Outcomes of additional BCG versus sequential gemcitabine + docetaxel in BCG-exposed high-risk non–muscle-invasive bladder cancer.

Abstract

e16600 Background: For BCG-exposed high-risk (HR) non-muscle-invasive bladder cancer (NMIBC), current standard of care encompasses additional BCG treatment. However, data on therapies in this emerging disease space remain limited. Methods: A retrospective review was conducted on BCG-exposed HR NMIBC patients treated with additional BCG or sequential gemcitabine+docetaxel (GemDoce). BCG-exposed HR NMIBC was defined according to the 2022 IBCG statement. Clinicopathologic and oncologic outcomes, including high-grade (HG) recurrence-free survival (RFS) and progression-free survival (PFS), were captured. Kaplan-Meier (KM) analysis was used to estimate HG RFS and PFS with comparisons made using the log-rank test. Subgroup analysis was also performed on patients who declined or were unable to undergo radical cystectomy (RC). Results: 115 BCG-exposed patients with HR NMIBC were identified, of whom 48 (41.7%) received BCG, 51 received GemDoce (44.3%), and 16 (13.9%) did not receive further treatment. Overall, most patients were male (88.7%), with a median age of 75.9 years (IQR: 69.4-81.1), and median follow-up of 20.6 months (IQR: 11.3-35.7). Patients treated with sequential GemDoce received more BCG doses prior to BCG exposed HR NMIBC diagnosis (Table 1; p<0.001). On KM analysis, additional BCG and sequential GemDoce showed similar oncologic outcomes as measured by HG RFS (p=0.5). PFS was shown to be improved by either treatments over no treatment (p<0.001). These findings were mirrored in KM subgroup analysis after excluding patients who underwent RC at any point. Conclusions: We report that additional BCG and sequential GemDoce have similar efficacy in BCG-exposed HR NMIBC. Validation of these findings in a larger patient population may inform updated practice guidelines regarding BCG-exposed HR NMIBC. Baseline clinicopathologic variables of patients upon BCG exposed HR NMIBC diagnosis. All Patients Additional BCG Sequential GemDoce No treatment p Total patients, n 115 48 51 16 Age (years), median (IQR) 75.9 (69-.4-81.1) 76.6 (69.6-81.5) 75.3 (70.0-79.9) 76.1 (67.5-81.6) 0.8 Male, n (%) 102 (88.7) 44 (91.7) 45 (88.2) 13 (81.25) 0.5 Smoking exposure, n (%) 77 (67.0) 32 (66.7) 35 (68.6) 10 (62.5) 0.9 # of BCG doses previously received, median (IQR) 6 (6-12) 6 (6-6) 12 (6-15) 6 (6-9.25) <0.001 BCG exposed subpopulation, n (%) <0.001  BCG-resistant NMIBC 36 (31.3) 19 (39.6) 15 (29.4) 2 (12.5)  Delayed relapse after inadequate BCG 45 (39.13) 25 (52.1) 12 (23.5) 8 (50.0)  Delayed relapse after adequate BCG 34 (29.6) 4 (8.3) 24 (47.1) 6 (37.5) pT-Stage, n (%) 0.2  Ta 62 (53.9) 23 (47.9) 32 (62.8) 7 (43.75)  T1 19 (16.5) 7 (14.6) 7 (13.7) 5 (31.25)  Tis 34 (29.6) 18 (37.5) 12 (23.5) 4 (25.0) Concomitant CIS, n (%) 18 (15.7) 10 (20.8) 7 (13.7) 1 (6.25) 0.3 Length of Follow-Up (months), median (IQR) 20.6 (11.3-35.7) 25.0 (12.4-38.9) 20.4 (10.7-32.0) 15.6 (6.9-35.6) 0.3