Differences in Survival of Clear Cell Metastatic Renal Cell Carcinoma According to Partial vs. Radical Cytoreductive Nephrectomy.

BACKGROUND: It is unknown whether previously reported other-cause mortality (OCM) advantage of partial cytoreductive nephrectomy (PCN) vs. radical cytoreductive nephrectomy (RCN) still applies to contemporary clear cell metastatic renal cell carcinoma (ccmRCC) patients. MATERIALS AND METHODS: We relied on the Surveillance, Epidemiology and End Results (SEER) database (2004-2019) to identify ccmRCC patients treated with PCN and RCN. Temporal trends of PCN rates within the SEER database were tabulated. After propensity score matching (PSM), cumulative incidence plots depicted 5-year OCM and cancer-specific mortality (CSM) of PCN and RCN patients. Multivariable Cox regression models tested for differences between PCN vs. RCN. RESULTS: Of 5149 study patients, 237 (5%) underwent PCN vs. 4912 (95%) RCN. In the SEER database 2004 to 2019, rates of PCN in ccmRCC patients increased from 3.0% to 8.0% (estimated annual percent change [EAPC]: 3.0%; P = .04). After PSM, 5-year OCM rates were 2.4 vs. 7.5% for respectively PCN vs. RCN patients (P = .036). 5-year CSM rates were 50.8 vs. 53.6% for respectively PCN and RCN patients (P = .57). In multivariable Cox regression models, PCN was associated with lower OCM (Hazard Ratio (HR): 0.39; 95% confidence interval (CI): 0.18-0.84; P = .02) but did not affect CSM rates (HR: 0.99; 95% CI: 0.76-1.29; P = .96). CONCLUSIONS: We confirm the existence of OCM advantage after PCN vs. RCN in contemporary ccmRCC patients.

Predictors of mid-term functional outcomes for robot-assisted Madigan simple prostatectomy: results of a multicentric series according to the BPH-6 achievement.

BACKGROUND: BPH-6 achievement remains an objective far to be evaluated for every technique currently available for the surgical management of bladder outlet obstruction (BOO) with the goal of preserving ejaculatory function. The aim of this study was to evaluate predictors of BPH-6 achievement of urethral-sparing robot assisted simple prostatectomy (us-RASP) on a large series performed at two tertiary-care centers. METHODS: Two institutional us-RASP datasets were merged, considering eligible all patients with a follow-up >12 months. Baseline, perioperative and functional data according to BPH-6 endpoint were assessed. Descriptive analysis was used. Frequencies and proportions were reported for categorical variables while medians and interquartile ranges (IQRs) were reported for continuously coded variables. A logistic regression model was built to identify predictors of BPH-6 achievement. For all statistical analyses, a two-sided P<0.05 was considered significant. RESULTS: Study cohort consisted of 94 eligible patients. The median follow-up was 40.7 months (IQR 31.3-54.2). Overall BPH-6 achievement was 54.7%. Compared to baseline, reduction of ≥30% in IPSS was observed in 93.6% of patients, reduction of <6 points for SHIM in 95.7% and response to MSHQ-EjD question 3 indicating emission of semen in 72.6%, respectively. On multivariable analysis, prostate volume between 110-180 mL (OR 0.09; 95% CI 0.01-0.92; P=0.043) and higher preoperative SHIM score (OR 1.18; 95% CI 1.05-1.32; P<0.01) were independent predictors of BPH-6 metric achievement. CONCLUSIONS: us-RASP may provide a complete resolution of BOO and preservation of ejaculatory function in sexually active men with a prostate volume ranging 110-180 mL.

Adverse upgrading and/or upstaging in contemporary low-risk prostate cancer patients.

BACKGROUND: Upgrading and/or upstaging in low-risk prostate cancer (PCa) patients may represent an indication for active treatment instead of active surveillance (AS). We addressed contemporary upgrading and/or upstaging rates in a large population based-cohort of low-risk PCa patients. MATERIALS AND METHODS: Whitin the SEER database (2010-2015), NCCN low-risk PCa patients were identified across management modalities: radical prostatectomy (RP), radiotherapy (RT) and non-local treatment (NLT). In RP patients, upgrading and/or upstaging rates were assessed in logistic regression models. RESULTS: Overall, of 27,901 low-risk PCa patients, 38% underwent RP vs 28% RT vs 34% NLT. RP patients were the youngest and harbored the highest percentage of positive cores and a higher rate of cT2a than NLT. At RP, 46.2% were upgraded to GGG ≥ 2, 6.0% to GGG ≥ 3 and 10.5% harbored nonorgan-confined stage (NOC, pT3-4 or pN1). Of NOC patients, 1.6% harbored GGG ≥ 3, 6.3% harbored GGG2 and 2.6% harbored GGG1. Of pT2 patients, 4.4% harbored GGG ≥ 3, 33.9% harbored GGG2 and 51.3% harbored GGG1. Age, PSA, percentage of positive cores and number of positive cores independently predicted the presence of NOC and/or GGG ≥ 3, but with low accuracy (63.9%). CONCLUSIONS: In low-risk PCa, critical changes between tumor grade and stage at biopsy vs RP may be expected in very few patients: NOC with GGG ≥ 3 in 1.6% and NOC with GGG2 in 6.3%. Other patients with upgrading and/or upstaging combinations will invariably harbor either pT2 or GGG1 that far less critically affect PCa prognosis.

Rates of metastatic prostate cancer in newly diagnosed patients: Numbers needed to image according to risk level.

BACKGROUND: The numbers needed to image to identify pelvic lymph node and/or distant metastases in newly diagnosed prostate cancer (PCa) patients according to risk level are unknown. METHODS: Relying on Surveillance, Epidemiology, and End Results (2010-2016), we tabulated rates and proportions of patients with (a) lymph node or (b) distant metastases according to National Comprehensive Cancer Network (NCCN) risk level and calculated the number needed to image (NNI) for both endpoints. Multivariable logistic regression analyses were performed. RESULTS: Of 145,939 newly diagnosed PCa patients assessable for analyses of pelvic lymph node metastases (cN1), 4559 (3.1%) harbored cN1 stage: 13 (0.02%), 18 (0.08%), 63 (0.3%), 512 (2.8%), and 3954 (14.9%) in low, intermediate favorable, intermediate unfavorable, high, and very high-risk levels. These resulted in NNI of 4619, 1182, 319, 35, and 7, respectively. Of 181,109 newly diagnosed PCa patients assessable for analyses of distant metastases (M1a-c ), 8920 (4.9%) harbored M1a-c stage: 50 (0.07%), 45 (0.1%), 161 (0.5%), 1290 (5.1%), and 7374 (22.0%) in low, intermediate favorable, intermediate unfavorable, high, and very high-risk. These resulted in NNI of 1347, 602, 174, 20, and 5, respectively. CONCLUSIONS: Our observations perfectly validated the NCCN recommendations for imaging in newly diagnosed high and very high-risk PCa patients. However, in unfavorable intermediate-risk PCa patients, in whom bone and soft tissue imaging is recommended, the NNI might be somewhat elevated to support routine imaging in clinical practice.

Outcomes of robotic-assisted versus open radical cystectomy in a large-scale, contemporary cohort of bladder cancer patients.

BACKGROUND AND OBJECTIVES: To test for differences in perioperative outcomes and total hospital costs (THC) in nonmetastatic bladder cancer patients undergoing open (ORC) versus robotic-assisted radical cystectomy (RARC). METHODS: We relied on the National Inpatient Sample database (2016-2019). Statistics consisted of trend analyses, multivariable logistic, Poisson, and linear regression models. RESULTS: Of 5280 patients, 1876 (36%) versus 3200 (60%) underwent RARC versus ORC. RARC increased from 32% to 41% (estimated annual percentage change [EAPC]: + 8.6%; p = 0.02). Rates of transfusion (8% vs. 16%), intraoperative (2% vs. 3%), wound (6% vs. 10%), and pulmonary (6% vs. 10%) complications were lower in RARC patients (all p < 0.05). Moreover, median length of stay (LOS) was shorter in RARC (6 vs. 7days; p < 0.001). Conversely, median THC (31,486 vs. 27,162$; p < 0.001) were higher in RARC. Multivariable logistic regression-derived odds ratios addressing transfusion (0.49), intraoperative (0.53), wound (0.68), and pulmonary (0.71) complications favored RARC (all p < 0.01). In multivariable Poisson and linear regression models, RARC was associated with shorter LOS (Rate ratio:0.86; p < 0.001), yet higher THC (Coef.:5,859$; p < 0.001). RARC in-hospital mortality was lower (1% vs. 2%; p = 0.04). CONCLUSIONS: RARC complications, LOS, and mortality appear more favorable than ORC, but result in higher THC. The favorable RARC profile contributes to its increasing popularity throughout the United States.

Cancer-specific mortality in patients with non-metastatic renal cell carcinoma who have undergone a nephrectomy and are eligible for adjuvant pembrolizumab.

BACKGROUND: Data in patients with malignant melanoma, who have been previously treated with pembrolizumab as adjuvant therapy, show a reduction in pembrolizumab efficacy upon rechallenge. We examined this scenario in patients with non-metastatic renal cell carcinoma (RCC) eligible for adjuvant pembrolizumab after nephrectomy. We hypothesized that a proportion of such patients will either require re-treatment with pembrolizumab upon metastatic progression prior to cancer-specific mortality (CSM) or die from other cause mortality (OCM). MATERIALS AND METHODS: We identified within the SEER database 10,635 patients, between 2004 and 2017, with a diagnosis of non-metastatic intermediate-high and high risk RCC, who had undergone nephrectomy and fulfilled criteria for enrollment in KEYNOTE-564. Kaplan-Meier analyses addressed overall survival (OS), CSM and OCM. RESULTS: 9,825 (92.4%) of the 10,635 patients had intermediate-high risk RCC and 9,456 (88.9%) underwent radical nephrectomy. Additionally, 760 (7.1%) harbored sarcomatoid features. In Kaplan-Meier analyses, median OS was 9.8 (9.1-11.4) years. At 10-years of follow-up, CSM rate was 36% and OCM rate was 22%. CONCLUSIONS: Based on CSM, our observations indicate that by 10-years of follow-up 36% of patients treated with adjuvant pembrolizumab will require a rechallenge, in a setting where a checkpoint inhibitor may have reduced efficacy. Moreover, at 10-years of follow-up, 22% of patients with RCC, previously treated with adjuvant pembrolizumab, will die of other causes. These percentages should be strongly considered prior to routine use of adjuvant pembrolizumab, especially given an OS benefit has not been proven.

Contemporary seminal vesicle invasion rates in NCCN high-risk prostate cancer patients.

BACKGROUND: Contemporary seminal vesicle invasion (SVI) rates in National Cancer Comprehensive Network (NCCN) high-risk prostate cancer (PCa) patients are not well known but essential for treatment planning. We examined SVI rates according to individual patient characteristics for purpose of treatment planning. MATERIALS AND METHODS: Within Surveillance, Epidemiology, and End Results (SEER) database (2010-2015), 4975 NCCN high-risk patients were identified. In the development cohort (SEER geographic region of residence: South, North-East, Mid-West, n = 2456), we fitted a multivariable logistic regression model predicting SVI. Its accuracy, calibration, and decision curve analyses (DCAs) were then tested versus previous models within the external validation cohort (SEER geographic region of residence: West, n = 2519). RESULTS: Out of 4975 patients, 28% had SVI. SVI rate ranged from 8% to 89% according to clinical T stage, prostate-specific antigen (PSA), biopsy Gleason Grade Group and percentage of positive biopsy cores. In the development cohort, these variables were independent predictors of SVI. In the external validation cohort, the current model achieved 77.6% accuracy vs 73.7% for Memorial Sloan Kettering Cancer Centre (MSKCC) vs 68.6% for Gallina et al. Calibration was better than for the two alternatives: departures from ideal predictions were 6.0% for the current model vs 9.8% for MSKCC vs 38.5% for Gallina et al. In DCAs, the current model outperformed both alternatives. Finally, different nomogram cutoffs allowed to discriminate between low versus high SVI risk patients. CONCLUSIONS: More than a quarter of NCCN high-risk PCa patients harbored SVI. Since SVI positivity rate varies from 8% to 89%, the currently developed model offers a valuable approach to distinguish between low and high SVI risk patients.

Non-organ confined stage and upgrading rates in exclusive PSA high-risk prostate cancer patients.

BACKGROUND: The pathological stage of prostate cancer with high-risk prostate-specific antigen (PSA) levels, but otherwise favorable and/or intermediate risk characteristics (clinical T-stage, Gleason Grade group at biopsy [B-GGG]) is unknown. We hypothesized that a considerable proportion of such patients will exhibit clinically meaningful GGG upgrading or non-organ confined (NOC) stage at radical prostatectomy (RP). MATERIALS AND METHODS: Within the Surveillance, Epidemiology, and End Results database (2010-2015) we identified RP-patients with cT1c-stage and B-GGG1, B-GGG2, or B-GGG3 and PSA 20-50 ng/ml. Rates of GGG4 or GGG5 and/or rates of NOC stage (≥ pT3 and/or pN1) were analyzed. Subsequently, separate univariable and multivariable logistic regression models tested for predictors of NOC stage and upgrading at RP. RESULTS: Of 486 assessable patients, 134 (28%) exhibited B-GGG1, 209 (43%) B-GGG2, and 143 (29%) B-GGG3, respectively. The overall upgrading and NOC rates were 11% and 51% for a combined rate of upgrading and/or NOC stage of 53%. In multivariable logistic regression models predicting upgrading, only B-GGG3 was an independent predictor (odds ratio [OR]: 5.29; 95% confidence interval [CI]: 2.21-14.19; p < 0.001). Conversely, 33%-66% (OR: 2.36; 95% CI: 1.42-3.95; p = 0.001) and >66% of positive biopsy cores (OR: 4.85; 95% CI: 2.84-8.42; p < 0.001), as well as B-GGG2 and B-GGG3 were independent predictors for NOC stage (all p ≤ 0.001). CONCLUSIONS: In cT1c-stage patients with high-risk PSA baseline, but low- to intermediate risk B-GGG, the rate of upgrading to GGG4 or GGG5 is low (11%). However, NOC stage is found in the majority (51%) and can be independently predicted with percentage of positive cores at biopsy and B-GGG.

Survival after radical prostatectomy versus radiation therapy in clinical node-positive prostate cancer.

AIM: To compare overall mortality (OM), cancer-specific mortality (CSM), and other cause mortality (OCM) rates between radical prostatectomy (RP) versus radiotherapy (RT) in clinical node-positive (cN1) prostate cancer (PCa). MATERIALS AND METHODS: Within Surveillance, Epidemiology, End Results (SEER) (2004-2016), we identified 4685 cN1 PCa patients, of whom 3589 (76.6%) versus 1096 (24.4%) were treated with RP versus RT. After 1:1 propensity score matching (PSM), Kaplan-Meier plots and Cox regression models tested the effect of RP versus RT on OM, while cumulative incidence plots and competing-risks regression (CRR) models addressed CSM and OCM between RP and RT patients. All analyses were repeated after the inverse probability of treatment weighting (IPTW). For CSM and OCM analyses, the propensity score was used as a covariate in the regression model. RESULTS: Overall, RT patients were older, harbored higher prostate-specific antigen values, higher clinical T and higher Gleason grade groups. PSM resulted in two equally sized groups of 894 RP versus 894 RT patients. After PSM, 5-year OM, CSM, and OCM rates were, respectively, 15.4% versus 25%, 9.3% versus 17%, and 6.1% versus 8% for RP versus RT (all p < 0.001) and yielded respective multivariate hazard ratios (HRs) of 0.63 (0.52-0.78, p < 0.001), 0.66 (0.52-0.86, p < 0.001), 0.71 (0.5-1.0, p = 0.05), all favoring RP. After IPTW, Cox regression models yielded HR of 0.55 (95% confidence interval [CI] = 0.46-0.66) for OM, and CRR yielded HRs of 0.49 (0.34-0.70) and 0.54 (0.36-0.79) for, respectively, CSM and OCM, all favoring RP (all p < 0.001). CONCLUSIONS: RP may hold a CSM advantage over RT in cN1 PCa patients.

Renal surgery for kidney cancer: is preoperative proteinuria a predictor of functional and survival outcomes after surgery? A systematic review of the literature.

INTRODUCTION: Proteinuria is considered both a known marker for the severity of chronic kidney disease (CKD) and a robust predictor of future renal function and cardiovascular morbidity and mortality in a general population. The urological community has long overlooked proteinuria as a marker of renal function. Recently, the American Urological Association (AUA) clinical practice guideline addressed this issue and suggested introducing proteinuria assessment prior to kidney cancer surgery. The aim of this systematic review was to provide evidence of proteinuria as a predictor of renal function impairment and survival outcomes after kidney surgery for renal tumors. EVIDENCE ACQUISITION: A systematic search was performed by using three search engines (PubMed, Embase®, and Web of Science) from January 2010 to November 2020. Study selection followed the PRISMA guidelines. After screening, ten articles and abstracts fully compatible with the PICOS were included in this systematic review. EVIDENCE SYNTHESIS: Overall, a total of 11,705 patients who underwent partial nephrectomy (PN) or radical nephrectomy (RN) were analyzed. When used as a binomial variable, proteinuria prior to surgery was detected from 10% to 33% of patients. Relying on both proteinuria and estimated glomerular filtration rate (eGFR) in the assessment of renal function yielded up to 33% higher rates of patients with preoperative renal impairment. Moreover, proteinuria increased the risk of long-term renal impairment after PN and RN as well as patients with preoperative proteinuria undergoing PN exhibited a greater risk of postoperative acute kidney injury (AKI). Among eligible studies, proteinuria was associated with diabetes, obesity, metabolic syndrome, hypertension and cardiovascular disease. Finally, proteinuria was an independent predictor of overall mortality, but not of cancer-specific mortality. CONCLUSIONS: Proteinuria yields a prognostic power beyond that provided by estimated glomerular filtration rate (eGFR) among patients undergoing renal cancer surgery, supporting its introduction in the preoperative assessment of renal function. However, well-designed multicenter prospective studies would be necessary to corroborate these results and provided urological community with high-grade recommendation for clinical practice.

Cancer-specific survival after radical prostatectomy versus external beam radiotherapy in high-risk and very high-risk African American prostate cancer patients.

BACKGROUND: To test for differences in cancer-specific mortality (CSM) rates between radical prostatectomy (RP) vs external beam radiotherapy (EBRT) in National Comprehensive Cancer Network (NCCN) high-risk African American patients, as well as Johns Hopkins University (JHU) high-risk and very high-risk patients. MATERIALS AND METHODS: Within the Surveillance, Epidemiology, and End Results database (2010-2016), we identified 4165 NCCN high-risk patients, of whom 1944 (46.7%) and 2221 (53.3%) patients qualified for JHU high-risk or very high-risk definitions. Of all 4165 patients, 1390 (33.5%) were treated with RP versus 2775 (66.6%) with EBRT. Cumulative incidence plots and competing risks regression models addressed CSM before and after 1:1 propensity score matching between RP and EBRT NCCN high-risk patients. Subsequently, analyses were repeated separately in JHU high-risk and very high-risk subgroups. Finally, all analyses were repeated after landmark analyses were applied. RESULTS: In the NCCN high-risk cohort, 5-year CSM rates for RP versus EBRT were 2.4 versus 5.2%, yielding a multivariable hazard ratio of 0.50 (95% confidence interval [CI] 0.30-0.84, p = 0.009) favoring RP. In JHU very high-risk patients 5-year CSM rates for RP versus EBRT were 3.7 versus 8.4%, respectively, yielding a multivariable hazard ratio of 0.51 (95% CI: 0.28-0.95, p = 0.03) favoring RP. Conversely, in JHU high-risk patients, no significant CSM difference was recorded between RP vs EBRT (5-year CSM rates: 1.3 vs 1.3%; multivariable hazard ratio: 0.55, 95% CI: 0.16-1.90, p = 0.3). Observations were confirmed in propensity score-matched and landmark analyses adjusted cohorts. CONCLUSIONS: In JHU very high-risk African American patients, RP may hold a CSM advantage over EBRT, but not in JHU high-risk African American patients.

Effect of Chemotherapy on Overall Survival in Contemporary Metastatic Prostate Cancer Patients.

INTRODUCTION: Randomized clinical trials demonstrated improved overall survival in chemotherapy exposed metastatic prostate cancer patients. However, real-world data validating this effect with large scale epidemiological data sets are scarce and might not agree with trials. We tested this hypothesis. MATERIALS AND METHODS: We identified de novo metastatic prostate cancer patients within the Surveillance, Epidemiology, and End Results (SEER) database (2014-2015). Kaplan-Meier plots and Cox regression models tested for overall survival differences between chemotherapy-exposed patients vs chemotherapy-naïve patients. All analyses were repeated in propensity-score matched cohorts. Additionally, landmark analyses were applied to account for potential immortal time bias. RESULTS: Overall, 4295 de novo metastatic prostate cancer patients were identified. Of those, 905 (21.1%) patients received chemotherapy vs 3390 (78.9%) did not. Median overall survival was not reached at 30 months follow-up. Chemotherapy-exposed patients exhibited significantly better overall survival (61.6 vs 54.3%, multivariable HR:0.82, CI: 0.72-0.96, p=0.01) at 30 months compared to their chemotherapy-naïve counterparts. These findings were confirmed in propensity score matched analyses (multivariable HR: 0.77, CI:0.66-0.90, p<0.001). Results remained unchanged after landmark analyses were applied in propensity score matched population. CONCLUSIONS: In this contemporary real-world population-based cohort, chemotherapy for metastatic prostate cancer patients was associated with better overall survival. However, the magnitude of overall survival benefit was not comparable to phase 3 trials.

Improvement in overall and cancer-specific survival in contemporary, metastatic prostate cancer chemotherapy exposed patients.

INTRODUCTION: Over the last decade, multiple clinical trials demonstrated improved survival after chemotherapy for metastatic prostate cancer (mPCa). However, real-world data validating this effect within large-scale epidemiological data sets are scarce. We addressed this void. MATERIALS AND METHODS: Men with de novo mPCa were identified and systemic chemotherapy status was ascertained within the Surveillance, Epidemiology, and End Results database (2004-2016). Patients were divided between historical (2004-2013) versus contemporary (2014-2016). Chemotherapy rates were plotted over time. Kaplan-Meier plots and Cox regression models with additional multivariable adjustments addressed overall and cancer-specific mortality. All tests were repeated in propensity-matched analyses. RESULTS: Overall, 19,913 patients had de novo mPCa between 2004 and 2016. Of those, 1838 patients received chemotherapy. Of 1838 chemotherapy-exposed patients, 903 were historical, whereas 905 were contemporary. Chemotherapy rates increased from 5% to 25% over time. Median overall survival was not reached in contemporary patients versus was 24 months in historical patients (hazard ratio [HR]: 0.55, p < 0.001). After propensity score matching and additional multivariable adjustment (age, prostate-specific antigen, GGG, cT-stage, cN-stage, cM-stage, and local treatment) a HR of 0.55 (p < 0.001) was recorded. Analyses were repeated for cancer-specific mortality after adjustment for other cause mortality in competing risks regression models and recorded virtually the same findings before and after propensity score matching (HR: 0.55, p < 0.001). CONCLUSIONS: In mPCa patients, chemotherapy rates increased over time. A concomitant increase in survival was also recorded.

Presence of biopsy Gleason pattern 5 + 3 is associated with higher mortality after radical prostatectomy but not after external beam radiotherapy compared to other Gleason Grade Group IV patterns.

BACKGROUND: We hypothesized that Gleason Grade Group (GGG) IV patients treated with radical prostatectomy (RP) or external beam radiotherapy (EBRT) exhibit different cancer-specific mortality (CSM) rates according to underlying Gleason patterns (GP): 4 + 4 versus 3 + 5 versus 5 + 3. MATERIALS AND METHODS: We identified all GGG IV patients treated with either RP or EBRT within the Surveillance, Epidemiology, and End Results 2004-2016 database. The effect of biopsy GP on CSM (3 + 5 vs. 4 + 4 vs. 5 + 3) was tested in Kaplan-Meier and multivariable competing risks regression models (adjusted for PSA, age at diagnosis, cT-, and cN-stage). RESULTS: Of 26,458 GGG IV patients, 14,203 (53.7%) were treated with EBRT and 12,255 (46.3%) with RP. Of RP patients, 15.3 versus 81.2 versus 3.4% exhibited biopsy GP 3 + 5 versus 4 + 4 versus 5 + 3 and respective 10-year CSM rates were 6.5 versus 6.2 versus 12.6% (p < .001). In multivariable analyses addressing RP patients, GP 5 + 3 was associated with two-fold higher CSM rate than GP 4 + 4 (p < .001), but not GP 3 + 5 (p = .1). Of EBRT patients, 7.6 versus 89.8 versus 2.6% exhibited biopsy GP 3 + 5 versus 4 + 4 versus 5 + 3 and respective 10-year CSM rates were 12.2 versus 13.8 versus 17.8% (p < .001). In multivariable analyses addressing EBRT patients, no CSM differences according to GP were observed (all p ≥ .4). CONCLUSION: In GGG IV RP candidates, the presence of biopsy GP 5 + 3 purports a significantly higher CSM than in GP 4 + 4 or 3 + 5. In GGG IV EBRT candidates, no significant CSM differences according to GP were recorded.

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.

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 (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.

Fusion US/MRI prostate biopsy using a computer aided diagnostic (CAD) system.

BACKGROUND: The aim of this study was 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. The χ2 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 PI-RADS 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% vs. 37.8%, 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%vs.11.1%, 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.

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

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.

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

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.