RESUMEN
PURPOSE: To assess the clinical performance of ProsTAV®, a blood-based test based on telomere associate variables (TAV) measurement, to support biopsy decision-making when diagnosing suspicious prostate cancer (PCa). METHODS: Preliminary data of a prospective observational pragmatic study of patients with prostate-specific antigen (PSA) levels 3-10 ng/ml and suspicious PCa. Results were combined with other clinical data, and all patients underwent prostate biopsies according to each center's routine clinical practice, while magnetic resonance imaging (MRI) before the prostate biopsy was optional. Sensitivity, specificity, positive and negative predicted values, and subjects where biopsies could have been avoided using ProsTAV were determined. RESULTS: The mean age of the participants (n = 251) was 67.4 years, with a mean PSA of 5.90 ng/ml, a mean free PSA of 18.9%, and a PSA density of 0.14 ng/ml. Digital rectal examination was abnormal in 21.1% of the subjects, and according to biopsy, the prevalence of significant PCa was 47.8%. The area under the ROC curve of ProsTAV was 0.7, with a sensitivity of 0.90 (95% CI, 0.85-0.95) and specificity of 0.27 (95% CI, 0.19-0.34). The positive and negative predictive values were 0.53 (95% CI, 0.46-0.60) and 0.74 (95% CI, 0.62-0.87), respectively. ProsTAV could have reduced the biopsies performed by 27% and showed some initial evidence of a putative benefit in the diagnosis pathway combined with MRI. CONCLUSIONS: ProsTAV increases the prediction capacity of significant PCa in patients with PSA between 3 and 10 ng/ml and could be considered a complementary tool to improve the patient diagnosis pathway.
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Antígeno Prostático Específico , Neoplasias de la Próstata , Humanos , Masculino , Neoplasias de la Próstata/diagnóstico , Neoplasias de la Próstata/patología , Neoplasias de la Próstata/sangre , Anciano , Estudios Prospectivos , Persona de Mediana Edad , Antígeno Prostático Específico/sangre , Biopsia , Sensibilidad y Especificidad , Imagen por Resonancia Magnética , Toma de Decisiones ClínicasRESUMEN
BACKGROUND: Current pathways in early diagnosis of prostate cancer (PCa) can lead to unnecessary biopsy procedures. Here, we used telomere analysis to develop and evaluate ProsTAV®, a risk model for significant PCa (Gleason score >6), with the objective of improving the PCa diagnosis pathway. METHODS: This retrospective, multicentric study analyzed telomeres from patients with serum PSA 3-10 ng/mL. High-throughput quantitative fluorescence in-situ hybridization was used to evaluate telomere-associated variables (TAVs) in peripheral blood mononucleated cells. ProsTAV® was developed by multivariate logistics regression based on three clinical variables and six TAVs. The predictive capacity and accuracy of ProsTAV® were summarized by receiver operating characteristic (ROC) curves and its clinical benefit with decision curves analysis. RESULTS: Telomeres from 1043 patients were analyzed. The median age of the patients was 63 years, with a median PSA of 5.2 ng/mL and a percentage of significant PCa of 23.9%. A total of 874 patients were selected for model training and 169 patients for model validation. The area under the ROC curve of ProsTAV® was 0.71 (95% confidence interval [CI], 0.62-0.79), with a sensitivity of 0.90 (95% CI, 0.88-1.0) and specificity of 0.33 (95% CI, 0.24-0.40). The positive predictive value was 0.29 (95% CI, 0.21-0.37) and the negative predictive value was 0.91 (95% CI, 0.83-0.99). ProsTAV® would make it possible to avoid 33% of biopsies. CONCLUSIONS: ProsTAV®, a predictive model based on telomere analysis through TAV, could be used to increase the prediction capacity of significant PCa in patients with PSA between 3 and 10 ng/mL.
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Antígeno Prostático Específico , Neoplasias de la Próstata , Masculino , Humanos , Persona de Mediana Edad , Estudios Retrospectivos , Neoplasias de la Próstata/diagnóstico , Neoplasias de la Próstata/genética , Biopsia , Curva ROCRESUMEN
INTRODUCTION: Ureteral complications after kidney transplantation are frequent and may have a negative impact on morbidity and graft function. Treatment modalities include conservative, endourological, and surgical techniques, with variable outcomes. The purpose of this study was to report the incidence, characteristics, treatment, and outcomes of ureteral complications at our center. METHODS: Retrospective study of kidney transplants performed at our unit between 2015 and 2020, analyzing incidence, characteristics, treatment, and outcomes of ureteral stenoses and fistulas. RESULTS: Of 648 kidney transplants, we present 3.24% stenosis and 2.16% ureteral fistulas, with a mean time from transplantation of 101.4 and 24.4 days, respectively. Primary treatment was open surgical repair in 52.4% stenosis and 100% fistulas, with a success rate of 90.9% and 71.4%, respectively. Anterograde balloon dilatations were performed in 33.3% of stenosis with 40% success. Three patients required surgery as a secondary approach with 100% success. Major complications (Clavien-Dindo III) were observed in 18.5% following surgical repair. After a mean follow-up of 31.1 ± 20.9 months, we observe 88.6% of functioning grafts. We found no significant differences in graft survival between patients with or without ureteral complications (p 0.948). CONCLUSION: Surgical repair of ureteral complications offers satisfactory results with low associated morbidity. Endourological techniques are less effective and should be reserved for selected cases. With adequate management, there is no impact on graft survival.
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Trasplante de Riñón , Obstrucción Ureteral , Fístula Urinaria , Humanos , Trasplante de Riñón/efectos adversos , Trasplante de Riñón/métodos , Constricción Patológica/cirugía , Estudios Retrospectivos , Obstrucción Ureteral/etiología , Obstrucción Ureteral/cirugía , Fístula Urinaria/etiología , Fístula Urinaria/cirugía , Complicaciones Posoperatorias/epidemiología , Complicaciones Posoperatorias/etiología , Complicaciones Posoperatorias/cirugíaRESUMEN
Leiomyomas are benign mesenchymal tumors which originate from smooth muscle cells. Extrauterine leiomyomas are rare and they may arise where smooth muscle cells are found. Their diagnosis is challenging due to their heterogeneous ways of presentation. Histological analysis may reveal areas of sarcomatous differentiation; therefore, complete resection of the entire tumor is the only curative treatment. There is no adjuvant therapy proved to increase overall survival. It is essential to develop a standardized protocol, detailing how to follow up these patients since it is not reported in the literature to date; however, it is advisable to follow them because the local recurrence rate is high if small implants remain. In this review, we present 3 cases of extrauterine leiomyomas diagnosed and treated in our hospital. The management was different in each case, highlighting the heterogeneity of this condition. According to the literature, there are no solid guidelines on their management. We compare our experience with the data available to date in order to support the existing knowledge and provide our expertise for future studies.
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Leiomioma , Humanos , Leiomioma/diagnóstico por imagen , Leiomioma/cirugía , Espacio Retroperitoneal , Miocitos del Músculo Liso/patologíaRESUMEN
PURPOSE: This study sought to determine health-related quality of life and self-reported complications associated with clean intermittent catheterization (CIC). DESIGN: Observational, cross-sectional study. SUBJECTS AND SETTING: The target population was patients cared for by the urology department at Hospital 12 de Octubre in Madrid, Spain, undergoing CIC for chronic urinary retention of any etiology (neurogenic bladder dysfunction, neobladder, and other). The sample comprised 50 respondents with a mean age of 49 years; a majority (66%, n = 33) were female. Participants performed an average of 4 CICs. METHODS: All participants completed the ISC-Q (Intermittent Self-Catheterization Questionnaire) and a questionnaire about CIC-associated complications. Data were collected in February 2019. RESULTS: A vast majority of respondents (98%, n = 49) indicated preparation for catheterization was simple, and 76% (n = 38) indicated the catheter was easy to insert. One in 5 (20%, n = 10) considered carrying catheters and supplies inconvenient, though 58% (n = 29) indicated it was easy to dispose of the catheters outside the home. Most respondents (98%, n = 49) indicated they felt self-conscious about their need to self-catheterize, and 16% (n = 8) felt that CIC created limitations when visiting friends and family. The most frequent complication was symptomatic urinary tract infections (UTIs); participants reported an average of 1.7 UTIs in the last year. Additional complications, such as epididymo-orchitis, urethral stenosis, and urethral bleeding, were reported by less than 5% (n = 2) of participants. CONCLUSIONS: Participants managed by CIC for chronic urinary retention of any cause reported acceptable levels of satisfaction with the procedure. The reported incidence of complications was low, except for UTIs.
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Cateterismo Uretral Intermitente , Vejiga Urinaria Neurogénica , Retención Urinaria , Infecciones Urinarias , Humanos , Masculino , Femenino , Persona de Mediana Edad , Cateterismo Uretral Intermitente/efectos adversos , Cateterismo Uretral Intermitente/métodos , Retención Urinaria/terapia , Retención Urinaria/complicaciones , Calidad de Vida , Autoinforme , Estudios Transversales , Infecciones Urinarias/etiología , Infecciones Urinarias/complicaciones , Cateterismo Urinario/efectos adversos , Cateterismo Urinario/métodosRESUMEN
PURPOSE: The purpose of the study was to compare the outcomes of high-risk non-muscle-invasive bladder cancer (HR-NMIBC) patients treated with BCG vs recirculating hyperthermic intravesical chemotherapy (HIVEC) with mitomycin C (MMC). METHODS: A pilot phase II randomized clinical trial was conducted including HR-NMIBC patients, excluding carcinoma in situ. Patients were randomized 1:1 to receive intravesical BCG for 1 year (once weekly for 6 weeks plus subsequent maintenance) or HIVEC with 40 mg MMC, administered using the Combat BRS system (once weekly instillations were given for 6 weeks, followed by once monthly instillation for 6 months). Total recirculating dwell time for HIVEC was 60 min at a target temperature of 43° ± 0.5 °C. Primary endpoint was recurrence-free survival. Secondary endpoints were time to recurrence, progression-free survival, cancer-specific survival, and overall survival at 24 months. Adverse events were routinely assessed. RESULTS: Fifty patients were enrolled. Mean age was 73.5 years. Median follow-up was 33.7 months. Recurrence-free survival at 24 months was 86.5% for HIVEC and 71.8% for BCG (p = 0.184) in the intention-to-treat analysis and 95.0% for HIVEC and 75.1% for BCG (p = 0.064) in the per protocol analysis. Time to recurrence was 21.5 and 16.1 months for HIVEC and BCG, respectively. Progression-free survival for HIVEC vs BCG was 95.7% vs 71.8% (p = 0.043) in the intention-to-treat analysis and 100% vs 75.1% (p = 0.018) in the per protocol analysis, respectively. Cancer-specific survival at 24 months was 100% for both groups and overall survival was 91.5% for HIVEC vs 81.8% for BCG. CONCLUSION: HIVEC provides comparable safety and efficacy to BCG and is a reasonable alternative during BCG shortages. TRIAL REGISTRATION: EudraCT 2016-001186-85. Date of registration: 17 March 2016.
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Hipertermia Inducida , Neoplasias de la Vejiga Urinaria , Adyuvantes Inmunológicos/uso terapéutico , Administración Intravesical , Anciano , Vacuna BCG/uso terapéutico , Humanos , Mitomicina/uso terapéutico , Recurrencia Local de Neoplasia/tratamiento farmacológico , Neoplasias de la Vejiga Urinaria/tratamiento farmacológicoRESUMEN
OBJECTIVES: To propose a clear definition and management pathway of patients with analgesic refractory colic pain (ARCP). PATIENTS AND METHODS: Prospective cohort study from February 2018 to February 2019 including patients with ARCP defined as ongoing renal colic pain after one dose of IV NSAID, IV paracetamol, and a parenteral opioid, given sequentially in that order. Patients were observed in-hospital under full parenteral analgesic management for 8-12 h, whenever patients had minimal or absent pain after conservative management (CM) they were discharged, and followed-up with new imaging within four weeks. If the pain was not controlled after CM, surgical management (double-J stent or ureteroscopy) was performed. We excluded patients with any other indication for urgent intervention or in cases where CM was deemed inappropriate (sepsis, acute renal failure, stones >10 mm in size, suspected concomitant urinary tract infection, bilateral ureteral stones, pregnancy, patients with a single kidney, kidney transplant recipients, difficult access to medical care or refusal to undergo CM). RESULTS: Data from 60 patients was collected. The only variable associated with an increased risk of failed CM was a history of previous renal colic (OR 3.98 [95% CI 1.14-13.84], p = 0.02). Neither gender, age, stone size, location, or hydronephrosis grade were able to predict CM failure. 41.6% of patients were successfully managed conservatively and only 8% of them required scheduled surgical management at follow-up. CONCLUSION: Our results show that a high proportion of patients with ARCP may be successfully managed conservatively with an extended observation period without complications at follow-up. These results should be replicated in a randomized controlled trial to confirm them.
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Analgésicos/uso terapéutico , Cólico/tratamiento farmacológico , Tratamiento Conservador , Manejo del Dolor/métodos , Acetaminofén/uso terapéutico , Adulto , Anciano , Anciano de 80 o más Años , Analgésicos Opioides/uso terapéutico , Antiinflamatorios no Esteroideos/uso terapéutico , Femenino , Humanos , Masculino , Persona de Mediana Edad , Dimensión del Dolor , Estudios ProspectivosRESUMEN
BACKGROUND: Abiraterone acetate, a drug that blocks endogenous androgen synthesis, plus prednisone is indicated for metastatic castration-resistant prostate cancer. We evaluated the clinical benefit of abiraterone acetate plus prednisone with androgen-deprivation therapy in patients with newly diagnosed, metastatic, castration-sensitive prostate cancer. METHODS: In this double-blind, placebo-controlled, phase 3 trial, we randomly assigned 1199 patients to receive either androgen-deprivation therapy plus abiraterone acetate (1000 mg daily, given once daily as four 250-mg tablets) plus prednisone (5 mg daily) (the abiraterone group) or androgen-deprivation therapy plus dual placebos (the placebo group). The two primary end points were overall survival and radiographic progression-free survival. RESULTS: After a median follow-up of 30.4 months at a planned interim analysis (after 406 patients had died), the median overall survival was significantly longer in the abiraterone group than in the placebo group (not reached vs. 34.7 months) (hazard ratio for death, 0.62; 95% confidence interval [CI], 0.51 to 0.76; P<0.001). The median length of radiographic progression-free survival was 33.0 months in the abiraterone group and 14.8 months in the placebo group (hazard ratio for disease progression or death, 0.47; 95% CI, 0.39 to 0.55; P<0.001). Significantly better outcomes in all secondary end points were observed in the abiraterone group, including the time until pain progression, next subsequent therapy for prostate cancer, initiation of chemotherapy, and prostate-specific antigen progression (P<0.001 for all comparisons), along with next symptomatic skeletal events (P=0.009). These findings led to the unanimous recommendation by the independent data and safety monitoring committee that the trial be unblinded and crossover be allowed for patients in the placebo group to receive abiraterone. Rates of grade 3 hypertension and hypokalemia were higher in the abiraterone group. CONCLUSIONS: The addition of abiraterone acetate and prednisone to androgen-deprivation therapy significantly increased overall survival and radiographic progression-free survival in men with newly diagnosed, metastatic, castration-sensitive prostate cancer. (Funded by Janssen Research and Development; LATITUDE ClinicalTrials.gov number, NCT01715285 .).
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Acetato de Abiraterona/administración & dosificación , Antagonistas de Andrógenos/administración & dosificación , Protocolos de Quimioterapia Combinada Antineoplásica/uso terapéutico , Prednisolona/administración & dosificación , Neoplasias de la Próstata/tratamiento farmacológico , Acetato de Abiraterona/efectos adversos , Adulto , Anciano , Anciano de 80 o más Años , Antagonistas de Andrógenos/efectos adversos , Antagonistas de Andrógenos/uso terapéutico , Protocolos de Quimioterapia Combinada Antineoplásica/efectos adversos , Humanos , Masculino , Persona de Mediana Edad , Metástasis de la Neoplasia/tratamiento farmacológico , Prednisolona/efectos adversos , Neoplasias de la Próstata/mortalidad , Neoplasias de la Próstata/radioterapia , Neoplasias de la Próstata/cirugía , Esteroide 17-alfa-Hidroxilasa/antagonistas & inhibidores , Análisis de SupervivenciaRESUMEN
OBJECTIVE: To assess the perioperative outcomes of holmium laser enucleation of the prostate (HoLEP) in real-life practice and investigate the factors influencing the safety and effectiveness of the technique. PATIENTS AND METHODS: Critical analysis of patients with benign prostate hyperplasia (BPH) treated with HoLEP over 10 years of routine practice in three hospitals. Analysed variables included: preoperative characteristics (prostate size, active antiplatelet/anticoagulant therapy, blood parameters. prostate-specific antigen (PSA) level, maximum urinary flow rate [Qmax ], and International Prostate Symptom Score [IPSS]), intraoperative variables (operation time, concomitant removal of bladder calculi, and complications), early postoperative outcomes (change in blood parameters, catheterisation time, and hospital stay), and 12-month follow-up outcomes (change in IPSS, PSA level, and Qmax ). RESULTS: The analysis included 963 patients, aged 48-91 years, with a mean (range) prostate size of 91 (35-247) mL. The mean (sd) operation time was 77 (29) min, and the hospital stay and catheterisation time were 4 (2) and 1.3 (2) days, respectively. In all, 56 patients (5.6%) required concomitant removal of bladder calculi and 36 (3.7%) were converted to open prostatectomy or transurethral resection of the prostate due to intraoperative complications. Patients had a significant decrease in haemoglobin and haematocrit, but no differences were seen between patients with and without anticoagulant/antiplatelet therapy and those with prostates ≥ and <100 mL. The concomitant removal of bladder calculi and having a prostate ≥100 mL resulted in a longer operation time, but did not influence the safety and effectiveness outcomes. CONCLUSIONS: HoLEP is suitable for real-life patients with BPH, irrespective of the presence of active treatment with anticoagulant/antiplatelet, bladder lithiasis or a prostate ≥100 mL.
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Terapia por Láser/métodos , Láseres de Estado Sólido/uso terapéutico , Complicaciones Posoperatorias/epidemiología , Próstata/cirugía , Hiperplasia Prostática/cirugía , Resección Transuretral de la Próstata/métodos , Anciano , Anciano de 80 o más Años , Holmio , Humanos , Incidencia , Masculino , Persona de Mediana Edad , Tempo Operativo , España/epidemiología , Resultado del TratamientoRESUMEN
BACKGROUND: Advances in life expectancy have led to an increase in the number of elderly people with end-stage renal disease (ESRD). Scarce information is available on the outcomes of kidney transplantation (KT) in extremely elderly patients based on an allocation policy prioritizing donor-recipient age matching. METHODS: We included recipients ≥75 years that underwent KT from similarly aged deceased donors at our institution between 2002 and 2015. Determinants of death-censored graft and patient survival were assessed by Cox regression. RESULTS: We included 138 recipients with a median follow-up of 38.8 months. Median (interquartile range) age of recipients and donors was 77.5 (76.3-79.7) and 77.0 years (74.7-79.0), with 22.5% of donors ≥80 years. Primary graft non-function occurred in 8.0% (11/138) of patients. Cumulative incidence rates for post-transplant infection and biopsy-proven acute rejection (BPAR) were 70.3% (97/138) and 15.2% (21/138), respectively. One- and 5-year patient survival were 82.1 and 60.1%, respectively, whereas the corresponding rates for death-censored graft survival were 95.6 and 93.1%. Infection was the leading cause of death (46.0% of fatal cases). The occurrence of BPAR was associated with lower 1-year patient survival [hazard ratio (HR) = 4.21, 95% confidence interval (CI) 1.64-10.82; P = 0.003]. Diabetic nephropathy was the only factor predicting 5-year death-censored graft survival (HR = 4.82, 95% CI 1.08-21.56; P = 0.040). CONCLUSIONS: ESRD patients ≥75 years can access KT and remain dialysis free for their remaining lifespan by using grafts from extremely aged deceased donors, yielding encouraging results in terms of recipient and graft survival.
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Rechazo de Injerto/etiología , Supervivencia de Injerto , Fallo Renal Crónico/cirugía , Trasplante de Riñón/efectos adversos , Complicaciones Posoperatorias/etiología , Donantes de Tejidos/provisión & distribución , Factores de Edad , Anciano , Anciano de 80 o más Años , Femenino , Rechazo de Injerto/patología , Humanos , Masculino , Complicaciones Posoperatorias/patología , Estudios Retrospectivos , Factores de RiesgoRESUMEN
BACKGROUND: In the interim analyses of the LATITUDE study, the addition of abiraterone acetate plus prednisone to androgen deprivation therapy (ADT) led to a significant improvement in overall survival and radiographic progression-free survival compared with placebos plus ADT in men with newly diagnosed high-risk metastatic castration-sensitive prostate cancer (mCSPC). Here, we present long-term survival outcomes and safety of abiraterone acetate plus prednisone and ADT from the final analysis of the LATITUDE study. METHODS: This is a multicentre, randomised, double-blind, phase 3 trial done at 235 sites in 34 countries. Eligible patients (men aged ≥18 years) had newly diagnosed, histologically or cytologically confirmed prostate cancer with metastases, Eastern Cooperative Oncology Group (ECOG) performance status of 0-2, and at least two of the three high-risk prognostic factors (Gleason score of ≥8, presence of three or more lesions on bone scan, or presence of measurable visceral metastasis except lymph node metastasis). Patients were randomly assigned (1:1) to receive abiraterone acetate (1000 mg) once daily orally plus prednisone (5 mg) once daily orally and ADT (abiraterone acetate plus prednisone group) or matching placebos plus ADT (placebo group); each treatment cycle was 28 days. Randomisation was done by a centralised interactive web response system in a country-by-country scheme using permuted block randomisation, stratified by presence of visceral disease and ECOG performance status. The coprimary endpoint of overall survival was assessed in the intention-to-treat population. This study is registered at ClinicalTrials.gov, number NCT01715285 and is complete. FINDINGS: Between Feb 12, 2013, and Dec 11, 2014, 1209 patients were screened, of whom ten were ineligible because of study site violations. 1199 patients were randomly assigned to either the abiraterone acetate plus prednisone group (n=597) or placebo group (n=602). After the results of the first interim analysis (cutoff date Oct 31, 2016), the study was unmasked to patients and investigators, and patients in the placebo group were allowed to cross over to receive abiraterone acetate and prednisone plus ADT treatment as per a protocol amendment (Feb 15, 2017) in an open-label extension phase of the study (up to 18 months from the protocol amendment). This final analysis (data cutoff Aug 15, 2018) was done after a median follow-up of 51·8 months (IQR 47·2-57·0) and 618 deaths (275 [46%] of 597 in the abiraterone acetate plus prednisone group and 343 [57%] of 602 in the placebo group). Overall survival was significantly longer in the abiraterone acetate plus prednisone group (median 53·3 months [95% CI 48·2-not reached]) than in the placebo group (36·5 months [33·5-40·0]), with a hazard ratio of 0·66 (95% CI 0·56-0·78; p<0·0001). The most common grade 3-4 adverse events were hypertension (125 [21%] in the abiraterone acetate plus prednisone group vs 60 [10%] in the placebo group vs three [4%] in the 72 patients who crossed over from placebo to abiraterone acetate plus prednisone) and hypokalaemia (70 [12%] vs ten [2%] vs two [3%]). Serious adverse events of any grade occurred in 192 (32%) of 597 patients in the abiraterone acetate plus prednisone group, 151 (25%) of 602 in the placebo group, and four (6%) of 72 in the crossover group. The most common treatment-related serious adverse event was hypokalaemia (four [1%] patients in the abiraterone acetate plus prednisone group and none in the other groups). Treatment-related deaths occurred in three (<1%) patients each in the abiraterone acetate plus prednisone group (gastric ulcer perforation, sudden death, and cerebrovascular accident) and the placebo group (sudden death, cerebrovascular accident, and pneumonia), with none in the crossover group. INTERPRETATION: The combination of abiraterone acetate plus prednisone with ADT was associated with significantly longer overall survival than placebos plus ADT in men with newly diagnosed high-risk mCSPC and had a manageable safety profile. These findings support the use of abiraterone acetate plus prednisone as a standard of care in patients with high-risk mCSPC. FUNDING: Janssen Research & Development.
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Acetato de Abiraterona/administración & dosificación , Antineoplásicos Hormonales/administración & dosificación , Protocolos de Quimioterapia Combinada Antineoplásica/administración & dosificación , Dexametasona/administración & dosificación , Neoplasias de la Próstata/tratamiento farmacológico , Inhibidores de la Síntesis de Esteroides/administración & dosificación , Acetato de Abiraterona/efectos adversos , Anciano , Antagonistas de Andrógenos/administración & dosificación , Antineoplásicos Hormonales/efectos adversos , Protocolos de Quimioterapia Combinada Antineoplásica/efectos adversos , Dexametasona/efectos adversos , Progresión de la Enfermedad , Método Doble Ciego , Humanos , Masculino , Persona de Mediana Edad , Clasificación del Tumor , Metástasis de la Neoplasia , Orquiectomía , Supervivencia sin Progresión , Neoplasias de la Próstata/mortalidad , Neoplasias de la Próstata/patología , Medición de Riesgo , Factores de Riesgo , Inhibidores de la Síntesis de Esteroides/efectos adversos , Factores de TiempoRESUMEN
Uncontrolled donation after circulatory death (uDCD) increases organ availability for kidney transplant (KT) with short-term outcomes similar to those obtained from donation after brain death (DBD) donors. However, heterogeneous results in the long term have been reported. We compared 10-year outcomes between 237 KT recipients from uDCD donors maintained by normothermic extracorporeal membrane oxygenation (nECMO) and 237 patients undergoing KT from standard criteria DBD donors during the same period at our institution. We further analyzed risk factors for death-censored graft survival in the uDCD group. Delayed graft function (DGF) was more common in the uDCD group (73.4% vs 46.4%; P < .01), although glomerular filtration rates at the end of follow-up were similar in the 2 groups. uDCD and DBD groups had similar rates for 10-year death-censored graft (82.1% vs 80.4%; P = .623) and recipient survival (86.2% vs 87.6%; P = .454). Donor age >50 years was associated with graft loss in the uDCD group (hazard ratio: 1.91; P = .058), whereas the occurrence of DGF showed no significant effect. uDCD KT under nECMO support resulted in similar graft function and long-term outcomes compared with KT from standard criteria DBD donors. Increased donor age could negatively affect graft survival after uDCD donation.
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Muerte Encefálica , Funcionamiento Retardado del Injerto/fisiopatología , Oxigenación por Membrana Extracorpórea/métodos , Supervivencia de Injerto , Trasplante de Riñón/mortalidad , Donantes de Tejidos/provisión & distribución , Obtención de Tejidos y Órganos/métodos , Adulto , Estudios de Cohortes , Femenino , Estudios de Seguimiento , Tasa de Filtración Glomerular , Humanos , Fallo Renal Crónico/cirugía , Pruebas de Función Renal , Masculino , Persona de Mediana Edad , Preservación de Órganos/métodos , Pronóstico , Factores de Riesgo , Tasa de SupervivenciaRESUMEN
OBJECTIVES: To assess the impact of transrectal versus transperineal prostate biopsy on erectile function. METHODS: This was a single-center, observational, prospective study of consecutive patients who underwent a prostate biopsy (transrectal or transperineal/fusion biopsy). Study participants completed the International Index of Erectile Function-5 questionnaire before the procedure, and 3 and 6 months after. Prostatic biopsies were carried out following the standard procedure for both techniques. RESULTS: The study included 135 male patients with a mean age of 63.5 years. At baseline, 28 patients (21%) presented normal erectile function, whereas 107 patients (82%) presented erectile dysfunction, which was severe in four (3%), moderate in 49 (36%) and mild in 54 (40%), with an overall mean International Index of Erectile Function-5 score of 17.70. After 3 months, the rates were 29%, 3%, 27% and 38%, respectively (mean International Index of Erectile Function-5 score 17.95). At 6 months, the rates were 30%, 6%, 28% and 34%, respectively (mean International Index of Erectile Function-5 score of 17.77). No significant differences between pre- and post-biopsy International Index of Erectile Function-5 scores at 3 and 6 months were observed, even when analyzing transrectal and transperineal separately. The number of biopsy cores and number of previous biopsies did not influence the International Index of Erectile Function-5 scores. CONCLUSIONS: Our findings suggest that prostate biopsy technique, number of biopsy cores and history of previous biopsy do not significantly impact erectile function in the medium term up to 6 months.
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Disfunción Eréctil/etiología , Enfermedades de la Próstata/diagnóstico , Procedimientos Quirúrgicos Urogenitales/efectos adversos , Anciano , Biopsia/efectos adversos , Biopsia/métodos , Humanos , Masculino , Persona de Mediana Edad , Estudios ProspectivosRESUMEN
BACKGROUND: In the LATITUDE trial, addition of abiraterone acetate plus prednisone to androgen deprivation therapy (ADT) improved overall survival compared with placebos plus ADT in patients with newly diagnosed, high-risk, metastatic castration-naive prostate cancer. Understanding the effects of treatments on patient-reported outcomes (PROs) and health-related quality of life (HRQOL) is important for treatment decisions; therefore we aimed to analyse the effects of ADT plus abiraterone acetate and prednisone versus ADT plus placebos on PROs and HRQOL in patients in the LATITUDE study. METHODS: In the multicentre, international, randomised, phase 3 LATITUDE trial, eligible patients were aged 18 years or older, had newly diagnosed, high-risk, metastatic castration-naive prostate cancer confirmed by bone scan (bone metastases) or by CT or MRI (visceral, soft tissue, or nodal metastases), and an Eastern Cooperative Oncology Group (ECOG) performance status score of 2 or less. Patients from 235 clinical sites in 34 countries were randomly assigned (1:1) following a country-by-country scheme done by permuted block randomisation (with two blocks) and stratified by the presence of visceral metastasis and ECOG performance status to receive ADT plus 1000 mg oral abiraterone acetate and 5 mg oral prednisone once daily or ADT plus placebos. Selection of ADT, chemical or surgical, was at the investigator's discretion. The co-primary endpoints of the trial, overall survival and radiographic progression-free survival, have been published. PRO data were collected directly on electronic tablet devices at the clinical sites during screening and before any other visit procedure on day 1 of cycles 1-3, monthly during cycles 4-13, and then every 2 months until the end of treatment, by use of the Brief Pain Inventory-Short Form (BPI-SF), Brief Fatigue Inventory (BFI), Functional Assessment of Cancer Therapy Prostate scale (FACT-P), and the EuroQol (EQ-5D-5L) questionnaires. PRO analyses were an exploratory endpoint. Analyses were by intention-to-treat. Results from the first pre-planned interim analysis (Oct 31, 2016), are presented here. This ongoing study is registered with Clinicaltrials.gov, number NCT01715285. FINDINGS: Between Feb 12, 2013, and Dec 11, 2014, 1199 patients were randomly assigned: 597 to ADT plus abiraterone acetate and prednisone and 602 to ADT plus placebos. Median follow-up was 30·9 months (IQR 21·2-33·2) in the ADT plus abiraterone acetate and prednisone group versus 29·7 months (1·4-43·5; 16·1-31·3) in the ADT plus placebos group. Median time to worst pain intensity progression assessed by the BPI-SF score was not reached in either group (ADT plus abiraterone acetate and prednisone, not reached [95% CI not reached to not reached]; 25th percentile 11·07 months [95% CI 9·23-18·43]; ADT plus placebos group, not reached [95% CI not reached to not reached]; 25th percentile 5·62 [95% CI 4·63-7·39]; hazard ratio [HR] 0·63 [95% CI 0·52-0·77]; p<0·0001). Median time to worst fatigue intensity was not reached in either the ADT plus abiraterone acetate and prednisone group (not reached [95% CI not reached to not reached]; 25th percentile 18·4 months [95% CI 12·9-27·7]) or the ADT plus placebos group (not reached [95% CI not reached to not reached]; 25th percentile 6·5 months [95% CI 5·6-9·2]; HR 0·65 [95% CI 0·53-0·81], p=0·0001). Median time to deterioration of functional status assessed by the FACT-P total score scale was 12·9 months (95% CI 9·0-16·6) in the ADT plus abiraterone acetate and prednisone group versus 8·3 months (7·4-11·1) in the ADT plus placebos group (HR 0·85 [95% CI 0·74-0·99]; p=0·032). INTERPRETATION: The addition of abiraterone acetate plus prednisone to ADT in patients with newly diagnosed, high-risk metastatic castration-naive prostate cancer improved overall PROs by consistently showing a clinical benefit in the progression of pain, prostate cancer symptoms, fatigue, functional decline, and overall HRQOL. FUNDING: Janssen Research & Development.
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Acetato de Abiraterona/uso terapéutico , Antagonistas de Andrógenos/uso terapéutico , Medición de Resultados Informados por el Paciente , Prednisona/uso terapéutico , Neoplasias de la Próstata Resistentes a la Castración/tratamiento farmacológico , Neoplasias de la Próstata Resistentes a la Castración/mortalidad , Anciano , Protocolos de Quimioterapia Combinada Antineoplásica/uso terapéutico , Supervivencia sin Enfermedad , Humanos , Internacionalidad , Estimación de Kaplan-Meier , Imagen por Resonancia Magnética/métodos , Masculino , Persona de Mediana Edad , Invasividad Neoplásica/patología , Estadificación de Neoplasias , Modelos de Riesgos Proporcionales , Neoplasias de la Próstata Resistentes a la Castración/patología , Calidad de Vida , Medición de Riesgo , Análisis de Supervivencia , Tomografía Computarizada por Rayos X/métodos , Resultado del TratamientoRESUMEN
OBJECTIVES: To comprehensively evaluate the efficacy and safety of the hexanic extract of Serenoa repens (HESr, Permixon® ; Pierre Fabre Médicament, Castres, France), at a dose of 320 mg daily, as monotherapy for the treatment of lower urinary tract symptoms associated with benign prostatic hyperplasia (LUTS/BPH). MATERIALS AND METHODS: We conducted a systematic review and meta-analysis of randomised controlled trials (RCTs) and prospective observational studies in patients with LUTS/BPH identified through searches in Medline, Web of Knowledge (Institute for Scientific Information), Scopus, the Cochrane Library, and bibliographic references up to March 2017. Articles studying S. repens extracts other than Permixon were excluded. Data were collected on International Prostate Symptom Score (IPSS), maximum urinary flow rate (Qmax ), nocturia, quality of life, prostate volume, sexual function, and adverse drug reactions (ADRs). Data obtained from RCTs and observational studies were analysed jointly and separately using a random effects model. A sub-group analysis was performed of studies that included patients on longer-term treatment (≥1 year). RESULTS: Data from 27 studies (15 RCTs and 12 observational studies) were included for meta-analysis (total N = 5 800). Compared with placebo, the HESr was associated with 0.64 (95% confidence interval [CI] -0.98 to -0.31) fewer voids/night (P < 0.001) and an additional mean increase in Qmax of 2.75 mL/s (95% CI 0.57 to 4.93; P = 0.01). When compared with α-blockers, the HESr showed similar improvements on IPSS (weighted mean difference [WMD] 0.57, 95% CI -0.27 to 1.42; P = 0.18) and a comparable increase in Qmax to tamsulosin (WMD -0.02, 95% CI -0.71 to 0.66; P = 0.95). Efficacy assessed using the IPSS was similar after 6 months of treatment between the HESr and 5α-reductase inhibitors (5ARIs). Analysis of all available published data for the HESr showed a mean improvement in IPSS from baseline of -5.73 points (95% CI -6.91 to -4.54; P < 0.001). HESr did not negatively affect sexual function and no clinically relevant effect was observed on prostate-specific antigen. Prostate volume decreased slightly. Similar efficacy results were seen in patients treated for ≥1 year (n = 447). The HESr had a favourable safety profile, with gastrointestinal disorders being the most frequent ADR (mean incidence of 3.8%). CONCLUSION: The present meta-analysis, which includes all available RCTs and observational studies, shows that the HESr (Permixon) reduced nocturia and improved Qmax compared with placebo and had a similar efficacy to tamsulosin and short-term 5-ARI in relieving LUTS. HESr (Permixon) appears to be an efficacious and well-tolerated therapeutic option for the long-term medical treatment of LUTS/BPH.
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Antagonistas de Andrógenos/farmacología , Inflamación/tratamiento farmacológico , Síntomas del Sistema Urinario Inferior/tratamiento farmacológico , Extractos Vegetales/farmacología , Hiperplasia Prostática/complicaciones , Biomarcadores/orina , Humanos , Inflamación/etiología , Inflamación/orina , Síntomas del Sistema Urinario Inferior/etiología , Síntomas del Sistema Urinario Inferior/fisiopatología , Masculino , Estudios Observacionales como Asunto , Fitoterapia , Hiperplasia Prostática/fisiopatología , Hiperplasia Prostática/orina , Ensayos Clínicos Controlados Aleatorios como Asunto , Serenoa , Resultado del TratamientoRESUMEN
PURPOSE: To assess the performance of the Brief Sexual Symptom Checklist for men (BSSC-M) questionnaire in General Practitioner's (GP) consults in Spain. METHODS: Multicenter, cross-sectional study conducted in Spain among men ≥50 years, visiting a GP for any reason, and being able to answer self-administered questionnaires. Patients receiving medicines for erectile dysfunction (ED) and those with poor functional status were excluded. Sexual satisfaction was assessed by the BSSC-M, ED by the Sexual Health Inventory for Men (SHIM), and quality of life (QoL) using a 5-point Likert scale. RESULTS: In all, 770 men met all the selection criteria and 556 patients (72.2%) reported sexually related problems, ED being the most frequent (n = 427; 55.5%). The SHIM score decreased progressively with the number of causes of sexual dissatisfaction. Prevalence of ED (SHIM ≤21) was greater in patients who referred problems with erection in the BSSC-M questionnaire (76 vs. 14%; p < 0.001). Multivariate analysis for ED prediction revealed that sexual dissatisfaction, QoL (average or low/very low), and the presence of 3 or more comorbidities significantly influenced the chances of having ED. CONCLUSIONS: Our results encourage the use of the BSSC-M for identifying suspicion of ED and other sexual problems in patients > 50 who visit their GP for a routine follow-up.
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Lista de Verificación , Disfunción Eréctil/diagnóstico , Atención Primaria de Salud , Calidad de Vida , Encuestas y Cuestionarios , Anciano , Estudios Transversales , Humanos , Masculino , Tamizaje Masivo/métodos , Persona de Mediana Edad , Estudios Multicéntricos como Asunto , Orgasmo , Prevalencia , Conducta Sexual , España/epidemiologíaRESUMEN
It is worth distinguishing between the two strategies of expectant management for prostate cancer. Watchful waiting entails administering non-curative androgen deprivation therapy to patients on development of symptomatic progression, whereas active surveillance entails delivering curative treatment on signs of disease progression. The objectives of the two management strategies and the patients enrolled in either are different: (i) to review the role of active surveillance as a management strategy for patients with low-risk prostate cancer; and (ii) review the benefits and pitfalls of active surveillance. We carried out a systematic review of active surveillance for prostate cancer in the literature using the National Center for Biotechnology Information's electronic database, PubMed. We carried out a search in English using the terms: active surveillance, prostate cancer, watchful waiting and conservative management. Selected studies were required to have a comprehensive description of the demographic and disease characteristics of the patients at the time of diagnosis, inclusion criteria for surveillance, and a protocol for the patients' follow up. Review articles were included, but not multiple papers from the same datasets. Active surveillance appears to reduce overtreatment in patients with low-risk prostate cancer without compromising cancer-specific survival at 10 years. Therefore, active surveillance is an option for select patients who want to avoid the side-effects inherent to the different types of immediate treatment. However, inclusion criteria for active surveillance and the most appropriate method of monitoring patients on active surveillance have not yet been standardized.
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Uso Excesivo de los Servicios de Salud , Próstata/patología , Neoplasias de la Próstata/tratamiento farmacológico , Espera Vigilante/métodos , Antagonistas de Andrógenos/uso terapéutico , Andrógenos/metabolismo , Progresión de la Enfermedad , Humanos , Masculino , Clasificación del Tumor , Antígeno Prostático Específico/sangre , Neoplasias de la Próstata/mortalidad , Neoplasias de la Próstata/patología , Espera Vigilante/economía , Espera Vigilante/normasRESUMEN
OBJECTIVE: To determine the accuracy of voided urinary cytology (VUC) in predicting of non-muscle-invasive bladder cancer (NMIBC) risk stratification before surgery. METHODS: We prospectively collected data from all patients diagnosed with bladder cancer in our institution over 2 years. We have analyzed VUC accuracy of positive and suspicious VUC in the detection of high-risk tumors and negative and atypical VUC in the detection of low-risk tumors. To test this accuracy, we assessed sensitivity, specificity, positive (PPV) and negative predictive values (NPV), diagnostic odds ratio (DOR), and generated ROC curves (receiver operating characteristic curve). RESULTS: With 224 patients included, the positive VUC subcategory showed a specificity of 92.4% (95%CI: 83.2%-97.5%) and a PPV of 91.4 (95%CI: 81%-97.1%). DOR in this subgroup was 6.81. In the suspicious VUC, specificity was 90.9% (95%CI: 81.3%-96.6%), PPV was 88% (95%CI: 75.7%-95.5%) and DOR was 4.23. Combined analysis of positive and suspicious cytologies for detecting high-risk NMIBC showed a sensitivity of 65% (95%CI: 57.3%-73.2%) and a DOR of 9.51. Negative VUC showed high specificity in detecting low-risk (93.2% [95%CI: 87.9%-96.7%]) and a DOR of 6.90 (95%CI: 3.07-15.46). Atypical VUC was the least accurate and had rather low specificity and predictive values. CONCLUSIONS: VUC appears to be a good, inexpensive and easily available method to determine risk stratification before surgery. This can be useful in daily practice to determine which patients should receive a single instillation of MMC and to prioritize patients more likely to have a high- risk tumor.
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Neoplasias de la Vejiga Urinaria , Humanos , Neoplasias de la Vejiga Urinaria/orina , Neoplasias de la Vejiga Urinaria/patología , Neoplasias de la Vejiga Urinaria/diagnóstico , Neoplasias de la Vejiga Urinaria/cirugía , Femenino , Masculino , Anciano , Persona de Mediana Edad , Estudios Prospectivos , Orina/citología , Medición de Riesgo/métodos , Anciano de 80 o más Años , Sensibilidad y Especificidad , Valor Predictivo de las Pruebas , Invasividad Neoplásica , Curva ROC , Neoplasias Vesicales sin Invasión Muscular , CitologíaRESUMEN
BACKGROUND: Benign prostatic hyperplasia (BPH) commonly causes lower urinary tract symptoms (LUTS) in men. Holmium (HoLEP) and thulium (ThuLEP) laser enucleation are established techniques for BPH treatment. Thulium fiber laser (TFL) for prostate enucleation (ThuFLEP) shows promising outcomes. METHODS: A prospective randomized multicenter study was conducted. Patients with BPH and LUTS unresponsive to medical therapy were enrolled. Preoperative, surgical, perioperative and postoperative data were recorded with follow-up at 3 and 6 months. The primary outcome was functional improvement, and the secondary outcome was safety in terms of complications. RESULTS: Two hundred patients were included (HoLEP 100, ThuFLEP 100). No significant baseline difference was found between groups. At 3 and 6 months we found statistically significant improvements from baseline for both HoLEP and ThuFLEP in efficacy: International Prostatic Symptoms Score (IPSS), IPSS-Quality of Life (QoL), maximum urinary flow rate (Q