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PURPOSE: Our study aimed to assess the oncological outcomes of sentinel node dissection during radical prostatectomy according to nodal location in comparison to extended pelvic lymph node dissection. MATERIALS AND METHODS: Prospectively collected data of clinically node-negative patients who underwent prostatectomy and extended lymph node dissection with or without sentinel node from January 2013 to January 2023 were retrospectively analyzed. The primary end point was to assess oncological outcomes on the whole population. Kaplan-Meier curves were used to depict biochemical and clinical recurrence-free survival. Multivariable Cox regression models assessed the impact of nodal location on single-photon emission computed tomography on oncological outcomes. Adjustment for case mix included: pathological T stage, ISUP (International Society of Urological Pathology) grade group, initial PSA, nodal burden, age at surgery, and surgical margin status. Secondarily, a propensity score match was performed according to age at surgery, PSA, biopsy ISUP, clinical T stage, and Briganti risk of nodal invasion. Survival and regression analyses were also performed in the matched population. RESULTS: Of the patients, 55.8% had at least 1 sentinel node outside of lymph node dissection template at single-photon emission computed tomography/CT. Log-rank test showed comparable 36-month biochemical (P = .3) and clinical recurrence-free survival (P = .6) among patients with sentinel node inside template, outside template, or extended pelvic lymph node dissection alone. At Cox regression, sentinel node location outside template was associated with lower hazard of metastases (HR 0.62; P = .04) in the overall cohort, while in the matched cohort benefits were observed only for biochemical recurrence (HR 0.57; P = .001). CONCLUSIONS: Wider nodal resection boundaries outside the "classic" template, driven by sentinel node procedure, have a positive impact on oncological outcomes in selected patient.
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Escisión del Ganglio Linfático , Prostatectomía , Neoplasias de la Próstata , Humanos , Masculino , Prostatectomía/métodos , Neoplasias de la Próstata/cirugía , Neoplasias de la Próstata/patología , Neoplasias de la Próstata/mortalidad , Persona de Mediana Edad , Escisión del Ganglio Linfático/métodos , Estudios Retrospectivos , Anciano , Biopsia del Ganglio Linfático Centinela/métodos , Ganglio Linfático Centinela/patología , Ganglio Linfático Centinela/cirugía , Ganglio Linfático Centinela/diagnóstico por imagen , Estadificación de Neoplasias , Metástasis Linfática , Resultado del TratamientoRESUMEN
PURPOSE: To define the impact of systematic biopsy (SB) cores directed in the same area of index lesion in patients undergoing targeted biopsy (TB) and SB for prostate cancer (PCa) suspicion. METHODS: We retrospectively analyzed data of biopsy-naïve patients with one single suspicious lesion at mpMRI who underwent TB plus SB at our institution between January 2015 and September 2021. A convenient sample of 336 patients was available for our analyses. The primary outcome was to evaluate the impact of overlapping SB cores directed to the index lesion at mpMRI. The secondary outcome was to evaluate the SB cores concordance in terms of highest Gleason Score Detection with TB cores. RESULTS: 56% of patients were found to have site-specific concordance. SB cores determined disease upgrade in 22.1% patients. Thirty-one (16.4%) site-concordant patients experienced upgrade through overlapping SB cores, while 149 (79.3%) had no benefit by SB cores, and 8 (4.3%) patients had the worst ISUP at TB cores. 50% of the patients with negative-TB were upgraded to insignificant PCa, and 17.5% was upgraded from negative to unfavorable-intermediate- or high-risk PCa. Overall, 14 (19.4%) patients were also upgraded from ISUP 1 on TB to csPCa, with 28.5% of these harboring high-risk PCa. In csPCas at TB, 9 (12.5%) patients were upgraded from intermediate- to high-risk disease by SB. CONCLUSIONS: TB alone consents to identify worst ISUP PCa in vast majority of patients scheduled for biopsy. A non-negligible number of patients are upgraded via-SB cores, including also index lesion overlapping cores. Omitting these cores might lead to a suboptimal patient management.
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Biopsia Guiada por Imagen , Neoplasias de la Próstata , Masculino , Humanos , Estudios Retrospectivos , Imagen por Resonancia Magnética , Neoplasias de la Próstata/patología , Espectroscopía de Resonancia MagnéticaRESUMEN
PURPOSE OF REVIEW: Transurethral resection of bladder tumour (TURBT) followed by pathology investigation of the obtained specimens is the initial step in the management of urinary bladder cancer (UBC). By following the basic principles of oncological surgery, en-bloc resection of bladder tumour (ERBT) aims to overcome the limitations associated with conventional transurethral resection, and to improve the quality of pathological specimens for a better decision making. The current bulk of evidence provides controversial results regarding the superiority of one technique over the other. The aim of this article is to summarize the recent data and provide evidence on this unanswered question. RECENT FINDINGS: Despite heterogeneous and controversial data, ERBT seems to have a better safety profile and deliver higher quality pathologic specimens. However, the recent evidence failed to support the hypothesized oncological potential benefits of ERBT in the initial surgical treatment of patients with UBC. SUMMARY: ERBT has gained increasing interest globally in the past decade. It continues to represent a promising strategy with a variety of features intended to solve the inherent limitations of TURBT. However, the current quality of evidence does not allow solid conclusions to be drawn about its presumed superiority compared with the conventional technique.
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Neoplasias Vesicales sin Invasión Muscular , Neoplasias de la Vejiga Urinaria , Humanos , Cistectomía/efectos adversos , Cistectomía/métodos , Procedimientos Quirúrgicos Urológicos/efectos adversos , Procedimientos Quirúrgicos Urológicos/métodos , Neoplasias de la Vejiga Urinaria/cirugía , Neoplasias de la Vejiga Urinaria/patología , Oncología MédicaRESUMEN
Background and Objectives: The aim of this article is to present a single-surgeon, open retroperitoneal lymph node dissection (RPLND) series for testicular cancer in a high-volume center. Materials and Methods: We reviewed data from patients who underwent RPLND performed by an experienced surgeon at our institution between 2000 and 2019. We evaluated surgical and perioperative outcomes, complications, Recurrence-Free Survival (RFS), Overall Survival (OS), and Cancer-Specific Survival (CSS). Results: RPLND was performed in primary and secondary settings in 21 (32%) and 44 (68%) patients, respectively. Median operative time was 180 min. Median hospital stay was 6 days. Complications occurred in 23 (35%) patients, with 9 (14%) events reported as Clavien grade ≥ 3. Patients in the primary RPLND group were significantly younger, more likely to have NSGCT, had higher clinical N0 and M0, and had higher nerve-sparing RPLND (all p ≤ 0.04) compared to those in the secondary RPLND group. In the median follow-up of 120 (56-180) months, 10 (15%) patients experienced recurrence. Finally, 20-year OS, CSS, and RFS were 89%, 92%, and 85%, respectively, with no significant difference in survival rates between primary vs. secondary RPLND subgroups (p = 0.64, p = 0.7, and p = 0.31, respectively). Conclusions: Open RPLND performed by an experienced high-volume surgeon achieves excellent oncological and functional outcomes supporting the centralization of these complex procedures.
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Neoplasias Testiculares , Masculino , Humanos , Centros de Atención Terciaria , Espacio Retroperitoneal/cirugía , Espacio Retroperitoneal/patología , Estudios Retrospectivos , Escisión del Ganglio Linfático/métodos , Estadificación de Neoplasias , Resultado del TratamientoRESUMEN
INTRODUCTION AND OBJECTIVES: Holmium laser enucleation of prostate (HoLEP) represents one of the most studied surgical techniques for benign prostatic hyperplasia (BPH). Its efficacy in symptom relief has been widely depicted. However, few evidence is available regarding the possible predictors of symptom recurrence. We aimed to evaluate long-term outcomes, symptom recurrence rate, and predictors in patients that underwent HoLEP. MATERIALS AND METHODS: We retrospectively analyzed data from patients that consecutively underwent HoLEP for BPH from 2012 to 2015 at two tertiary referral centers. Functional outcomes were evaluated by uroflowmetry parameters and International Prostate Symptom Score (IPSS) questionnaire administration at follow-up visits at 12, 24, and 60 months. The primary outcome was the symptomatic patients' rate presenting lower urinary tract symptoms (LUTS) after 60 months from surgery, defined as in case of one or more of the following: IPSS more than 7, post voidal residue (PVR) more than 20 ml, need for medical therapy for LUTS or redo surgery for bladder outlet obstruction. Multivariable logistic regression analyses evaluated predictors for being symptomatic at follow-up. Covariates consisted of: preoperative peak flow rate (PFR), PVR, and IPSS, prostate volume, age (all as continuous), and surgical technique. RESULTS: A total of 567 patients were available for our analyses. Median prostate volume was 80cc, with a median PFR of 8 ml/s and median PVR of 100cc. One hundred and twenty-five (22%) patients were found to be symptomatic at follow-up. Redo surgery was needed for 25 (4.4%) patients. After adjusting for possible confounders, an increase in preoperative PVR (odds ratio [OR] 1.005) and IPSS (OR 1.12) resulted as independent predictors for symptom recurrence (all p < 0.001). CONCLUSIONS: HoLEP can provide durable symptom relief regardless of the chosen technique. Patients with an important preoperative symptom burden or a high PVR should be carefully counseled on the risk of symptom recurrence.
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Terapia por Láser , Efectos Adversos a Largo Plazo , Síntomas del Sistema Urinario Inferior , Complicaciones Posoperatorias , Próstata , Hiperplasia Prostática , Anciano , Humanos , Terapia por Láser/efectos adversos , Terapia por Láser/instrumentación , Terapia por Láser/métodos , Láseres de Estado Sólido/uso terapéutico , Efectos Adversos a Largo Plazo/diagnóstico , Efectos Adversos a Largo Plazo/etiología , Efectos Adversos a Largo Plazo/cirugía , Síntomas del Sistema Urinario Inferior/etiología , Síntomas del Sistema Urinario Inferior/terapia , Masculino , Tamaño de los Órganos , Evaluación de Procesos y Resultados en Atención de Salud , Complicaciones Posoperatorias/diagnóstico , Complicaciones Posoperatorias/cirugía , Pronóstico , Próstata/patología , Próstata/cirugía , Hiperplasia Prostática/patología , Hiperplasia Prostática/fisiopatología , Hiperplasia Prostática/cirugía , Recurrencia , Reoperación/métodos , Reoperación/estadística & datos numéricos , Evaluación de Síntomas/métodos , Evaluación de Síntomas/estadística & datos numéricosRESUMEN
We performed a systematic review and meta-analysis to evaluate the role of platinum-based adjuvant chemotherapy (AC) in upper tract urothelial carcinoma. Eligible studies were identified using Pubmed/Medline, Cochrane library, Embase and meeting abstracts. Outcomes of interest included: overall survival (OS), cancer-specific survival (CSS) and disease-free survival (DFS). Platinum-based AC was associated with improved DFS, while the benefit in OS and CSS was not statistically significant compared to observation. Conversely, platinum-based AC showed a modest OS benefit in an analysis combing multivariable HRs with estimated HRs from Kaplan-Meier curves. Our results suggest that platinum-based AC is associated with improved DFS and a modest OS benefit in patients with locally advanced urothelial carcinomas.
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Carcinoma de Células Transicionales/tratamiento farmacológico , Quimioterapia Adyuvante/métodos , Compuestos de Platino/uso terapéutico , Neoplasias Urológicas/tratamiento farmacológico , Protocolos de Quimioterapia Combinada Antineoplásica/uso terapéutico , Carcinoma de Células Transicionales/mortalidad , Carcinoma de Células Transicionales/cirugía , Humanos , Estimación de Kaplan-Meier , Invasividad Neoplásica , Recurrencia Local de Neoplasia , Compuestos de Platino/administración & dosificación , Compuestos de Platino/efectos adversos , Análisis de Supervivencia , Neoplasias Urológicas/mortalidad , Neoplasias Urológicas/cirugíaRESUMEN
INTRODUCTION: Sacrocolpopexy (SC) is the main treatment option for the repair of anterior and apical pelvic organ prolapse (POP). Indications and technical aspects are not standardized, and the question remains whether it is necessary to place a mesh on both anterior and posterior vaginal walls, particularly in cases with only minor or no posterior compartment prolapse. The present study aimed to compare the anatomical and functional outcomes of single anterior mesh only versus anterior and posterior mesh procedures in SC. MATERIALS AND METHODS: Our prospectively maintained database on POP was used to identify patients who had undergone either abdominal or mini-invasive SC from January 2006 to October 2019. Patients with symptomatic or unmasked stress urinary incontinence (SUI) were not included in the study and were treated using the pubo-vaginal cystocele sling procedure. Objective outcomes included clinical evaluation of pre-existing or de novo POP by the halfway system and POP-q classifications, as well as the development of de novo SUI. Subjective outcomes were assessed using the Pelvic Floor Impact Questionnaire (PFIQ-7) with questions on bladder, bowel, and vaginal functions. Persistent or de novo constipation and overactive bladder were defined as bowel symptoms and urinary urgency/frequency/urinary incontinence after surgery. RESULTS: Ninety-five women with symptomatic anterior and apical POP underwent SC. Forty-one patients were treated with only anterior vaginal mesh (group A), and 54 with anterior and posterior mesh (group B). There were no differences between the pre- and post-operative characteristics of the 2 groups. In group B, there were 2 blood transfusions, 1 wound dehiscence, and 3 mesh erosions/extrusion after abdominal SC (Clavien-Dindo II), and in group A, there was 1 ileal lesion after laparoscopic SC (Clavien-Dindo III). There were no differences between the 2 groups in either anatomical or functional outcomes during 3 years of follow-up. CONCLUSIONS: SC with single anterior vaginal mesh has similar results to SC with combined anterior/posterior mesh, regardless of the surgical approach. The single anterior mesh may reduce the risk of complications (mesh erosion/extrusion), and offers better subjective outcomes with improved quality of life. Anterior/posterior mesh may be justified in the presence of clinically significant posterior POP.
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Prolapso de Órgano Pélvico , Incontinencia Urinaria de Esfuerzo , Femenino , Procedimientos Quirúrgicos Ginecológicos/efectos adversos , Procedimientos Quirúrgicos Ginecológicos/métodos , Humanos , Prolapso de Órgano Pélvico/cirugía , Calidad de Vida , Mallas Quirúrgicas/efectos adversos , Resultado del Tratamiento , Incontinencia Urinaria de Esfuerzo/complicaciones , Vagina/cirugíaRESUMEN
PURPOSE: To assess the role of the multiparametric Magnetic Resonance Imaging (mpMRI) in predicting the cribriform pattern in both the peripheral and transition zones (PZ and TZ) clinically significant prostate cancers (csPCas). MATERIAL AND METHODS: We retrospectively evaluated 150 patients who underwent radical prostatectomy for csPCa and preoperative mpMRI. Patients with negative (n = 25) and positive (n = 125) mpMRI, stratified according to the presence of prevalent cribriform pattern (PCP, ≥ 50%) and non-PCP (< 50%) at specimen, were included. Difference between the two groups were evaluated. Multivariate logistic regression was used to identify predictors of PCP among mpMRI parameters. The receiver operating characteristic (ROC) analysis was performed to evaluate the area under the curve (AUC) of apparent diffusion coefficient (ADC) and ADC ratio in detecting lesions harboring PCP. RESULTS: Considering 135 positive lesions at the mpMRI, 30 (22.2%) and 105 (77.8%) harbored PCP and non-PCP PCa. The PCP lesions had more frequently nodular morphology (83.3% vs 62.9%; p = 0.04) and significantly lower mean ADC value (0.87 ± 0.16 vs 0.95 ± 0.18; p = 0.03) and ADC ratio (0.52 ± 0.09 vs 0.60 ± 0.14; p = 0.003) when compared with non-PCP lesions. At univariate and multivariate analyses, mean ADC and ADC ratio resulted as independent predictors of the presence of the PCP of the PZ tumors(OR: 0.025; p = 0.03 and OR: 0.001; p = 0.004, respectively). At the ROC analysis, the AUC of mean ADC and ADC ratio to predict the presence of PCP in patients with PZ suspicious lesion at the mpMRI were 0.69 (95% CI 0.56-0.81P, p = 0.003) and 0.72 (95% CI 0.62-0.82P, p = 0.001), respectively. CONCLUSIONS: The mpMRI may correctly identify PCP tumors of the PZ and the mean ADC value and ADC ratio can predict the presence of the cribriform pattern in the PCa.
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Imágenes de Resonancia Magnética Multiparamétrica/métodos , Neoplasias de la Próstata/diagnóstico por imagen , Neoplasias de la Próstata/patología , Anciano , Humanos , Masculino , Persona de Mediana Edad , Próstata/diagnóstico por imagen , Próstata/patología , Próstata/cirugía , Prostatectomía , Neoplasias de la Próstata/cirugía , Estudios RetrospectivosRESUMEN
PURPOSE: To determine the clinical, pathological, and radiological features, including the Vesical Imaging-Reporting and Data System (VI-RADS) score, independently correlating with muscle-invasive bladder cancer (BCa), in a multicentric national setting. METHOD AND MATERIALS: Patients with BCa suspicion were offered magnetic resonance imaging (MRI) before trans-urethral resection of bladder tumor (TURBT). According to VI-RADS, a cutoff of ≥ 3 or ≥ 4 was assumed to define muscle-invasive bladder cancer (MIBC). Trans-urethral resection of the tumor (TURBT) and/or cystectomy reports were compared with preoperative VI-RADS scores to assess accuracy of MRI for discriminating between non-muscle-invasive versus MIBC. Performance was assessed by ROC curve analysis. Two univariable and multivariable logistic regression models were implemented including clinical, pathological, radiological data, and VI-RADS categories to determine the variables with an independent effect on MIBC. RESULTS: A final cohort of 139 patients was enrolled (median age 70 [IQR: 64, 76.5]). MRI showed sensitivity, specificity, PPV, NPV, and accuracy for MIBC diagnosis ranging from 83-93%, 80-92%, 67-81%, 93-96%, and 84-89% for the more experienced readers. The area under the curve (AUC) was 0.95 (0.91-0.99). In the multivariable logistic regression model, the VI-RADS score, using both a cutoff of 3 and 4 (P < .0001), hematuria (P = .007), tumor size (P = .013), and concomitant hydronephrosis (P = .027) were the variables correlating with a bladder cancer staged as ≥ T2. The inter-reader agreement was substantial (k = 0.814). CONCLUSIONS: VI-RADS assessment scoring proved to be an independent predictor of muscle-invasiveness, which might implicate a shift toward a more aggressive selection approach of patients' at high risk of MIBC, according to a novel proposed predictive pathway.
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Neoplasias de la Vejiga Urinaria , Anciano , Humanos , Imagen por Resonancia Magnética/métodos , Invasividad Neoplásica/patología , Estudios Prospectivos , Estudios Retrospectivos , Vejiga Urinaria , Neoplasias de la Vejiga Urinaria/diagnóstico por imagen , Neoplasias de la Vejiga Urinaria/cirugíaRESUMEN
PURPOSE: The conventional imaging flowchart for prostate cancer (PCa) staging may fail in correctly detecting lymph node metastases (LNM). Pelvic lymph node dissection (PLND) represents the only reliable method, although invasive. A new amino acid PET compound, [18F]-fluciclovine, was recently authorized in suspected PCa recurrence but not yet included in the standard staging work-up of primary PCa. A prospective monocentric study was designed to evaluate [18F]-fluciclovine PET/CT diagnostic performance for preoperative LN staging in primary high-risk PCa. METHODS: Consecutive patients (pts) with biopsy-proven PCa, standard staging (including [11C]choline PET/CT), eligible for PLND, were enrolled to undergo an investigational [18F]-fluciclovine PET/CT. Nodal uptake higher than surrounding background was reported by at least two readers (blinded to [11C]choline) using a visual 5-point scale (1-2 probably negative; 4-5 probably positive; 3 equivocal); SUVmax, target-to-background (aorta-A; bone marrow-BM) ratios (TBRs), were also calculated. PET results were validated with PLND. [18F]-fluciclovine PET/CT performance using visual score and semi-quantitative indexes was analyzed both per patient and per LN anatomical region, compared to conventional [11C]choline and clinical predictive factors (to note that diagnostic performance of [18F]-fluciclovine was explored for LNM but not examined for intrapelvic or extrapelvic M1 lesions). RESULTS: Overall, 94 pts underwent [18F]-fluciclovine PET/CT; 72/94 (77%) high-risk pts were included in the final analyses (22 pts excluded: 8 limited PLND; 3 intermediate-risk; 2 treated with radiotherapy; 4 found to be M1; 5 neoadjuvant hormonal therapy). Median LNM risk by Briganti nomogram was 19%. LNM confirmed on histology was 25% (18/72 pts). Overall, 1671 LN were retrieved; 45/1671 (3%) LNM detected. Per pt, median no. of removed LN was 22 (mean 23 ± 10; range 8-51), of LNM was 2 (mean 3 ± 2; range 1-10). Median LNM size was 5 mm (mean 5 ± 2.5; range 2-10). On patient-based analyses (n = 72), diagnostic performance for LNM resulted significant with [18F]-fluciclovine (AUC 0.66, p 0.04; 50% sensitivity, 81% specificity, 47% PPV, 83% NPV, 74% accuracy), but not with [11C]choline (AUC 0.60, p 0.2; 50%, 70%, 36%, 81%, and 65% respectively). Briganti nomogram (OR = 1.03, p = 0.04) and [18F]-fluciclovine visual score (≥ 4) (OR = 4.27, p = 0.02) resulted independent predictors of LNM at multivariable analyses. On region-based semi-quantitative analyses (n = 576), PET/CT performed better using TBR parameters (TBR-A similar to TBR-BM; TBR-A fluciclovine AUC 0.61, p 0.35, vs choline AUC 0.57 p 0.54; TBR-BM fluciclovine AUC 0.61, p 0.36, vs choline AUC 0.58, p 0.52) rather than using absolute LN SUVmax (fluciclovine AUC 0.51, p 0.91, vs choline AUC 0.51, p 0.94). However, in all cases, diagnostic performance was not statistically significant for LNM detection, although slightly in favor of the experimental tracer [18F]-fluciclovine for each parameter. On the contrary, visual interpretation significantly outperformed PET semi-quantitative parameters (choline and fluciclovine: AUC 0.65 and 0.64 respectively; p 0.03) and represents an independent predictive factor of LNM with both tracers, in particular [18F]-fluciclovine (OR = 8.70, p 0.002, vs OR = 3.98, p = 0.03). CONCLUSION: In high-risk primary PCa, [18F]-fluciclovine demonstrates some advantages compared with [11C]choline but sensitivity for metastatic LN detection is still inadequate compared to PLND. Visual (combined morphological and functional), compared to semi-quantitative assessment, is promising but relies mainly on readers' experience rather than on unquestionable LN avidity. TRIAL REGISTRATION: EudraCT number: 2014-003,165-15.
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Tomografía Computarizada por Tomografía de Emisión de Positrones , Neoplasias de la Próstata , Colina , Humanos , Metástasis Linfática , Masculino , Estadificación de Neoplasias , Estudios Prospectivos , Neoplasias de la Próstata/diagnóstico por imagen , Neoplasias de la Próstata/patologíaRESUMEN
BACKGROUND: Bladder cancer is the ninth most common type of cancer worldwide. In the past, radical cystectomy via open surgery has been considered the gold-standard treatment for muscle invasive bladder cancer. However, in recent years there has been a progressive increase in the use of robot-assisted laparoscopic radical cystectomy. The aim of the current project is to investigate the surgical, oncological, and functional outcomes of patients with bladder cancer who undergo radical cystectomy comparing three different surgical techniques (robotic-assisted, laparoscopic, and open surgery). Pre-, peri- and post-operative factors will be examined, and participants will be followed for a period of up to 24 months to identify risks of mortality, oncological outcomes, hospital readmission, sexual performance, and continence. METHODS: We describe a protocol for an observational, prospective, multicenter, cohort study to assess patients affected by bladder neoplasms undergoing radical cystectomy and urinary diversion. The Italian Radical Cystectomy Registry is an electronic registry to prospectively collect the data of patients undergoing radical cystectomy conducted with any technique (open, laparoscopic, robotic-assisted). Twenty-eight urology departments across Italy will provide data for the study, with the recruitment phase between 1st January 2017-31st October 2020. Information is collected from the patients at the moment of surgical intervention and during follow-up (3, 6, 12, and 24 months after radical cystectomy). Peri-operative variables include surgery time, type of urinary diversion, conversion to open surgery, bleeding, nerve sparing and lymphadenectomy. Follow-up data collection includes histological information (e.g., post-op staging, grading, and tumor histology), short- and long-term outcomes (e.g., mortality, post-op complications, hospital readmission, sexual potency, continence etc). DISCUSSION: The current protocol aims to contribute additional data to the field concerning the short- and long-term outcomes of three different radical cystectomy surgical techniques for patients with bladder cancer, including open, laparoscopic, and robot-assisted. This is a comparative-effectiveness trial that takes into account a complex range of factors and decision making by both physicians and patients that affect their choice of surgical technique. TRIAL REGISTRATION: ClinicalTrials.gov , NCT04228198 . Registered 14th January 2020- Retrospectively registered.
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Cistectomía/métodos , Laparoscopía/métodos , Escisión del Ganglio Linfático/métodos , Procedimientos Quirúrgicos Robotizados/métodos , Neoplasias de la Vejiga Urinaria/cirugía , Adolescente , Adulto , Anciano , Anciano de 80 o más Años , Femenino , Estudios de Seguimiento , Humanos , Italia , Masculino , Persona de Mediana Edad , Estudios Multicéntricos como Asunto , Ensayos Clínicos Controlados no Aleatorios como Asunto , Pronóstico , Estudios Prospectivos , Sistema de Registros , Proyectos de Investigación , Factores de Riesgo , Neoplasias de la Vejiga Urinaria/patología , Adulto JovenRESUMEN
Renal cell carcinoma (RCC) scenario has radically changed with the advent of immunotherapy; in this setting, the identification of predictive and prognostic factors represents an urgent clinical need to evaluate which patients are the best candidate for an immunotherapy approach. The aim of our study was to analyze the association between nivolumab in pretreated patients with metastatic RCC and clinicopathological features, metastatic sites, and clinical outcomes. A total of 37 patients treated between January 2017 and April 2020 in our institution were retrospectively evaluated. All patients received nivolumab as second- or later-line of therapy after progression on previous tyrosine kinase inhibitors. The primary outcomes were overall survival (OS) from immunotherapy start and OS from first-line start. Univariate analysis was performed through the log-rank test and a Cox regression proportional hazards model was employed in multivariable analysis. Of the 12 variables analyzed, 4 were significantly associated with prognoses at multivariate analysis. Cox proportional hazard ratio models confirmed that International Metastatic Renal-Cell Carcinoma Database Consortium (IMDC) risk group, liver metastases at diagnosis, and central nervous system (CNS) metastases at diagnosis were associated with worse OS with an estimated hazard ratio of 4.76 [95% confidence interval (CI), 2.05-19.8] for liver metastases and 2.27 (95% CI, 1.13-28.9) for CNS metastases. Pancreatic metastases at diagnosis were correlated to a better prognosis with an estimated hazard ratio of 0.15 (95% CI, 0.02-0.38). IMDC risk group, liver metastases at diagnosis, and CNS metastases at diagnosis may identify a population of patients treated with immunotherapy in second- or later-line associated with worse prognosis.
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Antineoplásicos Inmunológicos/uso terapéutico , Carcinoma de Células Renales/secundario , Neoplasias Renales/patología , Nivolumab/uso terapéutico , Adulto , Anciano , Anciano de 80 o más Años , Carcinoma de Células Renales/tratamiento farmacológico , Carcinoma de Células Renales/inmunología , Femenino , Estudios de Seguimiento , Humanos , Neoplasias Renales/tratamiento farmacológico , Neoplasias Renales/inmunología , Masculino , Persona de Mediana Edad , Pronóstico , Estudios Retrospectivos , Tasa de Supervivencia , Adulto JovenRESUMEN
OBJECTIVE: To describe the trend in surgical volume in urology in Italy during the coronavirus disease 2019 (COVID-19) outbreak, as a result of the abrupt reorganisation of the Italian national health system to augment care provision to symptomatic patients with COVID-19. METHODS: A total of 33 urological units with physicians affiliated to the AGILE consortium (Italian Group for Advanced Laparo-Endoscopic Surgery; www.agilegroup.it) were surveyed. Urologists were asked to report the amount of surgical elective procedures week-by-week, from the beginning of the emergency to the following month. RESULTS: The 33 hospitals involved in the study account overall for 22 945 beds and are distributed in 13/20 Italian regions. Before the outbreak, the involved urology units performed overall 1213 procedures/week, half of which were oncological. A month later, the number of surgeries had declined by 78%. Lombardy, the first region with positive COVID-19 cases, experienced a 94% reduction. The decrease in oncological and non-oncological surgical activity was 35.9% and 89%, respectively. The trend of the decline showed a delay of roughly 2 weeks for the other regions. CONCLUSION: Italy, a country with a high fatality rate from COVID-19, experienced a sudden decline in surgical activity. This decline was inversely related to the increase in COVID-19 care, with potential harm particularly in the oncological field. The Italian experience may be helpful for future surgical pre-planning in other countries not so drastically affected by the disease to date.
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COVID-19/epidemiología , Pandemias , SARS-CoV-2 , Enfermedades Urológicas/cirugía , Procedimientos Quirúrgicos Urológicos/estadística & datos numéricos , Comorbilidad , Procedimientos Quirúrgicos Electivos , Humanos , Italia/epidemiología , Encuestas y Cuestionarios , Enfermedades Urológicas/epidemiologíaRESUMEN
BACKGROUND: Aim of this study was to evaluate and compare perioperative outcomes of transperitoneal (TP) and retroperitoneal (TR) approaches in a multi-institutional cohort of minimally invasive partial nephrectomy (MI-PN). MATERIAL AND METHODS: All consecutive patients undergone MI-PN for clinical T1 renal tumors at 26 Italian centers (RECORd2 project) between 01/2013 and 12/2016 were evaluated, collecting the pre-, intra-, and postoperative data. The patients were then stratified according to the surgical approach, TP or RP. A 1:1 propensity score (PS) matching was performed to obtain homogeneous cohorts, considering the age, gender, baseline eGFR, surgical indication, clinical diameter, and PADUA score. RESULTS: 1669 patients treated with MI-PN were included in the study, 1256 and 413 undergoing TP and RP, respectively. After 1:1 PS matching according to the surgical access, 413 patients were selected from TP group to be compared with the 413 RP patients. Concerning intraoperative variables, no differences were found between the two groups in terms of surgical approach (lap/robot), extirpative technique (enucleation vs standard PN), hilar clamping, and ischemia time. Conversely, the TP group recorded a shorter median operative time in comparison with the RP group (115 vs 150 min), with a higher occurrence of intraoperative overall, 21 (5.0%) vs 9 (2.1%); p = 0.03, and surgical complications, 18 (4.3%) vs 7 (1.7%); p = 0.04. Concerning postoperative variables, the two groups resulted comparable in terms of complications, positive surgical margins and renal function, even if the RP group recorded a shorter median drainage duration and hospital length of stay (3 vs 2 for both variables), p < 0.0001. CONCLUSIONS: The results of this study suggest that both TP and RP are feasible approaches when performing MI-PN, irrespectively from tumor location or surgical complexity. Notwithstanding longer operative times, RP seems to have a slighter intraoperative complication rate with earlier postoperative recovery when compared with TP.
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Neoplasias Renales , Laparoscopía , Estudios de Seguimiento , Humanos , Neoplasias Renales/cirugía , Nefrectomía , Tempo Operativo , Espacio Retroperitoneal/cirugía , Estudios Retrospectivos , Resultado del TratamientoRESUMEN
PURPOSE: We evaluated possible factors predicting testicular cancer in patients undergoing testis sparing surgery. MATERIALS AND METHODS: We retrospectively analyzed the records of all patients who underwent testis sparing surgery for a small testicular mass at a total of 5 centers. All patients with 1 solitary lesion 2 cm or less on preoperative ultrasound were enrolled in the study. Testis sparing surgery consisted of tumor enucleation for frozen section examination. Immediate radical orchiectomy was performed in all cases of malignancy at frozen section examination but otherwise the testes were spared. Univariate and multivariate analysis were performed and ROC curves were produced to evaluate preoperative factors predicting testicular cancer. RESULTS: Overall 147 patients were included in the study. No patient had elevated serum tumor markers. Overall 21 of the 147 men (14%) presented with testicular cancer. On multivariate analysis the preoperative ultrasound diameter of the lesion was a predictor of malignancy (OR 6.62, 95% CI 2.26-19.39, p=0.01). On ROC analysis lesion diameter had an AUC of 0.75 (95% CI 0.63-0.86, p=0.01) to predict testicular cancer. At the best cutoff of 0.85 the diameter of the lesion had 81% sensitivity, 58% specificity, 24% positive predictive value and 95% negative predictive value. CONCLUSIONS: Our study confirms that small testicular masses are often benign and do not always require radical orchiectomy. Preoperative ultrasound can assess lesion size and the smaller the nodule, the less likely that it is malignant. Therefore, we suggest a stepwise approach to small testicular masses, including tumorectomy, frozen section examination and radical orchiectomy or testis sparing surgery according to frozen section examination results.
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Orquiectomía/métodos , Tratamientos Conservadores del Órgano/métodos , Neoplasias Testiculares/cirugía , Testículo/patología , Adulto , Biomarcadores de Tumor/sangre , Secciones por Congelación , Humanos , Masculino , Selección de Paciente , Periodo Preoperatorio , Curva ROC , Estudios Retrospectivos , Medición de Riesgo/métodos , Neoplasias Testiculares/sangre , Neoplasias Testiculares/diagnóstico , Neoplasias Testiculares/patología , Testículo/diagnóstico por imagen , Testículo/cirugía , Carga Tumoral , UltrasonografíaRESUMEN
OBJECTIVE: The objective of this study was to develop a clinical nomogram to predict gallium-68 prostate-specific membrane antigen positron emission tomography/computed tomography (68Ga-PSMA-11-PET/CT) positivity in different clinical settings of PSA failure. MATERIALS AND METHODS: Seven hundred three (n = 703) prostate cancer (PCa) patients with confirmed PSA failure after radical therapy were enrolled. Patients were stratified according to different clinical settings (first-time biochemical recurrence [BCR]: group 1; BCR after salvage therapy: group 2; biochemical persistence after radical prostatectomy [BCP]: group 3; advanced-stage PCa before second-line systemic therapies: group 4). First, we assessed 68Ga-PSMA-11-PET/CT positivity rate. Second, multivariable logistic regression analyses were used to determine predictors of positive scan. Third, regression-based coefficients were used to develop a nomogram predicting positive 68Ga-PSMA-11-PET/CT result and 200 bootstrap resamples were used for internal validation. Fourth, receiver operating characteristic (ROC) analysis was used to identify the most informative nomogram's derived cutoff. Decision curve analysis (DCA) was implemented to quantify nomogram's clinical benefit. RESULTS: 68Ga-PSMA-11-PET/CT overall positivity rate was 51.2%, while it was 40.3% in group 1, 54% in group 2, 60.5% in group 3, and 86.9% in group 4 (p < 0.001). At multivariable analyses, ISUP grade, PSA, PSA doubling time, and clinical setting were independent predictors of a positive scan (all p ≤ 0.04). A nomogram based on covariates included in the multivariate model demonstrated a bootstrap-corrected accuracy of 82%. The nomogram-derived best cutoff value was 40%. In DCA, the nomogram revealed clinical net benefit of > 10%. CONCLUSIONS: This novel nomogram proved its good accuracy in predicting a positive scan, with values ≥ 40% providing the most informative cutoff in counselling patients to 68Ga-PSMA-11-PET/CT. This tool might be important as a guide to clinicians in the best use of PSMA-based PET imaging.
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Tomografía Computarizada por Tomografía de Emisión de Positrones , Neoplasias de la Próstata , Ácido Edético/análogos & derivados , Isótopos de Galio , Radioisótopos de Galio , Humanos , Masculino , Nomogramas , Oligopéptidos , Antígeno Prostático Específico , Neoplasias de la Próstata/diagnóstico por imagen , Neoplasias de la Próstata/cirugíaRESUMEN
PURPOSE: To perform an external validation of a recently published nomogram aimed to predict positive 68Ga-PSMA-11 PET/CT in patients with biochemical recurrence (BCR) after radical prostatectomy (RP) by Rauscher et al. (Eur Urol 73(5):656-661, 2018). METHODS: Overall, 413 PCa patients with BCR after RP (two consecutive PSA ≥ 0.2 ng/ml) and PSA value between 0.2 and 1 ng/ml were included. A multivariable logistic regression model was produced to assess the predictors of positive 68Ga-PSMA-11 PET/CT results. The performance characteristics of the model were assessed by quantifying the predictive accuracy, according to model calibration. Yuden's index was used to find the best nomogram's cut-off. Finally, decision curve analysis (DCA) was implemented to quantify the nomogram's clinical value. RESULTS: In the external cohort, the overall detection rate of 68Ga-PSMA-11 PET/CT was 44% vs. 64.7% in the original population. At multivariate analysis, PSA at 68Ga-PSMA-11 PET/CT (OR: 7.06, p < 0.001) and ongoing ADT at time of 68Ga-PSMA-11 PET/CT (OR: 2.07, p = 0.03) were the only independent predictors of PET/CT positivity. The predictive accuracy of nomogram was suboptimal and comparable to that reported in the original model (64% vs. 67%, respectively). The calibration plot indicated suboptimal concordance. The best nomogram's cut-off to predict positive 68Ga-PSMA-11 PET/CT was 35% (AUC = 0.61). In DCA, the nomogram revealed clinical net benefit when the threshold probabilities of positive 68Ga-PSMA-11 PET/CT is > 35%. CONCLUSION: We assessed similar suboptimal predictive accuracies in the external cohort compared to the original one. PSA and ongoing ADT were confirmed as positive predictors, and the most informative nomogram cut-off resulted 35%.
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Tomografía Computarizada por Tomografía de Emisión de Positrones , Neoplasias de la Próstata , Ácido Edético/análogos & derivados , Isótopos de Galio , Radioisótopos de Galio , Humanos , Masculino , Recurrencia Local de Neoplasia , Nomogramas , Oligopéptidos , Antígeno Prostático Específico , Neoplasias de la Próstata/diagnóstico por imagen , Neoplasias de la Próstata/cirugíaRESUMEN
OBJECTIVES: To compare overall (OS), cancer-specific (CSS), recurrence-free survival (RFS) and postoperative renal function amongst patients with upper tract urothelial carcinoma (UTUC) of the distal (lower lumbar and pelvic) ureter, electively treated with segmental resection and termino-terminal anastomosis (TT) vs bladder cuff removal and ureteric re-implantation (RR). PATIENTS AND METHODS: A multicentre retrospective study, including 84 patients diagnosed with UTUC of the distal ureter and treated with TT or RR, is presented. The primary endpoint was to compare TT and RR in terms of OS, CSS and RFS. As a secondary outcome, we compared the postoperative creatinine values as an index of renal function in the two groups. RESULTS: Of 521 patients with UTUC, 65 (77.4%) and 19 (22.6%) patients underwent RR and TT, respectively. Pre- and postoperative characteristics were not statistically different between the two groups. The median follow-up period was 22.7 months. Patients treated with TT and those treated with RR did not have significantly different 5-year OS, CSS or RFS (73.7% vs 92.3%, P = 0.052; 94.7% vs 95.4%, P = 0.970: and 63.2% vs 53.9%, P = 0.489, respectively). No difference in postoperative creatinine variation emerged in association with the surgical technique (P = 0.411). CONCLUSION: Patients treated with TT or RR for UTUC showed comparable OS, CSS, RFS and postoperative renal function. Our data suggest that bladder cuff removal is not imperative in the treatment of distal ureteric UTUC, and TT can be a safe solution in selected cases.
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Carcinoma in Situ/cirugía , Reimplantación/métodos , Uréter/cirugía , Neoplasias Ureterales/cirugía , Vejiga Urinaria/cirugía , Anastomosis Quirúrgica , Biomarcadores de Tumor/metabolismo , Creatinina/metabolismo , Supervivencia sin Enfermedad , Femenino , Humanos , Italia/epidemiología , Masculino , Persona de Mediana Edad , Estudios Retrospectivos , Resultado del Tratamiento , Neoplasias Ureterales/mortalidadRESUMEN
OBJECTIVE: To identify meaningful predictors and to develop a nomogram of postoperative surgical complications in patients treated with partial nephrectomy (PN). PATIENTS AND METHODS: We prospectively evaluated 4308 consecutive patients who had surgical treatment for renal tumours, between 2013 and 2016, at 26 Italian urological centres (RECORd 2 project). A multivariable logistic regression for surgical complications was performed. A nomogram was created from the multivariable model. Internal validation processes were performed using bootstrapping with 1000 repetitions. RESULTS: Overall, 2584 patients who underwent PN were evaluated for the final analyses. The median (interquartile [IQR]) American Society of Anesthesiologists (ASA) score was 2 (2-3). In all, 72.4% of patients had clinical T1a (cT1a) stage tumours. The median (IQR) Preoperative Aspects and Dimensions Used for an Anatomical (PADUA) score was 7 (6-8). Overall, 34.3%, 27.7%, 38% of patients underwent open PN (OPN), laparoscopic PN (LPN), and robot-assisted PN (RAPN). Overall and major postoperative surgical complications were recorded in 10.2% and 2.5% of patients, respectively. At multivariable analysis, age, ASA score, cT2 vs cT1a stage, PADUA score, preoperative anaemia, OPN and LPN vs RAPN, were significant predictive factors of postoperative surgical complications. We used these variables to construct a nomogram for predicting the risk of postoperative surgical complications. At decision curve analysis, the nomogram led to superior outcomes for any decision associated with a threshold probability of >5%. CONCLUSION: Several clinical predictors have been associated with postoperative surgical complications after PN. We used this information to develop and internally validate a nomogram to predict such risk.