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

Background

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.

Methods

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.

Results

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 

Conclusions

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.

Clinical trial identification

Legal entity responsible for the study

N/A

Funding

Genentech Inc.

Disclosure

K. Wilson, E. Malangone-Monaco, D. Diakun: Employee of Truven Health Analytics, Inc., which was paid by Genentech to conduct this study. S. Satram-Hoang: Paid consultant to Genentech, which provided funding for this research. S-W. Lin, D. Tayama, S. Ogale: Employed by Genentech and own Genentech/Roche stock.