Urology Practice最新文献

Background: Patients with high-risk muscle-invasive urothelial carcinoma remain at substantial risk of disease recurrence. Randomized phase III trials have evaluated adjuvant programmed death 1 (PD-1) inhibitors in this setting, but the magnitude and consistency of benefit across patient subgroups remain incompletely defined.

Methods: We performed a systematic review and meta-analysis of randomized phase III trials comparing adjuvant PD-1 inhibitors with placebo or observation in patients with resected high-risk muscle-invasive urothelial carcinoma. Hazard ratios (HRs) for disease-free survival (DFS) and overall survival (OS), as well as risk ratios (RRs) for adverse events, were pooled using random-effects models. Prespecified subgroup analyses were conducted according to PD-L1 expression and prior receipt of cisplatin-based neoadjuvant chemotherapy.

Results: Two phase III trials encompassing patients treated with adjuvant nivolumab or pembrolizumab were included. Adjuvant PD-1 inhibitor therapy significantly improved DFS compared with control (pooled HR <1), with consistent benefit observed across PD-L1-defined subgroups and regardless of prior neoadjuvant cisplatin use. A favorable trend toward improved OS was observed, although survival data remain immature. Treatment was associated with a higher incidence of grade 3 or higher and immune-related adverse events compared with placebo or observation.

Conclusions: Among patients with resected high-risk muscle-invasive urothelial carcinoma, adjuvant PD-1 inhibitor therapy significantly improves disease-free survival with an acceptable safety profile. However, due to the limited number of studies and short follow-up periods, these findings should be considered preliminary, and longer follow-up is required to confirm any potential overall survival benefit.

Introduction: A predictive model from the Veterans Affairs National Health System estimates glomerular filtration rate (eGFR) 1-year following partial nephrectomy (PN). The model demonstrated a coefficient of determination (R²) of 0.66, with 82% of patients having a post-operative eGFR within 30% of the predicted GFR (P30). The purpose of this study is to assess its performance in patients enrolled in the renal hypothermia trial.

Methods: The model was externally validated using data from the renal hypothermia randomized clinical trial where GFR was measured using ^99mTc-DTPA plasma clearance pre-PN and 1-year post-PN. Model performance was evaluated using R², calibration slope, calibration plot, and precision (P10: within 10%; P20; within 20%; and P30 within 30%).

Results: The trial cohort included 175 patients with pre- and post-PN complete data. The R² was 0.67. The model was reasonably precise with 73 patients within 10% of predicted GFR (P10=41.7%), 129 within 20% of predicted GFR (P20=73.7%) and 156 within 30% of predicted GFR (P30=89.1%). The calibration slope was 1.04, with good calibration across a wide range of baseline renal function. Limitations include modest sample size, predominantly Caucasian patients, and restriction to open PN, limiting generalizability.

Conclusions: A recently developed model to predict post-operative GFR performed well when applied to clinical trial patients that had GFR measured using ^99mTc-DTPA plasma clearance. This model can be utilized as a component of informed decision-making when counseling patients on expected outcomes following partial nephrectomy.

Purpose: To evaluate real-world utility of adding Cxbladder Triage test to microhematuria diagnostic workflow in an integrated healthcare system.

Materials and methods: We conducted a retrospective matched cohort study of microhematuria patients tested with Cxbladder Triage, a urine-based biomarker of mRNA targets and clinical factors to assess urothelial cancer risk. We matched untested controls based on age, encounter date, and hematuria risk index score. The cohort was stratified by Cxbladder Triage result; low probability (<4.00, cystoscopy could be deferred) vs physician-directed protocol (≥4.00, cystoscopy recommended). We evaluated the use of cystoscopy, CT urograms, and new diagnoses of bladder cancer.

Results: We matched 3,353 patients tested with Cxbladder Triage with 3,353 controls according to American Urological Association (AUA) risk (15.7% AUA low risk for cases and controls, p=0.362). Among 3,353 tested patients, 2,670 (79.6%) had low probability of cancer and were less likely to undergo cystoscopy (3.8% vs 46.5% controls, p<0.001). Tested patients with elevated risk for cancer (n=683) were more likely to undergo cystoscopy (73.4% vs 45.7% controls, p<0.001). Similar patterns were seen for CT urogram (7.5% vs 11.7% low probability; 19.5% vs 13.3% physician-directed protocol, both p<0.001). Cancer detection was similar between both groups (0.3% tested vs 0.6% controls, p=0.105) and between tested patients with elevated risk vs untested controls (1.5% physician-directed protocol vs 0.6% controls, p=0.107).

Conclusions: Cxbladder Triage testing decreases burden of cystoscopy and CT urogram use among microhematuria patients. This test maintains similar cancer detection overall and among microhematuria patients at greater risk for underlying malignancy.

Introduction and objectives: The Veterans Affairs (VA) Health System recently implemented the Risk Analysis Index (RAI) to assess frailty prior to surgery. Elevated RAI scores trigger a "surgical pause" and geriatric consultation to reduce short-term morbidity. However, any cancer diagnosis, including localized prostate cancer (PCa), increases RAI, potentially overstating frailty in otherwise healthy patients. We hypothesized that low- or intermediate-risk PCa does not correlate with 30-day morbidity and mortality predicted by RAI.

Methods: We retrospectively reviewed patients with low- or intermediate-risk PCa who underwent radical prostatectomy at a single institution over five years. RAI-A (administrative) scores were calculated with and without including PCa. Thirty-day postoperative complications and mortality were compared to rates predicted by RAI-A using data from the original VASQIP study.

Results: Among 130 patients (median age 61), 53.4% had favorable intermediate-risk, 41.2% unfavorable intermediate-risk, and 5.3% low-risk PCa. Mean RAI-A excluding PCa was 8.58; including PCa it was 24.95. Corresponding VASQIP-predicted complication rates were 4.6% (2.5% grade IV-V) and 11.2% (5.6% grade IV-V). In our cohort, six patients (4.6%) experienced complications, none grade IV-V.

Conclusions: Including localized PCa in RAI-A calculations overestimates frailty and predicted morbidity. Excluding the PCa diagnosis may better reflect surgical risk in low- or intermediate-risk patients, preventing unnecessary delays in treatment.

Introduction: This investigator-initiated, prospective low-intervention phase 3 study evaluated the clinical utility of PSMA PET/CT imaging with ¹⁸F-flotufolastat (formerly ¹⁸F-rhPSMA-7.3) in men with newly diagnosed high-risk prostate cancer and negative conventional imaging. The primary endpoint was the rate of clinical upstaging and its effect on subsequent management.

Methods: A total of 113 treatment-naïve men meeting NCCN high-risk criteria were enrolled; 110 underwent PSMA PET/CT with ¹⁸F-flotufolastat. Prior to imaging, all patients had negative conventional staging, as determined by bone scan and CT or MRI. Imaging was performed 50-70 minutes post-injection of 8 mCi ± 20% ¹⁸F-flotufolastat. Results were interpreted by board-certified nuclear medicine physicians trained in PSMA imaging.

Results: ¹⁸F-flotufolastat identified extraprostatic disease in 36 of 110 patients (32.7%). Among these, 15 of 36 (41.7%) had isolated regional lymph node (N1) involvement, while 21 of 36 (58.3%) demonstrated distant metastatic (M1) disease. Of the patients who were upstaged, 34 of 36 patients (94.4%) had a change in their treatment plan. The most common treatment intensification included the addition of an androgen receptor inhibitor and expanded radiotherapy fields (50.0%). Further, 34.3% received upfront chemotherapy alongside an androgen receptor inhibitor and radiation. A minority (8.6%) proceeded with radical prostatectomy as a first step of a multimodality approach.

Conclusion: PSMA PET/CT with ¹⁸F-flotufolastat led to clinical upstaging in nearly one-third of men with high-risk prostate cancer and negative conventional imaging, resulting in significant treatment change in most patients. These findings support the integration of PSMA-targeted imaging into initial staging pathways for men with high-risk prostate cancer.