Compliance With Intravesical Bacillus Calmette-Guérin Therapy for Nonmuscle-Invasive Bladder Cancer.

INTRODUCTION

This study aims to evaluate demographic and clinical factors associated with noncompliance with intravesical bacillus Calmette-Guérin (BCG) therapy in patients with nonmuscle-invasive bladder cancer (NMIBC).

METHODS

A retrospective chart review was conducted of 239 patients with International Bladder Cancer Group intermediate- or high-risk NMIBC who received BCG therapy between 2012 and 2020 at a single academic/community practice. Compliance was assessed separately for receipt of adequate BCG, defined per Food and Drug Administration guidelines (≥5/6 induction doses and ≥2/3 maintenance doses), and for maintenance therapy adherence based on SWOG protocols (1 year for intermediate-risk disease, 3 years for high-risk disease). Compliance with maintenance instillations was defined as therapy administered within 1 month (intermediate risk) or 3 months (high risk) of the scheduled date. Associations between compliance and clinical or demographic factors, including clinical trial participation, were analyzed.

RESULTS

After exclusions, 209 patients were included. Adequate BCG was received by 189 (90.4%) patients. Male patients demonstrated higher maintenance compliance than female patients (82% vs 68%, P = .048). Clinical trial participation was strongly associated with maintenance compliance (97.8% vs 63.3%, P < .0001), as was high-risk disease status compared with intermediate-risk disease (P = .036). Race, age, insurance type, and distance to clinic were not significantly associated with compliance. Recurrence rates were low (13.3%) in this highly compliant cohort.

CONCLUSIONS

High rates of BCG compliance and low recurrence rates are achievable in an academic/community setting. Clinical trial participation, high-risk disease status, and male sex were associated with improved compliance. These findings may inform strategies to optimize BCG delivery and improve outcomes in NMIBC.