669 Background: Patients with high-risk (HR) non-muscle-invasive bladder cancer (NMIBC) are often treated with Bacillus Calmette-Guérin (BCG). This study was conducted to evaluate real-world clinical outcomes of BCG-naïve HR NMIBC patients after BCG initiation. Methods: A retrospective cohort study was conducted using the N Power Real World Data Network consisting of cancer registry data from community oncology practices in the US, validated through chart review (January 2016 - April 2025). BCG-naïve (no BCG within 2-years prior to current diagnosis) HR NMIBC (T1, high-grade Ta, and/or carcinoma in situ CIS) patients were included. Index date was the date of BCG initiation. Disease recurrence and progression (muscle-invasive bladder cancer MIBC, distant metastasis) after the index date were identified. Recurrence-free survival (RFS; time from the index date to first disease recurrence or death from any cause, whichever occurred first) was estimated using Kaplan-Meier analyses among all eligible patients and age 65+ subgroup. Patients were censored at earliest date of another cancer diagnosis or last abstraction, whichever occurred first. Time to radical cystectomy (RC; time from index date to RC date) is reported. Results: A total of 1,114 BCG-naïve HR NMIBC patients (n=883 65+ years) were included; median follow-up from index of 2.9 years (median age 73 years, 79% male, 93% White, 71% Medicare insurance 88% 65+). 55% of the patients were stage T1 +/- CIS, 35% high-grade Ta +/- CIS, and 10% CIS only at HR NMIBC diagnosis. Median time from HR NMIBC diagnosis to index was 11 weeks. Table contains real-world clinical outcomes of BCG-naïve HR NMIBC patients after index. Conclusions: These findings highlight the substantial clinical burden for BCG-treated HR NMIBC patients and the need for more effective treatments that can reduce recurrence. Real-world clinical outcomes of BCG-naïve HR NMIBC patients after BCG initiation. All HR NMIBC Patients (n= 1,114) 65+ (n= 883) Any recurrence, N (%) 351 (31.5%) 288 (32.6%) Progression, N (%) MIBC Distant metastasis 79 (7.1%)40 (3.6%) 65 (7.4%)29 (3.3%) Death, N (%) 198 (18%) 182 (21%) median RFS, years (95% CI) 4.6 (3.9-5.4) 3.9 (3.2-4.6) 5-year recurrence rate, % 47 50 RC, N (%) 67 (6.0%) 55 (6.2%) Median time to RC, months (min, max) 13 (3, 69) 13 (3, 50) RC among recurred patients, N (%) 58 (17%) 47 (16%) MIBC, muscle-invasive bladder cancer; RFS, recurrence-free survival; RC, radical cystectomy.
Babcock et al. (Sun,) studied this question.