A REAL-WORLD US COMMUNITY-BASED EVALUATION OF RECURRENCE AMONG INTERMEDIATE RISK NON-MUSCLE-INVASIVE BLADDER CANCER PATIENTS TREATED WITH BACILLUS CALMETTE-GUERIN
Author(s)
Aram Babcock, MBA, MS, RPh, PharmD, PhD1, Ke Meng, PhD2, Hema Dave, MD1, Vladimir Turzhitsky, MS, PhD2, Haojie Li, MD, PhD1;
1Merck & Co., Inc., Rahway, NJ, USA, 2Merck & Co., Inc., Boston, MA, USA
1Merck & Co., Inc., Rahway, NJ, USA, 2Merck & Co., Inc., Boston, MA, USA
OBJECTIVES: We evaluated real-world clinical outcomes of BCG-naive intermediate-risk (IR) non-muscle-invasive bladder cancer (NMIBC) patients after Bacillus Calmette-Guerin (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 (01JAN2016 - 16APR2025). BCG-naive (no BCG within 2-years prior to current diagnosis) IR NMIBC (solitary LG Ta > 3 cm; LG Ta, multifocal; HG Ta <= 3cm, or LG T1) patients were included. Index date was the date of BCG initiation. Any 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. Number of transurethral resections of bladder tumor (TURBT) and re-TURBT are reported.
RESULTS: A total of 820 BCG-naïve IR NMIBC patients (n=635 65+ years) were included (median age 72 years, 78% male, 93% White, 70% Medicare insurance [89% 65+]). Five-percent of the patients were either solitary LG Ta > 3 cm, or LG Ta and multifocal; 19.2% HG Ta <= 3cm, and 75.7% LG T1 at IR NMIBC diagnosis. Median time from IR NMIBC diagnosis to BCG initiation was 10 weeks. During a median follow-up from index date of 35 (min, max [17,51]) months, 30% (65+ 31%) of patients had any disease recurrence, 9.4% (65+ 9.3%) had progression, and about 60% (65+ 59%) received re-TURBT. The estimated 5-year recurrence rate was 50%.
CONCLUSIONS: These findings highlight the substantial clinical burden for BCG-treated IR NMIBC patients and the need for more effective treatments that can reduce recurrence.
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 (01JAN2016 - 16APR2025). BCG-naive (no BCG within 2-years prior to current diagnosis) IR NMIBC (solitary LG Ta > 3 cm; LG Ta, multifocal; HG Ta <= 3cm, or LG T1) patients were included. Index date was the date of BCG initiation. Any 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. Number of transurethral resections of bladder tumor (TURBT) and re-TURBT are reported.
RESULTS: A total of 820 BCG-naïve IR NMIBC patients (n=635 65+ years) were included (median age 72 years, 78% male, 93% White, 70% Medicare insurance [89% 65+]). Five-percent of the patients were either solitary LG Ta > 3 cm, or LG Ta and multifocal; 19.2% HG Ta <= 3cm, and 75.7% LG T1 at IR NMIBC diagnosis. Median time from IR NMIBC diagnosis to BCG initiation was 10 weeks. During a median follow-up from index date of 35 (min, max [17,51]) months, 30% (65+ 31%) of patients had any disease recurrence, 9.4% (65+ 9.3%) had progression, and about 60% (65+ 59%) received re-TURBT. The estimated 5-year recurrence rate was 50%.
CONCLUSIONS: These findings highlight the substantial clinical burden for BCG-treated IR NMIBC patients and the need for more effective treatments that can reduce recurrence.
Conference/Value in Health Info
2026-05, ISPOR 2026, Philadelphia, PA, USA
Value in Health, Volume 29, Issue S6
Code
SA54
Topic
Study Approaches
Disease
SDC: Oncology, SDC: Urinary/Kidney Disorders