Advertisement

Increased Bacillus Calmette-Guérin Treatment Intensity Associated With Improved Outcomes in Elderly Patients With Non–Muscle-invasive Bladder Cancer in United States Clinical Practice

      OBJECTIVE

      To characterize Bacillus Calmette-Guérin (BCG) treatment patterns and associated outcomes in a large cohort of patients with non–muscle-invasive bladder cancer (NMIBC).

      METHODS

      Our retrospective analysis of patients aged ≥66 years with stage 0-1 urothelial bladder carcinoma diagnosed between 2000 and 2012 in the United States Surveillance, Epidemiology, and End Results–Medicare database estimated proxies for recurrence and secondary events and both all-cause and bladder cancer–specific mortality. Proportional hazards models were used in conditional landmark analyses to compare adequate (≥5 induction instillations and ≥2 maintenance instillations) and inadequate BCG, stratified by National Comprehensive Cancer Network risk group.

      RESULTS

      Of 39,532 patients who met the selection criteria, 16,225 (41.0%) received BCG; of them, 4602 (28.4%; 11.6% overall) received adequate treatment. Adequately treated patients were slightly younger and healthier than inadequately treated patients. Half of patients with intermediate- and high-risk NMIBC did not receive BCG; few received adequate treatment. At the 12-month landmark, adequate BCG treatment was associated with decreased risks of recurrence and of cancer-specific and all-cause mortality in patients with intermediate- and high-risk disease.

      CONCLUSION

      We observed lower than expected use of adequate BCG treatment in patients with intermediate- to high-risk NMIBC despite evidence of improved outcomes, which suggested that practice patterns may not be in line with management recommendations in this population.
      To read this article in full you will need to make a payment

      Purchase one-time access:

      Academic & Personal: 24 hour online accessCorporate R&D Professionals: 24 hour online access
      One-time access price info
      • For academic or personal research use, select 'Academic and Personal'
      • For corporate R&D use, select 'Corporate R&D Professionals'

      Subscribe:

      Subscribe to Urology
      Already a print subscriber? Claim online access
      Already an online subscriber? Sign in
      Institutional Access: Sign in to ScienceDirect

      References

        • Anastasiadis A
        • de Reijke TM
        Best practice in the treatment of nonmuscle invasive bladder cancer.
        Ther Adv Urol. 2012; 4: 13-32
      1. Surveillance EaERP. Cancer Stat Facts: Bladder Cancer. Available at: https://seer.cancer.gov/statfacts/html/urinb.html. Accessed May 10, 2019.

        • Amling CL.
        Diagnosis and management of superficial bladder cancer.
        Curr Probl Cancer. 2001; 25: 219-278
        • Isharwal S
        • Konety B
        Non-muscle invasive bladder cancer risk stratification.
        Indian J Urol. 2015; 31: 289-296
        • Chang SS
        • Boorjian SA
        • Chou R
        • et al.
        Diagnosis and treatment of non-muscle invasive bladder cancer: AUA/SUO guideline.
        J Urol. 2016; 196: 1021-1029
        • Babjuk M
        • Bohle A
        • Burger M
        • et al.
        EAU guidelines on non-muscle-invasive urothelial carcinoma of the bladder: update 2016.
        Eur Urol. 2017; 71: 447-461
        • National Comprehensive Cancer Network
        NCCN Clinical Practice Guidelines in Oncology: Bladder Cancer. V1.2019.
        2018
        • Spencer BA
        • McBride RB
        • Hershman DL
        • et al.
        Adjuvant intravesical bacillus calmette-guerin therapy and survival among elderly patients with non-muscle-invasive bladder cancer.
        J Oncol Pract. 2013; 9: 92-98
        • National Cancer Institute
        SEER-Medicare: Brief Description of the SEER-Medicare Database.
        2018 (Available at:) (Accessed May 10, 2019)
        • Davidoff AJ
        • Zuckerman IH
        • Pandya N
        • et al.
        A novel approach to improve health status measurement in observational claims-based studies of cancer treatment and outcomes.
        J Geriatr Oncol. 2013; 4: 157-165
        • Deyo RA
        • Cherkin DC
        • Ciol MA
        Adapting a clinical comorbidity index for use with ICD-9-CM administrative databases.
        J Clin Epidemiol. 1992; 45: 613-619
        • Klabunde CN
        • Potosky AL
        • Legler JM
        • et al.
        Development of a comorbidity index using physician claims data.
        J Clin Epidemiol. 2000; 53: 1258-1267
        • National Cancer Institute Division of Cancer Control and Population Sciences
        SEER-Medicare: Selecting the Appropriate Comorbidity SAS Macro.
        2019 (Available at:) (Accessed May 10, 2019)
      2. National Cancer Institute Division of Cancer Control and Population Sciences. Healthcare Delivery Research Program: Comorbidity SAS Macro (2014 version).
        2018 (Available at:) (Accessed May 10, 2019)
      3. Chuo CY, Richards KA, Zivkovic M, et al. Validation of an algorithm in administrative claims to identify adequate intravesical Bacillus Calmette-Guérin therapy in elderly patients with non–muscle-invasive bladder cancer. Poster presented at: 33rd International Conference on Pharmacoepidemiology & Therapeutic Risk Management (ICPE 2017). August 26-30, 2017; Montreal, QC, Canada.

      4. United States Department of Health and Human Services. Food and Drug Administration. BCG-unresponsive nonmuscle invasive bladder cancer: developing drugs and biologics for treatment. Guidance for industry. 2018. Available at: https://www.fda.gov/media/101468/download. Accessed May 15, 2020.

        • Jarow J
        • Maher EV
        • Tang S
        • et al.
        Development of systemic and topical drugs to treat non-muscle invasive bladder cancer.
        Bl Cancer. 2015; 1: 133-136
        • Kamat AM
        • Sylvester RJ
        • Böhle A
        • et al.
        Definitions, end points, and clinical trial designs for non–muscle-invasive bladder cancer: recommendations from the International Bladder Cancer Group.
        J Clin Oncol. 2016; 34: 1935-1944
        • Giobbie-Hurder A
        • Gelber RD
        • Regan MM
        Challenges of guarantee-time bias.
        J Clin Oncol. 2013; 31: 2963-2969
        • Huang GJ
        • Hamilton AS
        • Lo M
        • et al.
        Predictors of intravesical therapy for nonmuscle invasive bladder cancer: results from the surveillance, epidemiology and end results program 2003 patterns of care project.
        J Urol. 2008; 180 (discussion 524): 520-524
        • Strope SA
        • Ye Z
        • Hollingsworth JM
        • et al.
        Patterns of care for early stage bladder cancer.
        Cancer. 2010; 116: 2604-2611
        • Bandari J
        • Maganty A
        • MacLeod LC
        • et al.
        Manufacturing and the market: rationalizing the shortage of Bacillus Calmette-Guerin.
        Eur Urol Focus. 2018; 4: 481-484
        • Kamat AM
        • Flaig TW
        • Grossman HB
        • et al.
        Expert consensus document: consensus statement on best practice management regarding the use of intravesical immunotherapy with BCG for bladder cancer.
        Nat Rev Urol. 2015; 12: 225-235
        • Hollenbeck BK
        • Ye Z
        • Dunn RL
        • et al.
        Provider treatment intensity and outcomes for patients with early-stage bladder cancer.
        J Natl Cancer Inst. 2009; 101: 571-580
        • Hollingsworth JM
        • Zhang Y
        • Krein SL
        • et al.
        Understanding the variation in treatment intensity among patients with early stage bladder cancer.
        Cancer. 2010; 116: 3587-3594
        • Chamie K
        • Saigal CS
        • Lai J
        • et al.
        Quality of care in patients with bladder cancer: a case report?.
        Cancer. 2012; 118: 1412-1421