Subsequent treatments and outcomes in bacillus Calmette-Guerin–unresponsive patients with high-risk non-muscle invasive bladder cancer with carcinoma in situ: A real-world data analysis.

Abstract

4604 Background: Intravesical (ives) Bacillus Calmette-Guerin (BCG) is the recommended first-line treatment (tx) option for patients (pts) with high-risk (HR) non-muscle-invasive bladder cancer (NMIBC). Despite initial activity, BCG fails in up to 50% of pts. Pts with BCG unresponsive HR NMIBC with Carcinoma in situ (CIS) are at high-risk of disease progression. Limited evidence is available about tx patterns and outcomes of these pts. The objective of this study is to characterize real-world tx patterns and assess corresponding outcomes. Methods: This retrospective cohort study utilized comprehensive claims augmented with electronic health records in the US HealthVerity dataset from Oct 2015 to Dec 2022. This analysis included NMIBC pts who received adequate BCG ( > = 7 doses) and had a CIS recurrence within 12 months of last BCG dose. Recurrence with CIS is defined as a transurethral resection of bladder tumor (TURBT) followed by a CIS diagnosis (dx) within 30 days. Descriptive analysis to characterize subsequent tx post BCG was performed for pts with at least 1 year of follow up post-recurrence. Time to recurrence or progression (defined as a TURBT followed by a BC dx within 30 days or starting a new line of tx) was used to assess outcomes of subsequent tx using Kaplan-Meier analysis. Results: We identified 23,280 pts with NMIBC who were treated with BCG between 2015 and 2022. Overall, 11,116 pts (48%) received > = 7 BCG doses and 1,094 pts recurred with CIS within 12 months of last BCG dose. Among them, 486 pts (44.4%) with BCG unresponsive HR NMIBC with CIS [79% males, median age 66 years (IQR: 60, 75)] received subsequent therapy. Median time from recurrence to tx initiation was 91 days (IQR: 41, 346). The most frequently administered tx was ives chemotherapy (ctx), accounting for 45% of cases (Table 1). Among pts receiving ives ctx (n = 217), 68% experienced recurrence or progression within 12 months with a median time to recurrence or progression of 174 days [139, 196]. Conclusions: Although guidelines recommend radical cystectomy for BCG unresponsive HR NMIBC patients with CIS, this RWD analysis revealed that over half of these patients received no further treatment for at least 1 year after their disease recurrence or progression. Among those treated, ives ctx was the most common tx. Therefore, the majority of patients were either undertreated or received ives ctx with only modest outcomes. This highlights the need for novel, more effective bladder-sparing therapies in this pt population. Subsequent line of treatment for BCG unresponsive HR NMIBC patients with CIS post BCG. Subsequent Treatment N =486 pts Intravesical ctx 217 (45%) Radical cystectomy 121 (25%) Intravesical BCG* 66 (14%) Interferon alpha + BCG 60 (12%) Systemic immunotherapy 22 (4%) *BCG treatment starting > 12 months post the last BCG dose is considered a new line of treatment.