Outcomes and prognostic factors in 3306 patients with relapsed/refractory chronic lymphocytic leukemia treated with ibrutinib outside of clinical trials: A nationwide study.

We performed a cohort study that included all patients with relapsed/refractory chronic lymphocytic leukemia (R/R CLL) who received ibrutinib in the Italian National Health Service. With a median follow-up of 42.2 months (IQR 30.8-54.6 months), the study involved 3306 patients with a median age of 72.1 years, of whom 42.6% had received ≥2 previous lines of treatment. The estimated 24-month probabilities of being on treatment and alive were 57.9% (95% confidence interval [CI]: 59.6-56.2) and 76.6% (95% CI: 75.2-78.1), respectively. The median time to treatment discontinuation (TTD) was 31.3 months (95% CI: 29.5-33.5). Out of 3306 patients, 2015 (60.9%) discontinued treatment, with 993 cases attributed to death or disease progression (30.0% of all cases). Among the 1022 patients who discontinued treatment for reasons other than progression or death, 564 (17.1%) patients did so due to toxicity or medical decision, while 458 patients (13.8%) were lost to follow-up. Multivariable analysis revealed that age, Eastern Cooperative Oncology Group Performance Status, the number of previous lines of therapy, refractoriness to the last treatment, and reduced renal function were associated with shorter TTD and overall survival (OS). The coexistence of 17p- and TP53 mutations had an independent unfavorable impact on TTD and OS. Nonstandard doses were associated with shorter TTD and advanced stage with shorter OS. The median OS postprogression and postdiscontinuation for other reasons were estimated at 12.9 (95% CI: 11.3-16.2) and 22.7 months (95% CI: 20.2-28.3), respectively. This large real-world study shows that ibrutinib is an effective treatment for R/R CLL. Baseline patient characteristics and double-hit TP53 aberrations were associated with inferior prognosis, and discontinuation due to CLL progression portended a poor outcome.

The impact of starting dose on overall survival in myelofibrosis patients treated with ruxolitinib: A prospective real-world study on AIFA monitoring registries.

Ruxolitinib is a JAK1/JAK2 inhibitor approved for the treatment of myelofibrosis (MF)-related splenomegaly or symptoms. The recommended starting dose depends on platelet count, regardless of haemoglobin level at baseline. In the recent years, an overall survival (OS) advantage was reported in patients treated with ruxolitinib compared with best available therapy. We analysed a large Italian cohort of 3494 patients identified by Agenzia Italiana del Farmaco (AIFA) monitoring registries. Of them, 2337 (66.9%) started at reduced dose: these patients were older (median age 70 vs. 67), with increased incidence of large splenomegaly (longitudinal diameter 20 vs. 19.1 cm, median volume 1064 cm3 vs. 1016 cm3), with higher IPSS risk (30.9% vs. 26.1%), and worse ECOG score (more than 1 in 14.3% vs. 9.8%). After balancing for baseline characteristics, Kaplan-Meier analysis showed a median OS of 78.2 months (95% CI 65.9-89) for patients who started at full dose and 52.6 (95% CI 49-56.6) months for patients who started with reduced dose (p < 0.001). Group analysis also showed a substantial difference in patients with intermediate-2 and high IPSS risk. The majority of MF patients in real-world analysis started with a reduced dose of ruxolitinib, which is associated with less favourable outcomes.

Robot-assisted Radical Prostatectomy with the Hugo RAS and da Vinci Surgical Robotic Systems: A Systematic Review and Meta-analysis of Comparative Studies.

BACKGROUND AND OBJECTIVE: The introduction of the Hugo RAS system represents a recent innovation in robotic surgery. The potential benefits and limitations of this system and its integration into clinical practice in urology have yet to be fully delineated. Our objective was to assess surgical, early oncological, and functional outcomes in studies comparing robot-assisted radical prostatectomy (RARP) performed with the new Hugo RAS system and the well-established da Vinci surgical system. METHODS: We conducted a systematic review and meta-analysis using PubMed, Web of Science, Scopus, and Embase databases. Eligible studies compared RARP outcomes in adult males between the Hugo RAS and da Vinci systems. The main endpoints were analyzed using a random-effects model, including perioperative outcomes (surgical times, estimated blood loss, length of hospital stay, Clavien-Dindo grade ≥2 complications), oncological outcomes (positive surgical margins and postoperative prostate-specific antigen), and functional outcomes (continence status and erectile function). KEY FINDINGS AND LIMITATIONS: Nine studies involving 1185 patients (478 Hugo RAS and 707 da Vinci) were included. Significant differences in pooled baseline characteristics included higher body mass index for the da Vinci cohort (p = 0.035) and a higher rate of palpable disease in the Hugo RAS cohort (p = 0.036). Docking time was significantly longer for the Hugo RAS, with a median difference of 6.1 min (95% confidence interval 3.9-8.2; I2 = 68.6%; p < 0.001; three studies). Overall, there were no significant differences in perioperative, oncological, and functional outcomes between the two systems. CONCLUSIONS AND CLINICAL IMPLICATIONS: Despite the preliminary nature of the evidence, this systematic review and meta-analysis show comparable surgical and clinical outcomes for RARP performed with the Hugo RAS system and the da Vinci robotic platform. PATIENT SUMMARY: We reviewed studies comparing the use of two different surgical robots for removal of the prostate. The results suggest that surgical and clinical outcomes with the new Hugo RAS robot are comparable to those with the established da Vinci robot for this procedure.

Clinical Significance of Perinephric Fluid Collection in Patients with Renal Colic and Urolithiasis: A Retrospective Analysis.

Background: Perinephric fluid is commonly identified in patients with renal colic and urolithiasis, especially in cases associated with hydronephrosis. However, its clinical relevance, particularly its impact on treatment decisions and prognosis, is not well established. Methods: This retrospective, single-center study included adult patients who presented to the emergency department (ED) with suspected renal colic between January 2021 and October 2023. Patients underwent ultrasound evaluations, which were analyzed for perinephric fluid, hydronephrosis, stone size, and stone location. Data on patient demographics, laboratory results, and clinical outcomes, including the need for urological interventions, were also collected and analyzed. Multivariate logistic regression was used to assess factors associated with perinephric fluid presence. Results: Of the 509 patients included, 200 (39.3%) had perinephric fluid. Hydronephrosis was significantly associated with perinephric fluid (OR: 4.14, p = 0.007), as were stones located in the proximal (OR: 3.06, p = 0.003) and distal ureter (OR: 2.31, p = 0.018). However, sonographic perinephric fluid did not significantly affect the likelihood of urological intervention, in-hospital complications, sepsis, acute kidney injury (AKI), acute kidney disease (AKD), and prolonged hospital stay. Conclusions: Perinephric fluid is a common finding in patients with renal colic and urolithiasis, particularly in cases involving hydronephrosis and ureteral stones. However, despite its prevalence, sonographic perinephric fluid was not significantly associated with the need for urological intervention, longer hospital stays, or worse clinical outcomes. Further prospective studies are required to clarify its clinical implications fully.

Extraperitoneal Robot-Assisted Radical Prostatectomy with the Hugo™ RAS System: Initial Experience at a High-Volume Robotic Centre.

Background: The Hugo™ Robotic-Assisted Surgery (Hugo™ RAS) system represents a novel advancement in robotic surgical technology. Despite this, there remains a scarcity of data regarding extraperitoneal robot-assisted radical prostatectomy (eRARP) using this system. Methods: We conducted a prospective study at Ospedale Regionale "F. Miulli" from June 2023 to January 2024, enrolling consecutive patients diagnosed with prostate cancer (PCa) undergoing eRARP ± lymph node dissection. All procedures employed a modular four-arm setup performed by two young surgeons with limited prior robotic surgery experience. This study aims to evaluate the safety and feasibility of eRARP using the Hugo™ RAS system, reporting comprehensive preoperative, intraoperative, and postoperative outcomes in the largest reported cohort to date. Results: A total of 50 cases were analyzed, with a mean patient age of 65.76 (±5.57) years. The median operative time was 275 min (Q1-Q3 150-345), and the console time was 240 min (Q1-Q3 150-300). The docking time averaged 10 min (Q1-Q3 6-20). There were no intraoperative complications recorded. Two major complications occurred within the first 90 days. At the 3-month mark, 36 patients (72%) achieved undetectable PSA levels (<0.1 ng/mL). Social continence was achieved by 66% of patients, while 40% maintained erectile function. Conclusions: eRARP utilizing the Hugo™ RAS system demonstrated effectiveness and safety in our study cohort. However, more extensive studies with larger cohorts and longer follow-up periods are necessary to thoroughly evaluate long-term outcomes.

Withdrawal notice to .

[This retracts the article DOI: 10.1016/j.lanepe.2024.100973.].

Oral supplementation with probiotics, potassium citrate, and magnesium in reducing crystalluria in stone formers: A phase II study.

INTRODUCTION: Crystalluria is an important indicator of renal stone recurrence. Mechanisms underlying urinary stone formation are still not fully understood and raising interests has been giving to intestinal commensal bacteria for their contribute in maintaining urinary solutes equilibrium. The aim of our phase II study was to examine the administration of potassium citrate, magnesium and probiotics in order to reduce crystalluria. MATERIALS AND METHODS: Since May 2021, we enrolled 23 patients candidates for ureterorenolithotripsy for calcium oxalate kidney stones with crystalluria and a normal metabolic profile. The analysis was validated by the Institution's Ethical Committee (no. approval STS CE Lazio 1/N-823). At discharge, patients were provided with daily food supplementation for 20 days of 1 billion Lactobacillus paracasei LPC09, 1 billion Lactobacillus plantarum LP01, 1 billion Bifidobacterium breve BR03, potassium (520 mg), citrate (1400 mg), and magnesium (80 mg). Crystalluria was re-assessed at 1, 3, 6, and 12-months follow-up by polarized light microscopy. RESULTS: After one month from the oral supplementation, no patient reported crystalluria; at 3 months, among the 20 participants available for re-evaluation, still no patient reported crystalluria. Instead, crystalluria was reported in three patients (15%) at 6 months, and in five patients (25%) at 12 months follow-up. CONCLUSIONS: The oral supplementation with Lactobacillus spp. and Bifidobacterium spp. was found able to reduce the prevalence of crystalluria in a cohort of patients with diagnosis of calcium oxalate kidney stones with crystalluria candidate to ureterorenolithotripsy.

Extraperitoneal robot-assisted radical prostatectomy by the da Vinci and Versius System: first comparative analysis.

BACKGROUND: Robotic-assisted surgery (particularly with the da Vinci Surgical System) has revolutionized urological interventions. The advent of the Versius Surgical System introduces a compelling alternative. This study compares outcomes of extraperitoneal robot-assisted radical prostatectomy (eRARP) using da Vinci and Versius, presenting the largest case series to date. METHODS: A retrospective analysis of 106 consecutive patients undergoing eRARP (July 2021-July 2023) with da Vinci and Versius. Surgical techniques involved extraperitoneal approaches, with a single surgeon ensuring consistency. Baseline characteristics, perioperative outcomes, and pathology results were analyzed. RESULTS: Baseline characteristics were comparable between da Vinci and Versius groups. While no significant differences were observed in overall operative time, estimated blood loss, and length of hospital stay, variations were noted in pelvic lymphadenectomy rates and nerve-sparing procedures. Pathology results revealed no significant disparities in International Society of Urological Pathology (ISUP) grades and positive surgical margins. However, a notable difference emerged in pathological N stage, with Versius showing a higher percentage of positive lymph nodes. CONCLUSIONS: This study provides a comprehensive comparative analysis of da Vinci and Versius in eRARP, representing the largest case series to date. While overall outcomes were similar, nuances in lymphadenectomy rates and Pathological N stage merit attention. Ongoing research and longer-term follow-up will refine our understanding, guiding urological surgeons in optimal robotic system selection.

Multiparametric Prostate MRI Accuracy of Prostate Imaging Reporting and Data System (v2.1) Scores 4 and 5: The Influence of Image Quality According to the Prostate Imaging Quality Score.

Purpose: The accuracy of multiparametric magnetic resonance imaging (mpMRI) heavily relies on image quality, as evidenced by the evolution of the prostate imaging quality (PI-QUAL) scoring system for the evaluation of clinically significant prostate cancer (csPC). This study aims to evaluate the impact of PI-QUAL scores in detecting csPC within PI-RADS 4 and 5 lesions. Methods: We retrospectively selected from our database all mpMRI performed from January 2019 to March 2022. Inclusion criteria were as follows: (1) mpMRI acquired in our institution according to the technical requirements from the PI-RADS (v2.1) guidelines; (2) single lesion scored as PI-RADS (v2.1) 4 or 5; (3) MRI-TBx performed in our institution; (4) complete histology report; and (5) complete clinical record. Results: A total of 257 male patients, mean age 70.42 ± 7.6 years, with a single PI-RADS 4 or 5 lesion undergoing MRI-targeted biopsy, were retrospectively studied. Of these, 61.5% were PI-RADS 4, and 38.5% were PI-RADS 5, with 84% confirming neoplastic cells. In high-quality image lesions (PI-QUAL ≥ 4), all PI-RADS 5 lesions were accurately identified as positive at the final histological examination (100% of CDR). For PI-RADS 4 lesions, 37 (23%) were negative, resulting in a cancer detection rate of 77% (95% CI: 67.51-84.83). Conclusions: The accuracy of mpMRI, independently of the PI-RADS score, progressively decreased according to the decreasing PI-QUAL score. These findings emphasize the crucial role of the PI-QUAL scoring system in evaluating PI-RADS 4 and 5 lesions, influencing mpMRI accuracy.

The role of alternative medicine and complimentary therapies in urologic disease: New horizons.

The world of complementary and alternative medicine (CAM) encompasses a wide range of practices, treatments, and products that fall outside the realm of conventional (mainstream) medicine. The use of complementary and CAM has become increasingly popular in Western nations. People are turning to CAM for a variety of reasons, including managing chronic diseases, relieving symptoms of various conditions, and improving their overall health and well-being. There's a growing trend of people using and showing interest in complementary and alternative medicine therapies, especially in Western countries. CAM encompasses a wide range of treatments, some offering complete alternatives to conventional medicine, while others aim to complement existing medical approaches. Urologists should stay informed about CAM to guide their patients effectively to treat patients in a modern and personalized way. The aim of review is to analyze the scenario of complimentary and alternative medicine with a specific focus in the urological field.

Corrigendum to "Comparison of baseline patient characteristics in Italian oncology drug monitoring registries and clinical trials: a real-world cross-sectional study" [The Lancet Regional Health - Europe 41 (2024) 100912].

[This corrects the article DOI: 10.1016/j.lanepe.2024.100912.].

2024 ASCO genitourinary cancers symposium: a focus on renal cell carcinoma.

In this article, we report the breakthrough acquisitions for renal cell carcinoma (RCC) management presented at the 2024 American Society of Clinical Oncology (ASCO) Genitourinary Cancers Symposium. The results from Keynote 564 showed an impressive overall survival (OS) advantage for pembrolizumab, in patients at higher risk of relapse after surgery and confirmed the benefit in terms of disease-free survival (DFS). Until now, pembrolizumab is the only immune checkpoint inhibitor (ICI) to prove a survival advantage. On the contrary, the results from CheckMate 914 trial showed the lack of benefit of adjuvant nivolumab. In the metastatic setting, the longer-term follow-up data of the CheckMate 9ER and CheckMate 214 trials reassessed the undoubtable role of ICI-based combination in first-line treatment, with a clear survival advantage in the subgroup of patients at intermediate/poor IMDC prognosis. No OS advantage was seen in favorable IMDC risk group patients. This 2024 ASCO Genitourinary Cancer Symposium laid the foundations for further knowledge development necessary for an increasingly personalized therapy for RCC patients.

Perioperative Outcomes of Robotic Radical Prostatectomy with Hugo™ RAS versus daVinci Surgical Platform: Propensity Score-Matched Comparative Analysis.

Background/Objectives: There is an urgent need for comparative analyses of the intraoperative, oncological, and functional outcomes of different surgical robotic platforms. We aimed to compare the outcomes of RARP performed at a tertiary referral robotic centre with the novel HugoTM RAS system with those performed with a daVinci surgical system, which is considered the reference standard. Methods: We analysed the data of 400 patients undergoing RARP ± pelvic lymph node dissection between 2021 and 2023, using propensity score (PS) matching to correct for treatment selection bias. All procedures were performed by three surgeons with HugoTM RAS or daVinci. Results: The PS-matched cohort included 198 patients with 99 matched pairs, balanced for all covariates. Positive surgical margins (PSMs) were found in 22.2% and 25.3% (p = 0.616) of patients, respectively, in the HugoTM RAS and daVinci groups. No significant differences were found for other important perioperative outcomes, including median (1st-3rd q) operative time (170 (147.5-195.5) vs. 166 (154-202.5) min; p = 0.540), median (1st-3rd q) estimated blood loss (EBL) (100 (100-150) vs. 100 (100-150) ml; p = 0.834), Clavien-Dindo (CD) ≥ 2 complications (3% vs. 4%; p = 0.498), and social continence at 3 months (73.7% vs. 74.7%; p = 0.353). In multiple analyses, no associations were found between surgical outcomes (PSM, length of PSM, operative time, EBL, length of catheterization, length of hospital stay, social continence at three months after surgery, and CD ≥ 2 complications) and the robotic platform. Conclusions: Our findings demonstrate that HugoTM RAS enables surgeons to safely and effectively transfer the level of proficiency they reached during their previous experience with the daVinci systems.

Robot-Assisted Radical Prostatectomy Performed with the Novel Hugo™ RAS System: A Systematic Review and Pooled Analysis of Surgical, Oncological, and Functional Outcomes.

Background/Objectives: to assess surgical, oncological, and functional outcomes of robot-assisted radical prostatectomy (RARP) performed using the novel Hugo™ RAS system. Methods: A systematic review was conducted following the PRISMA guidelines, using PubMed, Web of Science, Scopus, and Embase databases. Eligible papers included studies involving adult males undergoing RARP with the Hugo™ RAS platform, with at least ten patients analyzed. The pooled analysis was performed using a random-effect model. Results: Quantitative analysis was conducted on 12 studies including 579 patients. The pooled median docking time, console time, and operative time were 11 min (95% CI 7.95-14.50; I2 = 98.4%, ten studies), 142 min (95% CI 119.74-164.68; I2 = 96.5%, seven studies), and 176 min (95% CI 148.33-203.76; I2 = 96.3%, seven studies), respectively. The pooled median estimated blood loss was 223 mL (95% CI 166.75-280.17; I2 = 96.5%, eleven studies). The pooled median length of hospital stay and time to catheter removal were 2.8 days (95% CI 1.67-3.89; I2 = 100%, ten studies) and 8.3 days (95% CI 5.53-11.09; I2 = 100%, eight studies), respectively. The pooled rate of postoperative CD ≥ 2 complications was 4.1% (95% CI 1-8.5; I2 = 63.6%, eleven studies). The pooled rate of positive surgical margins and undetectable postoperative PSA were 20% (95% CI 12.6-28.5; I2 = 71.5%, nine studies) and 94.2% (95% CI 87.7-98.6; I2 = 48.9%, three studies), respectively. At three months, a pooled rate of social continence of 81.9% (95% CI 73.8-88.9; I2 = 66.7%, seven studies) was found. Erectile function at six months was 31% in one study. Conclusions: despite the preliminary nature of the evidence, this systematic review and pooled analysis underscores the feasibility, safety, and reproducibility of the Hugo™ RAS system in the context of RARP.

Predictive Factors for Major Complications and Urological Cancer Diagnosis in Older Adults (≥80 Years) Admitted to the Emergency Department for Hematuria.

Background: Gross Hematuria is a relevant cause of admission to the emergency department in the general population and particularly in older adults (≥80 years). This specific urological symptom is often underestimated and usually associated with benign conditions such as urinary infections or poor hydration. Nevertheless, hematuria could lead to severe acute complications or be the first symptom of urological cancers. Methods: We retrospectively analyzed clinical data from 1169 patients aged ≥80 years consecutively admitted to the emergency department for hematuria. The primary endpoint of the study was to identify risk factors for major complications, and the secondary endpoint was to analyze risk factors for urological cancer diagnosis. The median age was 85 years (IQR 82-88 years), and 908 (77%) were males. Among them, 449 (38.4%) had a past medical history of urological neoplasm (kidney, ureter, bladder, prostate, or urethral cancer). Results: Overall, 87 patients (7.4%) had major complications (patient death, septic shock, and admission to the intensive care unit). Worse vital signs at admission, fever, and confusion (p < 0.001, OR 18.0 IC 95% [5.5-58.7]; p = 0.015, OR 2.0 IC 95% [1.1-3.5]; p = <0.001, OR 4.2 IC 95% [1.9-3.5], respectively), as well as lower hemoglobin values and higher Charlson comorbidity index (p < 0.001, OR 0.8 IC 95% [0.7-0.9]), p = 0.002, OR = 1.2 [1.1-1.3]) were independent predictive factors for major complications. The multivariate analysis identified as risk factors for diagnosis of urological cancer older age, male sex and higher comorbidity (OR 1.05 IC95% [1-1.09]; OR 2.19 IC95% [1.42-3.39] and OR 1.11 IC95% [1.2-1.2], respectively); interestingly the presence of indwelling vesical catheter (IVC) (OR 0.44 IC95% [0.24-0.82]) resulted as an independent factor for absence of urological cancers. Conclusions: Hematuria is a frequent symptom in older adults admitted to the emergency department. While this is often associated with benign conditions, there are some risk factors for major complications and for urological cancer that must be taken into account to identify the patients who need further evaluation or prompt hospital admission.

Corrigendum to "Comparison of baseline patient characteristics in Italian oncology drug monitoring registries and clinical trials: a real-world cross-sectional study" [The Lancet Regional Health - Europe 41 (2024) 100912].

[This corrects the article DOI: 10.1016/j.lanepe.2024.100912.].

Assessing Trifecta and Pentafecta Success Rates between Robot-Assisted vs. Open Radical Cystectomy: A Propensity Score-Matched Analysis.

BACKGROUND: This study aimed to evaluate the surgical and oncological outcomes of robot-assisted radical cystectomy (RARC) versus open radical cystectomy (ORC) using trifecta and pentafecta parameters. METHODS: The clinical data of 41 patients who underwent RARC between 2018 and 2022 were prospectively collected and retrospectively compared to those of 330 patients undergoing ORC using 1:1 propensity score matching. Trifecta was defined as simultaneous negative surgical margins (SMs), a lymph node (LN) yield ≥ 16, and the absence of major complications (Clavien-Dindo grade III-V) within 90 days postoperatively. Pentafecta additionally included a 12-month recurrence-free rate and a time between the transurethral resection of a bladder tumor (TURBT) and radical cystectomy (RC) ≤ 3 months. The continuous variables were compared using the Mann-Whitney U test, and the categorical variables were analyzed using the chi-squared test. RESULTS: No statistically significant differences in trifecta and pentafecta success rates were observed between the RARC and ORC cohorts after propensity score matching. However, the RARC group exhibited significantly reduced blood loss (RARC: 317 mL vs. ORC: 525 mL, p = 0.01). CONCLUSIONS: RARC offers distinct advantages over ORC in terms of reduced blood loss, while trifecta and pentafecta success rates do not differ significantly between the two surgical approaches.

Ablative Treatments for Small Renal Masses and Management of Recurrences: A Comprehensive Review.

This review focuses on ablative techniques for small renal masses (SRMs), including radiofrequency ablation (RFA), cryoablation (CA), microwave ablation (MWA), and irreversible electroporation (IRE), and discusses recurrence management. Through an extensive literature review, we outline the procedures, outcomes, and follow-up strategies associated with each ablative method. The review provides a detailed examination of these techniques-RFA, CA, MWA, and IRE-elucidating their respective outcomes. Recurrence rates vary among them, with RFA and CA showing comparable rates, MWA demonstrating favorable short-term results, and IRE exhibiting promise in experimental stages. For managing recurrences, various strategies are considered, including active surveillance, re-ablation, or salvage surgery. Surveillance is preferred post-RFA and post-CA, due to slow SRM growth, while re-ablation, particularly with RFA and CA, is deemed feasible without additional complications. Salvage surgery emerges as a viable option for larger or resistant tumors. While ablative techniques offer short-term results comparable to surgery, further research is essential to understand their long-term effects fully. Decisions concerning recurrence management should consider individual and tumor-specific factors. Imaging, notably contrast-enhanced ultrasounds, plays a pivotal role in assessing treatment success, emphasizing the necessity of a multidisciplinary approach for optimal outcomes. The lack of randomized trials highlights the need for further research.

Comparison of baseline patient characteristics in Italian oncology drug monitoring registries and clinical trials: a real-world cross-sectional study.

Background: Generalizability of registrative clinical trials to real-world clinical practice is influenced by comparability of patients in the two settings. We compared characteristics of cancer patients in registrative trials with real-world clinical practice in Italy. Methods: Data on age, sex and performance status (PS) were derived from web-based monitoring registries developed by Italian Medicines Agency (AIFA) and corresponding registrative trials reported in the European Public Assessment Reports (EPAR) of European Medicines Agency (EMA). Weighted means were calculated in registries and trials and differences were described. Multivariate analysis was performed using Principal Component Analysis and Cluster Analysis. Findings: From January, 2013 to April, 2023, 419,461 unique pairs of patients and therapeutic indications were recorded in 129 AIFA registries. Within 140 related trials, 87,452 patients had been enrolled. Median age and rate of elderly (≥65 years old) patients were higher in monitoring registries than in clinical trials [mean difference of median age 5.3 years, p < 0.001; mean difference of elderly rate 17.17% (95% CI 1.06, 1.48)]. Overall, rate of female patients was not different between registries and trials [mean difference -0.55% (95% CI -1.06, -0.05)]. Mean rate of patients with deteriorated PS was low both in trials (3.1%) and in registries (4.3%) with a mean difference of 1.27% (95% CI 1.06, 1.48). Two clusters were identified with multivariate analysis: one including more registries (higher median age and elderly rate, lower female rate, higher rate of deteriorated patients), the other more trials (lower median age and elderly rate, higher female rate, lower rate of deteriorated patients). Interpretation: This study supports that cancer patients enrolled in trials do only partially represent those who have been treated in Italy in clinical practice. Inclusiveness of registrative trials should be increased to ensure generalizability of results to real-world population. Funding: Partially supported by Italian Ministry of Health.

Elderly and bladder cancer: The role of radical cystectomy and orthotopic urinary diversion.

The incidence of bladder cancer (BC) depends on advancing age and other risk factors, significantly impacting on surgical, functional and oncological outcomes. Radical cystectomy (RC) with urinary diversion is the gold standard therapy for muscle invasive bladder cancer; however, it remains a complex surgery and requires careful analysis of risk factors in order to potentially decrease post-surgical complication rates. Age in surgery is a limiting factor that can modify surgical and oncological outcomes, and is correlated with a high rate of post-dimssion hospital readmissions. The reconstruction of the bladder with the intestine represents a crucial point of radical cystectomy and the urinary derivation (UD) is at the center of many debates. A non-continent UD seems to be the best choice in elderly patients (>75 years old), while orthotopic neobladder (ON) is poorly practiced. We reviewed the literature to identify studies reporting outcomes, complications, patient- selection criteria, and quality-of-life data on elderly patients, who underwent ON following radical cystectomy. Reviewing the literature there is no clear evidence on the use of age as an exclusion criterion. Certainly, the elderly patient with multiple comorbidities is not eligible for ON, preferring other UD or rescue therapies. A careful preoperative selection of elderly patients could greatly improve clinical, surgical and oncological outcomes, giving the chance to selected patients to receive an ON.