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Impact of Oral Antithrombotic on Urinary Recovery Post-RARP

KEY TAKEAWAYS

  • The study aimed to investigate the effect of oral antithrombotic agents on urinary continence recovery after RARP.
  • Researchers noticed that oral antithrombotic agents may hinder urinary continence recovery after RARP.

A widely favored minimally invasive surgical option for treating prostate cancer. The increasing number of elderly patients is Robot-assisted radical prostatectomy (RARP), particularly those with cardiovascular and/or cerebrovascular conditions, undergoing this procedure has led to a rise in antithrombotic (AT) agent use among them. However, the impact of antithrombotic agents on postoperative urinary recovery remains insufficiently explored.

Masashi Oshima and the team aimed to analyze the differences in postoperative urinary continence recovery and oncological outcomes in patients undergoing RARP for localized prostate cancer, comparing those who adhered to antithrombotic agents with those who did not.

They performed an inclusive analysis involving a total of 394 patients who underwent conventional anterior RARP between February 2015 and February 2021. These patients were categorized into 2 groups: those taking oral antithrombotic agents and the control group. Urinary continence recovery, complications, and oncological outcomes were compared between the 2 groups. Additionally, a Cox proportional hazards analysis was conducted to identify clinical factors affecting urinary continence recovery.

No significant differences were observed between the groups, background data, and bleeding complications. However, recovery of continence was significantly poorer in the antithrombotic group in terms of complete pad-free status (HR: 0.53 [95% CI: 0.39-0.71]) and the use of ≤ 1 safety pad (HR: 0.74 [95% CI: 0.59-0.94]). The rate of anastomotic leakage on cystography was significantly higher in the antithrombotic group (20.9% vs. 6.7%).

A univariate analysis revealed that the use of antithrombotic agents, higher prostate-specific antigen levels, and a more advanced clinical stage were associated with poorer urinary continence recovery. Furthermore, multivariate analysis indicated that taking antithrombotic agents was an independent factor negatively associated with urinary continence recovery. There was no significant difference between the groups in the positive surgical margin rate (19.0% vs. 23.8%) or the biochemical-recurrence-free rate.

The study concluded that taking oral antithrombotic agents may be associated with poor urinary continence recovery following RARP.

The study received no funds.

Source: https://pubmed.ncbi.nlm.nih.gov/39342191/

Oshima M, Washino S, Yazaki K, et al. (2024). “Impact of oral antithrombotic agents on urinary continence recovery following robot-assisted radical prostatectomy: a retrospective cohort study.” BMC Urol. 2024;24(1):211. Published 2024 Sep 28. doi:10.1186/s12894-024-01594-6

Prognostic Value of Serum Fibronectin in NMIBC on BCG Therapy

KEY TAKEAWAYS

  • The study aimed to assess serum fibronectin and gene polymorphisms as predictors of recurrence and treatment response in patients with NMIBC on BCG therapy.
  • Researchers found elevated serum fibronectin predicts early recurrence in NMIBC but not BCG response.

Bladder cancer remains a major health concern, prompting continuous research into new biomarkers and therapeutic approaches. This study focuses on evaluating the role of serum fibronectin levels and fibronectin gene polymorphisms as potential biomarkers for predicting recurrence and treatment response in patients with non-muscle invasive bladder cancer (NMIBC) receiving intravesical BCG therapy.

Ali Nebioğlu and the team aimed to assess the prognostic value of these biomarkers in guiding treatment outcomes.

They performed an inclusive analysis between June 2022 and December 2022, prospectively examining data from 73 patients with NMIBC treated at the Mersin University Urology Clinic and 56 healthy individuals without malignancy. Patients were treated and monitored for intravesical BCG therapy when required. Serum fibronectin levels were measured using the enzyme-linked immunosorbent assay (ELISA) method, and Real-Time PCR was employed to analyze fibronectin gene RS10202709 and RS35343655 polymorphisms.

The mean serum fibronectin level in the patient group was 76.794 ± 66.998 ng/ml, compared to 50.486 ± 25.156 ng/ml in the control group, with the difference being statistically significant (P = 0.003). Out of the 73 patients, 53 experienced bladder cancer recurrence and were divided into early and late recurrence groups.

The early recurrence group had a mean fibronectin level of 102 ± 86.1 ng/ml, notably higher than the 44.7 ± 11.8 ng/ml observed in the late recurrence group. Patients with early recurrence demonstrated significantly elevated serum fibronectin levels compared to those with late recurrence (P < 0.001), indicating fibronectin’s potential as a prognostic biomarker.

The study concluded that the significantly higher concentrations of serum fibronectin levels observed in patients with bladder cancer highlight its potential as a valuable prognostic biomarker for early recurrence in NMIBC. However, its predictive value for response to BCG therapy remains limited.

This study was funded by the Mersin University Scientific Research Projects Unit as a project coded BAP 2022-1-TP3-4563.

Source: https://pubmed.ncbi.nlm.nih.gov/39342212/

Nebioğlu A, Tanrıverdi R, Başaranoğlu M, et al. (2024). “Evaluation of serum fibronectin levels and fibronectin gene polymorphism in patients receiving intravesical BCG therapy for non-muscle invasive bladder cancer and its prognostic value.” BMC Urol. 2024;24(1):210. Published 2024 Sep 28. doi:10.1186/s12894-024-01592-8

Intravesical Gemcitabine for NMIBC After BCG Treatment Failure

KEY TAKEAWAYS

  • The study aimed to evaluate gemcitabine’s efficacy in patients with NMIBC unresponsive to BCG therapy.
  • The results showed gemcitabine is a viable option for NMIBC patients unable or unwilling to undergo cystectomy.

Elahe Mirzaee and the team aimed to evaluate the effectiveness of intravesical gemcitabine in patients diagnosed with non-muscle invasive bladder cancer (NMIBC) who had experienced treatment failure following Bacillus Calmette-Guérin (BCG) therapy within the last year.

Researchers enrolled 28 patients with recurrent NMIBC between 2021 and 2023. All patients had previously undergone intravesical therapy within the past year, declined, or were unsuitable for cystectomy.

Participants were administered 2,000 mg/100 mL of gemcitabine weekly for 6 weeks. Response assessments occurred at 8 weeks, with follow-up evaluations scheduled every three months over 1 year.

The results demonstrated that 20 out of 28 patients (71.4%) responded completely to intravesical gemcitabine. About 8 patients (28.6%) did not achieve a complete response. There were significant differences in treatment response based on age, while gender did not influence outcomes.

Additionally, the results showed no notable association between tumor stage or grade and treatment response. Complete response rates were 66.7% for low-grade and 72.7% for high-grade tumors. During 1 year of follow-up, 28.6% of complete responders did not experience recurrence, while 42.9% developed recurrent disease. Only 1 patient developed muscle-invasive bladder cancer 10 months post-treatment and underwent cystectomy.

The study concluded that intravesical gemcitabine could be a viable option for patients with NMIBC unresponsive to BCG therapy, particularly those ineligible for or unwilling to undergo cystectomy.

No funding information was given.

Source: https://pubmed.ncbi.nlm.nih.gov/39342596/

Mirzaee E, Novin K, Fadavi P, et al. (2024). “Intravesical Gemcitabine for Non-Muscle Invasive Bladder Cancer after Bacillus Calmette-Guerin Treatment Failure: A Prospective Study.” Asian Pac J Cancer Prev. 2024;25(9):3173-3177. Published 2024 Sep 1. doi:10.31557/APJCP.2024.25.9.3173

Global Burden in Urologic Diseases BPH, UTI and GU Cancers

Global Burden in Urologic Diseases BPH, UTI and GU Cancers

KEY TAKEAWAYS

  • The study aimed to investigate the global burden and regional variations of common urologic diseases, including BPH, UTI, and cancers.
  • Researchers noted regional disparities in urologic disease burden, urging global collaboration to improve management.

The burden of common urologic diseases, such as benign prostatic hyperplasia (BPH), urinary tract infections (UTI), urolithiasis, bladder cancer, kidney cancer, and prostate cancer, varies across different geographic areas and specific regions. A comprehensive and detailed evaluation of the global burden of these urologic diseases is crucial to understanding their impact and informing healthcare strategies.

Hao Zi and the team aimed to assess the global distribution and regional differences in the prevalence and impact of these 6 urologic diseases.

They performed an inclusive analysis of data on incidence, prevalence, mortality, and disability-adjusted life-years (DALYs) for patients with the specified urologic diseases, categorized by age, sex, location, and year, using the Global Burden of Disease (GBD) 2021.

They evaluated the burden of these urologic diseases in relation to the socio-demographic index (SDI) and key attributable risk factors. Trends over time were examined by calculating estimated annual percentage changes (EAPC) with corresponding 95% confidence intervals (CI).

About 2021, BPH and UTI were identified as the leading causes of age-standardized incidence rate (ASIR) and age-standardized prevalence rate (ASPR), with rates of 5531.88 and 2782.59 per 100,000 persons, respectively. Prostate cancer emerged as the primary cause of both age-standardized mortality rate (ASMR) and age-standardized DALYs rate (ASDR), with rates of 12.63 and 217.83 per 100,000 persons, respectively. Between 1990 and 2021, an upward trend was observed in ASIR, ASPR, ASMR, and ASDR for UTI, while urolithiasis showed a downward trend.

The middle and low-middle SDI quintile levels demonstrated higher incidence, prevalence, mortality, and DALYs associated with UTI, urolithiasis, and BPH, whereas the high and high-middle SDI quintiles exhibited higher rates for the three cancers.

The burden of these 6 urologic diseases presented varied patterns by age and sex. In 2021, a high body mass index (BMI) contributed to 20.07% of kidney cancer deaths globally, while smoking was responsible for 26.48% of bladder cancer deaths and 3.00% of prostate cancer deaths.

The study concluded that the global burden of the six urologic diseases poses a considerable public health challenge, emphasizing the need for urgent international collaboration to enhance urologic disease management. This includes the development of effective diagnostic screening tools and the implementation of high-quality prevention and treatment strategies.

This study was funded by the National Key Research and Development Program (2022YFC3600700), the Fundamental Research Funds for the Central Universities (2042024YXA008), and the Young Top-notch Talent Cultivation Program of Hubei Province (for Prof. Xian-Tao Zeng).

Source: https://pubmed.ncbi.nlm.nih.gov/39294748/

Zi H, Liu MY, Luo LS, et al. (2024). “Global burden of benign prostatic hyperplasia, urinary tract infections, urolithiasis, bladder cancer, kidney cancer, and prostate cancer from 1990 to 2021.” Mil Med Res. 2024;11(1):64. Published 2024 Sep 18. doi:10.1186/s40779-024-00569-w

Efficacy of LE for Post-Op Leakage After RC

KEY TAKEAWAYS

  • The study aimed to investigate the efficacy of LE in managing post-operative lymphatic leakage in patients undergoing RC with PLND.
  • Researchers noticed that LE effectively addresses post-operative leaks after RC.

Although radical cystectomy (RC) along with pelvic lymph node dissection (PLND) is the standard approach for treating muscle-invasive bladder cancer (MIBC), it may lead to lymphatic leakage. Recent research has pointed to lymphatic embolization (LE) as a viable option for managing post-operative lymphatic leaks.

Consequently, Yoo Sub Shin and the team aimed to evaluate the outcomes of LE in patients who underwent RC and to analyze the factors associated with these outcomes.

They performed an inclusive analysis of patients who underwent LE after RC for BC between August 2017 and June 2023. Data were assessed for analysis in January 2024.

The patients were categorized into a clinical success group and a clinical failure group, with clinical failure defined as 1) requiring drainage catheter placement for more than 7 days after LE, 2) needing re-intervention before catheter removal, and 3) experiencing adverse events (AE) associated with LE. To identify factors associated with the outcomes of LE, a Logistic regression analysis was conducted.

About 45 patients who underwent LE after RC were analyzed. Of these 28 (62.2%) patients were classified as clinically successful, 4 patients required re-embolization, but none needed more than 2 intervention sessions. Lymphatic complications were experienced in 3 patients following LE.

In multivariable analysis, a maximal daily drainage volume of >1,000 mL/day (odds ratio [OR] = 4.729, 95% confidence interval [CI]: 1.018-21.974, P = 0.047) and diabetes mellitus (DM) (OR = 4.571, 95% CI: 1.128-18.510, P = 0.033) were identified as factors associated with the outcomes of LE.

The study concluded that LE is a potentially effective procedure for managing post-operative lymphatic leaks after RC, with few minor side effects. Patients with a daily drainage exceeding 1,000 mL/day or a medical history of diabetes mellitus are at an increased risk for re-intervention and clinical failure following LE.

The study received no funds.

Source: https://pubmed.ncbi.nlm.nih.gov/39316604/

Shin YS, Han K, Lee J, et al. (2024). “Lymphatic embolization for early post-operative lymphatic leakage after radical cystectomy for bladder cancer.” PLoS One. 2024;19(9):e0305240. Published 2024 Sep 24. doi:10.1371/journal.pone.0305240

ADT and BC Risk in Patients With Prostate Cancer

KEY TAKEAWAYS

  • The study aimed to investigate whether ADT reduces BC incidence in men with PCa.
  • ADT in patients with PCa was not associated with a statistically significant reduction in BC incidence.

Bladder cancer (BC) is more common in men than women. While the exact aetiology of bladder cancer remains unclear, sex hormones are thought to play a role. As such, it has been postulated that androgen deprivation therapy (ADT), a common treatment for prostate cancer (PCa), may reduce the risk of bladder cancer in men.

Josephine M Hyldgaard and the team aimed to examine the association between androgen deprivation therapy (chemical or surgical castration) and the incidence of bladder cancer in men diagnosed with prostate cancer.

The study used data from national Danish registries. A cohort of men diagnosed with PCa between 2002 and 2018 was identified and categorized based on whether they received antihormonal treatment (chemical castration, surgical castration, or no treatment) within the first year of diagnosis.

Each patient with PCa was matched with 10 age-matched individuals from the general population (comparison cohort). Cumulative incidence of BC, overall survival (OS), and BC-specific mortality were the main outcomes that were analyzed.

The study included 48,776 patients with PCa. The 5-year risk of BC was numerically lower in men who received any form of ADT (chemical castration: 0.7%, surgical castration: 1.1%) compared to those who did not receive ADT (1.3%). However, this difference was not statistically significant after adjusting for confounding factors. There was no association found between ADT and OS.

The study found that ADT, in the form of chemical or surgical castration, was not associated with a statistically significant reduction in BC incidence among patients with PCa.

Funding was not given.

Source: https://pubmed.ncbi.nlm.nih.gov/39319939/

Hyldgaard JM, Nørgaard M, Hjort PE, et al. (2024). “Bladder cancer incidence and mortality among men with and without castration therapy for prostate cancer – a nation-wide cohort study.” Acta Oncol. 2024;63:746-754. Published 2024 Sep 25. doi:10.2340/1651-226X.2024.40969

Efficacy of Nivo3/Ipi1 in Molecularly Selected mCRPC

KEY TAKEAWAYS

  • The study aimed to investigate the efficacy and safety of Nivo and Ipi in molecularly selected patients with mCRPC.
  • The primary endpoint was to determine DCR.
  • Researchers noticed that dual ICB with Nivo and Ipi achieved durable benefits in molecularly selected mCRPC.

Anti-PD1 immune checkpoint blockade (ICB) is currently approved for use as monotherapy in patients with metastatic castration-resistant prostate cancer (mCRPC) who have a tumor mutational burden (TMB) greater than 10 mutations per megabase (mut/Mb) or exhibit mismatch repair deficiency (MMRd). While dual anti-PD1/CTLA-4 therapy shows greater efficacy compared to monotherapy, the broader application of Nivolumab 1mg/kg and Ipilimumab 3mg/kg (Nivo1/Ipi3) in mCRPC is limited by associated toxicity.

Niven Mehra and the team aimed to explore the efficacy and safety of Nivo3/Ipi1 in patients with molecularly selected mCRPC.

They performed an inclusive analysis involving 69 molecularly selected patients with mCRPC having MMRd, non-synonymous TMB greater than 7 mut/Mb (hTMB), a BRCA2 mutation (BRCA2m), or biallelic inactivation of CDK12 (CDK12i).

Efficacy was assessed in cohort A, which comprised ICB-naïve patients with measurable disease as defined by RECIST1.1 (A1) and PCWG3 (A2). Safety evaluations were conducted in cohorts A and B, including patients who had received prior ICB monotherapy.

Patients were treated with Nivo3/Ipi1 every 3 weeks for 4 cycles, followed by Nivo at 480 mg every 4 weeks for up to 1 year. The primary endpoint was the disease control rate greater than 6 months (DCR>6), to exceed a DCR>6 of 22%.

About 69 patients initiated treatment between January 2021 and February 2024. The median age was 69 [range 50-82]. Cohort A included 65 patients, with 21 patients having MMRd (32%), 8 with hTMB (12%), 20 with BRCA2m (31%), and 16 exhibiting CDK12i (25%).

The median number of prior mCRPC treatments was 1 [range 0-5]. At the data cut-off, the median follow-up period was 12 months (mo) [range 1-42]. A DCR>6 was achieved in 38% (95% CI 27-51) of patients, with the highest rates observed in MMRd patients (81%), followed by hTMB (25%), CDK12i (19%), and BRCA2m patients (15%). The overall response rate (ORR), PSA50, and PSA90 responses were 38%, 47%, and 41%, respectively.

The median radiographic progression-free survival (rPFS) was 4.0 mo (95% CI, 3.5 to 12.0) in cohort A and 32.7 mo in patients with MMRd (95% CI, 21.8 to NR). Treatment-related adverse events (TRAEs) resulted in permanent discontinuation for 14 patients (20%). Grade ≥3 TRAEs occurred in 33 patients (48%) and included diarrhea and elevated transaminases, each affecting 10% of patients. There were 2 treatment-related deaths, specifically a bowel perforation, and euthanasia following grade 4 toxicity.

The study concluded that the trial of dual ICB in molecularly selected mCRPC successfully met its primary endpoint, demonstrating durable benefits across MMRd, hTMB, BRCA2m, and CDK12i subgroups. Outcomes for patients with MMRd were notably superior to those previously reported for ICB monotherapy.

The trial was sponsored by the Radboud University Medical Center.

Source: https://cslide.ctimeetingtech.com/esmo2024/attendee/confcal/show/session/18

Clinical Trial: https://clinicaltrials.gov/study/NCT04717154

Mehra N, Wilpe S.V, Westdorp H, et al. (2024). “Nivolumab 3mg/kg and ipilimumab 1mg/kg (nivo3/ipi1) in molecularly selected patients (pts) with metastatic castration-resistant prostate cancer (mCRPC).” Presented at ESMO 2024 (Abstract LBA72).

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