Resultados de la rama española del Estudio Randomizado Europeo de Screening del Cáncer de Próstata (ERSPC). Actualización tras 21 años de seguimiento / Results of the spanish section of the European Randomized Study of Screening for Prostate Cancer (ERSPC). Update after 21 years of follow-up

INTRODUCCIÓN Y OBJETIVO: El Estudio Randomizado Europeo de Screening del Cáncer de Próstata (ERSPC) tiene como objetivo probar si el cribado del cáncer de próstata (CaP) reduce la mortalidad por esta enfermedad. Este estudio multicéntrico (ocho países europeos) ha reclutado más de 180.000 varones asintomáticos. Tras un tiempo de seguimiento de 16 años se ha demostrado que el cribado con PSA reduce la mortalidad por CaP un 20%, sin efecto sobre la mortalidad global (por cualquier causa). En este artículo se ofrece una actualización de los resultados de la rama española del ERSPC tras 21 años de seguimiento. MATERIALES Y MÉTODOS: Como centro participante en el ERSPC se invitó a participar en el estudio a 18.612 varones entre los 45 y 70 años de edad de los municipios de Getafe y Parla (Madrid). Randomización en brazo intervención (determinación de PSA sérico), y en brazo control (seguimiento sin realizar pruebas). Se registraron los diagnósticos de CaP, así como la mortalidad por CaP y por todas las causas, realizando comparación entre ambos brazos del estudio de las curvas de supervivencia, y análisis pormenorizado de las causas de muerte. RESULTADOS: El estudio se llevó a cabo finalmente con 4.276 varones (2.415 brazo intervención, 1.861 brazo control). Las medianas de edad, PSA sérico y tiempo de seguimiento fueron 57 años, 0,9 ng/ml y 21,1 años respectivamente. Se diagnosticaron 285 CaP, 188 (7,8%) brazo intervención, 97 (5,2%) brazo control (p < 0,001). Un total de 216 (75,8%) debutaron en estadio clínico organoconfinado. Se registraron 994 fallecimientos, 544 (22,5%) en el brazo intervención y 450 (24,2%) en el brazo control. No se detectaron diferencias significativas entre los brazos del estudio en términos de mortalidad cáncer-específica (p = 0,768) o por todas las causas (p = 0,192). La principal causa de muerte fueron los tumores malignos (492 pacientes, 49,5% del total de muertes), siendo los sitios primarios más frecuentes pulmón y bronquios (29,5%), colon y recto (14,8%), y hematológicos (9,8%). Solo 20 pacientes (0,4% de los varones reclutados) fallecieron por CaP, sin diferencia significativa entre brazos del estudio. CONCLUSIONES: En esta actualización de los resultados de la rama española del estudio ERSPC tras 21 años de seguimiento, no hemos detectado un beneficio del cribado del CaP en términos de supervivencia global, ni cáncer específica

INTRODUCTION AND OBJECTIVE: The objective of the European Randomized Study of Screening for Prostate Cancer (ERSPC) is to assess whether prostate cancer (PCa) screening leads to an improvement of cancer-specific survival. This multicenter study (eight European countries) has recruited more than 180,000 asymptomatic men. After a follow-up period of 16 years, it has been shown that PSA screening reduces PCa mortality by 20%, and that it does not affect all-cause mortality. This article provides updated the results of the Spanish arm of the ERSPC after 21 years of follow-up. MATERIALS AND METHODS: The study invited 18,612 men (aged 45 - 70) of the Spanish section (Getafe and Parla, Madrid) to participate. They were randomly assigned to the intervention arm (serum PSA-based screening) and to the control arm (follow-up without intervention). The diagnoses of PCa were recorded, as well as the PCa-specific and all-cause mortality rates. A comparison between the survival curves of both arms of the study and detailed analysis of the causes of death were performed. RESULTS: The study finally included 4,276 men (2,415 intervention arm, 1,861 control arm). The median age, serum PSA and follow-up time were 57 years, 0.9 ng/ml and 21.1 years, respectively. There were 285 cases with PCa diagnosis, 188 (7.8%) from the intervention arm and 97 (5.2%) from the control arm (p < ,001). A total of 216 (75.8%) presented organ-confined disease. There were 994 deaths were recorded; 544 (22.5%) in the intervention arm and 450 (24.2%) in the control arm. No significant differences were detected between the arms of the study in terms of cancer-specific (p = .768) or all-cause (p = .192) mortality rates. The main cause of death was malignant tumors (492 patients, 49.5% of overall mortality), and the most frequent sites were lung and bronchus (29.5%), colon and rectum (14.8%), and hematologic (9.8%). Only 20 patients (0.4% of the patients recruited) died from PCa, with no significant difference between study arms. CONCLUSIONS: In this update of the results of the Spanish section of the ERSPC study after 21 years of follow-up, we have not detected a benefit of PCa screening in terms of overall and cancer-specific survival

Results of the spanish section of the European Randomized Study of Screening for Prostate Cancer (ERSPC). Update after 21 years of follow-up. / Resultados de la rama española del Estudio Randomizado Europeo de Screening del Cáncer de Próstata (ERSPC). Actualización tras 21 años de seguimiento.

INTRODUCTION AND OBJECTIVE: The objective of the European Randomized Study of Screening for Prostate Cancer (ERSPC) is to assess whether prostate cancer (PCa) screening leads to an improvement of cancer-specific survival. This multicenter study (eight European countries) has recruited more than 180,000 asymptomatic men. After a follow-up period of 16 years, it has been shown that PSA screening reduces PCa mortality by 20%, and that it does not affect all-cause mortality. This article provides updated the results of the Spanish arm of the ERSPC after 21 years of follow-up. MATERIALS AND METHODS: The study invited 18,612 men (aged 45 - 70) of the Spanish section (Getafe and Parla, Madrid) to participate. They were randomly assigned to the intervention arm (serum PSA-based screening) and to the control arm (follow-up without intervention). The diagnoses of PCa were recorded, as well as the PCa-specific and all-cause mortality rates. A comparison between the survival curves of both arms of the study and detailed analysis of the causes of death were performed. RESULTS: The study finally included 4,276 men (2,415 intervention arm, 1,861 control arm). The median age, serum PSA and follow-up time were 57 years, 0.9 ng/ml and 21.1 years, respectively. There were 285 cases with PCa diagnosis, 188 (7.8%) from the intervention arm and 97 (5.2%) from the control arm (p<,001). A total of 216 (75.8%) presented organ-confined disease. There were 994 deaths were recorded; 544 (22.5%) in the intervention arm and 450 (24.2%) in the control arm. No significant differences were detected between the arms of the study in terms of cancer-specific (p=.768) or all-cause (p=.192) mortality rates. The main cause of death was malignant tumors (492 patients, 49.5% of overall mortality), and the most frequent sites were lung and bronchus (29.5%), colon and rectum (14.8%), and hematologic (9.8%). Only 20 patients (0.4% of the patients recruited) died from PCa, with no significant difference between study arms. CONCLUSIONS: In this update of the results of the Spanish section of the ERSPC study after 21 years of follow-up, we have not detected a benefit of PCa screening in terms of overall and cancer-specific survival.

Reparación de las lesiones nerviosas en el antebrazo con tubo de silicona. Resultados clínicos a largo plazo / Repair of nerve injuries in the forearm using a silicone tube. Long-term clinical results

Objetivo: El objetivo del presente estudio es evaluar los resultados motores y sensitivos obtenidos tras la reparación de los nervios mixtos del antebrazo con tubo de silicona. Material y métodos: Estudio retrospectivo de 14 pacientes afectos de 16 lesiones de los troncos nerviosos en el antebrazo (7 medianos, 7 cubitales, 1 rama radial sensitiva, 1 rama cutánea dorsal cubital) en los que se realizó neurorrafia directa con tubo de silicona. En 11 pacientes existieron lesiones asociadas arteriales y tendinosas. Se realizó reparación secundaria en tres casos y primaria en los 13 restantes, dos de ellos durante un reimplante de miembro superior. La valoración se realizó mediante la escala de funcional descrita por Chanson. Resultados: Con un seguimiento medio de 24 meses y excluyendo dos casos que afectaban únicamente a ramos sensitivos, se obtuvieron un 64% de buenos o muy buenos resultados, 24% de resultados regulares y un caso de mal resultado. En 6 casos se retiró el tubo, por tumoración palpable no dolorosa en la zona de inserción en 4 pacientes, por la existencia de clínica compresiva y por herniación de los extremos nerviosos en el interior del tubo en otro. En todos los casos se pudo comprobar la restitución macroscópica de la estructura nerviosa. Conclusiones: El uso del tubo de silicona en la reparación de lesiones agudas, subagudas y crónicas de nervios periféricos en el antebrazo parece aportar buenos resultados en la mayoría de los casos, con restauración macroscópica de la anatomía del nervio y restitución de la función (AU)

Objective: The aim of the present study is to evaluate motor and sensory results obtained after reconstruction of peripheral nerve injuries in the forearm, using silicone tubes. Methods: A series of 16 injuries of forearm nerves (7 median, 7 ulnar, 1 radial sensory branch, 1 dorsal ulnar cutaneous branch) repaired with use of direct neurorraphy through a silicon tube were retrospectively studied. Eleven patients suffered associated arterial and tendinous injuries. Secondary nerve repair was performed in 3 cases and primary repair in 13, two of them in the context of re-implant of the upper limb. The series was evaluated using the functional scale described by Chanson. Results: At a mean follow-up of 24 months, and having 2 cases excluded due to isolated injury of sensory branches, we obtained a 64% of good or excellent results, 28% of satisfactory results and 1 bad result. The tube was removed in 6 cases; 4 due to palpable painless tumour in the site of insertion, a case with compression symptoms after complete nerve function restoration and another that showed herniation of the stumps. In 5 cases the macroscopic restoration of the nerve was verified at the time of tube removal. Conclusion: The use of silicone tubes in the reconstruction of acute, subacute and chronic nerve injuries in the forearm seems to give good results in most of the cases, with macroscopic anatomy restitution of the nerve and good functional recovery (AU)

[TVT and TOT for surgical correction of female stress urinary incontinence. Comparison between techniques]. / TVT y TOT para la corrección quirúrgica de la incontinencia femenina de stress. Comparacion de ambas técnicas.

OBJECTIVES: Retrospective analysis of a series of patients with stress urinary incontinence that underwent surgery in our department, by means of the TVT and TOT techniques. We evaluate post operative continence, considering "cured" the patient with complete continence and "failure" any type of involuntary stress urine leak, independently of its severity registering the time of its appearance. For this purpose we used the Kaplan-Meier analysis comparing both techniques with the Breslow test. Additionally, postoperative complications were evaluated. RESULTS: 128 patients who underwent surgery by TVT (69 patients, 53.9%) and TOT (59 patients, 46.1%). Mean age was 54.4 years for TVT (95% CI 52.0-56.8) and 59 years for TOT (95% CI 55.9-62.1). Mean follow-up time was 18.7 months for TVT (95% CI 15.6-21.9) and 7.4 months for TOT (95% CI 5.8-8.9). Overall continence rate was 86.7%, 88.4% for TVT and 84.7% for TOT The probability of being continent six months after surgery was 89.1% for TVT and 78.2% for TOT (no significant differences, p = 0.31), with almost all failures within the first six months after surgery. TVT was more frecuently associated with urgency symptoms (33.3%, p = 0.001) and urge incontinence (18.8%,p = 0.16), urinary retention (11.6%, p = 0.38), and prevesical hematoma requiring mesh retrieval. Greater post operative pain was observed with TOT (20.3%, p = 0.005). CONCLUSIONS: Our results evidence a similar efficacy with both techniques, with the failures appearing over the first months after surgery. Complications of the voiding urgency type are significantly more frequent with TVT.

TVT y TOT para la corrección quirúrgica de la incontinencia femenina de stress. Comparación de ambas técnicas / TVT and TOT for surgical correction of female stress urinary incontinence. Comparison between technique

Objetivo: Evaluar los resultados en nuestras manos con las técnicas TVT y TOT. Métodos: Análisis retrospectivo de pacientes con incontinencia urinaria de esfuerzo operadas en nuestro servicio, mediante las técnicas de TVT y TOT. Evaluamos la continencia postoperatoria, considerando a las pacientes curadas si presentaban continencia total y como fracaso a cualquier tipo de pérdida involuntaria con el esfuerzo, independientemente de su severidad, registrándose el momento de su aparición. Para ello se empleó un análisis Kaplan-Meier comparando ambas técnicas mediante test de Breslow. Además se evaluaron las complicaciones postoperatorias. Resultados: El análisis se realizó con 128 pacientes intervenidas mediante TVT (69 pacientes, 53,9%) y TOT (59 pacientes, 46,1%). La media de edad para el TVT fue de 54,4 años (IC 95% 52,0-56,8), y de 59 años para el TOT (IC 95% 55,9-62,1). El tiempo medio de seguimiento fue 18,7 meses (IC 95% 15,6-21,9) para el TVT y 7,4 meses (IC 95% 5,8-8,9) para TOT. La tasa global de continencia fue de 86,7%, siendo de 88,4% para TVT y 84,7% para TOT. La probabilidad de permanecer continente a partir de los 6 meses de la cirugía fue de 89,1% para el TVT y de 78,2% para el TOT (diferencia no significativa, p=0,31), con la práctica totalidad de los fracasos antes de los 6 meses postcirugía. Con el TVT se produjo mayor sintomatología de urgencia (33,3%, p= 0,001) e incontinencia de urgencia (18,8%, p= 0,16), retención de orina (11,6%, p=0,38), y dos pacientes con hematoma prevesical que requirieron la retirada de la malla. Se observó mayor dolor postoperatorio con el TOT (20,3%, p=0,005). Conclusiones: Nuestros resultados evidencian una eficacia similar con ambas técnicas, presentándose los fracasos durante los primeros meses tras el procedimiento. Las complicaciones tipo urgencia miccional son significativamente mayores con el TVT (AU)

Objectives: Retrospective analysis of a series of patients with stress urinary incontinence that underwent surgery in our department, by means of the TVT and TOT techniques. We evaluate post operative continence, considering «cured» the patient with complete continence and «failure» any type of involuntary stress rine leak, independently of its severity, registering the time of its appearance. For this purpose we used the Kaplan-Meier analysis comparing both techniques with the Breslow test. Additionally, postoperative complications were evaluated. Results: 128 patients who underwent surgery by TVT (69 patients, 53.9%) and TOT (59 patients, 46.1%). Mean age was 54.4 years for TVT (95% Cl 52.0-56.8) and 59 years for TOT (95% CI 55.9-62.1). Mean follow-up time was 18.7 months for TVT (95% CI 15.621.9) and 7.4 months for TOT (95% CI 5.8-8.9). Overall continence rate was 86.7%, 88.4% for TVT and 84.7% for TOT. The probability of being continent six months after surgery was 89.1% for TVT and 78.2% for TOT (no significant differences, p = 0.31), with almost all failures within the first six months after surgery. TVT was more frecuently associated with urgency symptoms (33.3%,p = 0.001) and urge incontinence (18.8%,p = 0.16), urinary retention (11.6%,p = 0.38), and prevesical hematoma requiring mesh retrieval. Greater post operative pain was observed with TOT (20.3%, p= 0.005). Conclusions: Our results evidence a similar efficacy with both techniques, with the failures appearing over the first months after surgery. Complications of the voiding urgency type are significantly more frequent with TVT (AU)

[Clinical significance of prostatic intraepithelial neoplasm and atypical small acinar proliferation: relationship with prostate cancer]. / Significado clínico de la neoplasia intraepitelial prostática y de la proliferación acinar focal atípica: relación con el cáncer de próstata.

INTRODUCTION: Prostatic intraepithelial neoplasia (PIN) and atypical small acinar proliferation (ASAP) in the setting of prostatic needle biopsies are considered premalignant although questions still remain. OBJECTIVES: In this paper, we have studied the clinical relevance of these histologic findings. MATERIAL AND METHODS: We collected 138 subjects (108 PIN, 30 ASAP); in 67% we performed a second biopsy and the rate of cancer in this late biopsy were 19% and 27% respectively. We cannot identify any clinical factor to predict the finding of cancer in the re-biopsy (PSA, age, digital rectal examination, prostatic volume). RESULTS: In the follow-up, we observed higher rates of cancer for the ASAP; the finding of ASAP was the single clinical or histopathological factor that was an independent predictor of cancer. CONCLUSIONS: We observed that the finding of ASAP was an indication for re-biopsy because of the higher rates of cancer; on the contrary, the paper of PIN in the prostatic needle biopsy still requires further investigation.

[Trends in the incidence of testicular germ cell cancer in a 300.000 inhabitants Spanish population (1991-2005)]. / Tendencia en la incidencia del cáncer testicular de células germinales en un área sanitaria española de 300.000 habitantes (1991-2005).

OBJECTIVE: To describe the features and the time trends of the testicular cancer in a spanish population. MATERIALS AND METHODS: Data on incident cases of testicular germ cell cancer diagnosed in our population were extracted from the Cancer Registry of our Department. We calculed annual incidence rates of testicular cancer, the Spanish population-adjusted annual percent change (APC), age of diagnosis and the different histologic types frequencies. RESULTS: The overall incidence rate rose from 0.84 per 100,000 males to 1.91 per 100,000 males from 1991 till 2005, with a peak of 6.77 per 100,000 males in 2003. The Spanish population-adjusted APC was 2.39%. By histologic subgroup, for seminomas: the incidence rate varied from 0.84 per 100,000 males to 0.64 per 100,000 (1991-2005), with a peak of 5.41 per 100,000 in 2003 and the Spanish population-adjusted APC was 6.06. For nonseminomas, the incidence rate varied from 1.66 per 100,000 to 1.28 per 100,000 (1992-2005), with a peak of 3.65 per 100.000 in 2001 and the Spanish population-adjusted APC was 12.74. Mean ages were 31.23 years (median 30, SD 8.56) for seminomas, and 23.68 years (median 25, SD 6.85) for nonseminomas, with statistic significance (p < 0.0001). DISCUSSION: The increasing testicular cancer incidence observed for this population follows the time trends showed in other European countries.

Significado clínico de la neoplasia intraepitelial prostática y de la proliferación acinar focal atípica: relación con el cáncer de próstata / Clinical significance of prostatic intraepithelial neoplasm and atypical small acinar proliferation: relationship with prostate cancer

Introducción: El papel de la neoplasia intraepitelial prostática (PIN) y de la proliferación acinar focal atípica (ASAP) en el marco de una biopsia transrrectal todavía no se encuentra por completo definido; aunque ambas lesiones han sido consideradas clásicamente premalignas, hoy en día la necesidad de la rebiopsia sistemática sigue siendo controvertido. Objetivos: En este trabajo hemos estudiado el papel de estas lesiones y su relación con el cáncer de próstata. Material y métodos: Se incluyeron 138 sujetos (108 PIN, 30 ASAP) a los que se le practicó rebiopsia al 67%; la tasa de cáncer en la rebiopsia inmediata fue del 19 y 27% respectivamente sin identificar ningún factor clínico para predecir cáncer en la rebiopsia (PSA, edad, tacto rectal, volumen prostático).Resultados: Durante el seguimiento, la mayor tasa de cáncer se observó en el ASAP, seguido del PIN y finalmente de las lesiones benignas; el único predictor clínico-patológico independiente de cáncer en este caso fue la existencia de ASAP en la primera biopsia transrrectal. Conclusiones: La necesidad de rebiopsiar sistemáticamente a los sujetos con PIN en la biopsia de próstata ha sido puesta en duda en la literatura reciente, mientras que la necesidad de rebiopsiar los ASAP sigue estando claramente indicado (AU)

Introduction: Prostatic intraepithelial neoplasia (PIN) and atypical small acinar proliferation (ASAP) in the setting of prostatic needle biopsies are considered premalignant although questions still remain. Objetives: In this paper, we have studied the clinical relevance of these histologic findings. Material and methods: We collected 138 subjects (108 PIN, 30 ASAP); in 67% we performed a second biopsy and the rate of cancer in this late biopsy were 19% and 27% respectively. We cannot identify any clinical factor to predict the finding of cancer in the re-biopsy (PSA, age, digital rectal examination, prostatic volume).Results: In the follow-up, we observed higher rates of cancer for the ASAP; the finding of ASAP was the single clinical or histopathological factor that was an independent predictor of cancer. Conclusions: We observed that the finding of ASAP was an indication for re-biopsy because of the higher rates of cancer; on the contrary, the paper of PIN in the prostatic needle biopsy still requires further investigation (AU)

Tendencia en la incidencia del cáncer testicular de células germinales en un área sanitaria española de 300.000 habitantes (1991-2005) / Trends in the incidence of testicular germ cell cancer in a 300.000 inhabitants spanish population (1991-2005)

Objetivo: Describir las características y tendencia temporal de los cánceres testiculares en un área sanitaria española. Material y métodos: Se realizó una búsqueda de todos los pacientes residentes en nuestra área sanitaria diagnosticados de cáncer testicular por primera vez. Se calcularon los datos de incidencia, cambio porcentual anual (APC) según tasa de incidencia ajustada a la población española, edad al diagnóstico y las frecuencias de los diferentes tipos histológicos tumorales. Resultados: La incidencia del cáncer testicular pasó de 0,84/100.000 varones en 1991 a 1,91/100.000 varones en2005, con un pico de 6,77/100.000 varones en 2003. El cambio porcentual anual (APC) ajustado a la población españolase calculó en 2,39%. Por subtipos histológicos, para los seminomas: la tasa de incidencia pasó de 0,84 a0,64/100.000 (1991-2005), con un pico de 5,41/100,000 en 2003 y un APC ajustado a la población española de 6,06. Para los no seminomas, la tasa de incidencia varió de 1,66 a 1,28/100.000 (1992-2005), con un pico de 3,65/100.000en 2001 y un APC ajustado a la población española de 12,74. La edad al diagnóstico fue, para los seminomas: media31,23, DE 8,56, mediana 30; y para los tumores no seminomatosos: media 23,68, DE 6,85, mediana 25. La comparación de las medias de ambas edades resultó estadísticamente significativa (p‹ 0,0001).Discusión: Existe un aumento de la incidencia del cáncer testicular de células germinales en nuestro medio, tal y como se ha demostrado en otros países (AU)

Objective: To describe the features and the time trends of the testicular cancer in a spanish population. Materials and methods: Data on incident cases of testicular germ cell cancer diagnosed in our population were extracted from the Cancer Registry of our Department. We calculed annual incidence rates of testicular cancer, the Spanish population-adjusted annual percent change (APC), age of diagnosis and the different histologic types frequencies. Results: The overall incidence rate rose from 0.84 per 100,000 males to 1.91 per 100,000 males from 1991 till 2005, with a peak of 6.77 per 100,000 males in 2003. The Spanish population-adjusted APC was 2.39%. By histologic subgroup, for seminomas: the incidence rate varied from 0.84 per 100,000 males to 0.64 per 100,000 (1991-2005), with apeak of 5.41 per 100,000 in 2003 and the Spanish population-adjusted APC was 6.06. For non seminomas, the incidence rate varied from 1.66 per 100,000 to 1.28 per 100,000 (1992-2005), with a peak of 3.65 per 100.000 in 2001 and theSpanish population-adjusted APC was 12.74. Mean ages were 31.23 years (median 30, SD 8.56) for seminomas, and23.68 years (median 25, SD 6.85) for non seminomas, with statistic significance (p‹ 0.0001). Discussion: The increasing testicular cancer incidence observed for this population follows the time trends showed in other European countries (AU)

[Prevalence and clinical meaning of focal and incidental prostate cancers]. / Prevalencia y significado clínico de los cánceres de próstata focales e incidentales.

OBJECTIVES: To calculate the proportion of focal and incidental prostate cancers (PCa) in our setting, to study their relationship with the findings in radical prostatectomy (RP) specimens, and to establish their clinical relevance in terms of progression and survival. MATERIAL AND METHODS: We selected patients with focal cancer, defined as a maximum extent of 3 mm in one or two adjacent prostate biopsy cores (transrectal ultrasound guided, sextant). In addition we included a group of patients with incidental T1a cancers (diagnosed after prostatectomy, nonpalpable, with less than 5% tumor in specimen). The proportion of those cancers over the total of tumors diagnosed in our health area was calculated. Also, clinical characteristics of such cancers were recorded (age, PSA, Gleason grade and score), and also therapy given. In cases that underwent RP, pathological findings were also recorded. Finally, survival analysis (Kaplan-Meier) was carried out to describe the natural history of these patients in terms of time to progression and time to death from PCa. RESULTS: From 819 patients diagnosed of PCa, 46 (5.6%) presented with focal cancer and 23 (2.8%) with stage T1a tumors. None of the patients with incidental cancer (T1a) underwent RP opposed to 17 of 46 focal T1c cancers (37%). Although none of these cases showed extracapsular extension, seminal vesicle invasion, or lymph node invasion, relevant disease (stage pT2b or higher) was found in 15 cases (88.2%) and pathological Gleason score > 7 in 2 cases (2.9%). With a mean follow-up time of 37.6 months (standard error 4.26), the probability of being free from any progression was, for T1a cancers at 2 and 5 years, of 75.4% and 57.1% respectively, and 94.4% and 94.4% respectively for T1c cases. No PCa deaths were recorded in the presented cases during the mentioned follow-up period. CONCLUSION: In our experience, the finding of microscopic or focal cancers in sextant prostate biopsy is related to a high proportion of clinically relevant tumors in RP specimens (88%). We think that expectant management of patients with such findings in prostate biopsy should be questioned.

[Urinary stress incontinence: surgical experience in our center]. / Incontinencia de esfuerzo: experiencia quirúrgica en nuestro centro.

INTRODUCTION: For the treatment of the urinary stress incontinence, there are many techniques, and today the gold standard is that described by Burch. We compared the global and each technique results about rates of postoperative continence and complications seen in our experience. MATERIALS AND METHODS: We made a retrospective analysis of 292 women that have the first surgery for urinary stress incontinence in our centre, between 1991 and 2006. We considered cure the patient who did not have any level of incontinence postoperative, we made a Kaplan-Meier analysis for the postoperative continence evaluation. Besides we studied the behaviour of the postoperative complications found. RESULTS: Mean age was 53.6 years old, and mean time of follow up was 15.6 months. The vaginal techniques were the most practised (138), followed by the TVT (57), abdominal Burch (38), vaginal wall Sling (33), and the less was the laparoscopic Burch (26). The best rates of postoperative continence after 2 years were observed in the patients treated by TVT (87.6%), then with vaginal wall Sling (84.9%), laparoscopic Burch (59.3%), abdominal Burch (59.1%), and the worst with vaginal techniques (48.2%) (p = 0.007). We found more urgency and urge incontinence in the patients treated by TVT (36.8% y 21.1% respectively), and postoperative pain with vaginal techniques (36.2%). Postoperative urine retention and postoperative high residual urine more with the vaginal wall sling (54.5%) and vaginal techniques (26.1%) respectively. CONCLUSIONS: We have the best results for the incontinence treatment in our population with the TVT technique.

[Natural history of metastasic prostate cancer treated with androgen deprivation therapy and secondary hormonal therapy efficiency]. / Historia natural del cáncer de próstata metastásico sometido a bloqueo hormonal y eficacia del tratamiento hormonal de segunda línea.

OBJECTIVE: to analyze metastatic prostate cancer progression in patients treated with hormonal blockade as well as second line hormonal treatments outcomes. PATIENTS AND METHODS: 199 metastatic patients were selected from a 455 hormonal treated patients pool. Time to biochemical progression was studied with Kaplan Meier analysis and patients were stratified according to pathological differentiation. Second line treatment lasting and efficacy were also assessed. RESULTS: 74 patients out of 192 metastatic patients (56.1%) progressed in terms of PSA. Median time to biochemical progression was 1.7 years (1.2-2.3, CI 95%). We did not find stadistical differences on pathological differentiation (p = 0.238). Second line treatment's efficacy, applied to 41 patients was 34.1%, without any stadistical differences among these treatments. Response treatment median time was 6.8 months without stadistical differences among different treatments (p = 0.220). CONCLUSIONS: hormonal blockade efficacy in metastatic prostate cancer has a limited value in time in our experience. One third of these patients have a limited response to a second line treatment although this response is even shorter in duration.

Prevalencia y significado clínico de los cánceres de próstata focales e incidentales / Prevalence and clinical meaning of focal and incidental prostate cancers

Objetivos: Calcular la proporción de cánceres de próstata (CaP) focales e incidentales en nuestro ámbito, investigar su relación con los hallazgos en la pieza de prostatectomía radical (PR), así como establecer su relevancia clínica en términos de progresión y supervivencia. Material y Métodos: Hemos seleccionado los pacientes con cáncer focal, definiendo éste como un máximo de 3 mm en uno o dos cilindros adyacentes en la biopsia prostática (dirigidas mediante ecografía transrectal, de modo randomizado sextante). Adicionalmente, hemos incluido un grupo de pacientes con cáncer incidental T1a (diagnosticados tras prostatectomía, no palpables, con tumor en menos del 5% del tejido obtenido). Se ha calculado la proporción de estos cánceres en nuestra área sanitaria sobre el total de tumores detectados, y registrando las características clínicas de dichos tumores (edad, PSA, grado y score de Gleason), así como el tratamiento efectuado. En los casos sometidos a PR, se han analizado los parámetros patológicos de la pieza. Por último, se ha realizado un análisis de supervivencia (Kaplan-Meier) para describir la evolución de estos pacientes en cuanto al tiempo hasta la progresión de la enfermedad y al fallecimiento por CaP. Resultados: De 819 pacientes con CaP, 46 (5,6%) presentaron cáncer focal y 23 (2,8%) tumores estadio T1a. Ninguno de los pacientes con tumor incidental (T1a) fue sometido a PR frente a 17 de los 46 cánceres focales T1c (37%). Aunque ninguno de los casos mostró enfermedad extracapsular, invasión de vesículas seminales, o invasión ganglionar, se detectó enfermedad relevante (estadio pT2b o superior) en 15 casos (88,2%) y un score de Gleason patológico >7 en 2 casos (2,9%). Con una media de seguimiento de 37,6 meses (error estándar 4,26), la probabilidad de permanecer libre de cualquier tipo de progresión para los T1a a los 2 y 5 años fue de 75,4% y 57,1% respectivamente, siendo de 94,4% y 94,4% respectivamente para los T1c. No se registraron fallecimientos por CaP en esta serie durante el seguimiento mencionado. Conclusión: En nuestra experiencia, el hallazgo de cáncer microscópico o focal en la biopsia randomizada sextante se corresponde una elevada proporción de tumores clínicamente relevantes en la pieza de PR (88%). Creemos que la actitud expectante ante dichos hallazgos en la biopsia prostática debe ser sometida a crítica

Objectives: To calculate the proportion of focal and incidental prostate cancers (PCa) in our setting, to study their relationship with the findings in radical prostatectomy (RP) specimens, and to establish their clinical relevance in terms of progression and survival. Material and methods: We selected patients with focal cancer, defined as a maximum extent of 3 mm in one or two adjacent prostate biopsy cores (transrectal ultrasound guided, sextant). In addition we included a group of patients with incidental T1a cancers (diagnosed after prostatectomy, nonpalpable, with less than 5% tumor in specimen). The proportion of those cancers over the total of tumors diagnosed in our health area was calculated. Also, clinical characteristics of such cancers were recorded (age, PSA, Gleason grade and score), and also therapy given. In cases that underwent RP, pathological findings were also recorded. Finally, survival analysis (Kaplan-Meier) was carried out to describe the natural history of these patients in terms of time to progression and time to death from PCa. Results: From 819 patients diagnosed of PCa, 46 (5.6%) presented with focal cancer and 23 (2.8%) with stage T1a tumors. None of the patients with incidental cancer (T1a) underwent RP opposed to 17 of 46 focal T1c cancers (37%). Although none of these cases showed extracapsular extension, seminal vesicle invasion, or lymph node invasion, relevant disease (stage pT2b or higher) was found in 15 cases (88.2%) and pathological Gleason score >7 in 2 cases (2.9%). With a mean follow-up time of 37.6 months (standard error 4.26), the probability of being free from any progression was, for T1a cancers at 2 and 5 years, of 75.4% and 57.1% respectively, and 94.4% and 94.4% respectively for T1c cases. No PCa deaths were recorded in the presented cases during the mentioned follow-up period. Conclusion: In our experience, the finding of microscopic or focal cancers in sextant prostate biopsy is related to a high proportion of clinically relevant tumors in RP specimens (88%). We think that expectant management of patients with such findings in prostate biopsy should be questioned

Incontinencia de esfuerzo: experiencia quirúrgica en nuestro centro / Urinary stress incontinence: surgical experience in our center

Introducción: Para el tratamiento quirúrgico de la incontinencia urinaria de esfuerzo existen múltiples técnicas, en la actualidad la de referencia es la descrita por Burch. Comparamos los resultados globales y de cada técnica en cuanto a las tasas de continencia postoperatoria y de complicaciones observadas en nuestra experiencia. Materiales y métodos: Hicimos un análisis retrospectivo de 292 mujeres operadas por primera vez por presentar incontinencia urinaria de stress en nuestro Centro, entre 1991 y 2006. Consideramos a las pacientes curadas si no presentaban ningún grado de incontinencia postoperatoria, se realizó un análisis de Kaplan – Meier para la evaluación de la continencia postoperatoria. Además estudiamos el comportamiento de las complicaciones postoperatorias presentadas. Resultados: La media de edad de las pacientes fue de 53,6 años, con un tiempo de seguimiento medio de 15,6 meses. La mayoría de las intervenciones fueron técnicas vaginales (138), seguida por los TVT (57), Burch abdominal (38), Sling con parche de vagina (33), y la menos utilizada fue el Burch laparoscópico (26). Las mejores tasas de continencia postoperatoria a los dos años se consiguieron con el TVT (87,6%), luego con el Sling con parche de vagina (84,9%), las siguientes con Burch laparoscópico (59,3%), Burch abdominal (59,1%), y las peores con técnicas vaginales (48,2 %), (p=0,007). Se observó mayor urgencia y urgencia-incontinencia postoperatorias en las pacientes operadas mediante TVT (36,8% y 21,1% respectivamente), y mayor dolor postoperatorio tras las técnicas vaginales (36,2%). La retención urinaria postoperatoria y residuo postmiccional elevado más comunes entre el Sling con parche de vagina (54,5%) y las técnicas vaginales (26,1%) respectivamente. Conclusiones: La técnica con mejores resultados para manejo de incontinencia en nuestra población es el TVT

Introduction: For the treatment of the urinary stress incontinence, there are many techniques, and today the gold standard is that described by Burch. We compared the global and each technique results about rates of postoperative continence and complications seen in our experience. Materials and methods: We made a retrospective analysis of 292 women that have the first surgery for urinary stress incontinence in our centre, between 1991 and 2006. We considered cure the patient who did not have any level of incontinence postoperative, we made a Kaplan – Meier analysis for the postoperative continence evaluation. Besides we studied the behaviour of the postoperative complications found. Results: Mean age was 53.6 years old, and mean time of follow up was 15.6 months. The vaginal techniques were the most practised (138), followed by the TVT (57), abdominal Burch (38), vaginal wall Sling (33), and the less was the laparoscopic Burch (26). The best rates of postoperative continence after 2 years were observed in the patients treated by TVT (87,6%), then with vaginal wall Sling (84,9%), laparoscopic Burch (59.3%), abdominal Burch (59,1%), and the worst with vaginal techniques (48,2%) (p=0,007). We found more urgency and urge incontinence in the patients treated by TVT (36,8% y 21,1% respectively), and postoperative pain with vaginal techniques (36,2%). Postoperative urine retention and postoperative high residual urine more with the vaginal wall sling (54,5%) and vaginal techniques (26,1%) respectively. Conclusions: We have the best results for the incontinence treatment in our population with the TVT technique

Historia natural del cáncer de próstata metastásico sometido a bloqueo hormonal y eficacia del tratamiento hormonal de segunda línea / Natural history of metastasic prostate cancer treated with androgen deprivation therapy and secondary hormonal therapy efficiency

Objetivos: analizar la evolución de los pacientes con cáncer de próstata metastásico sometidos a bloqueo androgénico hasta la progresión de la enfermedad, así como la eficacia de los tratamientos hormonales de segunda línea aplicados. Material y métodos: de 455 pacientes sometidos a bloqueo androgénico se seleccionaron 192 en estadio metastático. En éstos se analizó el tiempo desde el inicio del tratamiento hasta la progresión de PSA, estratificándose a los pacientes en función del grado de diferenciación histológica, mediante un análisis Kaplan-Meier. Asimismo se analizó la respuesta a manipulaciones hormonales de segunda línea aplicadas en términos de eficacia y duración de la misma. Resultados: de 192 pacientes con estadio clínico metastático al inicio del bloqueo, 74 (56,1%) presentaron progresión de PSA. La mediana de tiempo hasta la aparición de dicha progresión fue de 1,7 años (1,2-2,3; IC95), no hallándose diferencias al estratificar a los pacientes en función del grado de diferenciación al diagnóstico (p=0,238). La eficacia global del tratamiento hormonal de segunda línea, aplicado a 41 pacientes, fue de 34,1%, sin hallarse diferencias entre las tres modalidades. La mediana de tiempo de duración de dicha respuesta fue de 6,8 meses, no objetivándose diferencias estadísticamente significativas entre modalidades (p=0,220). Conclusiones: en nuestra experiencia, la eficacia del bloqueo hormonal en pacientes con cáncer prostático metastásico tiene una duración limitada. Aproximadamente un tercio de estos pacientes responde a manipulación hormonal de segunda línea, aunque la duración de dicha respuesta es aún más limitada

Objective: to analyze metastatic prostate cancer progression in patients treated with hormonal blockade as well as second line hormonal treatments outcomes. Patients and Methods: 199 metastatic patients were selected from a 455 hormonal treated patients pool. Time to biochemical progression was studied with Kaplan Meier analysis and patients were stratified according to pathological differentiation. Second line treatment lasting and efficacy were also assessed. Results:74 patients out of 192 metastatic patients (56.1%) progressed in terms of PSA. Median time to biochemical progression was 1.7 years (1.2-2.3, CI 95%). We did not find stadistical differences on pathological differentiation (p=0.238). Second line treatment’s efficacy, applied to 41 patients was 34.1%, without any stadistical differences among these treatments. Response treatment median time was 6.8 months without stadistical differences among different treatments (p=0.220). Conclusions: hormonal blockade efficacy in metastatic prostate cancer has a limited value in time in our experience. One third of these patients have a limited response to a second line treatment although this response is even shorter in duration

[Smoking habit and superficial bladder tumours' natural history]. / Efecto del tabaco sobre la evolución de los tumores de vejiga.

OBJECTIVES: To disclose the features of bladder cancer in current smokers at diagnosis and to study the differences in recurrence and progression between smokers and non-smokers. PATIENTS & METHODS: 786 consecutive patients with bladder cancer from 1991 to 2004 were studied in a retrospective manner and characteristics of smokers tumours were compared to non smokers. RESULTS: 377 (48%) patients were smokers at diagnosis. There were no differences in terms of age and T stage between smokers and non smokers (t student and Chi square). We found statistical differences in tumours grade, size and multiplicity ( Chi square, p=0.046, p=0.001 and p=0.12 respectly). No differences were found between smokers and non smokers according to recurrence. (Log Rank, Breslow y Tarone-Ware N.S.). We did find differences according to progression (Log Rank p=0.03, Breslow p=0.05 y Tarone-Ware p=0.03) although it did not support multivariate study. CONCLUSIONS: Currents smokers present bigger and higher grade tumors and, more frequently in a multiple fashion at diagnosis than non-smokers.

Efecto del tabaco sobre la evolución de los tumores de vejiga / Smoking habit and superficial bladder tumours´natural history

Objetivos: Evaluar las características de las neoplasias vesicales en pacientes fumadores en el momento del diagnóstico y estudiar las diferencias en recurrencia y progresión de los pacientes fumadores y los no fumadores. Pacientes y Métodos: Se revisaron 786 historias clínicas de pacientes con tumores vesicales de nuestra base de datos de una forma retrospectiva desde 1991 al 2004 y se analizaron las características tumorales así como el evento recurrencia y progresión de los pacientes fumadores frente a los no fumadores. Resultados: 377 (48%) pacientes eran fumadores al momento del diagnóstico. No encontramos diferencias significativas en cuanto a edad ni a categoría T tumoral entre ambos grupos (t student y Chi cuadrado). Sin embargo, si encontramos diferencias estadísticamente significativas en cuanto a grado tumoral, tamaño tumoral ( mayor o menor de 2 cm.) y multiplicidad (Chi cuadrado, p=0,046, p=0,001 y p=0,012 respectivamente). No encontramos diferencias significativas para la recidiva.(Log Rank, Breslow y Tarone-Ware N.S.). En cuanto a progresión si se aprecia una diferencia estadísticamente significativa entre fumadores y no fumadores en el estudio univariante (Log Rank p=0,03, Breslow p=0,05 y Tarone-Ware p=0,03) aunque no soporta el estudio multivariante. Conclusiones: No puede reconocerse el hábito tabáquico como un factor independiente de recurrencia o progresión en los tumores superficiales. Sin embargo, los fumadores debutan más frecuentemente con tumores de alto grado, de una manera múltiple y de un tamaño igual o superior a 2 cm. de una manera significativa frente a los no fumadores

Objectives: To disclose the features of bladder cancer in current smokers at diagnosis and to study the differences in recurrence and progression between smokers and non-smokers. Patients & Methods: 786 consecutive patients with bladder cancer from 1991 to 2004 were studied in a retrospective manner and characteristics of smokers tumours were compared to non smokers. Results: 377 (48%) patients were smokers at diagnosis. There were no differences in terms of age and T stage between smokers and non smokers (t student and Chi square). We found statistical differences in tumours grade, size and multiplicity ( Chi square, p=0.046, p=0.001 and p=0.12 respectly). No differences were found between smokers and non smokers according to recurrence. (Log Rank, Breslow y Tarone-Ware N.S.). We did find differences according to progression (Log Rank p=0.03, Breslow p=0.05 y Tarone-Ware p=0.03) although it did not support multivariate study. Conclusions: Currents smokers present bigger and higher grade tumors and, more frequently in a multiple fashion at diagnosis than non-smokers

[The meaning of PSA progression after radical prostatectomy. Preliminary results]. / Significado de la progresión de PSA tras prostatectomía radical. Resultados preliminares.

OBJECTIVES: To report our findings regarding to the natural history of prostate cancer (PCa) that shows recurrence after radical prostatectomy (RP), in terms of time to development of metastatic disease and death from PCa. To identify independent predictors of PSA recurrence. MATERIAL AND METHODS: Retrospective analysis of 227 patients with clinically localized PCa who underwent RP. The event PSA recurrence was defined as the presence of a postoperative PSA level of 0,2 ng/ml or higher at least 3 months after surgery. Hence, cases with shorter follow-up time were excluded from analysis. No adjuvant therapy (radiotherapy or hormonal therapy) was performed in the included population. Recurrence free survival was calculated during the follow-up period (Kaplan-Meier analysis). Uni and multivariate study was performed in order to assess the ability of factors as preoperative PSA level, Gleason score in surgical specimen, capsular penetration, positive surgical margins (excluding urethral), extracapsular extension, positive pelvic lymph nodes, and seminal vesicle invasion, to predict PSA recurrence. Finally, we selected the group of patients with PSA recurrence and calculated the probability of being free from distant metastatic disease during the follow-up period. Also, function of disease-specific survival was calculated. RESULTS: A total of 208 records were finally included in the study. Median age was 61 years. A total of 47 (22.6%) presented with extracapsular extension. Median follow-up time was 35.8 months, and 49 (23.6%) developed PSA recurrence. Recurrence free survival was 79.9% and 67.4% at 2 and 5 years, respectively. Only three factors were identified with the aid of multivariate analysis as independent predictors of recurrence: preoperative PSA >= 10 ng/ml (hazard ratio--HR--3.03), Gleason score in surgical specimen 8 or higher (HR 3.42), and the finding of capsular penetration (HR 2.17). When only patients with PSA recurrence were considered, 16.3% developed distant metastasis. Probabilities of being free from distant disease after PSA recurrence were 97.7% and 86.9% at 2 and 5 years respectively (actuarial median time 110.8 months). Only 2 patients died from PCa, therefore disease-specific mortality analysis was not performed. CONCLUSIONS: Although an important proportion of patients present with PSA recurrence after RP in our setting, the prognosis in term of development of metastatic disease is acceptable in the short-medium term. Anyway, further analysis will be needed to ascertain the evolution of these patients in the long term.

Significado de la progresión de PSA tras prostatectomía radical. Resultados preliminares / The meaning of PSA progression after radical prostatectomy. Preliminary results

Objetivos: Ofrecer nuestra experiencia respecto de la historia natural del cáncer de próstata (CaP) que sufre progresión tras la prostatectomía radical (PR), en términos de tiempo hasta la aparición de metástasis o hasta la muerte por esta enfermedad. Identificar los factores clínico-patológicos que pueden condicionar dicha evolución. Material y métodos: Análisis retrospectivo de 227 pacientes con CaP clínicamente localizado sometidos a PR. Se definió el evento progresión bioquímica (PBQ) como el presentar un PSA postoperatorio de 0,2 ng/ml al menos tres meses tras la cirugía, excluyendo del análisis los casos con tiempo de seguimiento inferior al mencionado. No se administró tratamiento precoz (radioterapia externa o bloqueo hormonal) en los pacientes incluidos. Se calculó la supervivencia libre de PBQ a lo largo del tiempo (análisis Kaplan-Meier). Se estudió (análisis uni y multivariante) la capacidad de factores como PSA preoperatorio, score de Gleason en la pieza, presencia de penetración capsular, margen quirúrgico afectado (excluyendo uretral), extensión extracapsular, presencia de ganglios positivos, y afectación de vesículas seminales, para predecir la recurrencia. Por último, para el grupo de pacientes que presentaron PBQ, calculamos la probabilidad de permanecer libre de metástasis a distancia a lo largo del seguimiento, así como la función de supervivencia cáncer-específica. Resultados: Un total de 208 registros fueron finalmente incluidos en el estudio. La mediana de edad fue de 61 años. Un total de 47 (22,6%) presentó estadio patológico extracapsular. La mediana de seguimiento fue de 35,8 meses. Un total de 49 (23,6%) presentaron PBQ. La probabilidad de permanecer libre de PBQ fue de 79,9% y 67,4% a los 2 y 5 años, respectivamente.Tan sólo tres factores fueron identificados por el modelo multivariante como predictores independientes de recurrencia: un PSA preoperatorio>= 10 ng/ml (hazard ratio –HR- 3,03), score de Gleason en la pieza quirúrgica entre 8 y 10 (HR 3,42), y el hallazgo de penetración capsular (HR2,17). De los pacientes que presentaron PBQ, 16,3% desarrolló metástasis a distancia. Las probabilidades de permanecer libre de metástasis tras la PBQ fueron calculadas en 97,7% y 86,9% a los 2 y a los 5 años respectivamente (mediana actuarial de 110,8 meses). Sólo 2 individuos fallecieron por CaP por lo que no se llevó a cabo análisis de mortalidad cáncer-específica. Conclusiones: A pesar de la notable proporción de pacientes con progresión de PSA tras la prostatectomía radical en nuestro entorno, su pronóstico a corto y medio plazo, en términos de desarrollo de metástasis, es aceptable. En cualquier caso, un nuevo análisis será necesario para verificarla evolución a largo plazo de estos pacientes

Objectives: To report our findings regarding to the natural history of prostate cancer (PCa) that shows recurrence after radical prostatectomy (RP), in terms of time to development of metastatic disease and death from PCa. To identify independent predictors of PSA recurrence. Material and methods: Retrospective analysis of 227 patients with clinically localized PCa who underwent RP. The event PSA recurrence was defined as the presence of a postoperative PSA level of 0,2 ng/ml or higher at least 3 months after surgery. Hence, cases with shorter follow-uptime were excluded from analysis. No adjuvant therapy (radiotherapy or hormonal therapy) was performed in the included population. Recurrence free survival was calculated during the follow-up period (Kaplan-Meier analysis). Uni and multivariate study was performed inorder to assess the ability of factors as preoperative PSA level, Gleason score in surgical specimen, capsular penetration, positive surgical margins(excluding urethral), extracapsular extension, positive pelvic lymph nodes, and seminal vesicle invasion, to predict PSA recurrence.Finally, we selected the group of patients with PSA recurrence and calculated the probability of being free from distant metastatic disease during the follow-up period. Also, function of disease-specific survival was calculated. Results: A total of 208 records were finally included in the study. Median age was 61 years. A total of 47 (22.6%) presented with extracapsular extension. Median follow-up time was 35.8 months, and 49 (23.6%) developed PSA recurrence. Recurrence free survival was 79.9% and 67.4% at 2 and 5 years, respectively. Only three factors were identified with the aid of multivariate analysis as independent predictors of recurrence: preoperative PSA >= 10 ng/ml (hazard ratio –HR- 3.03), Gleason score in surgical specimen 8 or higher (HR 3.42), and the finding of capsular penetration (HR 2.17). When only patients with PSA recurrence were considered, 16.3% developed distant metastasis. Probabilities of being free from distant disease after PSA recurrence were 97.7% and 86.9% at 2 and 5 years respectively (actuarial median time 110.8 months). Only 2 patients died from PCa, therefore disease-specific mortality analysis was not performed. Conclusions: Although an important proportion of patients present with PSA recurrence after RP in our setting, the prognosis in term of development of metastatic disease is acceptable in the short-medium term. Anyway, further analysis will be needed to ascertain the evolution of these patients in the long term