A real-world study of patterns of Bacillus Calmette-Guerin (BCG) use and associated adverse events (AEs) in non-muscle invasive bladder cancer (NMIBC) patients in the United States

Patterns of BCG use and associated AEs are not well understood. This study describes the demographic and clinical characteristics of NMIBC patients, and reports BCG-related AEs during BCG exposures. This was a retrospective, observational cohort study of 59,935 patients from a U.S. insurance claims database between 1/1/2005-6/30/2015. Adult patients with ≥ 1 diagnosis code for bladder cancer (BC); ≥ 1 procedure code for transurethral resection (TUR; first TUR = index date); ≥ 12 months of continuous enrollment pre-index; no evidence of BCG, chemotherapy, metastasis, or cystectomy pre-index; and no evidence of TUR in the 6 months pre-index were included. A total of 15,922 (27%) patients had BCG use post-index and of these, 13,579 (23%) received BCG prior to chemotherapy, metastasis or cystectomy and were used to further examine BCG treatment patterns and AEs. The population was majority male (75%), with an average age of 70 yrs. BCG treated patients were similar to non-BCG treated patients in terms of age, region, insurance type, and index year. A greater proportion of BCG treated patients were male (80% vs. 74%; p < .0001) and had lower National Cancer Institute (NCI) comorbidity score (47.7% vs. 49.1% with score ≥1; p < .0001) compared to non-BCG treated patients. Approximately 37% of all patients had more than 1 TUR procedure in follow-up. Within the BCG-treated cohort, approximately 31% initiated BCG within 30 days of their last TUR, and 19% received BCG more than 45 days after their last TUR. On average, patients received 8.6 administrations of BCG. Hematuria (11.8%), urinary tract infection (13.9%), arthralgia/myalgia (6.2%), and cystitis (4.9%) were the most prevalent AEs in BCG-treated patients. Despite evidence that BCG treatment following TUR procedure can prevent disease recurrence or progression, the majority (73%) of NMIBC patients did not receive BCG treatment following their TUR. BCG treated patients were similar to non-BCG treated patients in terms of demographics, but BCG treated patients were generally healthier compared to non-BCG treated patients.