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1.
Prostate ; 83(13): 1238-1246, 2023 09.
Artigo em Inglês | MEDLINE | ID: mdl-37290911

RESUMO

PURPOSE: To investigate the conditional overall survival (OS) of metastatic castration-resistant prostate cancer (mCRPC) patients receiving docetaxel chemotherapy. METHODS: We used deidentified patient-level data from the Prostate Cancer DREAM Challenge database and the control arm of the ENTHUSE 14 trial. We identified 2158 chemonaïve mCRPC patients undergoing docetaxel chemotherapy in the five randomized clinical trials. The 6-month conditional OS was calculated at times 0, 6, 12, 18, and 24 months from randomization. Survival curves of each group were compared using the log-rank test. Patients were then stratified into low- and high-risk groups based on the median predicted value of our recently published nomogram predicting OS in mCRPC patients. RESULTS: Nearly half (45%) of the study population was aged between 65 and 74 years. Median interquartile range prostate-specific antigen for the overall cohort was 83.2 (29.6-243) ng/mL, and 59% of patients had bone metastasis with or without lymph node involvement. The 6-month conditional survival rates at 0, 6, 12, 18, and 24 months for the entire cohort were 93% (95% confidence interval [CI]: 92-94), 82% (95% CI: 81-84), 76% (95% CI: 73-78), 75% (95% CI: 71-78), and 71% (95% CI: 65-76). These rates were, respectively, 96% (95% CI: 95-97), 92% (95% CI: 90-93), 84% (95% CI: 81-87), 81% (95% CI: 77-85), and 79% (95% CI: 72-84) in the low-risk group and 89% (95% CI: 87-91), 73% (95% CI: 70-76), 65% (95% CI: 60-69), 64% (95% CI: 58-70), and 58% (95% CI: 47-67) in the high-risk group. CONCLUSION: The conditional OS for patients undergoing docetaxel chemotherapy tends to plateau over time, with the main drop in conditional OS happening during the first year from initiating docetaxel treatment. That is the longer a patient survives, the more likely they are to survive further. This prognostic information could be a useful tool for a more accurate tailoring of both follow-up and therapies. PATIENT SUMMARY: In this report, we looked at the future survival in months of patients with metastatic castration resistant prostate cancer on chemotherapy who have already survived a certain period. We found that the longer time that a patient survives, the more likely they will continue to survive. We conclude that this information will help physicians tailor follow-ups and treatments for patients for a more accurate personalized medicine.


Assuntos
Neoplasias de Próstata Resistentes à Castração , Idoso , Humanos , Masculino , Protocolos de Quimioterapia Combinada Antineoplásica/uso terapêutico , Docetaxel/uso terapêutico , Prognóstico , Antígeno Prostático Específico/uso terapêutico , Neoplasias de Próstata Resistentes à Castração/patologia , Taxoides/uso terapêutico , Resultado do Tratamento
2.
World J Urol ; 41(10): 2647-2657, 2023 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-37552265

RESUMO

PURPOSE: Metaverse is becoming an alternative world in which technology and virtual experiences are mixed with real life, and it holds the promise of changing our way of living. Healthcare is already changing thanks to Metaverse and its numerous applications. In particular, Urology and urologic patients can benefit in many ways from Metaverse. METHODS: A non-systematic literature review identified recently published studies dealing with Metaverse. The database used for this review was PubMed, and the identified studies served as the base for a narrative analysis of the literature that explored the use of Metaverse in Urology. RESULTS: Virtual consultations can enhance access to care and reduce distance and costs, and pain management and rehabilitation can find an incredible support in virtual reality, reducing anxiety and stress and improving adherence to therapy. Metaverse has the biggest potential in urologic surgery, where it can revolutionize both surgery planning, with 3D modeling and virtual surgeries, and intraoperatively, with augmented reality and artificial intelligence. Med Schools can implement Metaverse in anatomy and surgery lectures, providing an immersive environment for learning, and residents can use this platform for learning in a safe space at their own pace. However, there are also potential challenges and ethical concerns associated with the use of the metaverse in healthcare. CONCLUSIONS: This paper provides an overview of the concept of the metaverse, its potential applications, challenges, and opportunities, and discusses the implications of its development in Urology.


Assuntos
Realidade Aumentada , Urologia , Humanos , Inteligência Artificial , Ansiedade , Bases de Dados Factuais
3.
World J Urol ; 41(4): 1025-1031, 2023 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-36754878

RESUMO

OBJECTIVES: To determine the incidence of preexisting opioid dependence in patients undergoing elective urological oncological surgery. In addition, to quantify the impact of preexisting opioid dependence on outcomes and cost of common urologic oncological procedures at a national level in the USA. METHODS: We used the National Inpatient Sample (NIS) to study 1,609,948 admissions for elective partial/radical nephrectomy, radical prostatectomy, and cystectomy procedures. Trends of preexisting opioid dependence were studied over 2003-2014. We use multivariable-adjusted analysis to compare opioid-dependent patients to those without opioid dependence (reference group) in terms of outcomes, namely major complications, length of stay (LOS), and total cost. RESULTS: The incidence of opioid dependence steadily increased from 0.6 per 1000 patients in 2003 to 2 per 1000 in 2014. Opioid-dependent patients had a significantly higher rate of major complications (18 vs 10%; p < 0.001) and longer LOS (4 days (IQR 2-7) vs 2 days (IQR 1-4); p < 0.001), when compared to the non-opioid-dependent counterparts. Opioid dependence also increased the overall cost by 48% (adjusted median cost $18,290 [IQR 12,549-27,715] vs. $12,383 [IQR 9225-17,494] in non-opioid-dependent, p < 0.001). Multivariable analysis confirmed the independent association of preexisting opioid dependence with major complications, length of stay in 4th quartile, and total cost in 4th quartile. CONCLUSIONS: The incidence of preexisting opioid dependence before elective urological oncology is increasing and is associated with adverse outcomes after surgery. There is a need to further understand the challenges associated with opioid dependence before surgery and identify and optimize these patients to improve outcomes.


Assuntos
Pacientes Internados , Transtornos Relacionados ao Uso de Opioides , Masculino , Humanos , Tempo de Internação , Complicações Pós-Operatórias/epidemiologia , Complicações Pós-Operatórias/etiologia , Estudos Retrospectivos , Transtornos Relacionados ao Uso de Opioides/epidemiologia , Transtornos Relacionados ao Uso de Opioides/complicações , Analgésicos Opioides/uso terapêutico , Incidência
4.
World J Urol ; 41(11): 3239-3247, 2023 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-37079076

RESUMO

PURPOSE: It is still not clear the role of perilesional biopsy (PL) and the extension of the random biopsy (RB) scheme to be adopted during mpMRI-guided ultrasound fusion biopsy (FB). To evaluate the increase in diagnostic accuracy achieved by PL and different RB schemes over target biopsy (TB). METHODS: We collected prospectively 168 biopsy-naïve patients with positive mpMRI receiving FB and concurrent 24-core RB. The diagnostic yields of the different possible biopsy schemes (TB only; TB + 4 PL cores; TB + 12-core RB; TB + 24-core RB) were compared by the McNemar test. Clinically significant (CS) prostate cancer (PCA) was defined according to the definition of the PROMIS trial. Regression analyses were used to identify independent predictors of the presence of any cancer, csPCA. RESULTS: The detection rate of CS cancers increased to 35%, 45%, and 49% by adding 4 PL cores, 12, and 24 RB cores, respectively (all p < 0.02). Notably, the largest scheme including 3 TB and 24 RB cores identified a small but statistically significant 4% increase in detection rate of CS cancer, as compared with the second largest scheme. TB alone identified only 62% of the CS cancers. Such figure increased to 72% by adding 4 PL cores, and to 91% by adding 14 RB cores. CONCLUSIONS: We found that PL biopsy increased the detection rate of CS cancers as compared with TB alone. However, the combination of those cores missed about 30% of the CS cancers identified with larger RB cores, notably including a considerable 15% of cases located contralaterally to the index tumor.


Assuntos
Imageamento por Ressonância Magnética Multiparamétrica , Neoplasias da Próstata , Masculino , Humanos , Neoplasias da Próstata/diagnóstico por imagem , Neoplasias da Próstata/patologia , Próstata/diagnóstico por imagem , Próstata/patologia , Biópsia Guiada por Imagem , Ultrassonografia , Imageamento por Ressonância Magnética , Ultrassonografia de Intervenção
5.
World J Urol ; 41(11): 3357-3366, 2023 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-37755520

RESUMO

OBJECTIVE: To evaluate the proportions of detected prostate cancer (PCa) and clinically significant PCa (csPCa), as well as identify clinical predictors of PCa, in patients with PI-RADS > = 3 lesion at mpMRI and initial negative targeted and systematic biopsy (initial biopsy) who underwent a second MRI and a re-biopsy. METHODS: A total of 290 patients from 10 tertiary referral centers were included. The primary outcome measures were the presence of PCa and csPCa at re-biopsy. Logistic regression analyses were performed to evaluate predictors of PCa and csPCa, adjusting for relevant covariates. RESULTS: Forty-two percentage of patients exhibited the presence of a new lesion. Furthermore, at the second MRI, patients showed stable, upgrading, and downgrading PI-RADS lesions in 42%, 39%, and 19%, respectively. The interval from the initial to repeated mpMRI and from the initial to repeated biopsy was 16 mo (IQR 12-20) and 18 mo (IQR 12-21), respectively. One hundred and eight patients (37.2%) were diagnosed with PCa and 74 (25.5%) with csPCa at re-biopsy. The presence of ASAP on the initial biopsy strongly predicted the presence of PCa and csPCa at re-biopsy. Furthermore, PI-RADS scores at the first and second MRI and a higher number of systematic biopsy cores at first and second biopsy were independent predictors of the presence of PCa and csPCa. Selection bias cannot be ruled out. CONCLUSIONS: Persistent PI-RADS ≥ 3 at the second MRI is suggestive of the presence of a not negligible proportion of csPca. These findings contribute to the refinement of risk stratification for men with initial negative MRI-TBx.


Assuntos
Imageamento por Ressonância Magnética Multiparamétrica , Neoplasias da Próstata , Masculino , Humanos , Imageamento por Ressonância Magnética , Neoplasias da Próstata/diagnóstico por imagem , Neoplasias da Próstata/patologia , Biópsia Guiada por Imagem , Centros de Atenção Terciária , Estudos Retrospectivos
6.
Eur Radiol ; 33(10): 7199-7208, 2023 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-37079030

RESUMO

AIM: To study the feasibility of radiomic analysis of baseline [18F]fluoromethylcholine positron emission tomography/computed tomography (PET/CT) for the prediction of biochemical recurrence (BCR) in a cohort of intermediate and high-risk prostate cancer (PCa) patients. MATERIAL AND METHODS: Seventy-four patients were prospectively collected. We analyzed three prostate gland (PG) segmentations (i.e., PGwhole: whole PG; PG41%: prostate having standardized uptake value - SUV > 0.41*SUVmax; PG2.5: prostate having SUV > 2.5) together with three SUV discretization steps (i.e., 0.2, 0.4, and 0.6). For each segmentation/discretization step, we trained a logistic regression model to predict BCR using radiomic and/or clinical features. RESULTS: The median baseline prostate-specific antigen was 11 ng/mL, the Gleason score was > 7 for 54% of patients, and the clinical stage was T1/T2 for 89% and T3 for 9% of patients. The baseline clinical model achieved an area under the receiver operating characteristic curve (AUC) of 0.73. Performances improved when clinical data were combined with radiomic features, in particular for PG2.5 and 0.4 discretization, for which the median test AUC was 0.78. CONCLUSION: Radiomics reinforces clinical parameters in predicting BCR in intermediate and high-risk PCa patients. These first data strongly encourage further investigations on the use of radiomic analysis to identify patients at risk of BCR. CLINICAL RELEVANCE STATEMENT: The application of AI combined with radiomic analysis of [18F]fluoromethylcholine PET/CT images has proven to be a promising tool to stratify patients with intermediate or high-risk PCa in order to predict biochemical recurrence and tailor the best treatment options. KEY POINTS: • Stratification of patients with intermediate and high-risk prostate cancer at risk of biochemical recurrence before initial treatment would help determine the optimal curative strategy. • Artificial intelligence combined with radiomic analysis of [18F]fluorocholine PET/CT images allows prediction of biochemical recurrence, especially when radiomic features are complemented with patients' clinical information (highest median AUC of 0.78). • Radiomics reinforces the information of conventional clinical parameters (i.e., Gleason score and initial prostate-specific antigen level) in predicting biochemical recurrence.


Assuntos
Tomografia por Emissão de Pósitrons combinada à Tomografia Computadorizada , Neoplasias da Próstata , Masculino , Humanos , Tomografia por Emissão de Pósitrons combinada à Tomografia Computadorizada/métodos , Antígeno Prostático Específico , Inteligência Artificial , Neoplasias da Próstata/diagnóstico por imagem , Neoplasias da Próstata/terapia , Estudos Retrospectivos
7.
Prostate ; 82(13): 1293-1303, 2022 09.
Artigo em Inglês | MEDLINE | ID: mdl-35790016

RESUMO

PURPOSE: Generalizable, updated, and easy-to-use prognostic models for patients with metastatic castration-resistant prostate cancer (mCRPC) are lacking. We developed a nomogram predicting the overall survival (OS) of mCRPC patients receiving standard chemotherapy using data from five randomized clinical trials (RCTs). METHODS: Patients enrolled in the control arm of five RCTs (ASCENT 2, VENICE, CELGENE/MAINSAIL, ENTHUSE 14, and ENTHUSE 33) were randomly split between training (n = 1636, 70%) and validation cohorts (n = 700, 30%). In the training cohort, Cox regression tested the prognostic significance of all available variables as a predictor of OS. Independent predictors of OS on multivariable analysis were used to construct a novel multivariable model (nomogram). The accuracy of this model was tested in the validation cohort using time-dependent area under the curve (tAUC) and calibration curves. RESULTS: Most of the patients were aged 65-74 years (44.5%) and the median (interquartile range) follow-up time was 13.9 (8.9-20.2) months. At multivariable analysis, the following were independent predictors of OS in mCRPC patients: sites of metastasis (visceral vs. bone metastasis, hazard ratio [HR]: 1.24), prostate-specific antigen (HR: 1.00), aspartate transaminase (HR: 1.01), alkaline phosphatase (HR: 1.00), body mass index (HR: 0.97), and hemoglobin (≥13 g/dl vs. <11 g/dl, HR: 0.41; all p < 0.05). A nomogram based on these variables was developed and showed favorable discrimination (tAUC at 12 and 24 months: 73% and 72%, respectively) and calibration characteristics on external validation. CONCLUSION: A new prognostic model to predict OS of patients with mCRPC undergoing first line chemotherapy was developed. This can help urologists/oncologists in counseling patients and might be useful to better stratify patients for future clinical trials.


Assuntos
Neoplasias de Próstata Resistentes à Castração , Idoso , Estudos de Coortes , Humanos , Masculino , Prognóstico , Neoplasias de Próstata Resistentes à Castração/tratamento farmacológico , Neoplasias de Próstata Resistentes à Castração/patologia , Ensaios Clínicos Controlados Aleatórios como Assunto , Análise de Sobrevida
8.
J Urol ; 208(4): 830-837, 2022 10.
Artigo em Inglês | MEDLINE | ID: mdl-36082555

RESUMO

PURPOSE: Our aim was to evaluate whether transperineal (TP) MRI-targeted prostate biopsy (TBx) may improve the detection of clinically significant prostate cancer (csPCa), defined as International Society of Urological Pathology ≥2, in comparison to transrectal (TR) TBx. MATERIALS AND METHODS: A multicenter retrospective cohort study comprising patients who underwent MRI-guided prostate biopsy was conducted. To address possible benefits of TP-TBx in the detection of prostate cancer (PCa) and csPCa, a cohort of patients undergoing TP-TBx were compared to patients undergoing TR-TBx. Multivariable logistic regression analyses were performed to assess predictors of PCa and csPCa detection. RESULTS: Overall, 1,936 and 3,305 patients who underwent TR-TBx vs TP-TBx at 10 referral centers were enrolled. The rate of PCa and csPCa diagnosed was higher for TP-TBx vs TR-TBx (64.0% vs 50%, p <0.01 and 49% vs 35%, p <0.01). At multivariable analysis adjusted for age, biopsy naïve/repeated biopsy, cT stage, Prostate Imaging-Reporting and Data System®, prostate volume, PSA, and number of biopsy cores targeted, TP-TBx was an independent predictor of PCa (odds ratio [OR] 1.37, 95% CI 1.08-1.72) and csPCa (1.19, 95% CI 1.12-1.50). When considering the approach according to the site of the index lesion, TP-TBx had a significantly higher likelihood than TR-TBx to detect csPCa in the apex (OR 4.81, 95% CI 1.03-6.27), transition/central zone (OR 2.67, 95% CI 1.42-5.00), and anterior zone (OR 5.62, 95% CI 1.74-8.13). CONCLUSIONS: The use of TP-TBx allows a better cancer grade definition and PCa risk assessment. This has important implication in the decision-making process and in patient counseling for further therapies.


Assuntos
Neoplasias da Próstata , Urologia , Humanos , Biópsia Guiada por Imagem , Imageamento por Ressonância Magnética , Masculino , Próstata/diagnóstico por imagem , Próstata/patologia , Neoplasias da Próstata/diagnóstico por imagem , Neoplasias da Próstata/patologia , Estudos Retrospectivos , Urologistas
9.
World J Urol ; 40(11): 2771-2779, 2022 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-36203101

RESUMO

PURPOSE: To investigate prevalence and predictors of renal function variation in a multicenter cohort treated with radical nephroureterectomy (RNU) for upper tract urothelial carcinoma (UTUC). METHODS: Patients from 17 tertiary centers were included. Renal function variation was evaluated at postoperative day (POD)-1, 6 and 12 months. Timepoints differences were Δ1 = POD-1 eGFR - baseline eGFR; Δ2 = 6 months eGFR - POD-1 eGFR; Δ3 = 12 months eGFR - 6 months eGFR. We defined POD-1 acute kidney injury (AKI) as an increase in serum creatinine by ≥ 0.3 mg/dl or a 1.5 1.9-fold from baseline. Additionally, a cutoff of 60 ml/min in eGFR was considered to define renal function decline at 6 and 12 months. Logistic regression (LR) and linear mixed (LM) models were used to evaluate the association between clinical factors and eGFR decline and their interaction with follow-up. RESULTS: A total of 576 were included, of these 409(71.0%) and 403(70.0%) had an eGFR < 60 ml/min at 6 and 12 months, respectively, and 239(41.5%) developed POD-1 AKI. In multivariable LR analysis, age (Odds Ratio, OR 1.05, p < 0.001), male gender (OR 0.44, p = 0.003), POD-1 AKI (OR 2.88, p < 0.001) and preoperative eGFR < 60 ml/min (OR 7.58, p < 0.001) were predictors of renal function decline at 6 months. Age (OR 1.06, p < 0.001), coronary artery disease (OR 2.68, p = 0.007), POD-1 AKI (OR 1.83, p = 0.02), and preoperative eGFR < 60 ml/min (OR 7.80, p < 0.001) were predictors of renal function decline at 12 months. In LM models, age (p = 0.019), hydronephrosis (p < 0.001), POD-1 AKI (p < 0.001) and pT-stage (p = 0.001) influenced renal function variation (ß 9.2 ± 0.7, p < 0.001) during follow-up. CONCLUSION: Age, preoperative eGFR and POD-1 AKI are independent predictors of 6 and 12 months renal function decline after RNU for UTUC.


Assuntos
Injúria Renal Aguda , Carcinoma de Células de Transição , Neoplasias Ureterais , Neoplasias da Bexiga Urinária , Sistema Urinário , Neoplasias Urológicas , Humanos , Masculino , Lactente , Nefroureterectomia , Carcinoma de Células de Transição/cirurgia , Nefrectomia , Taxa de Filtração Glomerular , Neoplasias da Bexiga Urinária/cirurgia , Estudos Retrospectivos , Neoplasias Urológicas/cirurgia , Rim/cirurgia , Rim/fisiologia , Injúria Renal Aguda/epidemiologia , Injúria Renal Aguda/etiologia , Neoplasias Ureterais/cirurgia
10.
J Urol ; 205(2): 356-369, 2021 02.
Artigo em Inglês | MEDLINE | ID: mdl-32935652

RESUMO

PURPOSE: Restaging of prostate cancer in patients with biochemical recurrence after radical treatment remains a challenging clinical scenario as current imaging modalities are suboptimal. To date, prostate specific membrane antigen positron emission tomography/computerized tomography seems to represent a very promising diagnostic tool in this setting. Therefore, we evaluated the detection rate of several positron emission tomography/computerized tomography prostate specific membrane antigen based tracers in the restaging of prostate cancer in patients with biochemical recurrence. MATERIALS AND METHODS: According to the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) statement, a systematic search was performed across MEDLINE®, Embase® and Web of Science™. PICOS (Patient, Intervention, Comparator, Outcome, Study Type), criteria consisted of P: patients with biochemical recurrence after radical prostatectomy and/or radiation therapy as primary treatment; I: studies using gallium-68-prostate specific membrane antigen-11, gallium-68-prostate specific membrane antigen inhibitor for imaging and therapy, gallium-68-trishydroxypyridinone-prostate specific membrane antigen, copper-64-prostate specific membrane antigen-617, fluorine-18-DCFPyL or fluorine-18-prostate specific membrane antigen-1007; C: no control group or positron emission tomography/computerized tomography comparative studies; O: patient specific overall detection rate; and S: retrospective/prospective studies. A meta-analysis of proportions and a network meta-analysis were performed. Heterogeneity was assessed using Cochran Q and I2 statistics. Quality was assessed by QUADAS-2 (University of Bristol, Bristol, United Kingdom). Funnel plots and Egger test were used for publication biases. RESULTS: A total of 43 studies including 5,832 patients were identified and included in the analysis. An overall detection rate of 74.1% (95% CI 69.2%-78.5%) was found, with no differences between tracers. The overall detection rates were 33.7%, 50.0%, 62.8%, 73.1% and 91.7% % in prostate specific antigen subgroups of less than 0.2 ng/ml, 0.2 to 0.49 ng/ml, 0.50 to 0.99 ng/ml, 1.0 to 1.99 ng/ml, and 2.0 ng/ml or greater, respectively. No difference between tracers was found according to prostate specific antigen doubling time or prostate specific antigen velocity. No tracer proved superior to the others through network meta-analysis. High heterogeneity and inconsistency were found across all analyses. Included studies showed a low risk of bias. CONCLUSIONS: Prostate specific membrane antigen positron emission tomography/computerized tomography for prostate cancer restaging in patients with biochemical recurrence achieves best detection rates (over 70%) if prostate specific antigen is below 1 ng/ml. At lower prostate specific antigen levels the detection rate of prostate specific membrane antigen positron emission tomography/computerized tomography is lower (33.7% for levels below 0.2 ng/ml and 50% for levels 0.2 to 0.49 ng/ml), despite being better than "older" tracers such as choline based positron emission tomography or computerized tomography/bone scintigraphy. Furthermore, no prostate specific membrane antigen tracer can be currently considered superior to others. Further studies are needed to better define the diagnostic performance and role of these imaging techniques.


Assuntos
Antígenos de Superfície , Glutamato Carboxipeptidase II , Recidiva Local de Neoplasia/diagnóstico por imagem , Tomografia por Emissão de Pósitrons combinada à Tomografia Computadorizada/métodos , Neoplasias da Próstata/diagnóstico por imagem , Humanos , Masculino , Imagem Molecular , Recidiva Local de Neoplasia/sangue , Metanálise em Rede , Antígeno Prostático Específico/sangue , Prostatectomia , Neoplasias da Próstata/sangue , Neoplasias da Próstata/cirurgia , Traçadores Radioativos
11.
J Urol ; 203(4): 751-759, 2020 04.
Artigo em Inglês | MEDLINE | ID: mdl-31689158

RESUMO

PURPOSE: Docetaxel represent the standard of care in patients with metastatic, hormone sensitive prostate cancer. However, androgen receptor axis targeted therapies have also been shown to be effective. We aimed to analyze findings in randomized controlled trials investigating first-line treatment for hormone sensitive prostate cancer. MATERIALS AND METHODS: We systematically reviewed the literature according to the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) criteria and the PICO (Population, Intervention, Comparator, Outcomes) methodology. Outcomes of interest were overall and progression-free survival, and the rate of high grade adverse events. RESULTS: No treatment was superior to docetaxel in terms of overall survival. However, abiraterone (HR 0.89, 95% CI 0.76-1.05), enzalutamide (HR 0.90, 95% CI 0.69-1.19) and apalutamide (HR 0.90, 95% CI 0.67-1.22) showed nonstatistically significant lower overall mortality rates than docetaxel. Abiraterone (HR 0.71, 95% CI 0.59-0.86), enzalutamide (HR 0.61, 95% CI 0.49-0.75) and apalutamide (HR 0.74, 95% CI 0.57-0.95) also showed statistically significant lower disease progression rates than docetaxel. Furthermore, abiraterone (OR 0.83, 95% CI 0.56-1.21) showed no statistically significant lower rate of high grade adverse events compared to docetaxel. Finally, enzalutamide (OR 0.56, 95% CI 0.35-0.92) and apalutamide (OR 0.44, 95% CI 0.24-0.79) showed statistically significant lower rates of high grade adverse events compared to docetaxel. CONCLUSIONS: Treatment with androgen receptor axis targeted therapies combined with androgen deprivation therapy in patients with hormone sensitive prostate cancer did not offer a statistically significant advantage in overall survival compared to the standard, docetaxel. However, it was associated with a lower disease progression rate. Moreover, apalutamide and enzalutamide offer a better safety profile.


Assuntos
Antagonistas de Androgênios/administração & dosagem , Antineoplásicos/administração & dosagem , Docetaxel/administração & dosagem , Neoplasias da Próstata/tratamento farmacológico , Antagonistas de Androgênios/efeitos adversos , Androstenos/administração & dosagem , Androstenos/efeitos adversos , Antineoplásicos/efeitos adversos , Benzamidas , Progressão da Doença , Docetaxel/efeitos adversos , Humanos , Masculino , Metanálise em Rede , Nitrilas , Feniltioidantoína/administração & dosagem , Feniltioidantoína/efeitos adversos , Feniltioidantoína/análogos & derivados , Intervalo Livre de Progressão , Neoplasias da Próstata/mortalidade , Neoplasias da Próstata/patologia , Ensaios Clínicos Controlados Aleatórios como Assunto , Padrão de Cuidado , Tioidantoínas/administração & dosagem , Tioidantoínas/efeitos adversos
12.
Urol Int ; 104(7-8): 559-566, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-32272471

RESUMO

PURPOSE: Population-based data on survival after radical cystectomy (RC) are lacking from Southern Europe. The aim of this study was to assess trends and determinants of perioperative mortality and long-term survival in the Veneto region (Northeastern Italy). METHODS: All patients submitted to RC for bladder cancer from January 2004 to December 2016 were identified from the regional archive of hospital discharge records. Age at surgery, gender, comorbidities, hospital volume, calendar period of surgery, and type of urinary diversion were retrieved; vital status and cause of death were obtained by linkage with mortality records. Determinants of 90-day mortality were assessed by multilevel logistic regression; long-term survival was investigated by the Kaplan-Meier method and Cox regression. RESULTS: Among 4,389 included patients, an increase in the share of patients aged ≥80 years (from 13% in 2004-2008 to 24% in 2013-2016, p < 0.001) and a decline in performing continent diversion (from 34.9 to 23.4%, p < 0.001) were observed across the study period. Ninety-day mortality did not change over time and was 4% for patients aged <70 years and 13.7% for those aged ≥80 years. Age- and comorbidities-adjusted mortality was significantly lower in hospitals performing >30 RCs/year (odds ratio 0.67, 95% confidence interval 0.48-0.93). At a median follow-up of 67 months, overall survival at 1 year and 5 years was 72 and 40%, respectively, with a higher rate among younger patients treated in high-volume hospitals. CONCLUSION: The population of patients treated with RC is rapidly ageing, with a high risk of perioperative and long-term mortality; this changing epidemiological scenario and better outcomes observed in high-volume hospitals support regionalization of the procedure.


Assuntos
Cistectomia , Neoplasias da Bexiga Urinária/mortalidade , Neoplasias da Bexiga Urinária/cirurgia , Idoso , Idoso de 80 Anos ou mais , Estudos de Coortes , Cistectomia/métodos , Feminino , Humanos , Itália , Masculino , Pessoa de Meia-Idade , Taxa de Sobrevida , Fatores de Tempo
14.
BJU Int ; 124(4): 621-628, 2019 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-30963680

RESUMO

OBJECTIVE: To simplify the original Preoperative Aspects and Dimensions Used for an Anatomical (PADUA) classification of renal tumours, generating a new system able to predict equally or better the risk of overall complications in patients undergoing partial nephrectomy (PN); and to test if the addition of the contact surface area (CSA) parameter improves the accuracy of the original PADUA and new Simplified PADUA REnal (SPARE) nephrometry classification systems. PATIENTS AND METHODS: We analysed the clinical records of 531 patients who underwent PN (open, laparoscopic and robot-assisted) for renal tumours at five tertiary academic referral centres from January 2014 to December 2016. The ability of each variable included in the PADUA classification to predict overall complications was tested using binary logistic regression analysis. The variables that were not statistically significant were excluded from the SPARE classification. In addition to the original PADUA and SPARE systems, another two models were generated adding tumour CSA. Receiver operating characteristic curve analysis was used to compare the ability of the four different models to predict overall complications. Binary logistic regression was used to perform both univariable and multivariable analyses looking for predictors of postoperative complications. Linear regression analysis was used to identify independent predictors of absolute change in estimated glomerular filtration rate (eGFR; ACE). RESULTS: The SPARE nephrometry score system including: (i) rim location, (ii) renal sinus involvement, (iii) exophytic rate, and (iv) tumour dimension; showed equal performance in comparison with the original PADUA score (area under the curve [AUC] 0.657 vs 0.664). Adding tumour CSA to the original PADUA (AUC 0.661) or to the SPARE (AUC 0.658) scores did not increase the accuracy of either system to predict overall complications. The SPARE system (odds ratio 1.2, 95% confidence interval 1.1-1.3) was an independent predictor of postoperative overall complications. Age (P < 0.001), body mass index (P < 0.001), Charlson Comorbidity Index (P = 0.02), preoperative eGFR (P < 0.001), and tumour CSA (P = 0.005) were independent predictors of ACE. Limitations include the retrospective design and the lack of central imaging review. CONCLUSIONS: The new SPARE score is comprised of only four variables instead of the original six and its accuracy to predict overall complications is similar to that of the original PADUA score. Addition of tumour CSA was not associated with an increase in prognostic accuracy. The SPARE system could replace the original PADUA score to evaluate the complexity of tumours suitable for PN.

15.
BJU Int ; 123(4): 639-645, 2019 04.
Artigo em Inglês | MEDLINE | ID: mdl-30253020

RESUMO

OBJECTIVES: To evaluate the ability of original tumour contact surface area (CSA) to predict postoperative complications and renal function impairment in a series of patients who underwent elective partial nephrectomy (PN) for renal masses. MATERIALS AND METHODS: We analysed the clinical records of 531 consecutive patients who underwent elective PN because of a suspicion of kidney cancer at five academic, high-volume centres between January 2014 and December 2016. Each participating centre evaluated prospectively the radiological images to evaluate the CSA and to assign a PADUA score. Several expert surgeons performed the surgical procedures in each participating centre. Binary logistic regression was used to perform both univariable and multivariable analyses to identify predictors of postoperative complications. Linear regression analysis was used to identify independent predictors of absolute change in estimated glomerular filtration rate (eGFR; ACE). RESULTS: The median (interquartile range) CSA value was 14.2 (7.4-25.1) cm2 . A total of 349 tumours (65.7%) had a CSA ≤ 20 cm2 and the remaining 182 (34.3%) had a CSA > 20 cm2 . PNs were performed using an open approach in 237 (44.6%) cases, a pure laparoscopic approach in 152 cases (28.6%), and a robot-assisted approach in the remaining 142 cases (26.7%). Multivariable analyses found that only age (odds ratio [OR] 1.037, 95% confidence interval [CI] 1.018-1.057) and PADUA score (OR 1.289, 95%CI 1.132-1.469) were independent predictors of postoperative complications. Tumour CSA (OR 1.020, 95%CI 1.010-1.030) was found to be an independent predictor of postoperative complications only when PADUA score was removed from the model. Age (from -0.639 to -0.306; P < 0.001); body mass index (from 0.267 to 1.076; P = 0.001), age-adjusted Charlson score (from -3.193 to -0.259; P = 0.02), preoperative eGFR value (from -0.939 to -0.862; P < 0.001) and tumour CSA (from -0.260 to -0.048; P = 0.005) were found to be independent predictors of ACE. CONCLUSIONS: Tumour CSA is an independent predictor of postoperative renal function. Conversely, at multivariable analysis, PADUA score outperformed tumour CSA to predict postoperative complications after PN. The complexity of The Leslie et al. formula for calculating tumour CSA is a potential limitation with regard to its diffusion and application in clinical practice.


Assuntos
Carcinoma de Células Renais/patologia , Neoplasias Renais/patologia , Rim/patologia , Nefrectomia , Complicações Pós-Operatórias/patologia , Idoso , Carcinoma de Células Renais/cirurgia , Feminino , Humanos , Testes de Função Renal , Neoplasias Renais/cirurgia , Masculino , Pessoa de Meia-Idade , Nefrectomia/métodos , Razão de Chances , Valor Preditivo dos Testes , Reprodutibilidade dos Testes , Resultado do Tratamento , Carga Tumoral
16.
J Urol ; 199(4): 927-932, 2018 04.
Artigo em Inglês | MEDLINE | ID: mdl-29154848

RESUMO

PURPOSE: We sought to determine the predictors of short-term and long-term renal function impairment after partial nephrectomy. MATERIALS AND METHODS: Clinical data on 769 consecutive patients who underwent partial nephrectomy were prospectively recorded at a total of 19 urological Italian centers from 2009 to 2012 in the RECORd 1 (Italian Registry of Conservative Renal Surgery) Project. We extracted clinical data on 708 of these patients who were alive, free of recurrent disease and with a minimum 2-year functional followup. RESULTS: Of the patients 47.3% underwent open, 36.6% underwent laparoscopic and 16.1% underwent robot-assisted partial nephrectomy. The median baseline estimated glomerular filtration rate was 84.5 ml/minute/1.73 m2 (IQR 69.9-99.1). Immediate (day 3 postoperatively), early (month 1) and late (month 24) renal function impairment greater than 25% from baseline was identified in 25.3%, 21.6% and 14.8% of cases, respectively. Female gender and the baseline estimated glomerular filtration rate were independent predictors of immediate, early and late renal function impairment. Age at diagnosis was an independent predictor of immediate and late impairment. Uncontrolled diabetes was an independent predictor of late impairment only. Open and laparoscopic approaches, and pedicle clamping were independent predictors of immediate and early renal function impairment. Overall 58 of 529 patients (11%) experienced postoperative cardiovascular events. Body mass index and late renal function impairment were independent predictors of those events. CONCLUSIONS: Surgically modifiable factors were significantly associated with worse immediate and early functional outcomes after partial nephrectomy while clinically unmodifiable factors affected renal function during the entire followup. Late renal function impairment is an independent predictor of postoperative cardiovascular events.


Assuntos
Carcinoma de Células Renais/cirurgia , Neoplasias Renais/cirurgia , Laparoscopia/efeitos adversos , Nefrectomia/efeitos adversos , Insuficiência Renal/fisiopatologia , Procedimentos Cirúrgicos Robóticos/efeitos adversos , Idoso , Carcinoma de Células Renais/fisiopatologia , Feminino , Seguimentos , Taxa de Filtração Glomerular , Humanos , Rim/fisiopatologia , Rim/cirurgia , Neoplasias Renais/fisiopatologia , Laparoscopia/métodos , Masculino , Pessoa de Meia-Idade , Nefrectomia/métodos , Período Pós-Operatório , Estudos Prospectivos , Recuperação de Função Fisiológica , Insuficiência Renal/etiologia , Procedimentos Cirúrgicos Robóticos/métodos , Fatores Sexuais , Resultado do Tratamento , Isquemia Quente/efeitos adversos
17.
BJU Int ; 122(6): 1075-1081, 2018 12.
Artigo em Inglês | MEDLINE | ID: mdl-29733492

RESUMO

OBJECTIVE: To investigate the effectiveness of motor imagery (MI) for technical skill and non-technical skill (NTS) training in minimally invasive surgery (MIS). SUBJECTS AND METHODS: A single-blind, parallel-group randomised controlled trial was conducted at the Vattikuti Institute of Robotic Surgery, King's College London. Novice surgeons were recruited by open invitation in 2015. After basic robotic skills training, participants underwent simple randomisation to either MI training or standard training. All participants completed a robotic urethrovesical anastomosis task within a simulated operating room. In addition to the technical task, participants were required to manage three scripted NTS scenarios. Assessment was performed by five blinded expert surgeons and a NTS expert using validated tools for evaluating technical skills [Global Evaluative Assessment of Robotic Skills (GEARS)] and NTS [Non-Technical Skills for Surgeons (NOTSS)]. Quality of MI was assessed using a revised Movement Imagery Questionnaire (MIQ). RESULTS: In all, 33 participants underwent MI training and 29 underwent standard training. Interrater reliability was high, Krippendorff's α = 0.85. After MI training, the mean (sd) GEARS score was significantly higher than after standard training, at 13.1 (3.25) vs 11.4 (2.97) (P = 0.03). There was no difference in mean NOTSS scores, at 25.8 vs 26.4 (P = 0.77). MI training was successful with significantly higher imagery scores than standard training (mean MIQ score 5.1 vs 4.5, P = 0.04). CONCLUSIONS: Motor imagery is an effective training tool for improving technical skill in MIS even in novice participants. No beneficial effect for NTS was found.


Assuntos
Anastomose Cirúrgica/educação , Competência Clínica , Simulação por Computador , Procedimentos Cirúrgicos Minimamente Invasivos/educação , Procedimentos Cirúrgicos Robóticos/educação , Cirurgiões/educação , Anastomose Cirúrgica/normas , Cognição , Educação Médica Continuada , Avaliação Educacional , Humanos , Procedimentos Cirúrgicos Minimamente Invasivos/normas , Avaliação de Programas e Projetos de Saúde , Reprodutibilidade dos Testes , Procedimentos Cirúrgicos Robóticos/normas , Análise e Desempenho de Tarefas
18.
Urol Int ; 100(1): 13-17, 2018.
Artigo em Inglês | MEDLINE | ID: mdl-29212084

RESUMO

OBJECTIVE: To evaluate perioperative outcomes and early survival in a series of octogenarians who underwent radical cystectomy (RC) and urinary diversion for bladder cancer. PATIENTS AND METHODS: We retrospectively evaluated the clinical records of 44 patients aged ≥80 years who underwent open RC and urinary diversion at 2 high-volume centers between July 2013 and December 2015. Estimated blood loss (EBL), transfusion rate, and length of hospital stay (LOS) were evaluated. Ninety-day postoperative complications were stratified according to the type of urinary diversion. Univariable analysis was performed to identify predictors of overall and major complications. Overall survival (OS) was estimated using the Kaplan-Meier method. RESULTS: Median age was 83 years (interquartile range [IQR] 81-85). Age-adjusted Charlson score was ≥4 in 37 (84%) patients, and American Society of Anesthesiologists score was ≥3 in 34 (77%) patients. Ileal conduit (IC) was performed in 21/44 (48%) cases, cutaneous ureterostomy (CU) in 20/44 (45%), and no urinary diversion was required for 3 (7%) dialytic patients. Median EBL was 700 mL (IQR 500-1,000) and 23 (52%) patients required blood transfusion. Median LOS was 13 days (IQR 10-18). Overall complications were recorded in 29 (66%) patients, with major complications observed in 12 (27%), with death occurring in 1. No differences in complications were observed between IC and CU. The 2-year OS estimate was 62.5%. CONCLUSIONS: Open RC in octogenarians has an acceptable rate of major complications and mortality. IC should be considered a good urinary diversion in these patients.


Assuntos
Cistectomia , Neoplasias da Bexiga Urinária/mortalidade , Neoplasias da Bexiga Urinária/cirurgia , Idoso de 80 Anos ou mais , Cistectomia/métodos , Humanos , Estudos Retrospectivos , Taxa de Sobrevida , Resultado do Tratamento , Derivação Urinária
19.
Int J Urol ; 25(6): 574-581, 2018 06.
Artigo em Inglês | MEDLINE | ID: mdl-29633372

RESUMO

OBJECTIVES: To assess the predictive accuracy and the clinical value of a recent nomogram predicting cancer-specific mortality-free survival after surgery in pN1 prostate cancer patients through an external validation. METHODS: We evaluated 518 prostate cancer patients treated with radical prostatectomy and pelvic lymph node dissection with evidence of nodal metastases at final pathology, at 10 tertiary centers. External validation was carried out using regression coefficients of the previously published nomogram. The performance characteristics of the model were assessed by quantifying predictive accuracy, according to the area under the curve in the receiver operating characteristic curve and model calibration. Furthermore, we systematically analyzed the specificity, sensitivity, positive predictive value and negative predictive value for each nomogram-derived probability cut-off. Finally, we implemented decision curve analysis, in order to quantify the nomogram's clinical value in routine practice. RESULTS: External validation showed inferior predictive accuracy as referred to in the internal validation (65.8% vs 83.3%, respectively). The discrimination (area under the curve) of the multivariable model was 66.7% (95% CI 60.1-73.0%) by testing with receiver operating characteristic curve analysis. The calibration plot showed an overestimation throughout the range of predicted cancer-specific mortality-free survival rates probabilities. However, in decision curve analysis, the nomogram's use showed a net benefit when compared with the scenarios of treating all patients or none. CONCLUSIONS: In an external setting, the nomogram showed inferior predictive accuracy and suboptimal calibration characteristics as compared to that reported in the original population. However, decision curve analysis showed a clinical net benefit, suggesting a clinical implication to correctly manage pN1 prostate cancer patients after surgery.


Assuntos
Técnicas de Apoio para a Decisão , Nomogramas , Prostatectomia , Neoplasias da Próstata/mortalidade , Idoso , Tomada de Decisão Clínica , Seguimentos , Humanos , Excisão de Linfonodo , Metástase Linfática , Masculino , Pessoa de Meia-Idade , Seleção de Pacientes , Valor Preditivo dos Testes , Antígeno Prostático Específico/sangue , Neoplasias da Próstata/sangue , Neoplasias da Próstata/patologia , Neoplasias da Próstata/cirurgia , Curva ROC , Taxa de Sobrevida , Resultado do Tratamento
20.
J Urol ; 197(3 Pt 1): 580-589, 2017 03.
Artigo em Inglês | MEDLINE | ID: mdl-27670916

RESUMO

PURPOSE: We developed a prognostic nomogram for patients with high grade urothelial carcinoma of the upper urinary tract after extirpative surgery. MATERIALS AND METHODS: Clinical data were available for 2,926 patients diagnosed with high grade urothelial carcinoma of the upper urinary tract who underwent extirpative surgery. Cox proportional hazard regression models identified independent prognosticators of relapse in the development cohort (838). A backward step-down selection process was applied to achieve the most informative nomogram with the least number of variables. The L2-regularized logistic regression was applied to generate the novel nomogram. Harrell's concordance indices were calculated to estimate the discriminative accuracy of the model. Internal validation processes were performed using bootstrapping, random sampling, tenfold cross-validation, LOOCV, Brier score, information score and F1 score. External validation was performed on an external cohort (2,088). Decision tree analysis was used to develop a risk classification model. Kaplan-Meier curves were applied to estimate the relapse rate for each category. RESULTS: Overall 35.3% and 30.7% of patients experienced relapse in the development and external validation cohort. The final nomogram included age, pT stage, pN stage and architecture. It achieved a discriminative accuracy of 0.71 and 0.76, and the AUC was 0.78 and 0.77 in the development and external validation cohort, respectively. Rigorous testing showed constant results. The 5-year relapse-free survival rates were 88.6%, 68.1%, 40.2% and 12.5% for the patients with low risk, intermediate risk, high risk and very high risk disease, respectively. CONCLUSIONS: The current nomogram, consisting of only 4 variables, shows high prognostic accuracy and risk stratification for patients with high grade urothelial carcinoma of the upper urinary tract following extirpative surgery, thereby adding meaningful information for clinical decision making.


Assuntos
Carcinoma/mortalidade , Carcinoma/patologia , Nomogramas , Neoplasias Urológicas/mortalidade , Neoplasias Urológicas/patologia , Urotélio , Carcinoma/cirurgia , Árvores de Decisões , Intervalo Livre de Doença , Feminino , Humanos , Masculino , Gradação de Tumores , Prognóstico , Sensibilidade e Especificidade , Neoplasias Urológicas/cirurgia
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