Use of 18F-fluoro-2-deoxy-d-glucose (18F-FDG) PET/CT for lymph node assessment before radical cystectomy in bladder cancer patients.

OBJECTIVE: To assess the diagnostic performance of 18F-fluoro-2-deoxy-d-glucose (18F-FDG) positron emission tomograpy (PET)/computed tomography (CT) in nodal staging before radical cystectomy (RC) and pelvic lymph node dissection (PLND) for bladder cancer (BCa). MATERIALS AND METHODS: This analysis was based on a cohort of 199 BCa patients undergoing RC and bilateral PLND between 2015 and 2022. Neoadjuvant chemotherapy (NAC) or immunotherapy (NAI) was administered after oncological evaluation. All patients received preoperative 18F-FDG PET/CT to assess extravesical disease. Point estimates for true negative, false negative, false positive, true positive, sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and accuracy of conventional imaging and PET/CT were calculated. Subgroup analysis in patients receiving neoadjuvant treatment was performed. RESULTS: At preoperative evaluation, 30 patients (15.1%) had 48 suspicious nodal spots on 18F-FDG PET/CT. At RC and bilateral PLND, a total of 4871 lymph nodes (LNs) were removed with 237 node metastases corresponding to 126 different regions. Pathological node metastases were found in 17/30 (57%) vs 39/169 patients (23%) with suspicious vs negative preoperative 18F-FDG PET/CT, respectively (sensitivity = 0.30, specificity = 0.91, PPV = 0.57, NPV = 0.77, accuracy = 0.74). On per-region analysis including 1367 nodal regions, LN involvement was found in 19/48 (39%) vs 105/1319 (8%) suspicious vs negative regions at PET/CT, respectively (sensitivity = 0.15, specificity = 0.98, PPV = 0.40, NPV = 0.92, ACC = 0.90). Similar results were observed for patients receiving NAC (n = 44, 32.1%) and NAI (n = 93, 67.9% [per-patient: sensitivity = 0.36, specificity = 0.91, PPV = 0.59, NPV = 0.80, accuracy = 0.77; per-region: sensitivity = 0.12, specificity = 0.98, PPV = 0.32, NPV = 0.93, ACC = 0.91]). Study limitations include its retrospective design and limited patient numbers. CONCLUSIONS: In eight out of 10 patients with negative preoperative 18F-FDG PET/CT, pN0 disease was confirmed at final pathology. No differences were found based on NAC vs NAI treatment. These findings suggest that 18F-FDG PET/CT could play a role in the preoperative evaluation of nodal metastases in BCa patients, although its cost-effectiveness is uncertain.

Comparative Effectiveness of Neoadjuvant Pembrolizumab Versus Cisplatin-based Chemotherapy or Upfront Radical Cystectomy in Patients with Muscle-invasive Urothelial Bladder Cancer.

BACKGROUND: Recent progresses in the use of immune checkpoint inhibitor (ICI) have challenged the therapeutic standards in patients with muscle-invasive urothelial bladder carcinoma (MIBC). OBJECTIVE: To compare neoadjuvant pembrolizumab followed by radical cystectomy (RC) versus neoadjuvant chemotherapy (NAC) and RC or upfront RC, according to cisplatin eligibility. DESIGN, SETTING, AND PARTICIPANTS: We conducted two separate analyses for cisplatin-eligible and cisplatin-ineligible cT2-4N0M0 MIBC patients. We used a propensity score adjustment that relied on inverse probability of treatment-weighting (IPTW). INTERVENTION: Pembrolizumab within the PURE-01 trial, and NAC and RC or upfront RC from a high-volume tertiary care referral center. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: The primary endpoint in both analyses was event-free survival (EFS), defined as freedom from recurrence, and/or death from any cause indexed from the date of treatment initiation or RC. The secondary endpoints included EFS in propensity score-matched patients, pathologic response rate, and recurrence-free survival (RFS) after RC. RESULTS AND LIMITATIONS: A total of 458 patients who underwent RC, with or without NAC, at Moffitt Cancer Center between October 2005 and October 2020, and 146 patients enrolled in PURE-01 were analyzed. In cisplatin-ineligible patients, EFS was superior in those receiving pembrolizumab (p < 0.001). The estimated 3-yr EFS was 77.8% (95% confidence interval [CI]: 63.5-95.2) for pembrolizumab and RC, and 36.1% (95% CI: 28.6-45.5) for upfront RC. EFS remained superior in those receiving neoadjuvant ICI (NICI) following IPTW (p < 0.001). In cisplatin-eligible patients, EFS was superior in those receiving pembrolizumab and RC (p < 0.001). The estimated 3-yr EFS was 86.9% (95% CI: 80.9-93.3) for pembrolizumab and 63.5% (95% CI: 56.5-71.4) for NAC. EFS remained superior in those receiving NICI following IPTW (p < 0.001). Pathologic responses and RFS in pembrolizumab-treated patients were also superior to those in NAC-treated patients. Results are limited by the retrospective nature of the study. CONCLUSIONS: In the first ever reported comprehensive comparison of outcomes between neoadjuvant ICI and NAC, followed by RC, or upfront RC, we report increased responses and improved oncologic outcomes with neoadjuvant ICI in patients with MIBC. PATIENT SUMMARY: We compared the results obtained from the use of pembrolizumab and radical cystectomy with standard-of-care treatments in patients with bladder carcinoma infiltrating the muscle layer. We reported increased response and survival rates possibilities with the use of immunotherapy, anticipating the possibility to set new therapeutic standards in these patients, pending the results of ongoing randomized studies.

The immune-related adverse events paradox in locally advanced or metastatic urothelial cancer after atezolizumab immunotherapy: analysis of individual patient data from IMvigor210 and IMvigor211 trials.

OBJECTIVE: To investigate the association between immune-related adverse events (irAEs) and oncological outcomes in patients with advanced urothelial cancer receiving immune checkpoint inhibitors (ICIs), and whether the administration of systemic corticosteroids diminishes therapeutic impact. PATIENTS AND METHODS: The association between irAEs occurrence and clinical progression-free survival (PFS), overall survival (OS), and cancer-specific survival (CSS) was tested by means of multivariable Cox or competing-risks regression, when appropriate. Patients experiencing irAEs were further stratified based on systemic corticosteroids administration. A sensitivity analysis was conducted by repeating all the analyses with median time to irAE as landmark point. RESULTS: We relied on individual participant data from two prospective trials for advanced urothelial cancer: IMvigor210 and IMvigor211. A total of 896 patients who received atezolizumab for locally advanced or metastatic urothelial cancer were considered. Overall, irAEs were recorded in 195 patients and the median time to irAEs was 64 days. On multivariable analysis, irAEs were inversely associated with the risk of disease progression (hazard ratio [HR] 0.50, 95% confidence interval [CI] 0.40-0.61; P < 0.001), overall mortality (HR 0.51, 95% CI 0.41-0.64; P < 0.001), and cancer-specific mortality (subdistributional HR [sHR] 0.55, 95% CI 0.45-0.72; P < 0.001). Moreover, our results did not refute the supposition that the administration of systemic corticosteroids does not impact oncological outcomes (PFS: HR 0.92, 95% CI 0.62-1.34, P = 0.629; OS: HR 0.86, 95% CI 0.51-1.64, P = 0.613; CSS: sHR 0.90, 95% CI 0.60-1.36, P = 0.630). The sensitivity analysis confirmed our findings. CONCLUSIONS: The development of irAEs while receiving atezolizumab treatment was associated with improved oncological outcomes, namely overall and cancer-specific mortality, and PFS. These findings seem to not be substantially affected by administration of systemic corticosteroids.

Robot-assisted Radical Prostatectomy Performed with Different Robotic Platforms: First Comparative Evidence Between Da Vinci and HUGO Robot-assisted Surgery Robots.

BACKGROUND: In the field of robotic surgery, there is a lack of comparative evidence on surgical and functional outcomes of different robotic platforms. OBJECTIVE: To assess the outcomes of patients receiving robot-assisted radical prostatectomy (RARP) at a high-volume robotic center with daVinci and HUGO robot-assisted surgery (RAS) surgical systems. DESIGN, SETTING, AND PARTICIPANTS: We analyzed the data of 542 patients undergoing RARP ± extended pelvic lymph node dissection at OLV hospital (Aalst, Belgium) between 2021 and 2023. All procedures were performed by six surgeons using daVinci or HUGO RAS robots; the use of one platform rather than the other did not follow any specific preference and/or indication. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: Multivariable analyses investigated the association between robotic system (daVinci vs HUGO RAS) and surgical outcomes after adjustment for patient- and tumor-related factors. Urinary continence recovery was defined as the use of no/one safety pad. RESULTS AND LIMITATIONS: A total of 378 (70%) and 164 (30%) patients underwent RARP with daVinci and HUGO RAS surgical systems, respectively. Despite a higher rate of palpable disease in the HUGO RAS group (34% vs 25%), baseline characteristics did not differ between the groups (all p > 0.05). After adjusting for confounders, we did not find evidence of a difference between the groups with respect to operative time (estimate: 16.71; 95% confidence interval [CI]: -6.35, 39.78; p = 0.12), estimated blood loss (estimate: 3.12; 95% CI: -67.03, 73.27; p = 0.9), and postoperative Clavien-Dindo ≥2 complications (odds ratio [OR]: 1.66; 95% CI: 0.34, 8.15; p = 0.5). On final pathology, 55 (15%) and 20 (12%) men in, respectively, the daVinci and the HUGO RAS group had positive surgical margins (PSMs; p = 0.5). On multivariable analyses, we did not find evidence of an association between a robotic system and PSMs (OR: 1.08; 95% CI: 0.56, 2.07; p = 0.8). Similarly, the odds of recovering continence did not differ between daVinci and HUGO RAS cases after both 1 mo (OR: 0.78; 95% CI: 0.45, 1.38; p = 0.4) and 3 mo (OR: 1.17; 95% CI: 0.49, 2.79; p = 0.7). CONCLUSIONS: Among patients receiving RARP with daVinci or HUGO RAS surgical platforms, we did not find differences in surgical and functional outcomes between the robots. This may be a result of a standardized surgical technique that allowed surgeons to transfer their skills between robotic systems. Awaiting future investigations with longer follow-up, these results have important implications for patients, surgeons, and health care policymakers. PATIENT SUMMARY: We compared surgical and functional outcomes of patients receiving robot-assisted radical prostatectomy with daVinci versus HUGO robot-assisted surgery (RAS) robots. The two platforms were able to achieve similar outcomes, suggesting that the introduction of HUGO RAS is safe and allows for optimal outcomes after radical prostatectomy.

Robot-assisted adrenalectomy: Step-by-step technique and surgical outcomes at a high-volume robotic center.

Objective: In the last years, robotic surgery was introduced in several different settings with good perioperative results. However, its role in the management of adrenal masses is still debated. In order to provide a contribution to this field, we described our step-by-step technique for robotic adrenalectomy (RA) and related modifications according to the type of adrenal mass treated. Methods: We retrospectively analyzed 27 consecutive patients who underwent RA at Onze-Lieve-Vrouw hospital (Aalst, Belgium) between January 2009 and October 2022. Demographic, intra- and post-operative, and pathological data were retrieved from our prospectively maintained institutional database. Continuous variables are summarized as median and interquartile range (IQR). Categorical variables are reported as frequencies (percentages). Results: Twenty-seven patients underwent RA were included in the study. Median age, body mass index, and Charlson's comorbidity index were 61 (IQR: 49-71) years, 26 (IQR: 24-29) kg/m2, and 2 (IQR: 0-3), respectively, and 16 (59.3%) patients were male. Median tumor size at computed tomography scan was 6.0 (IQR: 3.5-8.0) cm. Median operative time and blood loss were 105 (IQR: 82-120) min and 175 (IQR: 94-250) mL, respectively. No intraoperative complications were recorded. Overall postoperative complications rate was 11.1%, with a postoperative transfusion rate of 3.7%. A total of 10 (37.0%) patients harbored malignant adrenal masses. Among them, 3 (11.1%) had adrenocortical carcinoma, 6 (22.2%) secondary metastasis, and 1 (3.7%) malignant pheochromocytoma on final pathological exam. Only 1 (10.0%) patient had positive surgical margins. Conclusion: We described our step-by-step technique for RA, which can be safely performed even in case of high challenging settings as malignant tumors, pheochromocytoma, and large masses. The standardization of perioperative protocol should be encouraged to maximize the outcomes of this complex surgical procedure.

Transitioning from Da Vinci Si to Xi: assessing surgical outcomes at a high-volume robotic center.

PURPOSE: In the emerging field of robotics, only few studies investigated the transition between different robotic platforms in terms of surgical outcomes. We aimed at assessing surgical outcomes of patients receiving robot-assisted radical prostatectomy (RARP) and robot-assisted partial nephrectomy (RAPN) at a high-volume robotic center during the transition from Si to Xi Da Vinci surgical systems. METHODS: We analyzed data of 1884 patients undergoing RARP (n = 1437, 76%) and RAPN (n = 447, 24%) at OLV hospital (Aalst, Belgium) between 2011 and 2021. For both procedures, we assessed operative time, estimated blood loss, length of stay, and positive surgical margins. For RARP, we investigated length of catheterization and PSA persistence after surgery, whereas warm ischemia time, clampless surgery, and acute kidney injury (AKI) were assessed for RAPN. Multivariable analyses (MVA) investigated the association between robotic platform (Si vs. Xi) and surgical outcomes after adjustment for patient- and tumor-related factors. RESULTS: A total of 975 (68%) and 462 (32%) patients underwent RARP performed with the Si vs. Xi surgical system, respectively. Baseline characteristics did not differ between the groups. On MVA, we did not find evidence of a difference between the groups with respect to operative time (estimate: 1.07) or estimated blood loss (estimate: 32.39; both p > 0.05). Median (interquartile range [IQR]) length of stay was 6 (3, 6) and 4 (3, 5) days in the Si vs. Xi group, respectively (p < 0.0001). On MVA, men treated with the Xi vs. Si robot had lower odds of PSM (Odds ratio [OR]: 0.58; p = 0.014). A total of 184 (41%) and 263 (59%) patients received RAPN with the Si and Xi robotic system, respectively. Baseline characteristics, including demographics, functional data, and tumor-related features did not differ between the groups. On MVA, operative time was longer in the Xi vs. Si group (estimate: 30.54; p = 0.006). Patients treated with the Xi vs. Si system had higher probability of undergoing a clampless procedure (OR: 2.56; p = 0.001), whereas the risk of AKI did not differ between the groups (OR: 1.25; p = 0.4). On MVA, patients operated with the Xi robot had shorter length of stay as compared to the Si group (estimate: - 0.86; p = 0.003), whereas we did not find evidence of an association between robotic system and PSM (OR: 1.55; p = 0.3). CONCLUSION: We found that the Xi robot allowed for improvements in peri-operative outcomes as compared to the Si platform, with lower rate of positive margins for RARP and higher rate of off-clamp procedures for RAPN. Hospital stay was also shorter for patients operated with the Xi vs. Si robot, especially after robot-assisted partial nephrectomy. Awaiting future investigations-in particular, cost analyses-these results have important implications for patients, surgeons, and healthcare policymakers.

Different approaches for bladder neck dissection during robot-assisted radical prostatectomy: the Aalst technique

ABSTRACT Introduction: Bladder neck dissection is one of the most delicate surgical steps of robotic-assisted radical prostatectomy (RARP) [1, 2], and it may affect surgical margins rate and functional outcomes [3, 4]. Given the relationship between outcomes and surgical experience [5-7], it is crucial to implement a step-by-step approach for each surgical step of the procedure, especially in the most challenging part of the intervention. In this video compilation, we described the techniques for bladder neck dissection utilized at OLV Hospital (Aalst, Belgium). Surgical Technique: We illustrated five different techniques for bladder neck dissection during RARP. The anterior technique tackles the bladder neck from above until the urethral catheter is visualized, and then the dissection is completed posteriorly. The lateral and postero-lateral approaches involve the identification of a weakness point at the prostate-vesical junction and aim to develop the posterior plane - virtually until the seminal vesicles - prior to the opening of the urethra anteriorly. Finally, we described our techniques for bladder neck dissection in more challenging cases such as in patients with bulky middle lobes and prior surgery for benign prostatic hyperplasia. All approaches follow anatomic landmarks to minimize positive surgical margins and aim to preserve the bladder neck in order to promote optimal functional recovery. All procedures were performed with DaVinci robotic platforms using a 3-instruments configuration (scissors, fenestrated bipolar, and needle driver). As standard protocol at our Institution, urinary catheter was removed on postoperative day two [8]. Conclusions: Five different approaches for bladder neck dissection during RARP were described in this video compilation. We believe that the technical details provided here might be of help for clinicians who are starting their practice with this surgical intervention.

Different approaches for bladder neck dissection during robot-assisted radical prostatectomy: the Aalst technique.

INTRODUCTION: Bladder neck dissection is one of the most delicate surgical steps of robotic-assisted radical prostatectomy (RARP) [1, 2], and it may affect surgical margins rate and functional outcomes [3, 4]. Given the relationship between outcomes and surgical experience [5-7], it is crucial to implement a step-by-step approach for each surgical step of the procedure, especially in the most challenging part of the intervention. In this video compilation, we described the techniques for bladder neck dissection utilized at OLV Hospital (Aalst, Belgium). SURGICAL TECHNIQUE: We illustrated five different techniques for bladder neck dissection during RARP. The anterior technique tackles the bladder neck from above until the urethral catheter is visualized, and then the dissection is completed posteriorly. The lateral and postero-lateral approaches involve the identification of a weakness point at the prostate-vesical junction and aim to develop the posterior plane - virtually until the seminal vesicles - prior to the opening of the urethra anteriorly. Finally, we described our techniques for bladder neck dissection in more challenging cases such as in patients with bulky middle lobes and prior surgery for benign prostatic hyperplasia. All approaches follow anatomic landmarks to minimize positive surgical margins and aim to preserve the bladder neck in order to promote optimal functional recovery. All procedures were performed with DaVinci robotic platforms using a 3-instruments configuration (scissors, fenestrated bipolar, and needle driver). As standard protocol at our Institution, urinary catheter was removed on postoperative day two [8]. CONCLUSIONS: Five different approaches for bladder neck dissection during RARP were described in this video compilation. We believe that the technical details provided here might be of help for clinicians who are starting their practice with this surgical intervention.

Outcomes of Robot-assisted Radical Prostatectomy with the Hugo RAS Surgical System: Initial Experience at a High-volume Robotic Center.

Clinical data on robot-assisted radical prostatectomy (RARP) performed with the new Hugo robot-assisted surgery (RAS) system are scarce. We described surgical outcomes of 112 consecutive patients who underwent RARP ± extended pelvic lymph-node dissection (ePLND) at OLV Hospital (Aalst, Belgium) between February and November 2022. The median age was 65 yr (interquartile range [IQR] 60-70) and median preoperative prostate-specific antigen (PSA) was 7.9 ng/ml (5.8-10.7). Thirty-eight patients (34%) had International Society of Urological Pathology grade group ≥3 tumor on prostate biopsy. On preoperative magnetic resonance imaging, 26 (23%) patients had a suspicion of extraprostatic disease. The median operative time was 180 min (IQR 145-200) and 27 men (24%) underwent ePLND. On final pathology, 34 patients (31%) had extraprostatic disease and ten (9%) had positive surgical margins. The median number of nodes removed was 15 (IQR 9-19). Among men with data available on the first PSA after surgery, 88% (60/68) had undetectable PSA (<0.1 ng/ml). The probability of urinary continence (UC) recovery was 36% (95% confidence interval [CI] 28-47%) at 1 mo and 81% (95% CI 72-89%) at 3 mo. The median time to UC recovery was 36 d (95% CI 34-44). This is the first report of data on UC recovery and surgical pathology for patients undergoing RARP for prostate cancer performed with the Hugo RAS robotic system. Future investigations with longer follow-up are awaited. PATIENT SUMMARY: We describe surgical outcomes of patients undergoing robot-assisted surgical removal of the prostate for cancer performed with the Hugo RAS robotic system at our institution. In our experience this platform provided adequate results in terms of surgical results and early recovery of urinary continence. Studies with longer follow-up are awaited.

Robot-assisted sutureless partial nephrectomy for the treatment of fifteen bilateral renal masses in a patient with Von Hippel-Lindau syndrome: a case report from a high-volume robotic center.

Renal cell carcinoma is among major causes of death in patients with Von Hippel-Lindau (VHL) syndrome, and it usually presents with multiple and bilateral lesions that may require multiple renal surgeries. This, in turn, may compromise renal function, resulting in end-stage renal disease. To minimize renal function impairment in these patients, great importance is given to the preservation of functional parenchyma with the use of nephron-sparing techniques. Furthermore, new techniques such as off-clamp surgery, selective suturing or sutureless techniques may improve long-term functional outcomes. We described the case of a 27-year-old male patient with a family history of VHL disease affected by multiple, bilateral renal masses. He received bilateral, metachronous robot-assisted partial nephrectomies (RAPN) for a total of 15 renal lesions. No intra- or post-operative complications occurred, and the patient was discharged on the second postoperative day after both procedures. Serum creatinine after the second RAPN was 0.99 mg/dl (baseline value was 1.11 mg/dl). In patients with VHL syndrome and multiple renal lesions, robot-assisted partial nephrectomy, especially with the use of clampless and sutureless techniques, helps minimizing renal function impairment and should be performed when anatomically and technically feasible.

Epidemiology of Unconventional Histological Subtypes of Urethral Cancer.

INTRODUCTION: The aim of the study was to examine cancer-specific mortality (CSM) of unconventional urethral cancers. METHODS: Within the SEER (2004-2016) database, we analyzed CSM of 165 patients with unconventional urethral-cancer histology. Kaplan-Meier plots were used to test the effect of unconventional histologies in urethral cancer on CSM. RESULTS: Of 165 eligible patients, the Mullerian type accounted for 55 (33.3%) versus melanocytic (26.7%) versus neuroendocrine 25 (15.2%) versus lymphoma 22 (13.3%) versus mesenchymal/sarcoma 15 (9.1%) versus spindle cell 4 (2.1%) patients. Median age at diagnosis was 81 years in spindle cell, 75 in melanocytic, 74 in neuroendocrine and mesenchymal/sarcoma, 67 in lymphoma, and 62 years Mullerian type (p < 0.001). Of all, 116 (70.3%) were female. The Mullerian type exhibited the highest female ratio (96.4%) versus the lowest female ratio in neuroendocrine (24.0%). The Mullerian type was most frequent in African-American females. In Caucasian females, the melanocytic type was most frequent (49.1%). In African-American (38.9%) and Caucasian males (33.3%), neuroendocrine histology was most frequent. Three-year CSM was, respectively, 27.5%, 23.1% 22.3%, 20.5%, and 16.1% for melanocytic, mesenchymal/sarcoma, Mullerian type, neuroendocrine, and lymphoma histology. Median cancer-specific survival was 106 versus 10 months for combined nonmetastatic versus metastatic nonconventional histologies. CONCLUSION: Important age, sex, racial/ethnic group distribution, and survival differences exist between each unconventional urethral-cancer histological subtypes.

Race/Ethnicity may be an Important Predictor of Life Expectancy in Localized Prostate Cancer Patients: Novel Analyses Using Social Security Administration Life Tables.

PURPOSE: To test the effect of race/ethnicity on Social Security Administration (SSA) life tables' life expectancy (LE) predictions in localized prostate cancer (PCa) patients treated with either radical prostatectomy (RP) or external beam radiotherapy (EBRT). We hypothesized that LE will be affected by race/ethnicity. PATIENTS AND METHODS: We relied on the 2004-2006 Surveillance, Epidemiology, and End Results database to identify D'Amico intermediate- and high-risk PCa patients treated with either RP or EBRT. SSA life tables were used to compute 10-year LE predictions and were compared to OS. Stratification was performed according to treatment type (RP/EBRT) and race/ethnicity (non-Hispanic White, non-Hispanic Black, Hispanic/Latino, and Asian). RESULTS: Of 55,383 assessable patients, 40,490 were non-Hispanic White (RP 49.3% vs. EBRT 50.7%), 7194 non-Hispanic Black (RP 41.3% vs. EBRT 50.7%), 4716 Hispanic/Latino (RP 51.0% vs. EBRT 49.0%) and 2983 were Asian (RP 41.6% vs. EBRT 58.4%). In both RP and EBRT patients, OS exceeded life tables' LE predictions, except for non-Hispanic Blacks. However, in RP patients, the magnitude of the difference was greater than in EBRT. Moreover, in RP patients, OS of non-Hispanic Blacks virtually perfectly followed predicted LE. Conversely, in EBRT patients, the OS of non-Hispanic Black patients was worse than predicted LE. CONCLUSIONS: When comparing SEER-derived observed OS with SSA life table-derived predicted life expectancy, we recorded a survival disadvantage in non-Hispanic Black RP and EBRT patients, which was not the case in the three other races/ethnicities (non-Hispanic Whites, Hispanic/Latinos, and Asians). This discrepancy should ideally be confirmed within different registries, countries, and tumor entities. Furthermore, the source of these discrepant survival outcomes should be investigated and addressed by health care politics.

Robot-assisted simple prostatectomy with the novel HUGO™ RAS System: feasibility, setting, and perioperative outcomes.

Robot-assisted simple prostatectomy (RASP) has demonstrated better peri-operative outcomes as compared to open simple prostatectomy. However, RASP is still limited by platform availability and cost-effectiveness issues. The new surgical robots increasing competition may spread the robotic approach also in non-oncological fields. We reported the first RASP executed in Europe at OLV Hospital (Aalst, Belgium) performed with the novel HUGO™ Robot-Assisted Surgery (RAS) System. The platform consists of four independent carts, an open console, and a system tower equipped for both laparoscopic and robotic surgery. Our main goal was to demonstrate the technical feasibility of RASP with the novel HUGO™ RAS along with its safety in terms of perioperative outcomes and complications. We also aimed to describe our surgical setup. We collected patient's baseline characteristics, intraoperative and perioperative complications, postoperative outcomes, docking time, operative time, clashing of the instruments, or technical errors of the system. The procedure was performed in a 72-year-old male with a prostate volume of 155 g at preoperative imaging. No need for conversion to open/laparoscopic surgery and/or for additional port placement was required. No intraoperative complications, instrument clashes, or failure of the system that compromised the completion of the surgery were recorded. Docking, operative, and console times were 9, 150, and 120 minutes, respectively. The catheter was removed on the second postoperative day. No postoperative complications occurred. The postoperative uroflowmetry revealed a maximum flow of 26.2 mL/s, without postvoid residual volume. Robot-assisted simple prostatectomy with the HUGO™ RAS System is a feasible and safe procedure in terms of perioperative outcomes and complications. Our setup allowed for a rapid docking procedure and a smoothly completion of the surgery.

Robot-Assisted Sacropexy with the Novel HUGO Robot-Assisted Surgery System: Initial Experience and Surgical Setup at a Tertiary Referral Robotic Center.

Introduction and Hypothesis: Robotic sacropexy (RSC) emerged in the last years as a valid alternative to the laparoscopic technique. However, the robotic approach is still limited by platform availability and concerns about cost-effectiveness. Recently, new robotic platforms joined the market, lowering the costs and offering the possibility to expand the robotic approach. The aim of our study was to demonstrate the technical feasibility and safety of the procedure with this new platform along with the description of our surgical setting. Materials and Methods: We reported data on the first five consecutive patients who underwent RSC at Onze Lieve Vrouw Hospital (Aalst, Belgium), performed with the novel HUGO™ Robot-Assisted Surgery (RAS) System. The platform consists of four fully independent carts, an open console, and a system tower equipped for both laparoscopic and robotic surgery. We collected patients' characteristics, intraoperative data, intraoperative complications, and clashes of instruments. Results: All procedures were completed according to the same surgical setting and technique. No need for conversion to open/laparoscopic surgery and/or for additional port placement was required. No intraoperative complications, instrument clashes, or system failure that compromised the surgery's completion were recorded. Median interquartile range docking, operative, and console time were 8 (6-9), 130 (115-165), and 80 (80-115) minutes, respectively. Conclusion: This series represents the first worldwide report of a robot-assisted sacropexy executed with the novel HUGO RAS System. Awaiting future investigation, this preliminary experience provides relevant data in terms of operative room settings and perioperative outcomes that might be helpful for future adopters of this platform.

Impact of Early Dorsal Venous Complex Ligation on Urinary Continence Recovery after Robot-assisted Radical Prostatectomy: Results from a Phase 3 Randomized Controlled Trial.

BACKGROUND: Whether early ligation of the dorsal venous complex (DVC) might improve recovery of urinary continence (UC) after robot-assisted radical prostatectomy (RARP) has never been investigated in a prospective randomized study. OBJECTIVE: To assess whether early DVC ligation might affect UC recovery after RARP. INTERVENTION: DVC ligation (early vs standard). DESIGN, SETTING, AND PARTICIPANTS: A total of 312 patients with prostate cancer underwent primary RARP at a tertiary care institution. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: The primary outcome was UC recovery at 1 and 4 mo after RARP. UC was defined as 0 pads/1 safety pad per day. All patients completed the International Prostate Symptom Score (IPSS) and International Consultation of Incontinence Questionnaire (ICIQ)-Short Form questionnaires. Secondary outcomes were early (≤4 mo) erectile function recovery, the positive surgical margin (PSM) rate, 30-d Clavien-Dindo complications, and biochemical recurrence rates. Quality of life was assessed using the EQ-5D-5L questionnaire. The association between treatment arm and UC recovery was also tested using multivariable regression models. RESULTS AND LIMITATIONS: After surgery, 23 patients withdrew their consent and 29 were lost to follow-up, leaving 261 patients available for per-protocol analyses. Of these, 32 patients (24%) in the experimental group and 37 (29%) in the control group used no pad/one safety pad at 1 mo after RARP, whereas 96 (72%) in the control group versus 83 (65%) in the control group were continent at 4-mo follow-up (both p = 0.3). Median ICIQ and IPSS scores did not differ between the groups at both time points. The results were confirmed on multivariable regression analyses. PSMs were observed for 32 patients (25%) in the experimental group versus 30 (22%) in the control group (p = 0.6). The incidence of postoperative complications (17% experimental vs 13% control) and the 1-yr biochemical recurrence-free survival did not differ between the groups. CONCLUSIONS: In this randomized clinical trial, we did not find evidence that early ligation of the DVC during RARP was associated with better UC recovery after surgery in comparison to the standard technique. Given its safety in terms of surgical margins and complications, this technique may be considered as an option for surgical dissection according to the physician's preference. PATIENT SUMMARY: Our trial showed that for patients undergoing robot-assisted surgical removal of the prostate, the timing of a specific step to control bleeding from a network of veins draining the prostate did not affect recovery of urinary continence after surgery. The results indicate that earlier control of these veins may be considered as an option according to the surgeon's preference.

Predicting the probability of pT3 or higher pathological stage at radical prostatectomy: COVID19-specific considerations.

Background: We tested whether a model identifying prostate cancer (PCa) patients at risk of pT3-4/pN1 can be developed for use during COVID19 pandemic, in order to guarantee appropriate treatment to patients harboring advanced disease patients without compromising sustainability of care delivery. Methods: Within the Surveillance, Epidemiology and End Results database 2010-2016, we identified 27,529 patients with localized PCa and treated with radical prostatectomy. A multivariable logistic regression model predicting presence of pT3-4/pN1 disease was fitted within a development cohort (n=13,977, 50.8%). Subsequently, external validation (n=13,552, 49.2%) and head-to-head comparison with NCCN risk group stratification was performed. Results: In model development, age, PSA, biopsy Gleason Grade Group (GGG) and percentage of positive biopsy cores were independent predictors of pT3-4/pN1 stage. In external validation, prediction of pT3-4/pN1 with novel nomogram was 74% accurate versus 68% for NCCN risk group stratification. Nomogram achieved better calibration and showed net-benefit over NCCN risk group stratification in decision curve analyses. The use of nomogram cut-off of 49% resulted in pT3-4/pN1 rate of 65%, instead of the average 35%. Conclusion: The newly developed, externally validated nomogram predicts presence of pT3-4/pN1 better than NCCN risk group stratification and allows to focus radical prostatectomy treatment on individuals at highest risk of pT3-4/pN1.

Neoadjuvant Pembrolizumab and Radical Cystectomy in Patients with Muscle-Invasive Urothelial Bladder Cancer: 3-Year Median Follow-Up Update of PURE-01 Trial.

PURPOSE: The PURE-01 study (NCT02736266) pioneered the neoadjuvant immune-checkpoint inhibitor (ICI) therapy before radical cystectomy (RC) in patients with muscle-invasive urothelial bladder carcinoma (MIBC). We herein present the survival outcomes after a median follow-up of three years. PATIENTS AND METHODS: The intention-to-treat (ITT) population included 155 patients. Event-free survival (EFS) was defined as the time from pembrolizumab initiation until radiographic disease progression precluding RC, initiation of neoadjuvant chemotherapy, recurrence after RC, or death. Further outcomes were recurrence-free survival (RFS) post-RC and overall survival (OS). Multivariable Cox regression analyses for EFS were performed. Kaplan-Meier analyses compared EFS outcomes according with baseline programmed cell-death-ligand-1 (PD-L1) combined positive score (CPS) and according to the molecular subtypes. RESULTS: After a median (interquartile range, IQR) follow-up of 39 (30-47) months, 36-month EFS and OS were 74.4% [95% confidence interval (CI), 67.8-81.7] and 83.8% (95% CI, 77.8-90.2) in the ITT population, respectively. Overall, 143 (92.3%) patients underwent RC. Within the cohort of patients who did not receive additional chemotherapy (N = 125), 36-month RFS was 96.3% (95% CI, 91.6-100) for patients achieving a ypT0N0, 96.1% (95% CI, 89-100) for ypT1/a/isN0, 74.9% (95% CI, 60.2-93) for ypT2-4N0, and 58.3% (95% CI, 36.2-94.1) for ypTanyN1-3 response. EFS was significantly stratified among PD-L1 tertiles (lower tertile: 59.7% vs. medium tertile: 76.7% vs. higher tertile: 89.8%, P = 0.0013). The claudin-low and basal/squamous subtypes displayed the lowest rates of events. CONCLUSIONS: At a median follow-up of three years, PURE-01 results further confirm the sustained efficacy of neoadjuvant pembrolizumab before RC. PD-L1 expression was the strongest predictor of sustained response post-RC.

An external validation of the nocera nomogram: Predicting non-organ confined stage of ≥pT3 in cT1 clear cell renal cell carcinoma.

Background: Only one previously published study by Nocera et al. addressed the risk of upstaging to ≥pT3 in cT1 clear cell renal cell carcinoma (ccRCC) by using characteristics of the R.E.N.A.L and PADUA score (age, tumor size, rim location, exophytic rate, polar involvement) developing an accurate nomogram. However, this nomogram has never been externally validated yet. Material and methods: The study cohort consisted of 288 patients with cT1a-b ccRCC, diagnosed between 2008-2021 at the University Hospital Frankfurt, Germany. Analyses addressed clinical, tumor and radiographic characteristics. The external validation of the nomogram relied on accuracy calculations derived from the area under the curve of the receiver operator characteristic analysis. Results: Overall, 11.8% (n=34) patients harbored ≥pT3 ccRCC. Median radiographic tumor size (3.6 vs. 5.3cm), R.E.N.A.L. (8 vs. 9 points) and PADUA score (9 vs. 11 points), as well as proportions of renal sinus involvement (82.4% vs. 51.6%), renal hilus involvement (44.1 vs. 13.0%), and medial rim location significantly differed between the pT1-2 and ≥pT3 group (all p ≤ 0.01). In subgroup analyses of small renal mass ccRCC patients (<4cm, cT1a), only 3.8% (n=6) patients had ≥pT3 pathology. Upstaged patients were significantly older and more frequently had endophytic tumor than pT1-2 counterparts (p<0.05). The external validation of the Nocera nomogram showed a good accuracy of 76.6%. Using the suggested cut-off of 21%, 26.5% of patients exhibited ≥pT3 ccRCC. Conversely, within patients below cut-off, 5.9% patients exhibited ≥pT3 ccRCC. Conclusion: We reported the first external validation of the nomogram addressing the risk of ≥pT3 in cT1 ccRCC patients, demonstrating a good accuracy, with a low false-negative rate. Therefore, the nomogram can accurately be used for patients' counselling and treatment decision making.