Publications by authors named "Gabriele Tuderti"

37 Publications

Effect of vacation on urinary symptoms in health care workers: an Italian multicenter study.

Minerva Urol Nephrol 2021 Mar 29. Epub 2021 Mar 29.

Department of Urology, Sant'Andrea Hospital, Rome, Italy.

Background: Aim of our study was to assess the impact of vacation on urinary symptoms in health care workers.

Methods: Between March 2018 to October 2019 a survey was carried out by enrolling health care system workers in three centers. Demographic and clinical characteristics of health care workers (i.e. age, smoking status, medical history) were collected. Lower Urinary tract symptoms (LUTS) and work related quality of life were assessed before and after vacation with validated questionnaires: Overactive Bladder Questionnaire Short Form (OABq-sf), International Prostate Symptom Score (IPSS), Work-related Quality of Life (WRQOL) and SF-36 questionnaires. As well, Night Shift Workers (NSWs), defined as working at least one time a week from 8 pm to 8 am, were compared to traditional workers (TWs).

Results: A total of 236 participants (118 males and 118 females) with a median of 41 (32/49 IQR) years old were included in the survey. Healthcare workers presented after vacation an improvement in LUTS, in work related quality of life and overall health. Overall, 89 (37%) were NSWs and 147 (62%) subjects were TWs. NSWs reported a significant higher median OABq total score and IPSS than TWs: respectively, 27 (IQR 23-34) vs 20 (IQR 19-24) p 0,01, 2 (0/6) vs 0 (0/2) (p<0,01). No significative differences were found for WRQOL and SF36, respectively 66 (IQR 59/77) vs 67 (IQR 61/82) (p<0,29) and 98 (97/101) vs 98 (97/100) (p<0,79).

Conclusions: NSWs present worst urinary symptoms when compared to TWs. Vacation has a beneficial effect, particularly in NSWs, on urinary symptoms and work related quality of life.
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http://dx.doi.org/10.23736/S2724-6051.21.04274-0DOI Listing
March 2021

Comparison of Patient-reported Health-related Quality of Life Between Open Radical Cystectomy and Robot-assisted Radical Cystectomy with Intracorporeal Urinary Diversion: Interim Analysis of a Randomised Controlled Trial.

Eur Urol Focus 2021 Mar 9. Epub 2021 Mar 9.

Department of Urology, IRCCS Regina Elena National Cancer Institute, Rome, Italy.

Background: Open radical cystectomy (ORC) is still considered the reference approach for RC, although robot-assisted RC (RARC) has recently gained in popularity. There are literature reports on perioperative and oncologic outcomes of RARC, but functional outcomes and aspects related to health-related quality of life (HRQoL) remain unexplored.

Objective: To report an interim analysis of 1-yr HRQoL outcomes from an ongoing randomised controlled trial comparing ORC and RARC with totally intracorporeal urinary diversion (iUD) (ClinicalTrials.gov NCT03434132).

Design, Setting, And Participants: Patients with cT2-4N0M0 non-muscle-invasive bladder cancer or bacillus Calmette-Guérin failure who were candidates for cystectomy with curative intent without absolute contraindications to robotic surgery were included. A covariate adaptive randomisation based on the following variables was used: body mass index, American Society of Anesthesiologists score, preoperative haemoglobin level, cT stage, type of UD, and neoadjuvant chemotherapy.

Intervention: ORC or RARC with iUD.

Outcome Measurements And Statistical Analysis: Data from patient-reported European Organization for Research and Treatment of Cancer QoL questionnaires (QLQ-C30 and QLQ-BLM30) were collected at baseline and 1 yr. Continuous variables were compared using the Student t test.

Results And Limitations: At interim analysis, 51 patients (24 RARC, 27 ORC) were analysed. Overall, both groups reported significant worsening of body image and physical and sexual functions (all p ≤ 0.012). Patients receiving ORC were more likely to report significant 1-yr impairment of role functioning, symptoms scales and bowel symptoms (all p ≤ 0.048). Patients receiving RARC reported significant impairment of urinary symptoms and problems (p = 0.018).

Conclusions: This study suggests equivalence between RARC-iUD and ORC for most HRQoL domains. Notwithstanding, after 1 yr patients receiving ORC were more likely to experience a decline in role functioning and higher symptoms scale, while RARC-iUD patients were more likely to report significant increases in urinary symptoms and problems.

Patient Summary: We analysed 1-year data for health-related quality of life from an ongoing trial comparing open and robotic surgery for removal of the bladder in patients with bladder cancer. Robotic surgery seems to provide benefits for most quality-of-life items on patient-reported questionnaires. This trial is registered at ClinicalTrial.gov as NCT03434132.
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http://dx.doi.org/10.1016/j.euf.2021.03.002DOI Listing
March 2021

Fusion US/MRI prostate biopsy using a Computer Aided Diagnostic (CAD) system.

Minerva Urol Nefrol 2020 Nov 12. Epub 2020 Nov 12.

Department of Urology, Regina Elena National Cancer Institute, Rome, Italy.

Background: To investigate the impact of Computer Aided Diagnostic (CAD) system on the detection rate of prostate cancer (PCa) in a series of fusion prostate biopsy (FPB).

Methods: Two prospective transperineal FPB series (with or without CAD assistance) were analyzed and PCa detection rates compared with per patient and per target analyses. Chi-Square and Mann-Whitney test were used to compare categorical and continuous variables, respectively. Univariable and multivariable regression analyses were applied to identify predictors of any and clinically-significant (cs) PCa detection. Subgroup analyses were performed after stratifying for PIRADS Score and lesion location.

Results: Out of 183 FPB, 89 were performed with CAD assistance. At per patient analysis the detection rate of any PCa and of cs PCa were 56.3% and 30.6%, respectively; the aid of CAD was negligible for either any PCa or csPCa detection rates (p=0.45 and p=0.99, respectively). Conversely in a per target analysis, CAD-assisted biopsy had significantly higher positive predictive value (PPV) for any PCa versus MRI-only group (58%vs37.8%, p=0.001). PI-RADS Score was the only independent predictor of any and csPCa, either in per patient or per target multivariable regression analysis (all p<0.029). In a subgroup per patient analysis of anterior/transitional zone lesions, csPCa detection rate was significantly higher in the CAD cohort (54.5%vs11.1%, respectively; p=0.028), and CAD assistance was the only predictor of csPCa detection (p=0.013).

Conclusions: CAD assistance for FPB seems to improve detection of csPCa located in anterior/transitional zone. Enhanced identification and improved contouring of lesions may justify higher diagnostic performance.
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http://dx.doi.org/10.23736/S0393-2249.20.04008-4DOI Listing
November 2020

Robot-assisted radical cystectomy with intracorporeal neobladder: impact of learning curve and long-term assessment of functional outcomes.

Minerva Urol Nefrol 2020 Oct 5. Epub 2020 Oct 5.

Department of Urology, "Regina Elena" National Cancer Institute, Rome, Italy.

Background: There is paucity of data about functional outcomes of Robot-assisted Radical Cystectomy (RARC) with intracorporeal orhotopic neobladder (ICON), and the impact of learning curve (LC) on those outcomes remains to be addressed. We aimed to report long-term functional outcomes of our single center series of RARC with ICON, assessing the role of LC in their achievement.

Methods: Patients treated with Robot assisted radical cystectomy with intracorporeal orthotopic neobladder in our center between January 2012 an August 2019 were retrospectively analysed. Preoperative, clinical, perioperative, pathologic and functional data were reported. The first cases were divided in tertiles, for assessing the impact of learning curve on the outcomes evaluated. Long-term functional outcomes of the whole cohort were evaluated.

Results: Overall, 167 patients were included. Concerning tertiles analysis, operative time (p<0.001), incidence of low (p=0.002) and high grade (p=0.001) complications and hospital stay (p=0.04) decreased significantly over time. Day-time continence recovery probability was significantly lower in the initial case series (1-yr rate 68.4%, 87% and 89.8 for I, II and III tertile, respectively; p=0.04;). Accordingly, Trifecta achievement was significantly higher in II and III tertiles (p=0.01). At a median follow- up of 34 months, the incidence of significant renal function deterioration of the whole cohort was 16.7%. Overall, 12, 24 and 60-mo day-time continence rates were 74.8 %, 82.7 % and 82.7 %.

Conclusions: Patients treated at the beginning of the learning curve show worse perioperative and functional results. Once standardized the procedure, complications rates, hospital stay and daytime continence recovery experienced a significant improvement. At a long-term analysis of functional outcomes of our patients, renal function preservation and continence recovery results are encouraging.
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http://dx.doi.org/10.23736/S0393-2249.20.03948-XDOI Listing
October 2020

Assessing the Impact of the Absence of Detrusor Muscle in Ta Low-grade Urothelial Carcinoma of the Bladder on Recurrence-free Survival.

Eur Urol Focus 2020 Sep 6. Epub 2020 Sep 6.

Department of Urology, "Regina Elena" National Cancer Institute, Rome, Italy.

Background: Obtaining detrusor muscle (DM) in transurethral resection of bladder tumor (TURBt) specimen is considered a surrogate marker of resection quality. However, evidence was principally investigated in high-risk tumors. Therefore, DM sampling for low-grade (LG) urothelial carcinoma (UC) remains poorly investigated and certainly requires further investigation.

Objective: To assess whether the absence of DM in TURBt specimen has a negative impact on recurrence-free survival (RFS) in patients with a Ta LG UC.

Design, Setting, And Participants: A multicenter TURBt database was queried for "LG, Ta, UC of the bladder." All patients treated between 1996 and 2018 with tumor grade assessed according to both 1973 World Health Organization and 2004 WHO/International Society of Urological Pathology grading classifications and with a minimum follow-up of 1 yr were included. Patients with a previous history of high-grade UC, upper urinary tract UC, or bladder tumor differentiations other than UC were excluded.

Intervention: TURBt.

Outcome Measurements And Statistical Analysis: Baseline demographic, clinical, and pathologic data were analyzed. The European Organization for Research and Treatment of Cancer (EORTC) risk group was recorded. Kaplan-Meier analysis was performed to assess the predictive role of clinical and pathologic data for RFS. Univariable and multivariable Cox regression analyses were performed to identify the predictors of recurrence.

Results And Limitations: Overall, 521 patients were included. At Kaplan-Meier analysis, the low-risk cohort displayed significantly higher RFS than the intermediate-risk cohort (1-yr RFS 87% vs 79%; log-rank p = 0.007). At univariable Cox regression analysis, only gender, multiple tumors, tumor diameter ≥3 cm, and EORTC risk group were significant predictors of recurrence. Absence of DM had no impact on RFS. Multivariable Cox regression analysis confirmed gender and EORTC risk group as independent predictors of recurrence.

Conclusions: Absence of DM in TURBt specimen has negligible role in RFS of patients with Ta LG tumors of the bladder.

Patient Summary: In this study, we assessed the role that detrusor muscle (DM) in transurethral resection of bladder tumor specimen has in recurrence-free survival, in patients with a Ta low-grade urothelial carcinoma of the bladder. Absence of DM has no impact on tumor recurrence; therefore, it does not require additional attention.
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http://dx.doi.org/10.1016/j.euf.2020.08.007DOI Listing
September 2020

Impact of Clinical Response to Neoadjuvant Chemotherapy in the Era of Robot Assisted Radical Cystectomy: Results of a Single-Center Experience.

J Clin Med 2020 Aug 24;9(9). Epub 2020 Aug 24.

Department of Urology, Regina Elena National Cancer Institute, Via Elio Chianesi 53, 00144 Rome, Italy.

Background: Response to neoadjuvant chemotherapy (NACT) has been proven to be an established prognostic factor after open radical cystectomy (ORC). We evaluated the impact of NACT on survival outcomes of a single-institution robotic radical cystectomy (RARC) series.

Methods: From January 2012 to June 2020, 79 patients were identified. Baseline, demographic, perioperative, and pathologic data were described. Kaplan-Meier with the log-rank test was used to compare overall survival (OS) differences between complete, partial, and no-NACT responders, respectively. Univariable and multivariable regression analyses were performed to identify predictors of OS.

Results: Complete, partial, and absent response to NACT were recorded in 43 (54.4%), 21 (19%), and 15 (26.6%) patients, respectively. A complete response to NACT displayed a trend toward significant higher OS ( = 0.03). In univariable analysis, significant predictors of lower OS were hypertension (HR 3.37; CI 95% 1.31-8.62; = 0.01); advanced nodal involvement (HR 2.41; CI 95% 0.53-10.9; < 0.001); and incomplete response to NACT (HR 0.41; CI 95% 0.18-0.95; = 0.039). In multivariable analysis, the only independent predictor of worse OS was advanced pathologic N stages (HR 10.1; CI: 95% CI 2.3-44.3; = 0.002).

Conclusions: Complete response to NACT is associated with increased OS probability, but significant nodal residual disease remains the only independent predictor of OS after RARC.
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http://dx.doi.org/10.3390/jcm9092736DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7564756PMC
August 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

Perioperative and 1-year patient-reported outcomes of Freyer versus Millin versus Madigan robot-assisted simple prostatectomy.

World J Urol 2020 Jul 29. Epub 2020 Jul 29.

Department of Urology, IRCCS "Regina Elena" National Cancer Institute, Via Elio Chianesi 53, 00144, Rome, Italy.

Purpose: Robotic-assisted simple prostatectomy (RASP) is an established surgical procedure for the management of obstructive symptoms caused by large adenomas. Traditionally, this is performed according to the trans-vescical (Freyer) or trans-capsular (Millin) technique. We recently described a novel urethra-sparing (Madigan) robotic technique which showed promising preliminary results. In this study, we compared the above techniques for perioperative and 1-year patient-reported outcomes.

Methods: We retrospectively collected data from patients who underwent RASP across the three techniques, performed by two experienced surgeons in our center. We assessed patient self-reported pre-operative and post-operative functional outcomes with validated questionnaires: IPSS, IIEF short form, ICIQ short form, MSHQ Short Form. Continuous and categorical variables were compared between groups using the Mood's median test and the Chi-square tests, respectively.

Results: Millin, Madigan and Freyer procedures were performed in 23 (51%), 14 (31%) and 8 (18%) cases, respectively. No significant differences were observed for baseline ASA score, BMI, prostate volume, IPSS, IIEF, ICIQ and MSHQ scores (all p ≥ 0.2), as well as post-operative obstructive symptoms relief (IPSS: p = 0.25), continence (ICIQ: p = 0.54), complication rates (p = 0.32) and hospital stay (p = 0.23). Operative time was longer for Madigan procedures (p = 0.05). The 1-year MSHQ and IIEF scores were significantly higher in the Madigan cohort (p = 0.008 and p = 0.04, respectively).

Conclusion: RASP proved to be a safe surgical approach, providing an effective and durable relief of obstructive symptoms at mid-term follow-up regardless of the technique used. The Madigan technique provided significant benefits in terms of self-assessed quality of sexual function.
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http://dx.doi.org/10.1007/s00345-020-03391-wDOI Listing
July 2020

Head to Head Impact of Margin, Ischemia, Complications, Score Versus a Novel Trifecta Score on Oncologic and Functional Outcomes After Robotic-assisted Partial Nephrectomy: Results of a Multicenter Series.

Eur Urol Focus 2020 Jul 13. Epub 2020 Jul 13.

Department of Urology, Regina Elena National Cancer Institute, Rome, Italy.

Background: There is a paucity of data describing the ability of margin, ischemia, complications, score (MIC) and trifecta in predicting long-term outcomes of robotic-assisted partial nephrectomy (RAPN).

Objective: To compare a novel trifecta (negative margins, no significant complications, and perioperative estimated glomerular filtration rate [eGFR] decrease ≤30%) versus standard MIC as predictors of oncologic and functional results in a large series of RAPNs.

Design, Setting, And Participants: Between 2009 and 2019, a multicenter dataset was queried for patients with nonmetastatic renal masses who underwent RAPN at eight participating institutions.

Intervention: RAPN.

Outcome Measurements And Statistical Analysis: MIC and trifecta achievement were determined for the overall cohort and a subgroup undergoing off-clamp RAPN (ocRAPN), respectively. The overall survival (OS), recurrence-free survival (RFS), and new onset of end-stage renal disease (ESRD; defined as eGFR <30 ml/min) probabilities were assessed by the Kaplan-Meier method. Cox regression analyses were used to identify predictors of OS, RFS, and ESRD. For all analyses, two-sided p < 0.05 was considered significant.

Results And Limitations: Out of 1807 patients, MIC and trifecta were achieved in 71.1% (n = 1285) and 82.6% (n = 1492), respectively, and once restricted to the ocRAPN cohort, in 95.6% (n = 625) and 81.6% (n = 534), respectively. On Kaplan-Meier analysis, both MIC and trifecta achievement predicted higher OS and lower ESRD probabilities (all p < 0.014), while only trifecta achievement was a predictor of RFS probabilities (p = 0.009). On multivariable Cox regression, MIC did not predict any of the endpoints independently, while trifecta achievement was an independent predictor of higher OS (hazard ratio [HR] 0.4, 95% confidence interval [CI] 0.18-0.86; p = 0.019) and lower ESRD development probabilities (HR 0.32, 95% CI 0.15-0.72; p = 0.005).

Conclusions: Trifecta, initially described as comprehensive measures of perioperative outcomes, needs to stand the test of time. Compared with MIC, the recent trifecta was an independent predictor of clinically significant endpoints, namely, survival and ESRD development probabilities.

Patient Summary: Our novel trifecta represents a reliable method for estimating survival and development of end-stage renal disease after robotic-assisted partial nephrectomy.
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http://dx.doi.org/10.1016/j.euf.2020.06.021DOI Listing
July 2020

Minimally Invasive Partial Versus Total Adrenalectomy for the Treatment of Primary Aldosteronism: Results of a Multicenter Series According to the PASO Criteria.

Eur Urol Focus 2020 Jul 10. Epub 2020 Jul 10.

Department of Urology, IRCCS "Regina Elena" National Cancer Institute, Rome, Italy.

Background: Determination of success after adrenal-sparing surgery for primary aldosteronism (PA) is limited by the lack of standardized definitions of outcomes.

Objective: To evaluate the safety and effectiveness of minimally invasive partial adrenalectomy (MIPA) for PA by comparing perioperative and functional outcomes with minimally invasive total adrenalectomy (MITA) according to the Primary Aldosteronism Surgical Outcome (PASO) criteria.

Design, Setting, And Participants: Between March 2011 and April 2020, a multicenter adrenalectomy dataset was queried for "unilateral adrenal mass, PA, MIPA (n = 29), or MITA (n = 61)"at four participating Institutions.

Intervention: MITA and MIPA for PA.

Outcome Measurements And Statistical Analysis: Differences between continuous variables were assessed with the Wilcoxon rank sum test, while Pearson's χ test was used for categorical data. Complete, partial, and absent clinical success rates were assessed for the overall cohort and compared between groups.

Results And Limitations: The median tumor size was significantly higher in the MITA group (4.2 vs 2.7 cm; p = 0.001), while preoperative hypertension rate was significantly higher in the MIPA series (82.8% vs 57.4%, p = 0.01). The median length of hospital stay was increased in the MITA cohort (4 vs 3 d; p = 0.038). Overall, at a median follow-up of 42 mo (interquartile range 27-54 mo), complete, partial, and absent clinical success was observed in 60%, 17.7%, and 22.3% of cases, respectively. The complete clinical success rate was higher in the MIPA group (72.4% vs 54.1%), while a partial clinical success was higher in the MITA series (23% vs 6.8%). The absence of clinical success was comparable between groups (MITA 23% vs MIPA 20.7%).

Conclusions: MIPA showed excellent perioperative results with a complete clinical success rate of 72.4%. Owing to the heterogeneity of the PASO criteria in the assessment of partial or absent success, the quest for a univocal definition of satisfactory clinical outcomes in the treatment of PA remains open.

Patient Summary: We compared minimally invasive partial adrenalectomy (MIPA) and minimally invasive total adrenalectomy for the treatment of unilateral primary aldosteronism, assessing the outcomes with the Primary Aldosteronism Surgical Outcome (PASO) criteria. MIPA seems to provide comparable perioperative outcomes and midterm clinical success rates.
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http://dx.doi.org/10.1016/j.euf.2020.06.023DOI Listing
July 2020

On-clamp versus purely off-clamp robot-assisted partial nephrectomy in solitary kidneys: comparison of perioperative outcomes and chronic kidney disease progression at two high- volume centers.

Minerva Urol Nefrol 2020 Jun 22. Epub 2020 Jun 22.

Department of Urology, Regina Elena National Cancer Institute, Rome, Italy.

Background: Minimal literature describes the impact of hilar control on the progression to chronic kidney disease (pCKD) after robotic partial nephrectomy (RPN) in solitary kidneys (SK). The aim of this study was to compare purely off-clamp (ocRPN) vs on-clamp robotic partial nephrectomy (onRPN) in SK and to identify predictors of pCKD at two high-volume centers.

Methods: Between December 2013 and October 2019, 54 patients with SK underwent ocRPN and onRPN for renal tumors at two institutions. Baseline and perioperative data were analyzed. Newly onset of CKD stage 3b,4,5 (CKD3b,4,5) was assessed by Kaplan-Meier curves and compared for warm ischemia time (WIT) with the log-rank test. Cox regression analysis was used to identify predictors of pCKD.

Results: At a median follow-up of 13 months (IQR 6.3-34), newly onset of CKD3b and CKD 4,5 were observed in 11.1% and 7.4% of patients, respectively. onRPN was associated with a higher risk of progression to CKD 3b,4,5 stages (Fig 1; p=0.034) and higher rate of perioperative complications (p=0.03). On univariable analysis eGFR at discharge (eGFRd), positive surgical margins status (PSM) and WIT were predictors of newly onset of CKD3b,4,5 (each p <0.05). Multivariable analysis identified eGFRd (HR 0.88; CI 95% 0.81-0.96) and WIT (HR 1.09; CI 95% 1.02-1.16) as independent predictors of pCKD (each p <0.01). Main limitations include the retrospective nature of the study, the short-term follow-up and the lack of data adjustment for parenchymal volume loss.

Conclusions: eGFRd and WIT during RPN are independent predictors of pCKD in SK. In this setting a critical reduction of WIT should be achieved according to the oncologic outcome. In patients with SK, WIT represents the only surgical modifiable factor of RPN for avoiding a quicker onset of pCKD.
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http://dx.doi.org/10.23736/S0393-2249.20.03795-9DOI Listing
June 2020

The impact of treatment modality on survival in patients with clinical node-positive bladder cancer: results from a multicenter collaboration.

World J Urol 2021 Feb 30;39(2):443-451. Epub 2020 Apr 30.

Department of Urology, Luzerner Kantonsspital, Lucerne, Switzerland.

Purpose: To assess the impact of perioperative chemotherapy on survival in cN+ BCa patients and analyze it according to the pN status.

Methods: A retrospective analysis was conducted on 639 BCa patients with cTanyN1-3M0 BCa treated with radical cystectomy (RC) and bilateral lymph node dissection (LND) with or without perioperative chemotherapy in ten tertiary referral centers from 1990 to 2017. Selected cN+ patients received induction chemotherapy (IC), whereas adjuvant chemotherapy (ACT) was delivered to selected pN+ patients. Univariable and multivariable Cox regression analyses were used to predict overall mortality (OM) after surgery, adjusting for clinicopathological confounders. Kaplan-Meier analyses assessed OM according to the treatment modality.

Results: Overall, 356 (56%) patients were treated with surgery alone, 155 (24%) with IC followed by surgery, and 128 (20%) with ACT following surgery. Over a median follow-up of 25 months, 316 deaths were recorded. At univariable analysis, patients treated with IC and surgery had lower OM both considering cN+ [hazard ratio (HR) 0.65, 95% confidence interval (CI) 0.49-0.87, p = 0.004] and cN+pN- patients (HR 0.61, 95% CI 0.37-0.99, p = 0.05) compared to those treated with surgery alone. cN+pN+ patients treated with ACT experienced lower OM compared to those treated with IC or surgery alone at multivariable analysis (HR 0.40, 95% CI 0.22-0.74, p = 0.003).

Conclusion: Patients with cTany cN+ cM0 BCa benefit more in terms of OS when treated with IC followed by RC + LND compared to RC + LND alone, regardless of LNMs at final histopathology examination. More data are needed to assess the role of ACT in the management of cN+ patients.
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http://dx.doi.org/10.1007/s00345-020-03205-zDOI Listing
February 2021

Urinary expression of let-7c cluster as non-invasive tool to assess the risk of disease progression in patients with high grade non-muscle invasive bladder Cancer: a pilot study.

J Exp Clin Cancer Res 2020 Apr 17;39(1):68. Epub 2020 Apr 17.

Department of Research, Advanced Diagnostics and Technological Innovation, Genomic and Epigenetic Unit, Translational Research Area, IRCCS Regina Elena National Cancer Institute, Via Elio Chianesi 53, 00144, Rome, Italy.

Background: High grade non-muscle-invasive bladder cancer (HG-NMIBC) is a heterogeneous disease with variable risk of progression. Urinary microRNAs are promising biomarkers for BC detection and surveillance. Let-7c-5p miRNA, clustered with miR-99a-5p and -125b-5p, is deregulated in cancer, including BC. The aim of this study is to evaluate urinary let-7c cluster expression in Ta/T1 HG-NMIBC patients and its impact on progression-free survival (PFS).

Methods: Quantitative Real-Time-Polymerase-Chain-Reaction (qRT-PCR) was used to analyze the let-7c cluster expression in 57 urine and 49 neoplastic paired tissue samples prospectively collected from transurethral resection (TUR) HG-NMIBC patients. Twenty urine and 10 bladder tissue samples were collected and analyzed as normal controls. QRT-PCR was also used to detect intra-/extra-cellular let-7c cluster in BC cells. Receiver Operating Characteristic (ROC) curves were used to identify urinary miRNAs cut-off values predicting T-stage and PFS. Uni/multivariable Cox regression was performed to identify predictors of PFS. A nomogram predicting progression risk and a decision curve analysis (DCA) were performed.

Results: Urinary let-7c was significantly up-regulated in patients compared with controls, while the whole cluster was down-regulated in tumor tissues. Supporting these findings, in vitro comparison of extra-/intra-cellular ratios of cluster levels between BC cells, showed a higher ratio for let-7c in HG-NMIBC versus low-grade cells. Urinary let-7c cluster expression was increased in higher T-stage and was an independent predictor of progression. Lower EORTC-score and downregulation of urinary cluster were predictors of higher PFS on univariable Cox regression, while on multivariable analysis only cluster expression was an independent progression predictor. On DCA, a benefit was evident for patients with a PFS probability > 20%.

Conclusions: Urinary let-7c cluster evaluation may improve prognosis, identifying patients at risk of progression and addressing early radical treatment.
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http://dx.doi.org/10.1186/s13046-020-01550-wDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7164295PMC
April 2020

Comprehensive long-term assessment of outcomes following robot-assisted partial nephrectomy for renal cell carcinoma: the ROMe's achievement and its predicting nomogram.

Minerva Urol Nefrol 2020 Aug 16;72(4):482-489. Epub 2020 Apr 16.

Department of Urology, IRCCS "Regina Elena" National Cancer Institute, Rome, Italy.

Background: We proposed a new tool (named ROMe's) to summarize long-term outcomes after partial nephrectomy (PN), identified its predictors and generated a predicting nomogram.

Methods: A retrospective analysis of a multicenter dataset of patients with non-metastatic pT1-3a renal cell carcinoma was performed. Baseline demographic, clinical, pathologic and perioperative data were collected. ROMe's was defined as the concomitant lack of cancer-recurrences, death and newly onset Chronic Kidney Disease (CKD), at long term follow-up. Kaplan-Meier method investigated the predictive role of Trifecta on ROMe's achievement. Univariable and multivariable Cox regression analyses identified its predictors. A nomogram was generated and its accuracy was quantified using concordance index (CI). A calibration plot was obtained with 200 bootstraps resampling to explore nomogram performance at 5 years and decision curve analyses (DCA) assessed the net benefit of the model at 12, 36 and 60 months.

Results: We included 927 patients. The rates of ROMe's were 82%, 72% and 56% at 1, 3 and 5 years follow-up. At Kaplan-Meier analysis, patients who achieved Trifecta displayed a significantly higher probability of ROMe's (log rank P<0.001). Young age (OR=0.982; P=0.001), low RENAL score (OR=0.86; P=0.037), high preoperative filtration rate (OR=1.02; P<0.001) and Trifecta achievement (OR=2.03; P=0.015), were independent predictors of ROMe's. The nomogram showed a CI of 0.76 at 60 months. The 5-years calibration plot confirmed a good discrimination accuracy (0.74); on DCA, the net benefit of using the model was evident for probabilities >30%.

Conclusions: We conceived a triad to summarize the main long-term oncologic and functional outcomes after PN and generated a predicting nomogram.
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http://dx.doi.org/10.23736/S0393-2249.20.03813-8DOI Listing
August 2020

Impact of learning curve on perioperative outcomes of off-clamp minimally invasive partial nephrectomy: propensity score matched comparison of outcomes between training versus expert series.

Minerva Urol Nefrol 2020 Mar 16. Epub 2020 Mar 16.

"Regina Elena" National Cancer Institute, Roma, Italy.

Background: Off-Clamp Robotic partial nephrectomy (Off C-RPN) is a challenging technique, hard to teach since bleeding control is not easily reproducible in training settings. We compared preoperative outcomes of two propensity score matched (PSM) cohorts of patients undergone Off C-RPN by either a training or an expert surgeon in the same Institution.

Methods: The prospectively maintained "renal cancer" database was queried for "off-clamp", "robotic", "partial nephrectomy" performed between January 2017 and June 2018. Achievement of main outcomes along the learning curve of training surgeon was assessed with logistic regression and Lowess analysis. A 1:1 PSM analysis generated two populations homogeneous for demographics, ASA score, tumor size, nephrometry score, baseline hemoglobin and estimated glomerular filtration rate (eGFR). Multiple tumors, and imperative indications were excluded. Categorical and continuous variables were compared by Chi square and t test.

Results: Overall, 111 were treated by the expert, 51 by the training surgeon, respectively. Training surgeon experienced a significant decrease of console time (p=0.01). Patients treated by the expert surgeon had significantly larger tumors, higher PADUA and ASA scores (all p≤0.04). After applying the PSM, two cohorts of 29 patients, homogeneous for all baseline demographic and clinical variables (all p≥0.34) were selected. Hilar clamping was never necessary. Hospital stay, hemoglobin and eGFR at discharge, complication and positive surgical margins rates were comparable between the two cohorts (all p≥0.15).

Conclusions: Our results proved that the impact of learning curve on outcomes of Off C-RPN is negligible after completion of a proper training in minimally invasive surgery.
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http://dx.doi.org/10.23736/S0393-2249.20.03673-5DOI Listing
March 2020

Sex-Sparing Robot-Assisted Radical Cystectomy with Intracorporeal Padua Ileal Neobladder in Female: Surgical Technique, Perioperative, Oncologic and Functional Outcomes.

J Clin Med 2020 Feb 20;9(2). Epub 2020 Feb 20.

"Regina Elena" National Cancer Institute, Department of Urology, 00100 Rome, Italy.

Our aim was to illustrate our technique of sex-sparing (SS)-robot-assisted radical cystectomy (RARC) in female patients receiving an intracorporeal neobladder (iN). From January 2013 to June 2018, 11 female patients underwent SS-RARC-iN at a single tertiary referral center. Inclusion criteria were a cT ≤ 2 N0 M0 bladder tumor at baseline imaging (CT or MRI) and an absence of tumors in the bladder neck, trigone and urethra at TURB. Baseline, perioperative, and outcomes at one year were reported. The median operative time was 255 min and the median hospital stay was seven days. Low-grade Clavien complications occurred in four patients (36.3%), while high-grade complications were not observed in any. Seven patients (63.7%) had an organ-confined disease at the pathologic specimen; nodal involvement and positive surgical margins were not detected in any of the cases. At a median follow-up of 28 months (IQR 14-51), no patients developed new onset of chronic kidney disease stage 3b. After one year, daytime and nighttime continence rates were 90.9% and 86.4% respectively. Quality of life as well as physical and emotional functioning improved significantly over time (all ≤ 0.04), while urinary symptoms and sexual function worsened at three months with a significant recovery taking place at one year (all ≤ 0.04). Overall, 8 out of 11 patients (72.7%) were sexually active at the 12-month evaluation. In select female patients, SS-RARC-iN is an oncologically sound procedure associated with favorable perioperative and functional outcomes.
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http://dx.doi.org/10.3390/jcm9020577DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7073846PMC
February 2020

Surgical quality, cancer control and functional preservation: introducing a novel trifecta for robot-assisted partial nephrectomy.

Minerva Urol Nefrol 2020 Feb 12;72(1):82-90. Epub 2019 Dec 12.

Department of Urology, Regina Elena National Cancer Institute, Rome, Italy.

Background: In order to improve standard reporting of outcomes after partial nephrectomy, different "trifecta" systems have been conceived. The subjective assessment of the included parameters and the unreliability for off-clamp procedures limited their reproducibility; their role in predicting functional and oncologic outcomes has never been assessed. We propose a new trifecta, based on standardized parameters, that summarizes PN outcomes regardless the clamping technique used and predicts main clinical outcomes.

Methods: A retrospective analysis of a multicenter, multi-national dataset of patients with non-metastatic cT1-2 renal masses undergoing Robot-assisted partial nephrectomy was performed. Baseline demographic, clinical, pathologic and perioperative data were collected. Trifecta was defined as the coexistence of negative margins, no Clavien-Dindo ≥3 complications and ≤30% postoperative estimated glomerular filtration rate reduction. Univariable and multivariable regression analyses identified predictors of trifecta achievement. Kaplan-Meier method assessed differences in oncological outcomes between patients achieving trifecta or not. Univariable and multivariable Cox regression analysis identified predictors of newly onset chronic kidney disease stage ≥IIIa, recurrence-free and overall survival.

Results: Overall, 1492 patients achieved trifecta. This cohort displayed significantly lower incidence of newly onset IIIa-V chronic kidney disease stages (all P<0.001), higher recurrence-free (P=0.009) and overall (P=0.014) survival probabilities. Patients achieving trifecta had a 65% reduced risk of developing newly onset stage IIIb-V Chronic Kidney Disease and a 55% reduced risk of overall mortality. Heterogeneity of surgical technique is a limitation.

Conclusions: This novel reproducible trifecta is based on standardized parameters and is an independent predictor of severe chronic kidney disease development and mortality.
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http://dx.doi.org/10.23736/S0393-2249.19.03570-7DOI Listing
February 2020

Recovery from Anesthesia after Robotic-Assisted Radical Cystectomy: Two Different Reversals of Neuromuscular Blockade.

J Clin Med 2019 Oct 24;8(11). Epub 2019 Oct 24.

Department of Anaesthesiology, IRCCS Regina Elena National Cancer Institute, 00144 Rome, Italy.

During robot-assisted radical cystectomy (RARC), specific surgical conditions (a steep Trendelenburg position, prolonged pneumoperitoneum, effective myoresolution until the final stages of surgery) can seriously impair the outcomes. The aim of the study was to evaluate the incidence of postoperative nausea and vomiting (PONV) and ileus and the quality of cognitive function at the awakening in two groups of patients undergoing different reversals. In this randomized trial, patients that were American Society of Anesthesiologists physical status (ASA) ≤III candidates for RARC for bladder cancer were randomized into two groups: In the sugammadex (S) group, patients received 2 mg/kg of sugammadex as reversal of neuromuscolar blockade; in the neostigmine (N) group, antagonization was obtained with neostigmine 0.04 mg/kg + atropine 0.02 mg/kg. PONV was evaluated at 30 min, 6 and 24 h after anesthesia. Postoperative cognitive functions and time to resumption of intestinal transit were also investigated. A total of 109 patients were analyzed (54 in the S group and 55 in the N group). The incidence of early PONV was lower in the S group but not statistically significant (S group 25.9% vs. N group 29%; = 0.711). The Mini-Mental State test mean value was higher in the S group vs. the N group (1 h after surgery: 29.3 (29; 30) vs. 27.6 (27; 30), = 0.007; 4 h after surgery: 29.5 (30; 30) vs. 28.4 (28; 30), = 0.05). We did not observe a significant decrease of the PONV after sugammadex administration versus neostigmine use. The Mini-Mental State test mean value was greater in the S group.
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http://dx.doi.org/10.3390/jcm8111774DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6912240PMC
October 2019

Combined reporting of surgical quality, cancer control and functional outcomes of robot-assisted radical cystectomy with intracorporeal orthotopic neobladder into a novel trifecta.

Minerva Urol Nefrol 2019 Dec 10;71(6):590-596. Epub 2019 Oct 10.

Department of Urology, Regina Elena National Cancer Institute, Rome, Italy.

Background: To optimize outcomes reporting after robot-assisted radical cystectomy (RARC) with intracorporeal orthotopic neobladder (iON), we propose a novel trifecta, aimed to overcome the available pentafectas that neglect functional outcomes.

Methods: A retrospective analysis of prospectively maintained RARC-iON dataset was performed. Baseline demographic, clinical, pathologic, perioperative and follow-up data were collected. Trifecta was defined as the coexistence of daytime urinary continence, Clavien-Dindo ≥3 complication-free and recurrence-free status, all assessed at 1 year. Kaplan-Meier method assessed the role of trifecta achievement in predicting overall survival (OS) probabilities. Univariable and multivariable regression analyses identified predictors of trifecta achievement. The predictive accuracy of trifecta and other pentafectas on 3-year OS probability was plotted with receiver operating characteristic (ROC) analyses.

Results: The trifecta rate was 53% while 62% and 47% of patients achieved the University of Southern California (USC-P) and PROMETRICS group (PROM-P) pentafectas, respectively. On tertile analysis, both trifecta (P=0.011) and USC-P (P=0.043) rates significantly increased with surgical experience, while PROM-P did not (P=0.204). On ROC analysis, trifecta was the only significant predictor of 3-year OS probability (AUC=0.69, 95% CI:0.55-0.82; P=0.018). On Kaplan-Meier analysis, patients achieving trifecta displayed significantly higher OS probability (P=0.032); adjusted for covariates, each incremental case was associated with a 2% increased probability (OR: 1.02) of achieving trifecta on multivariable regression model.

Conclusions: Learning curve in RARC-iON has a significant impact on achievement of trifecta. This tool combines accurate measurement of surgical proficiency with an independent predictive value in assessing 3-year OS probabilities.
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http://dx.doi.org/10.23736/S0393-2249.19.03566-5DOI Listing
December 2019

Managing lines of therapy in castration-resistant prostate cancer: real-life snapshot from a multicenter cohort.

World J Urol 2020 Jul 12;38(7):1757-1764. Epub 2019 Oct 12.

Department of Urology, "Regina Elena" National Cancer Institute of Rome, Via Elio Chianesi 53, 00154, Rome, Italy.

Purpose: To provide a snapshot of toxicities and oncologic outcomes of Abiraterone (AA) and Enzalutamide (EZ) in a chemo-naïve metastatic castration-resistant prostate cancer (mCPRC) population from a longitudinal real-life multicenter cohort.

Methods: We prospectively collected data on chemo-naïve mCRPC patients treated with AA or EZ. Primary outcomes were PSA response, oncologic outcomes and toxicity profile. The Kaplan-Meier method was used to compare differences in terms of progression-free survival (PFS) between AA vs EZ and high- vs low-volume disease cohorts. Univariable and multivariable Cox regression analyses were performed to identify predictors of PFS. Toxicity, PSA response rates and oncologic outcomes on second line were compared with those observed on first line.

Results: Out of 137 patients, 88 received AA, and 49 EZ. On first line, patients receiving EZ had significantly higher PSA response compared with AA (95.9% vs 67%, p < 0.001), comparable toxicity rate (10.2% vs 16.3%, p = 0.437) and PFS probabilities (p = 0.145). Baseline PSA and high-volume disease were predictors of lower PFS probabilities at univariable analysis (p = 0.027 and p = 0.007, respectively). Overall, 28 patients shifted to a second-line therapy (EZ or radiometabolic therapy). Toxicity and PSA response rates on second line were comparable to those observed on first line (11.1% vs 12.4%, p = 0.77; 73.1% vs 77.4%, p = 0.62, respectively); 2-year PFS, cancer-specific and overall survival probabilities were comparable to those displayed in first-line cohort (12.1% vs 16.2%, p = 0.07; 85.7% vs 86.4%, p = 0.98; 71% vs 80.3%, p = 0.66, respectively).

Conclusions: Toxicity profile, PSA response rate and oncological outcomes were comparable between first-line and second-line courses in patients treated with either AA or EZ for mCRPC. Our findings showed the tolerability and oncological effectiveness, when feasible, of two lines of therapy other than chemotherapy.
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http://dx.doi.org/10.1007/s00345-019-02974-6DOI Listing
July 2020

Transnephrostomic Indocyanine Green-Guided Robotic Ureteral Reimplantation for Benign Ureteroileal Strictures After Robotic Cystectomy and Intracorporeal Neobladder: Step-By-Step Surgical Technique, Perioperative and Functional Outcomes.

J Endourol 2019 10 26;33(10):823-828. Epub 2019 Sep 26.

Department of Urology, "Regina Elena" National Cancer Institute, Rome, Italy.

To describe our surgical technique of robotic ureteroileal reimplantation (RUIR) for ureteroileal anastomosis strictures with the use of near-infrared fluorescence imaging (NIFI) after transnephrostomic antegrade injection of indocyanine green in patients previously treated with robot-assisted radical cystectomy and intracorporeal orthotopic neobladder. From March 2015 to December 2017, 10 consecutive patients underwent RUIR in our tertiary referral center. All patients previously underwent percutaneous nephrostomy and at least one antegrade stenting and stricture dilatation attempt. Clinical data were prospectively collected into our institutional dataset. Both perioperative and functional outcomes were assessed. Median time from robotic cystectomy to ureteroileal anastomosis strictures diagnosis was 5 months (interquartile range [IQR] 2-6). Median stricture length was 1.5 cm (IQR 1-2). Median operative time was 140 minutes (IQR 81-155), and median length of stay was 5 days (IQR 3-9). Two patients experienced Clavien grade 2 complications (urinary tract infection requiring antibiotics and blood transfusion, respectively). One patient underwent ileum resection and anastomosis due to bowel perforation (Clavien IIIb). At a median follow-up of 19 months (IQR 14-39), one patient developed a stricture recurrence. No patient developed worsening of renal function (newly onset chronic kidney disease stage 3b-4). Robotic reimplantation for ureteroileal anastomosis strictures is a safe and highly effective procedure, with a high success rate and excellent perioperative and functional outcomes. NIFI provides an easy guide to identify and progressively dissect the ureter.
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http://dx.doi.org/10.1089/end.2019.0376DOI Listing
October 2019

On-clamp versus off-clamp partial nephrectomy: Propensity score-matched comparison of long-term functional outcomes.

Int J Urol 2019 10 24;26(10):985-991. Epub 2019 Jul 24.

Department of Urology, "Regina Elena" National Cancer Institute, Rome, Italy.

Objectives: To compare long-term functional outcomes of off-clamp or on-clamp partial nephrectomy patients of two high-volume centers with cT1-2/N0 M0 renal tumors and baseline estimated glomerular filtration rate >60 mL/min.

Methods: A 3:1 propensity score-matched analysis was used to select two homogeneous cohorts to compare off-clamp versus on-clamp partial nephrectomy. Joinpoint regression analysis was used to compare the 2-8-year probabilities of estimated glomerular filtration rate modifications in both selected cohorts. The Kaplan-Meier method assessed the risk of developing a stage ≥3b chronic kidney disease during follow up. Multivariable analyses aimed to identify predictors of renal function deterioration. Perioperative complications and oncological outcomes were compared.

Results: Overall, 1073 patients were included (588 on-clamp and 485 off-clamp). After applying the propensity score-matched analysis, the two cohorts of 157 on-clamp and 472 off-clamp patients did not differ for all covariates, except for warm ischemia time and last estimated glomerular filtration rate. At joinpoint analysis, the off-clamp group showed higher probabilities of maintaining an unmodified estimated glomerular filtration rate (P = 0.02). The probability of developing a stage ≥3b chronic kidney disease was significantly higher (P < 0.001) in the on-clamp cohort. At multivariable analysis, estimated glomerular filtration rate at discharge and off-clamp approach were independent predictors of improved functional outcomes. Perioperative complications were comparable among the two cohorts (P = 0.67). There were not any statistically significant differences in terms of cancer-specific survival (P = 0.26) and overall survival (P = 0.18).

Conclusions: Off-clamp partial nephrectomy seems to offer a higher probability of maintaining 100% estimated glomerular filtration rate after surgery. In our cohort, patients undergoing on-clamp partial nephrectomy presented a 7.3-fold increased risk of developing a severe chronic kidney disease during follow up.
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http://dx.doi.org/10.1111/iju.14079DOI Listing
October 2019

Long-term oncologic outcomes of robot-assisted radical cystectomy (RARC) with totally intracorporeal urinary diversion (ICUD): a multi-center study.

World J Urol 2020 Apr 12;38(4):837-843. Epub 2019 Jun 12.

Department of Urology, IRCCS "Regina Elena" National Cancer Institute, Rome, Italy.

Purpose: To report survival outcomes after robot-assisted radical cystectomy (RARC) with intracorporeal urinary diversion (ICUD) for recurrent/muscle-invasive non-metastatic bladder cancer.

Methods: Prospectively maintained databases were queried for "robotic cystectomy AND ICUD". Patients treated after October 2013 and those treated without curative intent were excluded. Kaplan-Meier method was used to plot stage-specific survival outcomes, computed at 1, 2, and 5 years after surgery. Univariable and multivariable Cox analyses assessed predictors of recurrence-free (RFS), cancer-specific (CSS) and overall (OS) survival.

Results: 113 consecutive patients were included, mostly men (82%). Neoadjuvant chemotherapy was performed in 23% of cases, median lymph node (LN) yield was 36 (IQR 28-45) and the rate of positive surgical margins (PSM) was 8%. Orthotopic ileal neobladder was the preferred ICUD type (57%). An organ-confined disease was observed in 51% of cases and 21% were pT0 on final histology. Overall, 5-year RFS, CSS and OS probabilities were 58 ± 5%, 61 ± 5% and 54 ± 5%, respectively. At Kaplan-Meier method, tumor stage group was a significant predictor of survival probabilities (all p < 0.001) and this was confirmed at multivariable Cox regression analysis (RFS-OR 2.29; 95% CI 1.58-3.32; p < 0.001) (CSS-OR 1.82; 95% CI 1.3-2.53; p < 0.001) (OS-OR 2.14; 95% CI 1.46-3.14; p < 0.001). PSM status was associated to CSS (OR 2.54; 95% CI 1.13-5.69; p = 0.024) and OS (OR 2.82; 95% CI 1.17-6.77; p = 0.021), but did not predict RFS (p = 0.062).

Conclusions: Long-term oncologic outcomes after RARC with ICUD appear similar to recent robotic series with extracorporeal diversion and historical open experiences.
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http://dx.doi.org/10.1007/s00345-019-02842-3DOI Listing
April 2020

Metachronous Isolated Splenic Metastasis in a Young Patient With Renal Cell Carcinoma: Case Report and Literature Review.

Urology 2019 05 16;127:13-18. Epub 2019 Jan 16.

Department of Urology, IRCCS-Regina Elena National Cancer Institute, Rome, Italy.

Splenic metastasis is uncommon and is usually associated with widespread disease. Isolated splenic metastases from renal cancer are also rarer and are often an incidental finding. This eventuality may turn into a dangerous scenario due to a spontaneous splenic rupture leading to sudden death. At the best of our knowledge, only few cases of metastasis from renal cell carcinoma (RCC) have been documented in the literature. We hereby present a literature review of these cases and report a case of isolated splenic metastasis in a young man on active follow-up for a clear cell RCC clear cell Renal Cell Carcinoma (ccRCC).
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http://dx.doi.org/10.1016/j.urology.2019.01.007DOI Listing
May 2019

Off-clamp vs on-clamp robotic partial nephrectomy: Perioperative, functional and oncological outcomes from a propensity-score matching between two high-volume centers.

Eur J Surg Oncol 2019 Jul 9;45(7):1232-1237. Epub 2018 Dec 9.

Glickman Urological and Kidney Institute, Department of Urology, Cleveland Clinic, Cleveland, OH, USA. Electronic address:

Introduction: Aim of the study was to compare perioperative, functional and oncological outcomes after off-clamp vs on-clamp robotic partial nephrectomy (RPN).

Materials And Methods: Patients who underwent off-clamp or on-clamp (warm ischemia) RPN were extracted from 2 institutional prospectively-maintained databases. 123 patients who underwent off-clamp RPN at one institution were excluded, so that each institution contributed with unselected patients (institution 1:on-clamp RPN vs institution 2:off-clamp). 2:1 propensity-score matching (age, sex, smoking, diabetes, hypertension, ASA score, solitary kidney, preoperative eGFR, tumor size and R.E.N.A.L.score). Perioperative outcomes were compared. A linear mixed model was fitted to eGFR as the outcome regressed on fixed effects for 1) management of clamping (on-clamp/off-clamp), 2) time (at baseline, at discharge, at 12 and 24 months postoperatively), and 3) clamp/time interaction. Survival events were compared between groups.

Results: 1983 patients were pooled. After matching, 400 on-clamp vs 200 off-clamp patients were analyzed. No significant differences were found in key perioperative outcomes. The effect of on-clamp on eGFR changed over time. At discharge, groups had similar drop in eGFR. The difference between groups was greatest at 12-months postoperatively, with on-clamp patients showing a deficit of 5 ml/min. At 24-months follow-up, this gap shrunk to 2 ml/min. There were no significant differences in overall survival (p = 0.1), recurrence (χ = 0.008, p = 0.9), or metastasis free survival (χ = 0.962 p = 0.3). Only one cancer-specific death occurred in off-clamp group.

Conclusion: We confirm no significant differences in the perioperative and oncological outcomes between off-clamp and on-clamp RPN. Avoided ischemia benefits renal function within 1-year follow-up after surgery. At longer follow-up, difference with on-clamp is softened.
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http://dx.doi.org/10.1016/j.ejso.2018.12.005DOI Listing
July 2019

Urethra and Ejaculation Preserving Robot-assisted Simple Prostatectomy: Near-infrared Fluorescence Imaging-guided Madigan Technique.

Eur Urol 2019 03 12;75(3):492-497. Epub 2018 Dec 12.

Department of Urology, "Regina Elena" National Cancer Institute, Rome, Italy.

Background: With the increasing adoption of novel technologies and anatomical techniques, surgical management of benign prostatic hyperplasia (BPH) provides significant benefits in terms of obstruction relief, early urethral catheter removal, and faster return to daily activities. However, the main pitfall of BPH surgery in sexually active men remains ejaculatory dysfunction (EjD), which permanently affects quality of life.

Objective: To detail a novel technique for marking the intraprostatic urethra through a retrograde injection of indocyanine green to enhance selective dissection of prostatic lobes during urethra-sparing robot-assisted simple prostatectomy (US-RASP) with the use of near-infrared fluorescence imaging (NIFI).

Design, Setting, And Participants: Between January and September 2017, 12 consecutive male patients, who had BPH, were sexually active, and were motivated to preserve ejaculatory function, underwent US-RASP.

Surgical Procedure: US-RASP with NIFI to enhance the identification and preservation of the prostatic urethra.

Measurements: Clinical data were prospectively collected in our institutional RASP dataset. Perioperative and functional outcomes of US-RASP were both graded, and assessed according to Clavien grading system and validated questionnaires postoperatively (International Prostate Symptom Score [IPSS]; Male Sexual Health Questionnaire on EjD [MSHQ-EjD] Short Form) at 3 and 12mo.

Results And Limitations: Median preoperative prostate size was 102cc (interquartile range [IQR] 88-115). Median operative time was 150min (IQR 145-170). Median estimated blood loss was 250 (IQR 200-350). Continuous bladder irrigation was avoided in 83.4% of patients. Median time to catheter removal was 7d (IQR 7-7) with a median hospital stay of 3d (IQR 2-3). At 1-yr follow-up, median IPSS score, International Index of Erectile Function score, and MSHQ-EjD Short Form score were 5 (IQR 4-8), 26 (IQR 26-28), and 12 (IQR 1-14), respectively. Satisfactory anterograde ejaculation was reported in eight patients (66%).

Conclusions: We described a novel NIFI-guided technique to perform US-RASP. This technique showed promising early functional results, suggesting a significant role of intraprostatic urethral integrity for the preservation of ejaculatory function.

Patient Summary: We developed a novel robotic technique to perform simple prostatectomy with integral preservation of the prostatic urethra. This technique provided a high rate of ejaculatory function preservation.
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http://dx.doi.org/10.1016/j.eururo.2018.11.051DOI Listing
March 2019

Propensity-score-matched comparison of soft tissue surgical margins status between open and robotic-assisted radical cystectomy.

Urol Oncol 2019 03 14;37(3):179.e1-179.e7. Epub 2018 Nov 14.

Department of Urology, Comprehensive Cancer Center, Medical University of Vienna, Vienna General Hospital, Vienna, Austria; Department of Urology, Weill Cornell Medical College, New York Presbyterian Hospital, New York, NY; Department of Urology, University of Texas Southwestern Medical Center, Dallas, TX. Electronic address:

Introduction: The use of robotic-assisted radical cystectomy (RARC) is becoming more widespread. While its safety is accepted, its oncological efficacy as compared to the current standard, open radical cystectomy (ORC), remains debatable.

Materials And Methods: The aim of this study is to compare the rates of positive soft tissue surgical margins (STSM), between patients treated with RARC or ORC, using a large contemporaneous collaborative database. We included 2,536 patients with urothelial carcinoma of the bladder treated at 26 institutions. A propensity-score matching 1:1 was performed with 3 ORC patients matched to 1 RARC patient. The final cohort included 1,614 patients. Uni- and multivariable logistic regression analyses tested the impact of surgical technique on STSM status, before and after propensity-score matching.

Results: Overall, 870 (34%) patients underwent RARC and 1,666 (66%) ORC. The overall STSM rate was 11%; 10% in the ORC group and 13% in the RARC group. Within the propensity-score-matched cohort, the positive STSM rate were 14% and 13% in the ORC and RARC group, respectively (P = 0.1). In multivariable analysis, after propensity match RARC approach was not associated with the risk of a positive STSM (P = 0.1). These results were confirmed in the subgroup of patients with pathologic non-organ-confined or organ-confined diseases.

Conclusions: While treatment with RARC is associated with a higher absolute rate of STSM, the difference did not remain after adjustment for the effects of other established prognostic factors. Results from ongoing trials are awaited to assess the validity of these findings.
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http://dx.doi.org/10.1016/j.urolonc.2018.10.012DOI Listing
March 2019

"Ride the Green Light": Indocyanine Green-marked Off-clamp Robotic Partial Nephrectomy for Totally Endophytic Renal Masses.

Eur Urol 2019 06 24;75(6):1008-1014. Epub 2018 Sep 24.

Department of Urology, IRCCS "Regina Elena" National Cancer Institute, Rome, Italy.

Background: Complexity of robot-assisted partial nephrectomy (RAPN) mostly depends on tumor size and location. Totally endophytic renal masses represent a surgical challenge in terms of both intraoperative identification and anatomical dissection.

Objective: To detail a novel technique for marking preoperatively endophytic renal tumors with transarterial superselective intrarenal mass delivery of indocyanine green (ICG)-lipiodol mixture, in order to enhance surgical margins control during purely off-clamp (OC) RAPN with the use of near-infrared fluorescence imaging.

Design, Setting, And Participants: Between June and July 2017, 10 consecutive patients with totally endophytic renal masses underwent preoperative ICG tumor marking immediately followed by RAPN.

Surgical Procedure: Preoperative superselective transarterial delivery of a lipiodol-ICG mixture (1:2 volume ratio) into tertiary-order arterial branches feeding the renal mass prior to transperitoneal OC-RAPN.

Measurements: Clinical data were prospectively collected in our institutional RAPN dataset. Perioperative, pathological, and functional outcomes of RAPN were assessed.

Results And Limitations: Median tumor size was 3cm (interquartile range 2.3-3.8). The median PADUA score was 10 (9-11). Angiographic procedure was successful in all patients. Median operative time was 75min (65-85); median estimated blood loss was 250ml (200-350). No conversion to on-clamp PN or radical nephrectomy was needed. All patients had uneventful perioperative course; median hospital stay was 3 d (2-3). At discharge, median hemoglobin (Hgb) and percent estimated glomerular filtration rate (eGFR) drop were 3.3g/dl (2.1-3.3) and 11% (10-20%), respectively. Surgical margins were negative in all cases. One-year median ipsilateral renal volume and 1-yr eGFR percent decreases were 11.7% (6-20.9%) and 12.2% (5.3-13.7%), respectively.

Conclusions: We described a novel technique to simplify challenging RAPN based on ICG superselective transarterial tumor marking. Key benefits include quick intraoperative identification of the mass with improved visualization and real-time control of resection margins.

Patient Summary: Robot-assisted partial nephrectomy (RAPN) for totally endophytic renal masses is a technically demanding surgical procedure, sometimes requiring radical nephrectomy. This novel technique significantly simplified surgical complexity in our Institution. Further studies with larger cohorts are warranted to confirm whether this technique provides relevant intraoperative and functional advantages.
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http://dx.doi.org/10.1016/j.eururo.2018.09.015DOI Listing
June 2019

Novel Diagnostic Biomarkers of Prostate Cancer: An Update.

Curr Med Chem 2019 ;26(6):1045-1058

Department of Urology, "Regina Elena" National Cancer Institute, Rome, Italy.

Objective: In recent years, several biomarkers alternative to standard prostate specific antigen (PSA) for prostate cancer (PCa) diagnosis have become available. The aim of this systematic review is to assess the current knowledge about alternative serum and urinary biomarkers for the diagnosis of PCa.

Material And Methods: A research was conducted in Medline, restricted to English language articles published between December 2014 and June 2018 with the aim to update previously published series on PCa biomarkers. The preferred reporting items for systematic reviews and meta-analyses (PRISMA) criteria were used for selecting studies with the lowest risk of bias.

Results: Emerging role and actual controversies on serum and urine alternative biomarkers to standard PSA for PCa diagnosis, staging and prognosis assessment, such as prostate health index (PHI), PCA3, ConfirmMDx, Aberrant PSA glycosylation, MiPS, miRNAs are critically presented in the current review.

Conclusion: Although the use of several biomarkers has been recommended or questioned by different international guidelines, larger prospective randomized studies are still necessary to validate their efficacy in PCa detection, discrimination, prognosis and treatment effectiveness. To date, only PHI and 4Kscore have shown clinical relevance for discriminating more aggressive PCa. Furthermore, a new grading classification based on molecular features relevant for PCa risk-stratification and tailoring treatment is still needed.
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http://dx.doi.org/10.2174/0929867325666180914115416DOI Listing
June 2019