1036P - A real-world study of patterns of Bacillus Calmette-Guerin (BCG) use and associated adverse events (AEs) in non-muscle invasive bladder cancer (NMI...

Date 09 October 2016
Event ESMO 2016 Congress
Session Poster display
Topics Urothelial Cancers
Presenter Kathleen Wilson
Citation Annals of Oncology (2016) 27 (6): 351-358. 10.1093/annonc/mdw377
Authors K. Wilson1, E. Malangone-Monaco1, S. Satram-Hoang2, D. Diakun1, S. Lin3, D. Tayama4, S. Ogale5
  • 1Health Outcomes Research, Truven Health Analytics, 20814 - Bethesda/US
  • 2Department Of Epidemiology, Q.D. Research, Inc., 95746 - Granite Bay/US
  • 3Real World Data Science, Genentech Inc., 94080 - San Francisco/US
  • 4Medical Affairs, Genentech Inc., 94080 - San Francisco/US
  • 5Health Economics Outcomes Research, Genentech Inc., 94080 - San Francisco/US



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 


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



Genentech Inc.


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.