Time to event following bacillus Calmette-Guerin therapy initiation in Medicare beneficiaries with intermediate- to high-risk non-muscle invasive bladder cancer, 2010-2019.

Authors

null

Allison A. Petrilla

Inovalon, Inc., Bowie, MD

Allison A. Petrilla , Alison R. Silverstein , Anthony Eccleston , Allison Thompson , Julia Brinkmann , Temitope Bello , Jane Chang , Joseph C Cappelleri , Sanjana Chandrasekar , Amy L Schroeder

Organizations

Inovalon, Inc., Bowie, MD, Pfizer, Inc., Surrey, United Kingdom, Pfizer, Inc., New York, NY, Pfizer, Inc., Berlin, Germany, Pfizer, New York, NY, Pfizer Inc., New York, NY, Avalere Health, Washington, DC

Research Funding

Pharmaceutical/Biotech Company
Pfizer, Inc

Background: For patients with intermediate- to high-risk non-muscle invasive bladder cancer (NMIBC), standard of care includes transurethral resection (TURBT) followed by induction and maintenance intravesical immunotherapy with Bacillus Calmette-Guerin (BCG). This study describes characteristics and clinical outcomes of Medicare beneficiaries newly diagnosed with NMIBC who initiated BCG therapy following TURBT. Methods: Retrospective cohort study using Centers for Medicare and Medicaid-sourced Medicare Fee-for-Service medical/pharmacy claims (100% sample). Patient selection criteria: ≥1 bladder cancer diagnosis 2010-2019, no prior radiotherapy, systemic therapy, cystectomy, or metastasis in 6 months post-diagnosis, continuously enrolled in Medicare ≥12 months pre- and post-index (or death). Index date = date of first BCG instillation. A literature-based definition for adequate maintenance BCG defined adequate (≥7 instillations of BCG within 274 days of BCG initiation) and inadequate (remainder) BCG therapy for patient stratification. Events: time to BCG discontinuation, radical cystectomy, systemic therapy, radiation, and metastasis. Provider access to BCG (due to supply shortage), patient tolerability, and NMIBC risk status are not captured in claims data. Results: Of 46,052 BCG-treated patients eligible for analysis, 19,859 (43.1%) received adequate BCG therapy. The two cohorts had similar baseline characteristics (Table) and median duration of follow up (46 months). Median (interquartile range [IQR]) time from NMIBC diagnosis to BCG initiation was 2.8 (8.2) months for adequate, 3.7 (14.4) months for inadequate BCG. Time from BCG initiation to discontinuation, radical cystectomy, systemic therapy, radiation, and metastasis are reported in the table. Conclusions: Between 2010 and 2019, 57% of Medicare patients initiating BCG following diagnosis of NMIBC and TURBT may not have received adequate BCG therapy. Patients with inadequate BCG therapy had numerically shorter time to radical cystectomy, systemic therapy, radiation, and metastasis than those with adequate BCG therapy. Characteristics & Outcomes by Cohort.

Patient Characteristics & OutcomesAdequate BCG Therapy
(N = 19,859)
Inadequate BCG Therapy
(N = 26,193)
Age (mean years, SD)76.0 (7.3)76.7 (7.7)
Male sex (%)77.3%76.8%
Non-Hispanic White (%)93.1%92.2%
Number of BCG instillations during follow up (median, IQR)12.0 (8.0)6.0 (1.0)
BCG initiation to discontinuation (median months, IQR)13.3 (16.8)1.3 (8.6)
BCG initiation to radical cystectomy (median months, IQR)20.2 (21.7)12.4 (19.8)
BCG initiation to systemic chemotherapy (median months, IQR)23.7 (27.1)18.9 (29.2)
BCG initiation to radiation (median months, IQR)24.9 (33.6)23.9 (35.9)
BCG initiation to metastasis (median months, IQR)25.1 (30.2)21.8 (30.4)

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Abstract Details

Meeting

2023 ASCO Genitourinary Cancers Symposium

Session Type

Poster Session

Session Title

Poster Session B: Prostate Cancer and Urothelial Carcinoma

Track

Urothelial Carcinoma,Prostate Cancer - Advanced

Sub Track

Quality of Care/Quality Improvement and Real-World Evidence

Citation

J Clin Oncol 41, 2023 (suppl 6; abstr 473)

DOI

10.1200/JCO.2023.41.6_suppl.473

Abstract #

473

Poster Bd #

H14

Abstract Disclosures