Publications by authors named "Luigi Cormio"

105 Publications

Does Multiparametric Magnetic Resonance of Prostate Outperform Risk Calculators in Predicting Prostate Cancer in Biopsy Naïve Patients?

Front Oncol 2020 8;10:603384. Epub 2021 Jan 8.

Department of Urology and Organ Transplantation, University of Foggia, Foggia, Italy.

Background: European Association of Urology (EAU) guidelines recommend using risk-calculators (RCs), imaging or additional biomarkers in asymptomatic men at risk of prostate cancer (PCa).

Objectives: To compare the performance of mpMRI, a RC we recently developed and two commonly used RC not including mpMRI in predicting the risk of PCa, as well as the added value of mpMRI to each RC.

Design Setting And Participants: Single-center retrospective study evaluating 221 biopsy-naïve patients who underwent prebiopsy mpMRI.

Outcome Measurements And Statistical Analysis: Patients' probabilities of any PCa and clinically significant PCa (csPC, defined as Gleason-Score ≥3 + 4) were computed according to mpMRI, European Randomized Study of Screening for Prostate Cancer RC (ERSPC-RC), the Prostate Biopsy Collaborative Group RC (PBCG-RC) and the Foggia Prostate Cancer RC (FPC-RC). Logistic regression, AUC, and Decision curve analysis (DCA) were used to assess the accuracy of tested models.

Results And Limitation: The FPC-RC outperformed mpMRI in diagnosing both any PCa (AUC 0.76 0.69) and csPCa (AUC 0.80 0.75). Conversely mpMRI showed a higher accuracy in predicting any PCa compared to the PBCG-RC and the ERSPC-RC but similar performances in predicting csPCa. At multivariable analysis predicting csPCa and any PCa, the addition of mpMRI findings improved the accuracy of each calculator. DCA showed that the FPC-RC provided a greater net benefit than mpMRI and the other RCs. The addition of mpMRI findings improved the net benefit provided by each calculator.

Conclusions: mpMRI was outperformed by the novel FPC-RC and showed similar performances compared to the PBCG and ERSPC RCs in predicting csPCa. The addition of mpMRI findings improved the diagnostic accuracy of each of these calculators.
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http://dx.doi.org/10.3389/fonc.2020.603384DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7821426PMC
January 2021

Improvement of urinary tract symptoms and quality of life in benign prostate hyperplasia patients associated with consumption of a newly developed whole tomato-based food supplement: a phase II prospective, randomized double-blinded, placebo-controlled study.

J Transl Med 2021 Jan 6;19(1):24. Epub 2021 Jan 6.

Department of Medicine and Aging Sciences, Center for Advanced Studies and Technology (CAST), G.d'Annunzio University, Chieti, Italy.

Background: Benign prostatic hyperplasia (BPH) is the most common urologic disease among elderly men. The diagnosis of BPH is usually driven by lower urinary tract symptoms (LUTS) that can significantly affect patients' quality of life. This phase II prospective, randomized double-blinded, placebo-controlled study aimed to determine the efficacy and safety of a novel whole tomato-based food supplement on LUTS of patients diagnosed with BPH.

Methods: Forty consecutive patients with histologically proved BPH were randomized 1:1 to receive daily for 2 months a sachet (5 g) of a newly developed whole tomato food supplement (WTFS) (treatment = Group A) or placebo (Group B). Patients were asked to fill the International Prostatic Symptom Score (IPSS) questionnaire before and after treatment.

Results: All but 1 patient in Group B successfully completed the scheduled regimen. No side effects were recorded. Unlike placebo, treatment significantly reduced (P < 0.0002) LUTS since mean IPSS decreased from 9.05 ± 1.15 to 7.15 ± 1.04 (paired t-test, two-tailed P-value < 0.001), and improved life quality (P < 0.0001). A trend toward a reduction of total PSA levels was observed in WTFS treated patients (8.98 ng/mL ± 1.52 vs 6.95 ± 0.76, P = 0.065), with changes being statistically significant only in the subgroup of patients with baseline levels above 10 ng/mL (18.5 ng/mL ± 2.7 vs 10.3 ± 2.1, P = 0.009).

Conclusions: The new WTFS may represent a valid option for the treatment of symptomatic BPH patients. Unlike pharmacological treatments, the supplement is side effects free and highly accepted among patients.
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http://dx.doi.org/10.1186/s12967-020-02684-3DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7789791PMC
January 2021

Mini invasive approaches in the treatment of small renal masses: TC-guided renal cryoablation in elderly.

Arch Ital Urol Androl 2020 Dec 17;92(4). Epub 2020 Dec 17.

University of Foggia, Department of Urology and Organ Transplantation, Foggia; Department of Urology, Bonomo Teaching Hospital, Andria (BAT).

Background: Today, the goal of surgery is to achieve oncological efficacy with the lowest complication rate. Computed Tomography (CT)-guided cryoablation is proposed as a safe and effective technique. We report, our series of small renal masses treated with cryoablation in elderly (> 70 years).

Methods: From May 2014 to April 2019, 32 patients with median (IQR) age of 75.5 years (range 71-80) with small renal masses (< T1a) diagnosis, clinical anesthesia contraindications to nephron-sparing surgery or patient's will previous informed consent have been selected at our Urology Department. All patients underwent CT-guided cryoablation, preceded by needle biopsy. The cryoablation consisted in a procedure with an argon/helium gas-based system under local anesthesia. The follow-up included CT abdomen at 3, 6 and 12 months. The definition of incomplete treatment was the persistence of the lesion contrast enhancement (CE) at the end of the scan; the definition of relapse was the appearance of the CE to the 6-month control CT.

Results: The median follow-up was 30 months (IQR 1-59). The median size of the tumor was 3.85 cm (IQR 1.6-4.5). All patients underwent lesion biopsy resulting in diagnosis of Renal Cell Carcinoma (RCC) in 29 patients (90.7%) and oncocytoma in 3 patients (9.3%). A median of 2 cryoprobes (IQR 1- 3) was used and 2/3 cycles of freeze-thaw of the duration of 10 minutes or 5 minutes were performed. Complications were: 3 asymptomatic transitional perirenal effusion, 2 lumbar pain well-controlled by analgesic drug. Hospital stay was 2 days (range 1-3). No case showed incomplete treatment and local relapse or metastates at the CT abdomen-pelvis with contrast medium at 12 months.

Conclusions: This study shows the efficacy and safety of percutaneous cryoablation of small renal masses in elderly population. The procedure is easy to perform, with low complication rates and well tolerated by the elderly patients.
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http://dx.doi.org/10.4081/aiua.2020.4.309DOI Listing
December 2020

How Can the COVID-19 Pandemic Lead to Positive Changes in Urology Residency?

Front Surg 2020 24;7:563006. Epub 2020 Nov 24.

Department of Urology, IEO European Institute of Oncology IRCCS, Milan, Italy.

The COVID-19 outbreak, in a few weeks, overloaded Italian hospitals, and the majority of medical procedures were postponed. During the pandemic, with hospital reorganization, clinical and learning activities performed by residents suffered a forced remodulation. The objective of this study is to investigate how urology training in Italy has been affected during the COVID-19 era. In this multi-academic study, we compared residents' training during the highest outbreak level with their previous activity. Overall 387 (67.1%) of the 577 Italian Urology residents participated in a 72-h anonymous online survey with 36 items sent via email. The main outcomes were clinical/surgical activities, social distancing, distance learning, and telemedicine. Clinical and learning activity was significantly reduced for the overall group, and after categorizing residents as those working only in COVID hospitals, both "junior" and "senior" residents, and those working in any of three geographical areas created (Italian regions were clustered in three major zones according to the prevalence of COVID-19). A significant decrease in outpatient activity, invasive diagnostic procedures, and endoscopic and major surgeries was reported. Through multivariate analysis, the specific year of residency has been found to be an independent predictor for all response modification. Being in zone 3 and zone 2 and having "senior" resident status were independent predictors associated with a lower reduction of the clinical and learning activity. Working in a COVID hospital and having "senior" resident status were independent predictors associated with higher reduction of the outpatient activity. Working in zone 3 and having "senior" resident status were independent predictors of lower and higher outpatient surgical activity, respectively. Working in a COVID hospital was an independent predictor associated with robotic surgical activity. The majority of residents reported that distance teaching and multidisciplinary virtual meetings are still not used, and 44.8% reported that their relationships with colleagues decreased. The COVID-19 pandemic presents an unprecedented challenge, including changes in the training and education of urology residents. The COVID era can offer an opportunity to balance and implement innovative solutions that can bridge the educational gap and can be part of future urology training.
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http://dx.doi.org/10.3389/fsurg.2020.563006DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7732553PMC
November 2020

Nomogram predicting 30-day mortality after nephrectomy in the contemporary era: Results from the SEER database.

Int J Urol 2021 Mar 14;28(3):309-314. Epub 2020 Dec 14.

Division of Urology, Virginia Commonwealth University Health, Richmond, Virginia, USA.

Objectives: To assess contemporary 30-day mortality rates after partial and radical nephrectomy in USA, and to develop a predictive model of 30-day mortality.

Methods: We relied on the National Cancer Institute Surveillance, Epidemiology and End Results database. A multivariable logistic regression analysis was fitted to predict 30-day mortality. A nomogram was built based on the coefficients of the logit function. Internal validation was carried out using the leave-one-out cross-validation. Calibration was graphically investigated.

Results: A total of 102 146 patients who underwent partial nephrectomy (n = 36 425; 35.7%) or radical nephrectomy (n = 65 721; 64.3%) between 2005 and 2015 were included in the analysis. The median age at diagnosis was 62 years. A total of 11 921 (11.7%) patients were African American. The clinical stage was T1-T2 in 79 452 (77.8%), T3 in 16 141 (15.8%) and T4/T1-4-M1 in 6553 (6.4%) patients. Overall, 497 deaths occurred during the initial 30 days after nephrectomy (0.49% 30-day mortality rate). Stratified by type of surgery, the 30-day mortality rate was 0.16% for partial nephrectomy and 0.67% for radical nephrectomy. At univariate analyses, age, tumor size, stage and surgical procedure emerged as predictors of 30-day mortality (all P < 0.001). All of these covariates were included in the multivariable logistic regression model. The area under the curve after leave-one-out cross-validation was 0.808 (95% confidence interval 0.788-0.828), and the model showed good calibration in the range of predicted probability <10%.

Conclusions: Contemporary rates of 30-day mortality in patients undergoing radical or partial nephrectomy are very low. Age and tumor stage are key determinants of 30-day mortality. We present a predictive model that provides individual probabilities of 30-day mortality after nephrectomy, and it can be used for patient counseling prior surgery.
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http://dx.doi.org/10.1111/iju.14461DOI Listing
March 2021

Advanced ureteroscopic techniques for the management of kidney stones.

Curr Opin Urol 2021 Jan;31(1):58-65

Department of Urology and Organ Transplantation, University of Foggia.

Purpose Of Review: Recent years witnessed significant changes in the endourological management of renal tones because of the development of new, more advanced instruments. Retrograde intrarenal surgery (RIRS) has gained particular advantage from such technological progress and now tends to be considered the gold standard treatment for uncomplicated less than 20 mm renal stones. Using a step-by-step approach, this review aims to highlight current achievements but also unsolved problems in RIRS.

Recent Findings: Several technical details of RIRS, including preoperative stenting, use of ureteral access sheets, lithotripsy method, and renal drainage, remain open to discussion and linked to surgeon's preference. Moreover, there is a wide range of variation in efficacy and safety data, with major complications being episodic but often under-reported.

Summary: RIRS has gained increased popularity among the urological community. This is certainly because of the continuous technological advancements, which have continuously improved the RIRS performance but also to the perception of ease and safety of this procedure when compared with the other available treatment modalities, particularly percutaneous nephrolitotomy. Indeed, the reported advances in RIRS technique have significantly improved the outcomes of this procedure but care should be taken not to underestimate its potential challenges.
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http://dx.doi.org/10.1097/MOU.0000000000000835DOI Listing
January 2021

Modulation of complement activation by pentraxin-3 in prostate cancer.

Sci Rep 2020 10 27;10(1):18400. Epub 2020 Oct 27.

Fondazione Policlinico Universitario A. Gemelli IRCCS, Largo A. Gemelli 8, 00168, Rome, Italy.

Pentraxin 3 (PTX3) is an essential component of the innate immune system and a recognized modulator of Complement cascade. The role of Complement system in the pathogenesis of prostate cancer has been largely underestimated. The aim of our study was to investigate the role of PTX3 as possible modulator of Complement activation in the development of this neoplasia. We performed a single center cohort study; from January 2017 through December 2018, serum and prostate tissue samples were obtained from 620 patients undergoing prostate biopsy. A group of patients with benign prostatic hyperplasia (BPH) underwent a second biopsy within 12-36 months demonstrating the presence of a prostate cancer (Group A, n = 40) or confirming the diagnosis of BPH (Group B, N = 40). We measured tissue PTX3 protein expression together with complement activation by confocal microscopy in the first and second biopsy in group A and B patients. We confirmed that that PTX3 tissue expression in the first biopsy was increased in group A compared to group B patients. C1q deposits were extensively present in group A patients co-localizing and significantly correlating with PTX3 deposits; on the contrary, C1q/PTX3 deposits were negative in group B. Moreover, we found a significantly increased expression of C3a and C5a receptors within resident cells in group A patient. Interestingly, C1q/PTX3 deposits were not associated with activation of the terminal Complement complex C5b-9; moreover, we found a significant increase of Complement inhibitor CD59 in cancer tissue. Our data indicate that PTX3 might play a significant pathogenic role in the development of this neoplasia through recruitment of the early components of Complement cascade with hampered activation of terminal Complement pathway associated with the upregulation of CD59. This alteration might lead to the PTX3-mediated promotion of cellular proliferation, angiogenesis and insensitivity to apoptosis possible leading to cancer cell invasion and migration.
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http://dx.doi.org/10.1038/s41598-020-75376-zDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7591881PMC
October 2020

Using biomarkers in patients with positive multiparametric magnetic resonance imaging: 4Kscore predicts the presence of cancer outside the index lesion.

Int J Urol 2021 Jan 27;28(1):47-52. Epub 2020 Sep 27.

Department of Urology, Icahn School of Medicine at Mount Sinai, New York, NY, USA.

Objectives: To evaluate if the blood biomarker, 4Kscore, in addition to multiparametric magnetic resonance imaging information could identify patients who would benefit from undergoing only a targeted biopsy.

Methods: We retrospectively analyzed a population of 256 men with positive multiparametric magnetic resonance imaging who underwent standard + targeted biopsy at Mount Sinai Hospital, New York, NY, USA. 4Kscore (OPKO Health, Miami, FL, USA) was sampled from all patients before biopsy. Uni- and multivariable binary logistic regression analyses were carried out to predict clinically significant prostate cancer, defined as International Society of Urological Pathology grade group ≥2, in standard biopsy cores. The model with the best area under the curve was selected and internal validation was carried out using the leave-one-out cross-validation.

Results: The developed model showed an area under the curve of 0.86. Carrying out only targeted biopsy in patients with a model-derived probability <12.5% resulted in 39.5% (n = 101) fewer standard biopsies and a 33.9% (n = 20) reduction of detecting grade group 1 disease, while missing grade group ≥2 in 5.2% (n = 4) using standard biopsy only and 1.1% (n = 1) using standard biopsy + targeted biopsy.

Conclusions: 4Kscore in combination with multiparametric magnetic resonance imaging can help to reduce unnecessary standard biopsy and decrease detection of clinically insignificant prostate cancer.
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http://dx.doi.org/10.1111/iju.14385DOI Listing
January 2021

Combined Use of Prostate-specific Antigen Density and Magnetic Resonance Imaging for Prostate Biopsy Decision Planning: A Retrospective Multi-institutional Study Using the Prostate Magnetic Resonance Imaging Outcome Database (PROMOD).

Eur Urol Oncol 2020 Sep 21. Epub 2020 Sep 21.

Department of Urology and Organ Transplantation, University of Foggia, Foggia, Italy.

Background: Previous studies suggested that prostate-specific antigen (PSA) density (PSAd) combined with magnetic resonance imaging (MRI) may help avoid unnecessary prostate biopsy (PB) with a limited risk of missing clinically significant prostate cancer (csPCa; Gleason grade group [GGG] >1).

Objective: To define optimal diagnostic strategies based on the combined use of PSAd and MRI in patients at risk of prostate cancer (PCa).

Design, Setting, And Participants: A retrospective analysis of the international multicenter Prostate MRI Outcome Database (PROMOD), including 2512 men having undergone PSAd and prostate MRI before PB between 2013 and 2019, was performed.

Outcome Measurements And Statistical Analysis: Rates of avoided PB, missed GGG 1, and csPCa according to 10 strategies based on PSAd values and MRI reporting scores (Prostate Imaging Reporting and Data System [PI-RADS]/Likert/IMPROD biparametric prostate MRI Likert). Decision curve analysis (DCA) was used to statistically compare the net benefit of each strategy. Combined systematic and targeted biopsies were used for reference.

Results And Limitations: According to DCA, the best strategy in biopsy-naive patients was #7 (PI-RADS/Likert 4-5 or PI-RADS/Likert 3 if PSAd >0.2), which avoided 41.2% PBs while missed 44% of GGG 1 and 10.9% of csPCa cases. From a clinical standpoint, however, strategies with a lower risk of missing csPCa included #10 (PI-RADS/Likert 4-5 or PI-RADS 3 if PSAd >0.10 or PSAd >0.2), which avoided 27% PBs while missing 24.4% GGG 1 and 4% csPCa cases, or #5 (PI-RADS/Likert 3-5 or PSAd>0.15), which avoided 14.7% PBs while missing 9.3% GGG 1 and 1.7% csPCa cases. Similar results were found in patients with a previous negative biopsy. This study is limited by its retrospective nature, and no central review of MRI and histopathological findings.

Conclusions: Combined PSAd and MRI findings allows individualization of the decision to perform PB on the basis of the risk of missing PCa that both patients and clinicians are ready to accept to avoid this procedure.

Patient Summary: We compared several biopsy strategies based on a combination of prostate magnetic resonance imaging findings and prostate-specific antigen density, providing a readily available tool for each center and practicing urologist to counsel patients about their individual risk of significant prostate cancer.
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http://dx.doi.org/10.1016/j.euo.2020.08.014DOI Listing
September 2020

Expanding Active Surveillance Inclusion Criteria: A Novel Nomogram Including Preoperative Clinical Parameters and Magnetic Resonance Imaging Findings.

Eur Urol Oncol 2020 Sep 2. Epub 2020 Sep 2.

Department of Urology, Icahn School of Medicine at Mount Sinai, New York, NY, USA.

Background: Current European Association of Urology, American Urological Association, and National Comprehensive Cancer Network guidelines recommend active surveillance (AS) for selected intermediate-risk prostate cancer (PCa) patients. However, limited evidence exists regarding which men can be selected safely.

Objective: To externally validate the Gandaglia risk calculator (Gandaglia-RC), designed to predict adverse pathology (AP) at radical prostatectomy (RP) and thus able to improve selection of intermediate-risk PCa patients suitable for AS, and to assess whether addition of magnetic resonance imaging (MRI) findings (MAP model) improves the predictive ability of Gandaglia-RC.

Design, Setting, And Participants: This is a retrospective analysis of a single-center cohort of 1284 consecutive men with low- and intermediate-risk PCa treated with RP between 2013 and 2019.

Outcome Measurements And Statistical Analysis: AP was defined as non-organ-confined disease and/or lymph node invasion and/or pathological grade group≥3 at RP. Logistic regression was used to calculate the predictors of AP; calculated coefficients were used to develop a risk score. Receiver operating characteristic curve analysis and decision curve analysis were performed to evaluate the net benefit within models.

Results And Limitations: At multivariable analysis, age at surgery, prostate-specific antigen, systematic and targeted biopsy Gleason grade group, MRI prostate volume, Prostate Imaging Reporting and Data System score, and MRI extraprostatic extension were significantly associated with AP. The model significantly improved the ability of Gandaglia-RC to predict AP (area under the curve 0.71 vs 0.63 [p<0.0001]). Using a 30% threshold, the proportions of men eligible for AS were 45% and 77% and the risks of AP were 16% and 17%, for Gandaglia-RC and MAP model, respectively.

Conclusions: Compared with Gandaglia-RC, the MAP model significantly increased the number of patients eligible for AS without significantly increasing the risk of AP at RP.

Patient Summary: In this report, we have developed a risk prediction tool to select men for conservative treatment of prostate cancer. Using the novel tool, more men could safely be allocated to conservative treatment rather than surgery or radiation.
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http://dx.doi.org/10.1016/j.euo.2020.08.001DOI Listing
September 2020

Enzalutamide in patients with castration-resistant prostate cancer: retrospective, multicenter, real life study.

Minerva Urol Nefrol 2020 Aug 4. Epub 2020 Aug 4.

Department of Urology, ASL Abruzzo2, Chieti, Italy -

Background: Metastatic castration-resistant prostate cancer (mCRPC) is the final stage of pCa history and represents a clinically relevant phenotype with an elevated burden of mortality. The aim of the present study is to evaluate the efficacy and safety of enzalutamide in a "real-life" setting in mCRPC patients.

Methods: Data about all mCRPC patients treated with enzalutamide from September 2017 to September 2018 were collected. Demographics, comorbidities, clinical parameters, outcomes, toxicity, overall survival and progression free survival were analyzed.

Results: Overall 158 patients were enrolled. Mean age was 75.8 (±8.7) years with a baseline median PSA of 16.5 (IQR 7.4-47.8) ng/mL. The median follow-up lasted 7.7 (IQR 4-14.1) months. Of all the 10.1% of patients reported grade 3-4 adverse events. 43.7% of patients experienced a progression. Overall the 6 and 12 months PFS rates were 69.5% (95% CI: 61.7-78.3%) and the 45.6% (95% CI: 36.5-57.1%); a median baseline PSA >16 ng/mL (HR:2.0, 95% CI: 1.2-3.3, p=0.005), the use of opioid (HR:3.1, 95% CI 1.9-5.0, p<0.001), a previous treatment (abiraterone, docetaxel or abiraterone + docetaxel) were significantly associated with higher rates of cancer progression. Conversely, a brief pain questionnaire of 0-1 (HR: 0.4, 95% CI: 0.2-0.7, p<0.001), a 12 weeks 50% PSA reduction (HR: 0.4, 95% CI: 0.2-0.8, p=0.006) and a longer time to mCRPC (HR: 0.4, 95% CI: 0.3-0.7, p=0.002) were related to lower cancer progression rates.

Conclusions: Our data shows an effective and safe profile of enzalutamide in a "realworld" perspective in patients with mcRPC.
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http://dx.doi.org/10.23736/S0393-2249.20.03723-6DOI Listing
August 2020

Neoadjuvant Chemotherapy Before Radical Cystectomy: Why We Must Adhere?

Curr Drug Targets 2021 ;22(1):14-21

University of Foggia, Department of Urology and Renal Transplantation, Italy.

Aim: This study provides a critical literature review on state-of-the-art and novel strategies in the field of neoadjuvant treatments for muscle-invasive bladder cancer (MIBC).

Methods: A nonsystematic literature review was performed using PubMed, Scopus and Clinical Trials.gov to retrieve papers related to neoadjuvant treatments for MIBC over the past 15 years. Prospective and retrospective studies were included.

Results: Platinum-based treatment is the gold standard and mainly consists of a combination of cisplatin with vinblastine, methotrexate, doxorubicin, gemcitabine, adriamycin or even epirubicin. The 5- year absolute overall survival benefit of MVAC is 5% and the absolute disease-free survival improves by 9%. CMV treatment is associated with a 10-year overall survival improving from 30% to 36% and a 16% reduction in mortality. Gemcitabine and cisplatin regimen provides complete response in 20% of cases, with non-inferior oncological outcomes compared to MVAC regimen. Recent prospective trials investigating neoadjuvant immunotherapy show a high rate of complete response, from 29% with atezolizumab to 39.5% with pembrolizumab. The tyrosine kinase inhibitor pathway is being explored and could offer an interesting strategy to improve survival outcomes.

Conclusion: Available evidence suggests better oncological outcomes for MIBC patients receiving neoadjuvant treatment before radical cystectomy. While MVAC remains the standard of care in cisplatin eligible patients, novel strategies are under development for cisplatin-ineligible patients, whereby immunotherapy seems to hold great promise.
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http://dx.doi.org/10.2174/1389450121666200802022150DOI Listing
January 2021

Upstaging to pT3a in Patients Undergoing Partial or Radical Nephrectomy for cT1 Renal Tumors: A Systematic Review and Meta-analysis of Outcomes and Predictive Factors.

Eur Urol Focus 2020 Jun 19. Epub 2020 Jun 19.

Division of Urology, VCU Health System, Richmond, VA, USA. Electronic address:

Context: Predictors of upstaging from cT1 to pT3a renal masses are poorly inquired, and this remains an area of controversial findings.

Objective: To evaluate predictors and outcomes of upstaging from cT1 to pT3a in patients undergoing surgical removal of a renal tumor.

Evidence Acquisition: A systematic literature search was performed to identify relevant articles using three electronic engines (PubMed, Embase, and Web of Science). Only studies looking at upstaging to pT3a in patients undergoing either partial nephrectomy (PN) or radical nephrectomy (RN) for cT1 renal tumor were included. Study selection was performed according to the Preferred Reporting Items for Systematic Review and Meta-analysis (PRISMA) statement.

Evidence Synthesis: Thirteen studies, including 21869 patients (cT1/pT3a: 1256 [5.7%]; cT1/pT1: 20613 [93.3%]), were identified. Patients in the upstaged group were older (weighted mean difference [WMD]: 3.89; p < 0.00001) and mostly male (odds ratio [OR]: 1.23; p = 0.04). Renal tumors were larger (WMD: 0.98; p < 0.00001), more complex (OR: 2.38; p < 0.0001), and with a higher rate of cT1b masses (OR: 3.36; p < 0.00001). The cT1/pT3a group had a higher rate of other renal cell carcinoma histological subtypes (OR: 1.59; p = 0.04), as well as higher odds of Fuhrman grade ≥3 (OR: 2.57; p < 0.00001) and positive surgical margins (OR: 1.85; p = 0.007). Five-year recurrence-free survival (RFS) was worse in the upstaged group (OR: 0.31; p = 0.02). Age (OR: 1.03; p < 0.00001), tumor size (OR: 1.51; p < 0.00001), and RENAL score (OR: 2.80; p = 0.0004) were predictors of upstaging. Upstaging was associated with overall survival (hazard ratio [HR]: 1.94; p = 0.05), cancer-specific survival (HR: 2.24; p = 0.007), and RFS (HR: 2.17; p < 0.00001).

Conclusions: Upstaging to pT3a in case of surgical removal of a cT1 renal tumor is an uncommon event, which however can translate into worse oncological outcomes. Both patient (older age) and tumor (larger size and higher complexity) characteristics are associated with a higher risk of upstaging. There is very limited evidence regarding whether RN would be better than PN in these cases. There remains an unmet need for tools to better characterize renal masses in the preoperative setting.

Patients Summary: About 6% of surgically treated localized renal tumors can be found to be locally advanced on final pathology after surgery. This "upstaging" can translate into worse oncological outcomes. There are patient and tumor characteristics that are associated with an increased the risk of upstaging.
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http://dx.doi.org/10.1016/j.euf.2020.05.013DOI Listing
June 2020

Early and Late Efficacy on Wound Healing of Silver Nanoparticle Gel in Males after Circumcision.

J Clin Med 2020 Jun 11;9(6). Epub 2020 Jun 11.

Department of Urology, Azienda Ospedaliera Universitaria Integrata di Verona, 37126 Verona, Italy.

We evaluate the early and late safety and efficacy of silver nanoparticle (AgNPs) in wound healing after circumcision. This multicenter prospective comparative non-randomized observational study compares wound dressing with AgNPs (group A) vs. gentamicin cream (group B). Follow-up included objective evaluation at 10 and 30 days by the Southampton Scoring System (SSS) and Stony Brook Scar Evaluation Scale (SBSES). We enrolled 392 males: 194 in group A, and 198 in group B. At 10 days follow-up, in group A, the SSS scale was grade 1 in 49.5% and grade 2 in the remaining; meanwhile, in group B, grade 1 was in 58%, grade 2 in 34.3%, and grade 4 in 7.6%. At 30 days follow-up, grade 1 healing was 97.4% and 98.4% in group A and B, respectively. At 10 days follow-up, the mean SBSES score was 3.58 and 3.69 in group A and B, respectively; while at 30 days follow-up, 4.81 and 4.76 in group A and B, respectively. Only in group B did 7.6% of males have antibiotic therapy due to pus discharge. No patients needed surgical wound revision. AgNPs led to a late but safer healing, they were non-inferior to the antibiotic cream wound dressing efficacy, and they avoided pus discharge and the need for oral antibiotics due to their polymer material.
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http://dx.doi.org/10.3390/jcm9061822DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7356923PMC
June 2020

Urinary Tract Large Cell Neuroendocrine Carcinoma: Diagnostic, Prognostic and Therapeutic Issues.

Anticancer Res 2020 May;40(5):2439-2447

Urology and Renal Transplantation Unit, Department of Medical and Surgical Sciences, University of Foggia, Foggia, Italy.

Large cell neuroendocrine carcinoma (LCNEC) of the urinary tract is a high-grade neuroendocrine tumor with distinct pathological features, usually portending an aggressive clinical behavior in comparison to conventional urothelial carcinoma. Due to its low prevalence, little is known about its clinical management and there is no current standard of care. The aim of this review was to summarize the current knowledge about LCNEC of the bladder, ureter and kidney, with relevance to diagnostic, prognostic and therapeutic issues, through a systematic analysis of clinical, pathological and outcome data retrieved from the literature.
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http://dx.doi.org/10.21873/anticanres.14213DOI Listing
May 2020

Bioptic intraprostatic chronic inflammation predicts adverse pathology at radical prostatectomy in patients with low-grade prostate cancer.

Urol Oncol 2020 Oct 25;38(10):793.e19-793.e25. Epub 2020 Mar 25.

Department of Urology and Organ Transplantation, University of Foggia, Foggia, Italy.

Purpose: To determine the potential role of bioptic inflammation (Irani score) in predicting adverse pathology (AP) at radical prostatectomy (RP) in patients with low-grade (ISUP Gleason Group [ISUP GG] 1 and 2) prostate cancer (CaP).

Methods: After institutional review board-approval, we identified patients who underwent prostate biopsy, had bioptic Irani score assessment, were diagnosed with low-grade CaP (ISUP GG 1-2, prostate-specific antigen [PSA] <20 ng/ml), and underwent RP. The impact of standard clinicopathological variables and bioptic Irani Score (G = grade and A = aggressiveness) on AP at RP, defined as stage ≥T3 and/or ISUP GG ≥3, was assessed by univariate and multivariate logistic regression analysis.

Results: A total of 282 patients were eligible for this study. AP at RP occurred in 37 of 214 (17.3%) patients with ISUP GG 1, and 26 of 68 (38.2%) with ISUP GG 2. At univariate analysis, serum PSA, PSA density, bioptic ISUP GG, number of positive cores, total percentage of core involvement and Irani G score emerged as significant risk factors of AP. At multivariate analysis, however, only PSA density, bioptic ISUP GG, total percentage of core, and Irani G score kept statistical significance. The area under the curve for the resulting model was 0.75.

Conclusions: This is the first study demonstrating that low-grade inflammation is associated with a significantly increased risk of AP at RP. These findings would support the concept of prostatic inflammation being inversely correlated with presence and aggressiveness of CaP. Further studies are needed to externally validate the role of this readily available parameter in the decision-making process of patients with low-grade CaP.
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http://dx.doi.org/10.1016/j.urolonc.2020.02.025DOI Listing
October 2020

Performance of prostate multiparametric MRI for prediction of prostate cancer extra-prostatic extension according to NCCN risk categories: implication for surgical planning.

Minerva Urol Nefrol 2020 Dec 16;72(6):746-754. Epub 2020 Mar 16.

Department of Urology, Icahn School of Medicine at Mount Sinai, New York, NY, USA.

Background: Prediction of extra-prostatic extension (EPE) in men undergoing radical prostatectomy (RP) is of utmost importance. Great variability in the performance of multiparametric magnetic resonance imaging (mpMRI) has been reported for prediction of EPE. The present study aimed to determine the diagnostic performance of mpMRI for predicting EPE in different National Comprehensive Cancer Network (NCCN) risk categories.

Methods: Overall 664 patients who underwent radical prostatectomy with a staging mpMRI were enrolled in this single-center, retrospective study. Patients with mpMRI report non-compliant with PI-RADSv2.0, were excluded. Patients were stratified according to NCCN criteria: very low/low (VLR-LR) to High Risk (HR) in order to assess final pathology EPE rates (focal and established). Sensitivity, specificity, positive and negative predictive values of staging mpMRI were computed in each group. Univariable and multivariable analysis were used to evaluate predictors of positive surgical margins.

Results: Pathological evaluation demonstrated established and focal EPE in 60 (9%) and 106 (16%) patients, respectively, while mpMRI suspicion for EPE was present in 180 (27%) patients. Age, preoperative PSA, PSA density, number of positive cores, NCCN groups, prostate volume, mpMRI suspicion for EPE, PIRADSv2.0 and lesion size differed significantly between the patients with any EPE and without EPE (all P≤0.05). The sensitivity of mpMRI in detecting any EPE varied from 12% (95% CI: 0.6-53%) in VLR-LR to 83% (66-93%) in HR while the corresponding values for the specificity were 92% (85-96%) and 63% (45-78%), respectively. Patients with false-negative mpMRI EPE prediction were more likely to have positive surgical margins in univariable (OR: 2.14; CI: 1.18, 3.87) as well as multivariable analysis adjusting for NCCN risk categories (OR: 1.97; CI: 1.08, 3.60).

Conclusions: The performance of mpMRI for prediction of EPE varies greatly between different NCCN risk categories with a low positive predicting value in patients at low to favorable intermediate risk and a low negative predictive value in patients at Unfavorable intermediate to high risk PCa. Given that mpMRI EPE misdiagnosis could have a negative impact on oncological and functional outcomes, NCCN risk categories should be considered when interpreting mpMRI findings in PCa patients.
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http://dx.doi.org/10.23736/S0393-2249.20.03688-7DOI Listing
December 2020

Impact of time to second transurethral resection on oncological outcomes of patients with high-grade T1 bladder cancer treated with intravesical Bacillus Calmette-Guerin.

World J Urol 2020 Dec 15;38(12):3161-3167. Epub 2020 Feb 15.

Department of Urology and Renal Transplantation, University of Foggia, Foggia, Italy.

Purpose: To determine the impact of time to restaging transurethral resection (Re-TUR) on recurrence-free survival (RFS), progression-free survival (PFS), and cancer specific survival (CSS) of patients with high-grade T1 bladder cancer (BC) treated with intravesical Bacillus Calmette-Guerin (BCG).

Materials And Patients: Our prospectively maintained NMIBC databases were queried to identify patients with high-grade T1 BC who underwent Re-TUR before receiving intravesical BCG treatment (induction + 1-year maintenance). Patients were divided into three groups based on time to Re-TUR (group A: ≤ 6 weeks; group B: > 6-12 weeks; group C: > 12-18 weeks). Kaplan-Meier plots were used to estimate differences in RFS, PFS, and CSS. Multivariate Cox regression analysis was used to assess the impact of time to Re-TUR on oncological outcomes.

Results: Overall, 269 high-grade T1 BC patients were eligible for the analysis. Nineteen (7.1%) had concomitant CIS. Median follow-up was 49.3 (IQR 25-65) months. Kaplan-Meier plots showed no differences in RFS, PFS, and CSS between the three groups. Multivariate Cox regression analysis showed that Group B had a slightly better RFS, while the other outcomes were not affected by time to Re-TUR.

Conclusions: This is the first study testing the role of time to Re-TUR in a homogeneous population of patients with high-grade T1 BC who received complete BCG treatment. The study challenged the concept the sooner the Re-TUR the better, since time to Re-TUR did not significantly affect oncological outcomes.
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http://dx.doi.org/10.1007/s00345-020-03108-zDOI Listing
December 2020

Evaluation of Patterns of Presentation, Practice, and Outcomes of Upper Tract Urothelial Cancer: Protocol for an Observational, International, Multicenter, Cohort Study by the Clinical Research Office of the Endourology Society.

JMIR Res Protoc 2020 Jan 24;9(1):e15363. Epub 2020 Jan 24.

Istanbul Medipol University, Istanbul, Turkey.

Background: Available guidelines on the management of upper tract urothelial carcinoma (UTUC) are restricted due to the lack of strong evidence-based recommendations. Adequate, well-powered randomized trials are missing due to the rarity of the disease. To overcome this problem, we need alternative study designs to provide generalizable data.

Objective: The primary aim of this registry is to provide a real-world overview on patterns of presentation and management of UTUC. Secondary objectives include comparison of outcomes of different treatments and tumor stages and evaluation of compliance with the current European Association of Urology recommendations for UTUC.

Methods: For this observational, international, multicenter, cohort study, clinical data of consecutive patients suspected of having UTUC, irrespective of type of management, will be prospectively collected up to 5 years after inclusion. Data on the patterns of presentation, diagnostics, and treatment as well as short-, mid-, and long-term oncological and functional outcomes will be analyzed. Possible associations between variables, basal characteristics, and outcomes will be tested by multivariable analyses. The methodology will address potential sources of bias and confounders.

Results: The registry was initiated in November 2014 after obtaining institutional review board approval. Data collection started in December 2014. At the time of submission of this manuscript, 2451 patients from 125 centers from 37 countries were included. Inclusion of patients will be closed 5 years after initiation of the registry. Quality checks will be performed centrally with continuous communication and feedback with the centers to ensure accuracy. The first results are expected in the first trimester of 2020.

Conclusions: This large observational prospective cohort will generate landmark "real-world" data and hypotheses for further studies. We expect these data to optimize the management of UTUC, provide insights on harms and benefits of treatment, and serve as quality control.

Trial Registration: ClinicalTrials.gov NCT02281188; https://clinicaltrials.gov/ct2/show/NCT02281188.

International Registered Report Identifier (irrid): DERR1-10.2196/15363.
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http://dx.doi.org/10.2196/15363DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7007587PMC
January 2020

Staging Accuracy of Multiparametric Magnetic Resonance Imaging in Caucasian and African American Men Undergoing Radical Prostatectomy.

J Urol 2020 Jul 24;204(1):82-90. Epub 2020 Jan 24.

Department of Urology, Icahn School of Medicine at Mount Sinai, New York, New York.

Purpose: We compared the performance of multiparametric magnetic resonance imaging for the prediction of extraprostatic extension in African American and Caucasian American men and evaluated racial disparities in pathological outcomes after radical prostatectomy.

Materials And Methods: We identified 975 patients who underwent radical prostatectomy with preoperative multiparametric magnetic resonance imaging between January 2013 and April 2019 at our institution. Multivariable logistic regression analysis was performed predicting pathological extraprostatic extension, high grade prostate cancer (final pathology GGG [Gleason Grade Group] 3 or greater) in the overall population and pathological upgrading (final pathology GGG 3 or greater) in patients with a diagnosis of GGG 1-2 prostate cancer. Adverse pathology was defined as pT3 and/or GGG 3 or greater.

Results: A total of 221 (23%) patients were African American. Preoperatively 594 (60.9%) were GGG 1-2 (low risk group) and 381 (39.1%) GGG 3 or greater (high risk group). In the low risk group rates of pathological extraprostatic extension (18% vs 12.8%, p=0.14), adverse pathology (18% vs 13.4%, p=0.2) or upgrading (9.4% vs 12.1%, p=0.4) were similar between races. Similarly, in the high risk group there was no difference in rates of pathological extraprostatic extension. On multivariable analysis multiparametric magnetic resonance imaging predicted the presence of extraprostatic extension (OR 1.80, 95% CI 1.29-2.50) and high grade prostate cancer (OR 1.82, 95% CI 1.25-2.67) on final pathology. Conversely, race did not predict the outcomes of interest (all values p >0.05). Multiparametric magnetic resonance imaging showed comparable sensitivity (22.22% vs 27.84%), specificity (89.2% vs 79.2%), positive predictive value (89.2% vs 83.4%) and negative predictive value (89.2% vs 83.4%) between African American and Caucasian America men, respectively.

Conclusions: The accuracy of multiparametric magnetic resonance imaging in staging prostate cancer was similar in African American and Caucasian American patients and no difference was found between races in pathological outcomes after radical prostatectomy. These findings suggest that access to and use of advanced diagnostic tests may help mitigate prostate cancer racial disparities.
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http://dx.doi.org/10.1097/JU.0000000000000774DOI Listing
July 2020

Role of androgen receptor expression in non-muscle-invasive bladder cancer: a systematic review and meta-analysis.

Histol Histopathol 2020 May 5;35(5):423-432. Epub 2019 Dec 5.

AGILE Group (Italian Group for Advanced Laparoscopic and Robotic Urologic Surgery), Italy.

In order to evaluate the potential prognostic/predictive role of androgen receptor (AR) expression in non-muscle-invasive bladder cancer (NMIBC), and whether it may represent a therapeutic target, we conducted a systematic search of the literature using 'androgen receptor or AR', 'testosterone', 'bladder cancer' and 'non-muscle invasive bladder cancer or NMIBC' as keywords. Eleven studies met the inclusion/exclusion criteria. No significant association was found between AR status and patients' gender (p=0.232), tumor size (p=0.975), tumor stage (p=0.237), tumor grade (p=0.444), tumor multicentricity (p=0.397), concomitant CIS (p=0.316) and progression of disease (p=0.397). On the other hand, relative lack of AR expression was significantly correlated to recurrent disease (p=0.001). Evidence for a direct correlation between AR expression and recurrence-free survival of patients with NMIBC indicate ARs as potential markers of BC behavior; moreover, the finding of a role of androgen blockade therapy in improving survival highlights the potential clinical application of this pathway, which deserves to be further explored.
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http://dx.doi.org/10.14670/HH-18-189DOI Listing
May 2020

Avoiding Unnecessary Magnetic Resonance Imaging (MRI) and Biopsies: Negative and Positive Predictive Value of MRI According to Prostate-specific Antigen Density, 4Kscore and Risk Calculators.

Eur Urol Oncol 2020 10 20;3(5):700-704. Epub 2019 Sep 20.

Department of Urology, Icahn School of Medicine at Mount Sinai, New York, NY, USA.

The 2019 European Association of Urology guidelines recommend multiparametric magnetic resonance imaging (mpMRI) for biopsy-naïve patients with clinical suspicion of prostate cancer (PC) and avoiding biopsy in patients with negative mpMRI and low clinical suspicion. However, consensus on the optimal definition of low clinical suspicion is lacking. We evaluated 266 biopsy-naïve patients who underwent mpMRI, the 4Kscore test, and prostate biopsy to define the best strategy to avoid unnecessary testing and biopsies. The European Randomized Study of Screening for Prostate Cancer risk calculator (ERSPC-RC) and prostate-specific antigen density (PSAd) were also considered. For men with Prostate Imaging-Reporting and Data System v2.0 (PI-RADS) 1⿿2 lesions, the highest negative predictive value was observed for those with low or intermediate 4Kscore risk (96.9% and 97.1%), PSAd <0.10ng/ml/cm (98.7%), and ERSPC-RC <2% (98.7%). For men with PI-RADS 3⿿5 lesions the lowest positive predictive value was observed for those with low 4Kscore risk (0%), PSAd <0.10ng/ml/cm (13.2%), and ERSPC-RC <2% (12.3%). The best biopsy strategy was an initial 4Kscore followed by mpMRI if the 4Kscore was>7.5% and a subsequent biopsy if the mpMRI was positive (PI-RADS 3⿿5) or the 4Kscore was ⿥18%. This would result in missing 2.7% (2/74) of clinically significant PCs (csPCs) and avoiding 34.2% of biopsies. Initial mpMRI followed by biopsy for negative mpMRI (PI-RADS 1⿿2) if the 4Kscore was ⿥18% or PSAd was ⿥0.10ng/ml/cm resulted in a similar percentage of csPC missed (2.7% [2/74] and 1.3% [1/74]) but slightly fewer biopsies avoided (25.2% and 28.1%). Physicians should consider clinical risk screening tools when ordering and interpreting mpMRI results to avoid unnecessary testing and diagnostic errors. PATIENT SUMMARY: Performing the 4Kscore test in conjunction with multiparametric magnetic resonance imaging for men with a clinical suspicion of prostate cancer may help to reduce unnecessary biopsies.
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http://dx.doi.org/10.1016/j.euo.2019.08.015DOI Listing
October 2020

Is Repeat Transurethral Resection Always Needed in High-Grade T1 Bladder Cancer?

Front Oncol 2019 4;9:465. Epub 2019 Jun 4.

Urology and Renal Transplantation Unit, Department of Medical and Surgical Sciences, University of Foggia, Foggia, Italy.

Re-staging transurethral resection, the so-called repeat TUR (Re-TUR), is mandatory in case of incomplete first transurethral resection of bladder tumor (TURBT). In completely resected high grade T1 tumors, Re-TUR is recommended but question remains whether it provides advantages in terms of recurrence-free survival (RFS), progression-free survival (PFS), and cancer specific survival (CSS). The present study aimed to determine whether Re-TUR improves such outcomes in patients with completely resected high-grade T1 bladder cancer (BC). We queried our prospectively maintained database to identify patients with completely resected high-grade T1 BC who underwent (Group A) or not (Group B) Re-TUR before starting intravesical instillations of Bacillus Calmette-Guerin (BCG). The impact of Re-TUR as well as of other tested variables on RFS, PFS, and CSS was tested by Kaplan-Meier method and Log-rank testing. A total of 118 patients underwent Re-TUR, which pointed out no BC in 61 (51.7%), NMIBC in 54 (45.8%) and pT2 disease in 3 (2.5%). The 3 patients with pT2 disease underwent cystectomy, whereas all others were offered BCG treatment. Forty-two patients refused BCG treatment while 2 did not complete it; therefore, Group A (Re-TUR before BCG treatment) consisted of 71 patients whereas Group B consisted of 40 patients who refused Re-TUR but completed BCG treatment. Mean follow-up was 60 months (range 12-142). Kaplan-Meier curves and Log-rank testing showed no difference in RFS, PFS and CSS between patients who had (Group A) or had not (Group B) Re-TUR before starting BCG treatment. Our findings suggest that a Re-TUR in patients with a completely resected high-grade T1 BC does not translate into a better oncological outcome. Given its impact on both patients and healthcare system, the need for Re-TUR in completely resected high grade T1 BC should be further investigated into the framework of a randomized study.
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http://dx.doi.org/10.3389/fonc.2019.00465DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6558035PMC
June 2019

Major Acute Cardiovascular Events After Transurethral Prostate Surgery: A Population-based Analysis.

Urology 2019 Sep 28;131:196-203. Epub 2019 May 28.

Department of Surgery, Division of Urology, VCU Health, Richmond, VA.

Objective: To test the prevalence and predictors of major acute cardiovascular events (MACE) after transurethral prostate surgery (TPS).

Material And Methods: The American College of Surgeons National Surgical Quality Improvement Program database (2011-2016) was queried for patients who underwent transurethral resection of the prostate, photoselective vaporization, or laser enucleation. MACE included: cerebrovascular events, cardiac arrest, myocardial infarction, deep venous thrombosis requiring therapy, and pulmonary embolism episodes occurred up to 30 days after discharge. Univariable and multivariable logistic regression models tested MACE predictors and effect of MACE on perioperative mortality. Within covariates significant at univariable analyses a stepwise selection, based on Akaike Information Criterion values, was performed to fit the most appropriate multivariable model.

Results: Overall 44,939 patients were included in our analyses. Of these 365 (0.8%) had MACE within 30 days after surgery. The strongest MACE predictors were recent congestive heart failure (odds ratio [OR]: 2.1, 95% confidence interval [CI]: 1.2-3.7, P = .007), transfusions (OR: 2.5, 95% CI: 1.5-4.1, P <.001) and preoperative Systemic Inflammatory Response Syndrome or sepsis (OR: 2.6, 95% CI: 1.6-4.2, P <.001). Similarly, inpatient (OR: 2.0, 95% CI: 1.6-2.5, P <.001) and nonelective (OR: 1.5, 95% CI: 1.1-2.1, P = .012) patients experienced higher MACE rates. Perioperative mortality rates were statistical significantly higher in MACE patients (OR: 13.1, 95% CI: 8.2-21.0, P <.001).

Conclusion: Up to 1% of patients undergoing transurethral prostate surgery experience MACE. MACE are burdened by high mortality rates (up to 14% in MACE patients). Proper patient selection and postoperative monitoring are necessary to reduce MACE incidence and mortality rates.
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http://dx.doi.org/10.1016/j.urology.2019.05.014DOI Listing
September 2019

Diagnostic and prognostic roles of CK20 in the pathology of urothelial lesions. A systematic review.

Pathol Res Pract 2019 Jun 6;215(6):152413. Epub 2019 Apr 6.

Urology and Renal Transplantation Unit, Department of Medical and Surgical Sciences, University of Foggia, Foggia, Italy.

Cytokeratin 20 (CK20) is one of the most common immunohistochemical markers in the routine practice of a pathology lab, as biopsies from the urinary tract encompass a wide spectrum of lesions which may pose issues in their detection and classification. In this review, we aim to outline the diagnostic accuracy and prognostic value of CK20 in flat urothelial lesions, papillary non-invasive and invasive urothelial carcinoma, molecular subgroups and variant histology, and we briefly discuss its limitations and potential pitfalls.
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http://dx.doi.org/10.1016/j.prp.2019.04.005DOI Listing
June 2019

Defining Prostate Cancer at Favorable Intermediate Risk: The Potential Utility of Magnetic Resonance Imaging and Genomic Tests.

J Urol 2019 07 7;202(1):102-107. Epub 2019 Jun 7.

Department of Urology, Icahn School of Medicine at Mount Sinai , New York , New York.

Purpose: We determined whether prostate multiparametric magnetic resonance imaging and genomic biomarkers might help further define patients with favorable intermediate risk prostate cancer which could safely be considered suitable for active surveillance.

Materials And Methods: From our institutional database we identified 509 patients who underwent radical prostatectomy with preoperative magnetic resonance imaging and a postoperative Decipher® prostate cancer test. According to the NCCN® (National Comprehensive Cancer Network®) risk stratification 125 men had favorable intermediate and 171 had unfavorable intermediate risk disease. Univariable and multivariable binary logistic regression analyses were done to test the utility of different variables in predicting adverse pathology, defined as Gleason Grade Group greater than 2, pT3b or pN1.

Results: On univariable analysis favorable intermediate risk, multiparametric magnetic resonance imaging and the prostate cancer test significantly predicted adverse pathology. On multivariable analysis favorable intermediate risk and the prostate cancer test maintained independent predictive value while multiparametric magnetic resonance imaging did not meet statistical significance (p = 0.059). The 19 patients at favorable intermediate risk with high genomic risk had an adverse pathology rate slightly higher than patients at unfavorable intermediate risk (42.1% vs 39.8%, p = 0.56). Those at low genomic risk had an adverse pathology rate slightly lower than patients at very low or low risk (7.5% vs 10.2%, p = 0.84). The 31 patients at favorable intermediate risk but at high multiparametric magnetic resonance imaging and genomic risk had an adverse pathology rate slightly lower than patients at unfavorable intermediate risk (25.8% vs 39.8%, p = 0.14). Those at low multiparametric magnetic resonance imaging and genomic risk had an adverse pathology rate slightly lower than patients at very low or low risk (8.5% vs 10.2%, p = 0.89).

Conclusions: Multiparametric magnetic resonance imaging and the Decipher test allowed us to better define the risk of adverse pathology in patients at favorable intermediate risk who were diagnosed with prostate cancer.
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http://dx.doi.org/10.1097/JU.0000000000000134DOI Listing
July 2019

Prognostic and therapeutic role of HER2 expression in micropapillary carcinoma of the bladder.

Mol Clin Oncol 2019 Feb 7;10(2):205-213. Epub 2018 Dec 7.

Department of Urology and Renal Transplantation, University Hospital, I-71121 Foggia, Italy.

Micropapillary carcinoma of the bladder (MPBC) is a variant type of infiltrating urothelial carcinoma, which portends a poor biological behavior in terms of disease stage at first diagnosis and clinical outcome; its peculiar morphology raises issues concerning the ability of tumor detection by imaging techniques and proper biopsy procedure, and the appropriate treatment for non-muscle infiltrating and muscle-infiltrating MPBC remains a matter of debate. On the basis of its established prognostic and therapeutic role in breast and gastro-esophageal cancer in the first instance, the human epidermal growth factor receptor-2 (HER2) has been investigated in selected case series of MPBC over the last 10 years. The aim of the present review was to summarize the existing evidence on HER2 status in MPBC, and to discuss its present and future utility in risk assessment and treatment choice of this uncommon, yet aggressive, disease.
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http://dx.doi.org/10.3892/mco.2018.1786DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6327213PMC
February 2019

Combined Plaque Incision, Buccal Mucosa Grafting, and Additional Tunica Albuginea Plication for Peyronie's Disease.

Sex Med 2019 Mar 11;7(1):48-53. Epub 2018 Dec 11.

Department of Urology and Renal Transplantation, University of Foggia, Foggia, Italy.

Introduction: Surgery remains the gold standard for treatment in stable patients with penile deformity associated to Peyronie's disease (PD).

Aim: To evaluate the long-term results of plaque incision and buccal mucosa grafting (BMG), with or without additional tunica albuginea plication (TAP), in the correction of severe penile curvatures secondary to PD.

Methods: 72 patients with severe curvature caused by PD, normal erections, and stable disease entered this prospective study. Preoperatively, they underwent penile duplex ultrasounds with measurement of curvature and length of affected side. All procedures were carried out by 1 surgeon. Patients were seen at 1, 3, 6, and 12 months postoperatively, then yearly. Subjective outcome was assessed by the Sexual Encounter Profile (SEP) questionnaire, and objective outcome was assessed by an intracavernous injection (ICI) test performed within the first year for evaluating penile rigidity, straightness, and length.

Main Outcome Measure: Long-term outcomes include penile straightening, penile shortening, and sexual satisfaction.

Results: Mean curvature was 71.32 ± 17.6° (range 40-110); 33 (45.8%) patients had a 2-sided curvature with a mean second curvature of 33.79 ± 12.2° (range 10-60). Additional TAP was needed in 60% of patients for complete straightening or graft stretching. All patients resumed unassisted intercourse 1 month after surgery; 4 (5.5%) refused follow-up, claiming excessive penile shortening. In the remaining 68, the ICI test showed no recurvature, shortening, or de novo erectile dysfunction. At mean follow-up of 62.01 ± 34.3 months (range 12-135), all were able to obtain an erection (SEP-1), 97.1% to penetrate (SEP-2), and 89.7% to successfully complete intercourse (SEP-3); 80.9% of them were satisfied with erection hardness (SEP-4) and 86.8% were overall satisfied (SEP-5), with the main reason for dissatisfaction being expectation of better length and rigidity.

Conclusion: BMG, with or without TAP, provides excellent long-term results and is safe and reproducible, representing a valuable treatment option for PD, but great care should be taken in patient counseling to avoid unrealistic expectations. Cormio L, Mancini V, Massenio P. Combined Plaque Incision, Buccal Mucosa Grafting, and Additional Tunica Albuginea Plication for Peyronie's Disease. Sex Med 2019;7:48-53.
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http://dx.doi.org/10.1016/j.esxm.2018.11.002DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6377369PMC
March 2019

Morphological and Immunohistochemical Biomarkers in Distinguishing Prostate Carcinoma and Urothelial Carcinoma: A Comprehensive Review.

Int J Surg Pathol 2019 Apr 3;27(2):120-133. Epub 2018 Dec 3.

1 University Hospital, Foggia, Italy.

The differential diagnosis between high-grade prostate carcinoma and infiltrating urothelial carcinoma (UC) in transurethral resection prostate specimens as well as cystoprostatectomy specimens may often be challenging due to morphologic and clinical overlap of the 2 entities. Such distinction has critical therapeutic and staging consequences, yet it is hampered by both issues in morphology and by the low accuracy rates of single immunohistochemical markers, as reported in literature. This review aims to provide a comprehensive analysis of the available morphological and immunohistochemical parameters, which may allow to discriminate between prostate carcinoma and urothelial carcinoma in the proper clinical context and to discuss their diagnostic applications in daily practice.
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http://dx.doi.org/10.1177/1066896918814198DOI Listing
April 2019

Human Epidermal Growth Factor Receptor 2 in Non-Muscle Invasive Bladder Cancer: Issues in Assessment Methods and Its Role as Prognostic/Predictive Marker and Putative Therapeutic Target: A Comprehensive Review.

Urol Int 2019 21;102(3):249-261. Epub 2018 Nov 21.

Department of Urology and Renal Transplantation, University of Foggia, Foggia, Italy.

Although human epidermal growth factor receptor 2 (HER2) plays a prognostic and predictive role in breast and gastric cancer, its function in bladder cancer (BC) is still controversial. A comprehensive review of the literature has been carried out. An electronic search of databases from PubMed, Scopus, Google Scholar was implemented. The search terms were: "BC," "bladder carcinoma," "bladder neoplasm," "human epidermal growth factor 2," "HER2," "HER-2," "c-erbB-2," "c-erbB2," "erbB-2," "erbB2," "neu," "marker," "biomarker," and "prognosis". Results of the review consented to (a) summarize the available data on HER2 a predictor of recurrence and/or progression free survival on univariate and multivariate analysis, (b) explore the related issues in assessing HER2 status on these tumor samples, since they may severely impair its predictive function, and (c) report the state-of-the art of HER2 as a putative therapeutic target in BC and especially non-muscle invasive BC. HER2 stands out for being a prognostic factor as well as a therapeutic target in various cancers. Data from the literature concerning its use in BC provide conflicting results, probably due to the inherent complexity of BC biology. Efforts should be made to establish a suitable tumor-specific scoring system, and to assess single drugs' efficacy in well-designed clinical trials.
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http://dx.doi.org/10.1159/000494359DOI Listing
December 2019