Real-world prostate-specific antigen reduction and survival outcomes of metastatic hormone-sensitive prostate cancer patients treated with apalutamide: An observational, retrospective, and multicentre study.

Background: Metastatic hormone-sensitive prostate cancer (mHSPC) treatment has changed drastically during the last years with the emergence of androgen receptor-targeted agents (ARTAs). ARTA combined with androgen deprivation therapy has demonstrated better oncological and survival outcomes in these patients. However, the optimal choice among different ARTAs remains uncertain due to their analogous efficacy. Objectives: The objective of this study was to describe prostate-specific antigen (PSA) response and oncological outcomes of patients with mHSPC treated with apalutamide. Material and methods: Medical records from three different hospitals in Spain were used to conduct this study. Patients diagnosed with mHSPC and under apalutamide treatment were included between March 2021 and January 2023. Data regarding PSA response, overall survival (OS), and radiographic progression-free survival (rPFS) were collected and stratified by metastasis volume, timing, and stating. Results: 193 patients were included; 34.2% of patients were de novo mHSPC, and the majority was classified as m1b. The 18-month OS and rPFS were 92.5% and 88.9%, respectively. Patients with PSA levels ≤0.2 ng/ml showcased an 18-month OS rate of 98.7%, contrasting with 65.3% for those with PSA >0.2 ng/ml. Similar trends emerged for rPFS (97.4% and 53.7%, respectively). When differentiating between low-volume and high-volume metastasis, the OS rate stood at 98.4% and 80.7%, respectively, while the rPFS rates were 93% and 81.6%, respectively. No significant differences were found between groups stratified by metastasis timing. Conclusion: This real-world study on patients with mHSPC treated with apalutamide plus androgen deprivation therapy revealed robust oncological outcomes, aligning with the emerging evidence. The study's hallmark finding highlights the significance of rapid and deep PSA response as a predictor of improved oncological and survival outcomes.

Simultaneous pancreas-kidney transplantation: Early complications and long-term outcomes - a single-center experience.

INTRODUCTION: This study aimed to assess the prevalence and severity of complications after simultaneous pancreas-kidney transplantation (SPKT) and to evaluate its influence on both grafts' long-term results. METHODS: This was an observational, retrospective study including 39 consecutive SPKT cases from 2000-2018. Complications were classified into kidney-related and pancreas-related. The severity of complications was assessed using the modified Clavien-Dindo scale. Kaplan-Meier curve analysis and log-rank tests were used. Cox regression was performed for the multivariate analysis. RESULTS: All 39 recipients had long-term type I diabetes. Twenty-one (53.8%) patients suffered a Clavien-Dindo ≥IIIa complication. Most complications were pancreas-related, with 17 (43.6%) patients suffering from one. Kidney-related major complications were seen in 11 (28.2%) patients. Patient survival at one, five, and 15 years was 89.7%, 87.1%, and 83.9%, respectively; kidney survival was 87.1%, 81.4%, and 73.6%, respectively; and pancreas survival was 76.9%, 71.3%, and 72%, respectively. Pancreas graft survival was influenced by the presence of major postoperative complications; patients and kidney graft survival were not. CONCLUSIONS: Complications after SPKT influence pancreas graft survival. Despite the high rate of complications, our results suggest that patient and kidney graft survival may not be affected by complications.

[Hand-assisted laparoscopic nephroureterectomy for the treatment of upper urinary tract transitional cancer]. / Nefroureterectomía laparoscópica mediante laparoscopia asistida por la mano para el tratamiento del carcinoma transicional del tracto urinario superior.

OBJECTIVE: To report our series of patients undergoing hand-assisted laparoscopic nephroureterectomy (HALNU) using the pluck-off procedure. MATERIALS AND METHODS: Twenty patient undergoing HALMU for upper urinary tract urothelial tumors from November 2002 to December 2007 were assessed. Demographic, clinical, surgical, and oncological data were assessed. RESULTS: Mean patient age was 69 years. Mean operating time and mean intraoperative bleeding were 176 min and 381 mL respectively. Twenty percent of patients required transfusion of blood products. Conversion to open surgery was not required in any patient. Major and minor complications occurred in 25% and 30% of patients respectively.Mean time to oral intake was 48 hours, and mean hospital stay was 5 days.Pathological study revealed transitional cell carcinoma in all cases: grade I in 5%, grade II in 60%, and grade III in 35% of patients. Clinical stage was pTa in 5%, pT1 in 20%, pT2 in 25%, pT3 in 40%, and pT4 in 10% of patients. A bladder recurrence rate of 30% and a 49% overall survival were seen after a mean follow-up of 33 months (5-73). Six-year cancer-specific survival was 67%. No patient developed either peritoneal or surgical bed recurrence. CONCLUSIONS: HALMU using the pluck-off procedure is a feasible, safe, and effective surgery. Both surgical and oncological results are similar to those of open surgery and pure laparoscopy.

Role of the 4Kscore test as a predictor of reclassification in prostate cancer active surveillance.

BACKGROUND: Management of active surveillance (AS) in low-risk prostate cancer (PCa) patients could be improved with new biomarkers, such as the 4Kscore test. We analyze its ability to predict tumor reclassification by upgrading at the confirmatory biopsy at 6 months. METHODS: Observational, prospective, blinded, and non-randomized study, within the Spanish National Registry on AS (AEU/PIEM/2014/0001; NCT02865330) with 181 patients included after initial Bx and inclusion criteria: PSA ≤10 ng/mL, cT1c-T2a, Grade group 1, ≤2 cores, and ≤5 mm/50% length core involved. Central pathological review of initial and confirmatory Bx was performed on all biopsy specimens. Plasma was collected 6 months after initial Bx and just before confirmatory Bx to determine 4Kscore result. In order to predict reclassification defined as Grade group ≥2, we analyzed 4Kscore, percent free to total (%f/t) PSA ratio, prostate volume, PSA density, family history, body mass index, initial Bx, total cores, initial Bx positive cores, initial Bx % of positive cores, initial Bx maximum cancer core length and initial Bx cancer % involvement. Wilcoxon rank-sum test, non-parametric trend test or Fisher's exact test, as appropriate established differences between groups of reclassification. RESULTS: A total of 137 patients met inclusion criteria. Eighteen patients (13.1%) were reclassified at confirmatory Bx. The %f/t PSA ratio and 4Kscore showed differences between the groups of reclassification (Yes/No). Using 7.5% as cutoff for the 4Kscore, we found a sensitivity of 89% and a specificity of 29%, with no reclassifications to Grade group 3 for patients with 4Kscore below 7.5% and 2 (6%) missed Grade group 2 reclassified patients. Using this threshold value there is a biopsy reduction of 27%. Additionally, 4Kscore was also associated with changes in tumor volume. CONCLUSIONS: Our preliminary findings suggest that the 4Kscore may be a useful tool in the decision-making process to perform a confirmatory Bx in active surveillance management.

Alternativa terapéutica para el dolor pélvico crónico de origen vesical / New approach in treatment of pelvic chronic pain syndrome (CPPS)

Introducción: El dolor pélvico crónico (DPC) es un problema complejo e importante tanto por su frecuencia como por sumorbilidad. Cuando se presenta asociado con síntomas miccionales deberemos pensar en un origen vesical. Objetivo: Evaluar la respuesta a un tratamiento intravesical, al que denominamos Formula Sedante, en pacientes con dolor pélvico crónico de origen vesical, refractarios a otros tratamientos. Material y métodos: Entre junio 2005 y septiembre de 2008, 14 pacientes (edad media de 59 años), 12 mujeres y 2 hombres, con DPC de origen vesical siguieron un tratamiento intravesical con “Formula Sedante”, como terapia de segunda línea. Su composición es Dexametasona, Nitrofurantoína, Lidocaína y Suero salino. Evaluamos el dolor (escala 0-10), la frecuencia miccional y la mejoría subjetiva del paciente. Resultados: El dolor global medio fue de 6’4 de base, al mes y a los 6 meses fue de 4’7 y 3’5 respectivamente. El 75% de los pacientes mostró una disminución de los valores en la escala de dolor. La frecuencia miccional diurna mejoró un 28%al mes del tratamiento y un 40% a los 6 meses. Un 70 % de los pacientes refirió sentir mejoría tras la pauta de instilaciones, de los cuales en torno a un 80% la evaluó como “moderadamente mejor” o “mucho mejor”, tanto al mes como a los 6 meses del tratamiento. Ninguno de los pacientes presento efectos secundarios reseñables. Conclusiones: Consideramos el tratamiento de instilación intravesical con “Formula Sedante” una opción útil y segura, como segunda línea de tratamiento, para el dolor pélvico crónico de origen vesical (AU)

Introduction: Chronic pelvic pain syndrome (CPPS) is a complex problem that is a major cause of morbidity and disability. Objetive: To evaluate the feasibility, safety and efficacy of intravesical instillation of a new therapeutic tool in patients suffering from CPPS. Methods: Between june 2005 and september 2008 we recruited 14 patients (mean age 59) who had been diagnosed with CPPS, and refractory to previous treatments. The intravesical solution consisted of steroids, local anaesthetic, antibiotic and saline solution. Was evaluated the intensity of pain; voiding frequency and subjective improvement (with patient global improvement impression PGI-I).Results: Global pain at baseline was 6,4, at 1 month and 6 months 4,7 and 3,5. 75% of the patients showed improvement in the reduction of pain. Voiding frequency at baseline was 22’5 daily. At one and six months, voiding frequency was 16,2and 13,5 respectively. According to the PGI-I test 30% of patients were much better, 30% moderate improvement, 10%slight improvement and 30% with no changes at 1 month. At 6 months, 15% of patients were much better, 40% moderated improvement, 15% slight improvement and 30% with no changes. None of the patients felt worse than before treatment. Conclusions: Therapeutic results of our intravesical solution traduces in an improvement of pain and voiding frequency reduction with no side-effects. Patients benefit of this improvement in the PGI-I test that reflects an improvement in quality of life. We consider this treatment a second-line approach for CPPS in which gold standard management is still a challenge (AU)

Nefroureterectomía laparoscópica mediante laparoscopia asistida por la mano para el tratamiento del carcinoma transicional del tracto urinario superior / Hand-assisted laparoscopic nephroureterectomy for the treatment of upper urinary tract transitional cancer

Objetivo: Describimos nuestra serie de pacientes sometidos a nefroureterectomía por vía laparoscópica asistida por la mano (NU-LAM), con escisión cistoscópica circunferencial del uréter distal intramural. Material y métodos: Evaluamos a 20 pacientes sometidos a NU-LAM por tumor urotelial detracto urinario superior, entre noviembre-2002 y diciembre-2007. Valoramos datos demográficos y clínicos, quirúrgicos y datos oncológicos. Resultados: La media de edad de los pacientes fue de 69 años. La media del tiempo quirúrgico y el sangrado intraoperatorio fue de 176 min y 381 cc, respectivamente. El 20% de los pacientes requirió transfusión de hemoderivados. En ninguna ocasión fue necesaria la conversión a cirugía abierta y la tasa de complicaciones fue del 25% para las mayores y del 30% para las menores. Los pacientes iniciaron tolerancia oral a las 48 h de media, con una estancia media hospitalaria de 5 días. El estudio histológico catalogó al tumor urotelial en: grado I: 5% de los casos; grado II: 60%,y grado III: 35% de los casos; estadio clínico: Ta: 5%; T1: 20%; T2: 25%; T3: 40%, y T4: 10%. Con un seguimiento medio de 33 meses (5-73) se objetivó una tasa de recidiva vesical del 30%, una supervivencia global del 49% y una supervivencia cáncer específica del 67%, a los 6 años de seguimiento. Ningún paciente presentó cuadro de recidiva en el peritoneo ni en el lecho quirúrgico. Conclusiones: La NU-LAM con escisión cistoscópica del uréter distal es una técnica factible, segura y efectiva. Los resultados, tanto operatorios como oncológicos, son comparables con la cirugía abierta y con la laparoscopia pura (AU)

Objective: To report our series of patients undergoing hand-assisted laparoscopic nephroureterectomy (HALNU) using the pluck-off procedure. Materials and methods: Twenty patient undergoing HALMU for upper urinary tract urothelial tumors from November 2002 to December 2007 were assessed. Demographic, clinical, surgical, and oncological data were assessed. Results: Mean patient age was 69 years. Mean operating time and mean intraoperative bleeding were 176 min and 381 mL respectively. Twenty percent of patients required transfusion of blood products. Conversion to open surgery was not required in any patient. Major and minor complications occurred in 25% and 30% of patients respectively. Mean time to oral intake was 48 hours, and mean hospital stay was 5 days. Pathological study revealed transitional cell carcinoma in all cases: grade I in 5%, grade II in 60%, and grade III in 35% of patients. Clinical stage was pTa in 5%, pT1 in 20%, pT2 in25%, pT3 in 40%, and pT4 in 10% of patients. A bladder recurrence rate of 30% and a 49% overall survival were seen after a mean followup of 33 months (5-73). Six-year cancer-specific survival was 67%. No patient developed either peritoneal or surgical bed recurrence. Conclusions: HALMU using the pluck-off procedure is a feasible, safe, and effective surgery. Both surgical and oncological results are similar to those of open surgery and pure laparoscopy (AU)