To evaluate long-term renal function in patients with chronic kidney disease (CKD) Stage IIIa who underwent radical cystectomy and orthotopic neobladder (RC/ONB) compared to matched controls. Patients and MethodsUsing our Institutional Review Board-approved institutional database, patients with a glomerular filtration rate (GFR) of 45-59.9 mL/min/1.73 m 2 who underwent RC/ONB were identified. A control group of patients with a GFR of ≥60 mL/min/1.73 m 2 was selected. Groups were matched based on age, baseline hypertension/diabetes mellitus, perioperative chemotherapy, and preoperative hydronephrosis. A decrease in GFR of >10 mL/min/1.73 m 2 during the follow-up was considered significant. A multivariate Cox regression analysis was performed to identify predictors of GFR decline in each group. ResultsOf 1237 patients who underwent RC/ONB, 508 patients were included (254 per group). The mean preoperative GFR was 53.3 mL/min/1.73 m 2 in the study group and 78.8 mL/min/1.73 m 2 in controls. The median follow-up was 3.7 years. During follow-up, GFR stayed at or above baseline in 51% of the study patients compared to 46% of the controls (P = 0.5). The mean time to a significant GFR decline in the study patients was significantly longer compared to the controls (5.6 vs 2 years, respectively; P < 0.001). In multivariate analysis, neoadjuvant chemotherapy was found to be the strongest predictor of a significant GFR decline as well as GFR decline below baseline (hazard ratio [HR] 2.15, 95% confidence interval [CI] 1.4-3.29, P = 0.004; and HR 2.15, 95% CI 1.4-3.29, P < 0.001, respectively). ConclusionPatients with CKD Stage IIIa who undergo ONB appear to have comparable long-term renal function to those with a GFR of ≥60 mL/min/1.73 m 2 . An ONB reconstruction is a safe option for patients with CKD Stage IIIa desiring a continent diversion.

Objectives: Bladder cancer (BC) is a common urinary tract cancer with a variable clinical course. With recurrence as high as 70%, cystoscopy and urine cytology are routinely employed during follow-up of patients with a history of non-muscle invasive bladder cancer (NMIBC). Although multiple FDA approved urine-based tests for BC detection and surveillance exist, diagnostic accuracy of these urine-based assays is still suboptimal. Here, we evaluate the diagnostic value of a newly developed non-invasive DNA methylation-based test for surveillance of NMIBC. Methods: We included patients undergoing blue-light surveillance cystoscopy for NMIBC between February 2019 and September 2021. Urine samples were collected at each surveillance cystoscopy prior any genitourinary manipulation. Samples were analyzed with Bladder CARE, a urine-based test that measures the methylation level of 3 bladder cancer specific biomarkers (TRNA-Cys, SIM2, and NKX1-1) and two internal control loci using methylation-sensitive restriction enzymes coupled with qPCR. Results are reported as Bladder CARE Index (BCI) score and categorized as “positive” (BCI &gt; 5), “high risk” (2.5 &lt; BCI ≤ 5) or “negative” (BCI ≤ 2.5). Association between BCI score and category, cytology and cystoscopy findings were assessed. Results: A total of 503 samples were collected from 159 patients (median age of 73, 77% male). 103 biopsies were performed during surveillance cystoscopies, of which 26 (25%) showed evidence of cancer recurrence.Bladder CARE was positive (22) or high-risk (4) in all the positive biopsies, while cytology was atypical only in 7 and highly suspicious in 2. Among 77 negative biopsies, Bladder CARE was positive in 27 collected from 20 patients, 8 of whom developed recurrence detected during subsequent follow ups. Cytology was atypical in 2 of these 8 recurrence patients. 3 patients with positive Bladder CARE results and normal cystoscopies developed upper tract urothelial carcinoma later. Bladder CARE test was able to predict the recurrence within a median of 7 months prior cystoscopy. The Receiver Operating Characteristic (ROC) curve using the BCI values demonstrated the sensitivity, specificity, positive predictive values, and negative predictive value of 93%, 65%, 73.5%, and 89.5%, respectively (Table 1). Conclusions: Urine cytology had low sensitivity and PPV for urothelial carcinoma in this cohort. Our findings demonstrated the necessity of more accurate urine biomarkers in the surveillance of NMIBC patients. Our preliminary results showed that Bladder CARE test has high sensitivity and can potentially predict future recurrence. Citation Format: Paolo Piatti, Sanam Ladi-Seyedian, Sidney Roberts, Farshad Sheybaee Moghadam, Alireza Ghoreifi, Jeffrey Bhasin, Benjamin Jara, Lucy Sanossian, Yap Ching Chew, Sumeet Bhanvadia, Hooman Djaladat, Anne Schuckman, Gangning Liang, Siamak Daneshmand. DNA methylation markers for the surveillance of non-muscle invasive bladder cancer: Results from a prospective pilot study [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2023; Part 1 (Regular and Invited Abstracts); 2023 Apr 14-19; Orlando, FL. Philadelphia (PA): AACR; Cancer Res 2023;83(7_Suppl):Abstract nr 3335.

with previous radiation or surgery and the high risk of infection. Patients must be appropriately informed about these risks.

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TURBTs. 41/63 (65%) patients achieved CR at 3 months, of whom 39 (95%), 30 (73%), and 25 (61%) remained disease-free at 6, 9, and 12 months after treatment initiation, respectively. 13/41 (32%) patients with CR at 3 months had a disease recurrence. The 9-month DOR rate was 73% (ie, the probability that a patient will maintain CR for at least 9 months [12 months after treatment initiation] is 73%). Adverse events were primarily mild or moderate and included (!10% of patients) dysuria (41%), pollakiuria (21%), hematuria (16%), micturition urgency (14%), urinary tract infection (14%), and fatigue (11%). One death occurred but was not related to treatment.CONCLUSIONS: Primary chemoablation of LG IR NMIBC using UGN-102 results in a high rate of disease eradication with encouraging durability and may provide an alternative to repetitive surgery for these patients. A Phase 3, randomized, controlled trial of UGN-102 for treatment of LG IR NMIBC is ongoing. NCT03558503