Long-Term Oncologic Outcomes of Off-Clamp Robotic Partial Nephrectomy for Cystic Renal Tumors: A Propensity Score Matched-Pair Comparison of Cystic versus Pure Clear Cell Carcinoma.

Few data are available on survival outcomes of partial nephrectomy performed for cystic renal tumors. We present the first long-term oncological outcomes of cystic (cystRCC) versus pure clear cell renal cell carcinoma (ccRCC) in a propensity score-matched (PSM) analysis. Our "renal cancer" prospectively maintained database was queried for "cystRCC" or "ccRCC" and "off-clamp robotic partial nephrectomy" (off-C RPN). The two groups were compared for age, gender, tumor size, pT stage, and Fuhrman grade. A 1:3 PSM analysis was applied to reduce covariate imbalance to <10% and two homogeneous populations were generated. Student t- and Chi-square tests were used for continuous and categorical variables, respectively. Ten-year oncological outcomes were compared between the two cohorts using log-rank test. Univariable Cox regression analysis was used to identify predictors of disease progression after RPN. Out of 859 off-C RPNs included, 85 cases were cystRCC and 774 were ccRCC at histologic evaluation. After applying the PSM analysis, two cohorts were selected, including 64 cystRCC and 170 ccRCC. Comparable 10-year cancer-specific survival probability (95.3% versus 100%, p = 0.146) was found between the two cohorts. Conversely, 10-year disease-free survival probability (DFS) was less favorable for pure ccRCC than cystRCC (66.69% versus 90.1%, p = 0.035). At univariable regression analysis, ccRCC histology was the only independent predictor of DFS probability (HR 2.96 95% CI 1.03-8.47, p = 0.044). At the 10-year evaluation, cystRCC showed favorable oncological outcomes after off-C RPN. Pure clear cell variant histology displayed a higher rate of disease recurrence than cystic lesions.

Learning curve for intracorporeal robotic Padua ileal bladder: 10-year functional assessment from a high-volume single-centre series.

OBJECTIVES: To assess the impact of the learning curve (LC) on perioperative and long-term functional outcomes of a consecutive single-centre series of robot-assisted radical cystectomy with Padua intracorporeal orthotopic neobladder. PATIENTS AND METHODS: Patients treated between 2013 and 2022 were included, with ≥1 year of follow-up. The entire cohort was divided in tertiles. Categorical and continuous variables were compared. Joinpoint regression analysis was used to identify significant changes over the decade in linear slope of the 1-year day- and night-time continence. Uni- and multivariable Cox regression analyses identified predictors of day- and night-time continence recovery. Day-time continence was defined as 'totally dry' (no pads), night-time continence as pad wetness ≤50 mL (one safety pad). RESULTS: Overall, 200 patients were included. The mean hospital stay (P = 0.002) and 30-day complications (P = 0.04) significantly reduced over time; the LC significantly impacted on Trifecta achievement (P < 0.001). The 1-year day- and night-time continence probabilities displayed a significant improving trend (day-time continence annual average percentage change [AAPC] 11.45%, P < 0.001; night-time continence AAPC 10.05%, P = 0.009). The LC was an independent predictor of day- (hazard ratio [HR] 1.008; P < 0.001) and night-time continence (HR 1.004; P = 0.03) over time. CONCLUSION: Patients at the beginning of the LC had significantly longer hospitalisations, more postoperative complications, and lower Trifecta rates. At the 10-year analyses, we observed a significant improving trend for both the 1-year day- and night-time continence probabilities, highlighting the crucial role of the LC. However, we are unable to assess the case volume needed to achieve a plateau in terms of day- and night-time continence rates.

Adrenalectomy for Metastasis: The Impact of Primary Histology on Survival Outcome.

Adrenalectomy is commonly considered a curative treatment in case of adrenal gland as site of metastasis. In the present study, we evaluated the impact of primary tumor histology on survival outcomes after a minimally invasive adrenal mastectomy for a solitary metachronous metastasis. From May 2004 to August 2020, we prospectively collected data on minimally invasive adrenalectomies whose pathological examination showed a metastasis. All patients only received metastasectomies that were performed with curative intent, or to achieve non-evidence of disease status. Adjuvant systemic therapy was not administered in any case. Cancer-specific survival (CSS) was assessed using the Kaplan-Meier method. Univariable and multivariable Cox regression analyses were applied to identify independent predictors of CSS. Out of 235 laparoscopic and robotic adrenalectomies, the pathologic report showed metastases in 60 cases. The primary histologies included 36 (60%) renal cell carcinoma (RCC), 9 (15%) lung cancer, 6 (10%) colon cancer, 4 (6.7%) sarcoma, 3 (5%) melanoma and 2 (3.3%) bladder cancer. RCC displayed significantly longer survival rates with a 5-year CSS of 55.9%, versus 22.8% for other histologies (log-rank p = 0.01). At univariable analysis, disease-free interval (defined as the time from adrenalectomy to evidence of disease progression) < 12 months and histology were predictors of CSS (p = 0.003 and p < 0.001, respectively). At multivariable Cox analysis, the only independent predictor of CSS was primary tumor histology (p = 0.005); patients with adrenal metastasis from colon cancer and bladder cancer showed a 5.3- and 75.5-fold increased risk of cancer death, respectively, compared to patients who had RCC as primary tumor histology. Oncological outcomes of adrenal metastasectomies are strongly influenced by primary tumor histology. A proper discussion of the role of surgery in a multidisciplinary context could provide optimal treatment strategies.

Robot-assisted Radical Cystectomy with Totally Intracorporeal Urinary Diversion Versus Open Radical Cystectomy: 3-Year Outcomes from a Randomised Controlled Trial.

BACKGROUND AND OBJECTIVE: Randomised controlled trials (RCTs) comparing open radical cystectomy (ORC) and robot-assisted RC (RARC) have involved an extracorporeal approach for urinary diversion (UD), undermining the potential benefits of a totally robotic procedure. Our objective was to compare 3-yr outcomes from a RCT comparing ORC to RARC with totally intracorporeal UD (iUD). METHODS: Patients with cT2-4 N0 M0 or bacillus Calmette-Guérin-failed high-grade non-muscle-invasive urothelial carcinoma who were candidates for RC without absolute contraindications to robotic surgery were included. A covariate adaptive randomisation process based on body mass index, American Society of Anesthesiologists score, preoperative haemoglobin, type of UD, neoadjuvant chemotherapy, and cT stage was used. The primary endpoint was to investigate the superiority of RARC with iUD in terms of a 50% reduction in transfusion rate. Secondary outcomes included adherence to an early recovery after surgery protocol, perioperative and postoperative outcomes, readmission and complication rates, a cost analysis, and functional, oncological, and health-related quality-of-life outcomes. KEY FINDINGS AND LIMITATIONS: Overall, 116 patients were enrolled. The primary endpoint was confirmed, as the overall perioperative transfusion rate was significantly lower in the RARC cohort, with an absolute risk reduction of 19% (95% confidence interval 2-36%; p = 0.046). No differences in perioperative and postoperative complications and 3-yr oncological outcomes were observed between the groups. Despite the superiority of ORC on quantitative analysis of night-time pad use, there were no differences in the probabilities of recovery of daytime and night-time continence. Body image was significantly better in the RARC cohort. Cost analysis confirmed that RARC is a more expensive surgical procedure. CONCLUSIONS AND CLINICAL IMPLICATIONS: Our findings support RARC with iUD as a safe surgical option; the transfusion rate was reduced by 50% and the complication rates and 3-yr oncological outcomes were comparable to those with ORC. The minimally invasive nature of RARC was reflected in better body image perception in this cohort. The probabilities of daytime and night-time continence recovery were comparable between the groups. Higher costs remain a drawback of robotic surgery. PATIENT SUMMARY: This RCT demonstrated a 50% transfusions rate's reduction compared to ORC. We confirmed safety and feasibility of RARC with i-UD providing comparable peri- and postoperative complication rates, as well as, 3yr oncologic outcomes to those of ORC. Patients receiving either RARC-iUD or ORC had comparable probabilities of urinary continence recovery after surgery.

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.

The association of the type and number of D'Amico high-risk criteria with rates of pathologically non-organ-confined prostate cancer.

Introduction: The aim of this study was to assess the association between the type and number of D'Amico high-risk criteria (DHRCs) with rates of pathologically non-organ-confined (NOC) prostate cancer in patients treated with radical prostatectomy (RP) and pelvic lymphadenectomy (PLND). Material and methods: In the Surveillance, Epidemiology, and End Results database (2004-2016), we identified 12961 RP and PLDN patients with at least one DHRC. We relied on descriptive statistics and multivariable logistic regression models. Results: Of 12 961 patients, 6135 (47%) exclusively harboured biopsy Gleason score (GS) 8-10, 3526 (27%) had clinical stage ≥T2c, and 1234 (9.5%) had prostate-specific antigen (PSA) >20 ng/mL. Only 1886 (15%) harboured any combination of 2 DHRCs. Finally, all 3 DHRCs were present in 180 (1.4%) patients. NOC rates increased from 32% for clinical T stage ≥T2c to 49% for either GS 8-10 only or PSA >20 ng/mL only and to 66-68% for any combination of 2 DHRCs, and to 84% for respectively all 3 DHRCs, which resulted in a multivariable logistic regression OR of 1.00, 2.01 (95% CI 1.85-2.19; p <0.001), 4.16 (95% CI 3.69-4.68; p <0.001), and 10.83 (95% CI 7.35-16.52; p <0.001), respectively. Conclusions: Our study indicates a stimulus-response effect according to the type and number of DHRCs. Hence, a formal risk-stratification within high-risk prostate cancer patients should be considered in clinical decision-making.

Open versus robot-assisted radical cystectomy: pentafecta and trifecta achievement comparison from a randomised controlled trial.

OBJECTIVES: To compare University of Southern California (USC) Institute of Urology pentafecta and trifecta achievement comparing open radical cystectomy (ORC) vs robot-assisted RC (RARC) with totally intracorporeal urinary diversion (iUD) from a randomised controlled trial (RCT). PATIENTS AND METHODS: Patients were eligible for randomisation if they had a diagnostic transurethral resection of bladder tumour with clinical T stage (cT)2-4, cN0, cM0, or recurrent high-grade non-muscle-invasive bladder cancer and no anaesthesia contraindications to robotic surgery. Patients were enrolled with a covariate adaptive randomisation process based on the following variables: body mass index, American Society of Anesthesiologists score, preoperative haemoglobin, planned UD, neoadjuvant chemotherapy, and cT stage. USC pentafecta was defined as the combination at 1 year after surgery of: negative soft tissue surgical margins, ≥16 lymph node (LN) yield, absence of major (Clavien-Dindo Grade ≥III) complications at 90 days, absence of UD-related long-term sequalae, and absence of clinical recurrence. Trifecta was defined as the coexistence of daytime urinary continence, absence of major complications and recurrence-free status, all assessed at 1 year. Continuous and categorical variables were compared using Student's t-test and chi-square test, respectively. Univariable logistic regression analysis was performed to assess the role of USC pentafecta and trifecta achievement on health-related quality of life (HRQoL). RESULTS: There was no statistically significant difference in USC pentafecta and trifecta achievement between groups. Among secondary outcomes, univariable logistic regression analysis was performed and both 1-year USC pentafecta and trifecta achievement were predictors of 2-year unmodified global HRQoL. CONCLUSIONS: This study supports equivalence of RARC-iUD and ORC with regard to surgical quality as described by the USC pentafecta and trifecta. We described a significant impact of USC pentafecta and trifecta achievement on global health status/HRQoL, providing a strict correlation between objective evaluation of surgical outcomes and self-reported HRQoL.

"Single Knot-Single Running Suture" Vesicourethral Anastomosis with Posterior Musculofascial Reconstruction during Robot-Assisted Radical Prostatectomy: A Step-by-Step Guide of Surgical Technique.

Background: Our aim is to describe Gallucci's (VV-G) technique for vesicourethral anastomosis and posterior musculofascial reconstruction (PMFR) during robot-assisted radical prostatectomy (RARP) and to assess early urinary continence recovery and perioperative outcomes. VV-G consists of a "single knot-single running suture" vesicourethral anastomosis with PMFR. Methods: Between September 2019 and October 2021, we prospectively compared VV-G vs. conventional Van Velthoven anastomosis (VV-STD) during RARP. We excluded patients with urinary incontinence, pelvic radiotherapy, and urethral and BPH surgery prior to RARP. Social continence (SC) recovery, perioperative complications, and length of hospital stay (LOS) were compared between VV-G vs. VV-STD. SC was defined as 0-1 pad/die. We applied 1:1 propensity score matching (PSM) adjusting for different covariates (age, Charlson Comorbidity Index, BMI, prostate volume, nerve-sparing and lymph node dissection). Results: From 166 patients, 1:1 PSM resulted in two equally sized groups of 40 patients each with no residual differences (all p ≥ 0.2). VV-G yielded higher 3-month SC rates than VV-STD (97.5 vs. 55.0%, p < 0.001). A tiny difference was still recorded at one-year follow-up (97.5 vs. 80.0%, p = 0.029, HR: 2.90, 95% CI: 1.74-4.85, p < 0.001). Conversely, we observed no differences in any perioperative complications (15.0 vs. 22.5%, OR: 0.61, 95% CI 0.19-1.88, p = 0.4) and LOS (3 vs. 4 days, Δ: -0.69 ± 0.61, p = 0.1). Conclusions: VV-G significantly improved early SC recovery without increasing perioperative morbidity. In our opinion, VV-G represents an easy-to-learn and easy-to-teach technique due to its single-suture, single-knot, and symmetrical design.

The Impact of Metastasectomy on Survival Outcomes of Renal Cell Carcinoma: A 10-Year Single Center Experience.

OBJECTIVES: The role of surgical metastasectomy (MST) in solitary or oligometastasis from renal cell carcinoma (RCC) and its impact on survival outcomes remains poorly addressed. We evaluated the impact of MST on overall survival (OS) in patients with oligometastatic (m)RCC. MATERIALS AND METHODS: The institutional renal cancer prospective database was examined for cases treated with partial or radical nephrectomy who developed metastatic disease during follow-up. Patients with evidence of clinical metastasis at first diagnosis were excluded. Patients considered unfit for MST received systemic treatment (ST); all others received MST. The impact of MST vs. the ST only cohort was assessed with the Kaplan-Meier method. Age, gender, bilaterality, histology, AJCC stage of primary tumor, surgical margins, local vs. distant metastasis and MST were included in univariable and multivariable regression analyses to assess the predictors of OS. RESULTS: Overall, at a median follow-up of 16 months after primary treatment, 168 patients with RCC developed asynchronous metastasis at the adrenal gland, lung, liver, spleen, peritoneal, renal fossa, bone, nodes, brain and thyroid gland. Nine patients unfit for any treatment were excluded. The site of metastasis was treated with surgical MST (77/159, 48.4%), with or without previous or subsequent ST, while 82/159 cases (51.2%) received ST only. The 2-year, 5-year and 10-year OS probabilities were 93.8%, 82.8% and 79.5%, respectively. After multivariable analysis, MST and the primary tumor AJCC stage were independent predictors of OS probabilities (p = 0.019 and p = 0.035, respectively). After Kaplan-Meier analysis, MST significantly improved OS probabilities versus patients receiving ST (p < 0.001). LIMITATIONS: The main drawbacks of our research were the small sample size from a single-tertiary referral institution, as well as the absent or different ST lines in the cohort of patients receiving MST. CONCLUSIONS: When an NED status is achievable, surgical MST of mRCC significantly impacts OS, delaying and not precluding further subsequent ST.

Long-term oncologic and functional outcomes following robot-assisted radical cystectomy and intracorporeal Padua ileal bladder: results from a single high-volume center.

PURPOSE: To report long-term oncologic and functional outcomes of a large consecutive single center series of Robot-assisted radical cystectomy (RARC)- intracorporeal (IC) Urinary Diversion (UD), identifying their predicting factors. METHODS: A single center Bladder cancer (BC) database was queried for "RARC" and "ICUD", including patients treated between January 2012 and September 2020. Kaplan-Meier curves were assessed disease-free (DFS), cancer-specific (CSS) and overall survival (OS) probability. Univariable (UV) and multivariable (MV) analysis were adopted to identify predictors of DFS, CSS and OS. Kaplan-Meier method evaluated day- and night-time continence recovery probabilities; UV and MV analysis were adopted to identify predictors of Day-time continence. RESULTS: Overall, 251 patients were included. Among them, 192 patients underwent intracorporeal ileal orthotopic neobladder (ION) (76.5%). Five-year DFS, CSS and OS rates were 66.5%, 65.4% and 61.5%; pT stage ≥ 3 and pathologic nodal involvement were identified as negative independent predictors of DFS (HR 2.39, p = 0.001, HR 4.64, p ≤ 0.001), CSS (HR 2.20, p = 0.01, HR 3.97, p < 0.001) and OS (HR 2.25, p = 0.005, HR 3.95, p < 0.001). In RARC-ION patients, Trifecta rate was 64.1%. One-year day- and night-time continence rates were 78.6% and 48.3%. Age (HR 0.98, p = 0.03), female gender (HR 0.57, p = 0.008) and complications Clavien grade ≥ 3 (HR 0.55, p = 0.03) were identified as independent predictors of day-time incontinence. CONCLUSIONS: Long-term oncologic outcomes and their predicting factors seem aligned to the largest historical open series and multi-institutional robotic series data. According to the identified predicting factors undermining a proper achievement of day-time continence, this represents an objective support, in order to properly advice specific sub-group of patients.

Racial/ethnic disparities in the distribution and effect of type and number of high-risk criteria on mortality in prostate cancer patients treated with radiotherapy.

Objective: To assess differences in the distribution of type and number of D'Amico high-risk criteria (DHRCs) according to race/ethnicity (R/E) and their effect on cancer-specific mortality (CSM) in prostate cancer (PCa) patients treated with external beam radiotherapy (RT). Methods: In the SEER database (2004-2016), we identified 31,002 PCa patients treated with RT with at least one DHRCs, namely PSA >20 ng/dL, biopsy Gleason Grade Group 4-5, and clinical T stage ≥T2c. Competing risks regression (CRR) model tested the association between DHRCs and 5-year CSM in all R/E subgroups. Results: Of 31,002 patients, 20,894 (67%) were Caucasian, 5256 (17%) were African American, 2868 (9.3%) were Hispanic-Latino, and 1984 (6.4%) were Asian. The distributions of individual DHRCs and combinations of two DHRCs differed according to R/E, but not for the combination of three DHRCs. The effect related to the presence of a single DHRC, and combinations of two or three DHRCs on absolute CSM rates was lowest in Asians (1.2-6.8%), followed by in African Americans (2.3-12.2%) and Caucasians (2.3-12.1%), and highest in Hispanic/Latinos (1.7-13.8%). However, the opposite effect was observed in CRR, where hazard ratios were highest in Asians vs. other R/Es: Asians 1.00-2.59 vs. others 0.5-1.83 for one DHRC, Asians 3.4-4.75 vs. others 0.66-3.66 for two DHRCs, and Asians 7.22 vs. others 3.03-4.99 for all three DHRCs. Conclusions: R/E affects the proportions of DHRCs. Moreover, within the four examined R/E groups, the effect of DHRCs on absolute and relative CSM metrics also differed. Therefore, R/E-specific considerations may be warranted in high-risk PCa patients treated with RT.

Assessing the Trade-off Between the Safety and Effectiveness of Off-clamp Robotic Partial Nephrectomy for Renal Masses with a High RENAL Score: A Propensity Score-matched Comparison of Perioperative and Functional Outcomes in a Multicenter Analysis.

BACKGROUND: Tumors with a high nephrometry score represent a challenging surgical scenario for which robotic partial nephrectomy (RPN) is a primary option in expert hands. OBJECTIVE: To compare perioperative and functional outcomes of off-clamp and on-clamp RPN in patients with renal masses with a high RENAL score (≥9). DESIGN, SETTING, AND PARTICIPANTS: For this retrospective analysis, an RPN data set including 1604 patients treated at three institutions between 2003 and 2021 was queried for cases with a RENAL score ≥9. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: We used 1:1 propensity score matching (PSM) to select a cohort in which imbalances between the off-clamp and on-clamp groups were minimized. We used χ2 and Student t tests to compare categorical and continuous variables, respectively. The Kaplan-Meier method was used to compare the probability of having an estimated glomerular filtration rate (eGFR) ≥45 ml/min during follow-up. Univariable and multivariable analyses were performed to identify predictors of a trifecta outcome (negative surgical margin status, no Clavien-Dindo grade ≥3 complications, eGFR decline ≤30%) and of retaining eGFR ≥45 ml/min over time. RESULTS AND LIMITATIONS: From an overall cohort of 354 patients (142 on-clamp, 212 off-clamp), a homogeneous PSM cohort of 78 patients in each group was selected (p ≥ 0.17). In the PSM cohort, operative time was significantly shorter in the off-clamp group (p < 0.001). There were no differences between the groups in the rates of severe complications (p = 0.32) and positive surgical margins (p = 0.24). The rate of trifecta achievement was significantly higher in the off-clamp group (83.3% vs 67.9%; p = 0.03). Warm ischemia time >20 min was independently negatively associated with trifecta achievement (odds ratio 0.32, 95% confidence interval 0.14-0.74). Moreover, the off-clamp group had a significantly higher probability of retaining eGFR ≥45 ml/min over time (3 yr: 95.9% vs 81.6%; p = 0.03); every 1-min increase in warm ischemia time reduced this probability by 1.3%. CONCLUSIONS: We found a favorable trade-off between the benefits and risks of off-clamp RPN, with similar perioperative outcomes and a net benefit in terms of trifecta achievement and long-term renal function outcomes in comparison to on-clamp RPN. PATIENT SUMMARY: The complexity of surgery for kidney tumors can be assessed using the RENAL score, which is a measure of the location and size of a kidney tumor. In a multicenter series of patients with tumors with a high RENAL score, we compared outcomes between strategies with (on-clamp) and without (off-clamp) clamping of kidney blood vessels during robot-assisted removal of part of the affected kidney. We found that off-clamp surgery results in better postoperative kidney function.

Definition and Diagnosis of Oligometastatic Bladder Cancer: A Delphi Consensus Study Endorsed by the European Association of Urology, European Society for Radiotherapy and Oncology, and European Society of Medical Oncology Genitourinary Faculty.

BACKGROUND: In contrast to other cancers, the concept of oligometastatic disease (OMD) has not been investigated in bladder cancer (BC). OBJECTIVE: To develop an acceptable definition, classification, and staging recommendations for oligometastatic BC (OMBC) spanning the issues of patient selection and the roles of systemic therapy and ablative local therapy. DESIGN, SETTING, AND PARTICIPANTS: A European consensus group of 29 experts, led by the European Association of Urology (EAU), the European Society for Radiotherapy and Oncology (ESTRO), and the European Society of Medical Oncology (ESMO), and including members from all other relevant European societies, was established. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: A modified Delphi method was used. A systematic review was used to build consensus questions. Consensus statements were extracted from two consecutive surveys. The statements were formulated during two consensus meetings. Agreement levels were measured to determine if consensus was achieved (≥75% agreement). RESULTS AND LIMITATIONS: The first survey included 14 questions and the second survey had 12. Owing to a considerable lack of evidence, which was the major limitation, definition was limited in the context of de novo OMBC, which was further classified as synchronous OMD, oligorecurrence, and oligoprogression. A maximum of three metastatic sites, all resectable or amenable to stereotactic therapy, was proposed as the definition of OMBC. Pelvic lymph nodes represented the only "organ" not included in the definition of OMBC. For staging, no consensus on the role of 18F-fluorodeoxyglucose positron emission tomography/computed tomography was reached. A favourable response to systemic treatment was proposed as the criterion for selection of patients for metastasis-directed therapy. CONCLUSIONS: A consensus statement on the definition and staging of OMBC has been formulated. This statement will help to standardise inclusion criteria in future trials, potentiate research on aspects of OMBC for which consensus was not achieved, and hopefully will lead to the development of guidelines on optimal management of OMBC. PATIENT SUMMARY: As an intermediate state between localised cancer and disease with extensive metastasis, oligometastatic bladder cancer (OMBC) might benefit from a combination of systemic treatment and local therapy. We report the first consensus statements on OMBC drawn up by an international expert group. These statements can provide a basis for standardisation of future research, which will lead to high-quality evidence in the field.

Regional differences in total hospital costs for radical cystectomy in the United States.

OBJECTIVES: To test for regional differences in total hospital costs (THC) across the United States in bladder cancer patients treated with open radical cystectomy (ORC) or robotic-assisted radical cystectomy (RARC). MATERIALS: We relied on the National Inpatient Sample (NIS) database (2016-2019) and stratified RC patients according to census region (Midwest, Northeast, South, West). Primary statistical analyses consisted of THC-trend analyses and multivariable log-link linear regression models, after adjustment for hospital clustering (Generalized Estimating Equation function) and discharge disposition weighting. Finally, sensitivity analysis, relying on most favorable patient cohort, was performed. RESULTS: Of 5280 eligible patients, 1441 (27%), 1031 (20%), 1854 (35%) and 954 (18%) underwent RC in the Midwest, Northeast, South and West, respectively. Median THC was 28,915$ and differed significantly between regions (Midwest: 28,105$; Northeast: 28,886$; South: 26,096$; West: 38,809$; p < 0.001). After stratification between ORC and RARC, highest THC was invariably recorded in the West: ORC 36,137$ vs 23,941-28,850$ and RARC 43,119$ vs 28,425-29,952$ (both p < 0.05). In multivariable log-link linear regression models, surgery in the West was independently associated with higher THC: ORC (Exponent beta [Exp[ß]]: 1.39; 95%-CI: 1.32-1.47; p < 0.001) and RARC (Exp[ß]: 1.46; 95%-CI: 1.38-1.55; p < 0.001). Results remained unchanged when analyses were refitted in most favorable patient subgroup. CONCLUSIONS: Important regional differences in ORC and RARC THC distinguish the West from other United States regions. The THC discrepancy clearly requires closer examination to identify underlying processes that contribute to inflated costs in the West.

The Effect of Sex on Disease Stage and Survival after Radical Cystectomy in Non-Urothelial Variant-Histology Bladder Cancer.

BACKGROUND: Female sex in patients treated by radical cystectomy (RC) is associated with more advanced stage and worse survival. However, studies supporting these findings mostly or exclusively relied on urothelial carcinoma of the urinary bladder (UCUB) and did not address non-urothelial variant-histology bladder cancer (VH BCa). We hypothesized that female sex is associated with a more advanced stage and worse survival in VH BCa, similarly to that of UCUB. MATERIALS AND METHODS: Within the SEER database (2004-2016), we identified patients aged ≥18 years, with histologically confirmed VH BCa, and treated with comprehensive RC. Logistic regression addressing the non-organ-confined (NOC) stage, as well as cumulative incidence plots and competing risks regression addressing CSM for females vs. males, were fitted. All analyses were repeated in stage-specific and VH-specific subgroups. RESULTS: Overall, 1623 VH BCa patients treated with RC were identified. Of those, 38% were female. Adenocarcinoma (n = 331, 33%), neuroendocrine tumor (n = 304, 18%), and other VH (n = 317, 37%) were less frequent in females but not squamous cell carcinoma (n = 671, 51%). Across all VH subgroups, female patients had higher NOC rates than males did (68 vs. 58%, p < 0.001), and female sex was an independent predictor of NOC VH BCa (OR = 1.55, p = 0.0001). Overall, five-year cancer-specific mortality (CSM) were 43% for females vs. 34% for males (HR = 1.25, p = 0.02). CONCLUSION: In VH BC patients treated with comprehensive RC, female sex is associated with a more advanced stage. Independently of stage, female sex also predisposes to higher CSM.

The association of type and number of high-risk criteria with cancer specific mortality in prostate cancer patients treated with radiotherapy.

BACKGROUND: To assess the association between of type and number of D'Amico high-risk criteria (DHRCs) with rates of cancer-specific mortality (CSM) in prostate cancer (PCa) patients treated with external beam radiotherapy (RT). METHODS: In the Surveillance, Epidemiology, and End Results database (2004-2016), we identified 34,908 RT patients with at least one DHRCs, namely prostate-specific antigen (PSA) >20 ng/dL (hrPSA), biopsy Grade Group (hrGG) 4-5, clinical T stage (hrcT) ≥T2c. Multivariable Cox regression models (CRM), as well as competing risks regression (CRR) model, which further adjust for other cause mortality, tested the association between DHRCs and 5-year CSM. RESULTS: Of 34,908 patients, 14,777 (42%) exclusively harbored hrGG, 5641 (16%) hrPSA, 4390 (13%) had hrcT. Only 8238 (23.7%) harbored any combination of two DHRCs and 1862 (5.3%) had all three DHRCs. Five-year CSM rates ranged from 2.4% to 5.0% when any individual DHRC was present (hrcT, hrPSA, hrGG, in that order), versus 5.2% to 10.5% when two DHRCs were present (hrPSA+hrcT, hrcT+hrGG, hrPSA+hrGG, in that order) versus 14.4% when all three DHRCs were identified. In multivariable CRM hazard ratios relative to hrcT ranged from 1.07 to 1.76 for one DHRC, 2.20 to 3.83 for combinations of two DHRCs, and 5.11 for all three DHRCs. Multivariable CRR yielded to virtually the same results. CONCLUSIONS: Our study indicates a stimulus-response effect according to the type and number of DHRCs. This indicates potential for risk-stratification within HR PCa patients that could be applied in clinical decision making to increase or reduce treatment intensity.

Open vs robotic intracorporeal Padua ileal bladder: functional outcomes of a single-centre RCT.

PURPOSE: Functional outcomes of robot-assisted (RA) radical cystectomy (RC) with intracorporeal orthotopic neobladder (i-ON) have been poorly investigated. The study aimed to report functional outcomes of a prospective randomized controlled trial (RCT) comparing open RC (ORC) and RARC with i-ON. METHODS: Inclusion criteria were cT2-4/N0/M0, or BCG-failure high-grade urothelial carcinoma, candidate to RC with curative intent. A covariate adaptive randomization process was used, based on the following variables: BMI, ASA score, haemoglobin levels, cT-stage, neoadjuvant chemotherapy, urinary diversion. Day-time continence was defined as "totally dryness", nigh-time continence as pad wetness ≤ 50 cc. Continence recovery probabilities were compared between arms with Kaplan-Meier method and Cox regression analysis was performed to identify predictors of continence recovery. HRQoL outcomes analysis was assessed with a generalized linear mixed effect regression (GLMER) model. RESULTS: Out of 116 patients randomized, 88 received ON. Quantitative analysis of functional outcomes reported similar results in terms of day continence, while a better night continence status in ORC cohort was observed. However, 1-yr day- and night-time continence recovery probabilities were comparable. Night-time micturition frequency < 3 h was the only predictor of nigh-time continence recovery. At GLMER, 1-yr body image and sexual functioning were significantly better in RARC cohort, while urinary symptoms were comparable between arms. CONCLUSION: Despite superiority of ORC at quantitative night-time pad use analysis, we showed comparable day- and night-time continence recovery probabilities. At 1-yr analysis of HRQoL outcomes, urinary symptoms were comparable between arms, while RARC patients reported lower body image and sexual functioning worsening.

Purely Off-Clamp Laparoscopic Partial Nephrectomy Stands the Test of Time: 15 Years Functional and Oncologic Outcomes from a Single Center Experience.

BACKGROUND: Nephron-sparing surgery represents the gold standard treatment for organ-confined renal tumors. We present 15-years of outcomes after off-clamp laparoscopic partial nephrectomy (ocLPN). METHODS: a retrospective analysis was performed on patients who underwent ocLPN between May 2001 and December 2005. Baseline demographic, clinical, pathologic, surgical, functional and survival data were collected. The Kaplan-Meier method evaluated group-specific oncologic outcomes at 5, 10 and 15 years and the log rank test assessed differences between groups. The same analysis investigated the probabilities of developing a significant renal function impairment (sRFI) and achieving ROMeS. Cox analyses identified predictors of this latter tricomposite outcome. RESULTS: We included 63 patients whose median tumor size was 3 cm (IQR:2-4). At 15 years, the chances of developing local recurrence, metachronous renal cancers or distant metastases were 2 ± 2%, 23 ± 6% and 17 ± 5%, respectively. Consequently, disease-free, cancer-specific and overall-survival probabilities were 68 ± 6%, 90 ± 4% and 72 ± 6%. MCRSS and UCISS well predicted oncologic outcomes. Overall, nine (14%) patients experienced an sRFI and 33 (52%) achieved ROMeS. Age (HR: 1.046; p = 0.033) and malignant histology (low-risk cancers HR: 3.233, p = 0.048) (intermediate/high risk cancers HR: 5.721, p = 0.023) were independent predictors of ROMeS non-achievement. CONCLUSIONS: At 15 years from ocLPN, most of patients will experience both excellent functional and oncologic outcomes.

Development of a Pocket Nomogram to Predict Cancer and Disease Specific Survival After Radical Cystectomy For Bladder Cancer: The CRAB Nomogram.

OBJECTIVES: To develop an easy tool to predict cancer specific (CSS) and disease-free survival (DFS) in patients with bladder cancer treated with radical cystectomy. METHODS: Data from a consecutive series of 2395 patients with primitive or progression to muscle invasive bladder cancer (MIBC) undergone to radical cystectomy and lymph nodes dissection in 5 centers were evaluated. Using Cox proportional hazards analyses, the Cancer of the bladder risk assessment (CRAB) nomogram was generated. Accuracy of the nomogram was evaluated by Harrell's C test. Internal validation of the model was performed using 200 bootstraps. RESULTS: Median age was 66 (IQR 58/73) years; 612/2395 (26%) patients presented an advanced pathological stage (≥pT3a); 478/2395 (20%) presented positive lymph nodes. Overall, 729/2395 (30%) presented local or distant recurrence with a median DFS of 42 (IQR 14/89) months. Overall, 642/2395 (27%) died of bladder cancer with a median follow up of 48 (IQR 22/92) months. On univariate Cox proportional hazards analyses, age, stage, and lymph nodes density were a significant predictor of 3 and5 years CSS and DFS. Accuracy of the CRAB nomogram was 0.73 and 0.71 respectively. CONCLUSION: CRAB nomogram can be a practical and easily applicable tool that may help urologists to classify the long-term CSS and DFS of patients treated with radical cystectomy and to predict the oncological outcome.

The impact of locoregional treatments for metastatic castration resistant prostate cancer on disease progression: real life experience from a multicenter cohort.

BACKGROUND: Available data on medical treatment of metastatic castration resistant prostate cancer (mCRPC) support the use of more than one therapy line to delay chemotherapy. We evaluate in a longitudinal real life multicenter cohort, the oncological outcome of mCRPC patients treated with Abiraterone Acetate (AA) and Enzalutamide (EZ) in a chemo-naïve setting, who received locoregional treatments for subsequent development of oligorecurrent disease. METHODS: We prospectively collected data on chemo-naïve mCRPC patients, who received either AA or EZ as first or second line treatment between Oct-2012 and Nov-2020 at 5 centers. High-volume disease at mCRPC onset was defined as bulky positive nodes (≥5 cm) or more than 6 bone metastases. Survival probabilities were computed at 12, 24, 48 and 60 months after treatment start. The impact of loco-regional treatments on progression free survival (PFS) were assessed with the Kaplan-Meier method and the log-rank test was applied. RESULTS: Overall, 117 chemo-naive mCRPC patients received a first line therapy. Fifty-seven (48.7%) patients received AA and 60 (51.3%) received EZ. Eight (6.7%) patients underwent salvage chemotherapy after first line failure. Overall, 28 patients shifted to a second line therapy. Two-yr progression-free, cancer-specific and overall survival probabilities were 65.5%, 82.2% and 78.4% respectively. Since diagnosis of mCRPC, oligo progression occurred in 25 patients who received stereotactic radiation therapy (23/25, 92%) focused on metastasis (4 nodal sites and 19 bones) or salvage lymph node dissection (2/25, 8%). At Kaplan-Meier analysis, patients with low volume disease displayed higher PFS probabilities (log rank p = 0.009) and in this subgroup of patients loco-regional treatments had a significant impact on PFS (p = 0.048), while it was negligible in the whole cohort and in patients with high volume disease (p = 0.6 and p = 0.75). CONCLUSIONS: Low-volume mCRPC patients are exposed to improved PFS and seem to benefit from locoregional treatments.