos de conservación vesical (AU)

[Radical cystectomy in the treatment of cancer of the bladder]. / La cistectomía radical en el tratamiento del cáncer de vejiga.

OBJECTIVE: To analyze retrospectively the efficacy of radical cystectomy alone in the treatment of transitional cell carcinoma of the bladder. METHODS: 125 patients who underwent radical cystectomy were evaluated. The mean follow-up was 62 months. At the time of the study, 65 patients were alive (3 with bladder tumor and 1 with a second primary) and 60 patients had died (50 from bladder cancer and 10 from other causes). Nine patients were lost to follow-up. The Kaplan-Meier method was used for the survival analysis and the log-rank test for the comparison of the variables. RESULTS: The overall survival at 5 years was 50% and the cancer-specific survival was 56%. By tumor stage, the cancer-specific survival at 3 and 5 years were respectively: 83% and 85% for pT1, 78% and 70% for pT2, 52% and 42% for pT3, 24% and 12% for pT4 and 14% for pN+ (p < 0.0001). No differences were found between stages pT2a (73% and 68%) and pT2b (71% and 53%) (p = 0.2). The survival was significantly higher in patients with no residual tumor in the cystectomy specimen (pT0) (93% and 83%) than in those with residual tumor (60% and 53%) (p = 0.03). CONCLUSIONS: Radical cystectomy alone in the treatment of transitional cell carcinoma of the bladder was found to be effective in patients with tumor stage pT2. It is less effective in patients with tumor in the advanced stages (pT3 or pT4) or lymph node invasion. Radical cystectomy is an overtreatment in patients with no residual tumor in the cystectomy specimen.

[Usefulness of free PSA/total PSA ratio in the diagnosis of prostatic cancer in symptomatic patients with PSA levels ranging from 2.5 to 20 ng/ml]. / Utilidad del cociente PSA libre/PSA total en el diagnóstico del cáncer de próstata en pacientes sintomáticos con niveles de PSA entre 2,5 y 20 ng/ml.

OBJECTIVE: To evaluate the value of free PSA/total PSA ratio (fPSA/tPSA) to boost total PSA (tPSA) specificity in the diagnosis of prostate cancer in a series of symptomatic patients. MATERIAL AND METHOD: Prospective study on 334 patients presenting symptoms compatible with PBH and tPSA (ProStatus, Wallace Oy, Turku, Finland) between 2.5 and 20 ng/ml, and mean age 67.2 +/- 7 (49-87). Patients were divided into 3 groups: Group I (normal DRE and tPSA between 2.5 and 10 ng/ml)--189 patients. Group II (normal DRE and tPSA between 10 and 20 ng/ml)--78 patients. Group III (suspicion DRE and sPSA between 2.5 and 20 ng/ml)--67 patients. For each group, the sensitivity, specificity and ROC curves were calculated for several cut-off values of the lPSA/tPSA ratio. RESULTS: Group I--Prostate cancer was diagnosed in 11% (20/189) patients. Significant differences were found only in the lPSA/tPSA ratio (p = 0.01). Using 27% as the cut-off value, cancer would have been diagnosed in 95% (19 of 20) patients, decreasing the total number of negative biopsies by 21% (39 of 189). Group II--Prostate cancer was diagnosed in 19% (15/78) patients. The only significant differences found were in prostate volume (p = 0.02). Using 30% as the cut-off value, 93% (14 of 15) patients with cancer would have been diagnosed, decreasing the total number of biopsies by 6.5% (5 of 78) and the number of negative biopsies by 8% (5 of 63). Group III--Prostate cancer was detected in 72% (48/67) patients. Significant differences were found in lPSA/tPSA ratio (p = 0.003), prostate volume (p = 0.02) and presence of ultrasound nodes (p = 0.004). Using 25% as the cut-off value, 96% (46 of 48) of patients with cancer would have been diagnosed, decreasing the total number of biopsies by 13% (9 of 67) and the number of negative biopsies by 47% (9 of 19). CONCLUSIONS: We advise use of lPSA/tPSA ratio only in patients with normal DRE and tPSA between 2.5 and 10 ng/ml. Biopsing patients with lPSA percent equal to or lower than 27% would have prevented 23% of negative biopsies while still maintaining a diagnostic sensitivity of 95%.

Utilidad del cociente PSA libre/PSA total en el diagnóstico del cáncer de próstata en pacientes sintomáticos con niveles de PSA entre 2,5 y 20 ng/ml / Value of free PSA/total PSA ratio in the diagnosis of prostate cancer in symptomatic patients with PSA levels between 2,5 and 20 ng/ml

OBJETIVO: Evaluación de la utilidad del cociente PSA libre / PSA total (PSAl/PSAt) para incrementar la especificidad del PSA total (PSAt), en el diagnóstico del cáncer de próstata en una serie de pacientes sintomáticos. MATERIAL Y MÉTODO: Estudio prospectivo sobre 334 pacientes con síntomas compatibles con HBP y PSAt (ProStatus TM , Wallace Oy, Turku, Finland) entre 2,5 y 20 ng/ml, con una edad media de 67,2 ñ 7 (49-87). Se dividieron en 3 grupos: Grupo I (tacto rectal normal y PSAt entre 2,5 y 10 ng/ml) - 189 pacientes. Grupo II (tacto rectal normal y PSAt entre 10 y 20 ng/ml) - 78 pacientes. Grupo III (tacto rec-tal sospechoso y PSAt entre 2,5 y 20 ng/ml) - 67 pacientes. Se calculó la sensibilidad, especificidad y curvas ROC para diferentes puntos de corte del cociente PSAl/PSAt en cada grupo. RESULTADOS: Grupo I - En el 11 por ciento (20/189) de los pacientes se diagnosticó cáncer de próstata. Sólo se encontraron diferencias sig-nificativas en el cociente de PSAl/PSAt (p = 0,01). Utilizando el 27 por ciento como punto de corte, habríamos diagnosticado el 95 por ciento (19 de 20) de los pacientes con cáncer, disminuyendo en un 21 por ciento (39 de 189) el total de las biopsias, y en un 23 por ciento (39 de 169) el número de biopsias negativas. Grupo II - En el 19 por ciento (15/78) de los pacientes se detectó cáncer de próstata. Sólo se encontraron diferencias significativas en el volumen prostático (p = 0,02). Utilizando el 30 por ciento como punto de corte habríamos diagnosticado el 93 por ciento (14 de 15) de los pacientes con cáncer, disminuyendo en un 6,5 por ciento (5 de 78) el total de las biopsias y en un 8 por ciento (5 de 63) el número de biopsias negativas. Grupo III - En el 72 por ciento (48/67) de los pacientes se detectó cáncer de próstata. Se encontraron diferencias significativas en el cociente de PSAl/PSAt (p = 0,003), el volumen prostático (p = 0,02) y la existencia de nódulos ecográficos (p = 0,004). Utilizando el 25 por ciento como punto de corte habría-mos diagnosticado el 96 por ciento (46 de 48) de los pacientes con cáncer, disminuyendo en un 13 por ciento (9 de 67) el total de las biopsias, y en un 47 por ciento (9 de 19) el número de biopsias negativas. CONCLUSIONES: Aconsejamos la utilización del índice de PSAl/PSAt sólo en los pacientes con tacto rectal normal y PSAt entre 2,5 y 10 ng/ml. La biopsia de los pacientes con un porcentaje de PSAl menor o igual al 27 por ciento, habría evitado el 23 por ciento de las biopsias negativas manteniendo una sensibilidad diagnóstica del 95 por ciento (AU)

Need for intravenous urography in patients with primary transitional carcinoma of the bladder?

OBJECTIVE: To assess the need for and the efficacy of intravenous urography in the detection of a synchronous upper tract urothelial tumor (UTUT) in patients with primary bladder tumor. MATERIALS: Between 1986 and 1996, 793 patients were diagnosed as having primary tumor of the bladder with pathological confirmation of transitional cell carcinoma. All patients underwent intravenous urography prior to transurethral resection. The mean age of the patients was 66.4 years, and 87.7% of them were male. Of these patients, 72% had superficial tumors, while the remaining 28% had infiltrative tumors. Histological classification of the tumors was: grade I, 10%; grade II, 45%, and grade III, 45%. A chi(2) test was used for statistical analysis. RESULTS: The incidence of upper tract urothelial tumors was 1.1% (9 patients), although intravenous urography only diagnosed 6 cases (0.7%). No differences were seen between patients with or without UTUT with regard to histological grade (p = 0.7), multiple bladder tumors (p = 0.7) and tumor infiltration (p = 0.9). In 5.8% of the patients an unsuspected associated pathology was detected which required treatment in 1.4% of the cases. CONCLUSIONS: Due to the low incidence of UTUT (1.1%) in our series and to the fact that intravenous urography was effective in diagnosing synchronous UTUT in only 66.6% of cases, we do not consider that this procedure should be routinely performed in the diagnostic workup of patients with primary transitional cell tumor of the bladder.