TREATMENT AND RECURRENCE PATTERNS AMONG BACILLUS CALMETTE-GUÉRIN EXPERIENCED PATIENTS WITH RECURRENT, PAPILLARY-ONLY HIGH-RISK NON-MUSCLE INVASIVE BLADDER CANCER
Author(s)
Sabree Burbage, PharmD, MPH1, Shawn Du, PhD1, Mukul Singhal, PhD1, Bruno Emond, MSc2, Carmine Rossi, PhD2, Rebecca Bungay, MSc3, Steven Liu, MSc4, Dominic Pilon, MSc2, Ali R. Khaki, MD5;
1Johnson & Johnson, Horsham, PA, USA, 2Analysis Group, ULC., Montréal, QC, Canada, 3Analysis Group, ULC., Toronto, ON, Canada, 4Analysis Group, Inc., Boston, MA, USA, 5Stanford University School of Medicine, Palo Alto, CA, USA
1Johnson & Johnson, Horsham, PA, USA, 2Analysis Group, ULC., Montréal, QC, Canada, 3Analysis Group, ULC., Toronto, ON, Canada, 4Analysis Group, Inc., Boston, MA, USA, 5Stanford University School of Medicine, Palo Alto, CA, USA
OBJECTIVES: Intravesical Bacillus Calmette-Guérin (BCG) has long been the bladder-sparing standard of care for high-risk non-muscle invasive bladder cancer (HR-NMIBC). Yet, over two thirds experience recurrence following treatment. This study aimed to assess treatment and recurrence patterns among BCG-experienced, papillary-only Medicare patients with recurrent HR-NMIBC in the United States.
METHODS: A retrospective cohort study using SEER-Medicare data (01/01/2007-12/31/2022) was conducted among patients ≥65 years old with papillary-only HR-NMIBC (T1 or high-grade Ta, without carcinoma in situ) who received adequate BCG induction (i.e., ≥5 BCG instillations in 70 days) and recurred within 12 months of BCG discontinuation (discontinuation defined as >180 days without BCG). Among patients who received a bladder-sparing treatment (i.e., BCG re-induction, intravesical therapy, or immunotherapy) within 90 days of initial recurrence, time to subsequent recurrence, defined as transurethral resection, biopsy, BCG re-induction, other intravesical therapy, cystectomy, radiotherapy, or systemic chemotherapy, was assessed using Kaplan-Meier analyses. Follow-up was censored at the earliest of loss of eligibility, plan switch, death, or end of data.
RESULTS: Among 2,016 BCG-experienced papillary-only patients with recurrent HR-NMIBC, 262 received subsequent treatment within 90 days of recurrence (mean age 76 years; 78% male; 94% White; mean Charlson Comorbidity Index 1.6; 32% smoking history). The majority received bladder-sparing treatments (63%), the most common being intravesical therapy (34%), followed by BCG re-induction (20%), and immunotherapy (9%); 37% received cystectomy. Among those receiving bladder-sparing treatment after initial recurrence, median time to subsequent recurrence was 7 months, with 27%, 44%, and 61% experiencing recurrence within 3, 6, and 12 months, respectively.
CONCLUSIONS: In this real-world cohort of BCG-experienced papillary-only patients with recurrent HR-NMIBC who received subsequent treatment, most received bladder-sparing treatments, predominantly intravesical therapy. Despite this, more than half recurred within 1 year, highlighting an unmet need for more effective bladder-sparing treatments with durable response after BCG.
METHODS: A retrospective cohort study using SEER-Medicare data (01/01/2007-12/31/2022) was conducted among patients ≥65 years old with papillary-only HR-NMIBC (T1 or high-grade Ta, without carcinoma in situ) who received adequate BCG induction (i.e., ≥5 BCG instillations in 70 days) and recurred within 12 months of BCG discontinuation (discontinuation defined as >180 days without BCG). Among patients who received a bladder-sparing treatment (i.e., BCG re-induction, intravesical therapy, or immunotherapy) within 90 days of initial recurrence, time to subsequent recurrence, defined as transurethral resection, biopsy, BCG re-induction, other intravesical therapy, cystectomy, radiotherapy, or systemic chemotherapy, was assessed using Kaplan-Meier analyses. Follow-up was censored at the earliest of loss of eligibility, plan switch, death, or end of data.
RESULTS: Among 2,016 BCG-experienced papillary-only patients with recurrent HR-NMIBC, 262 received subsequent treatment within 90 days of recurrence (mean age 76 years; 78% male; 94% White; mean Charlson Comorbidity Index 1.6; 32% smoking history). The majority received bladder-sparing treatments (63%), the most common being intravesical therapy (34%), followed by BCG re-induction (20%), and immunotherapy (9%); 37% received cystectomy. Among those receiving bladder-sparing treatment after initial recurrence, median time to subsequent recurrence was 7 months, with 27%, 44%, and 61% experiencing recurrence within 3, 6, and 12 months, respectively.
CONCLUSIONS: In this real-world cohort of BCG-experienced papillary-only patients with recurrent HR-NMIBC who received subsequent treatment, most received bladder-sparing treatments, predominantly intravesical therapy. Despite this, more than half recurred within 1 year, highlighting an unmet need for more effective bladder-sparing treatments with durable response after BCG.
Conference/Value in Health Info
2026-05, ISPOR 2026, Philadelphia, PA, USA
Value in Health, Volume 29, Issue S6
Code
RWD124
Topic
Real World Data & Information Systems
Topic Subcategory
Health & Insurance Records Systems
Disease
SDC: Oncology, SDC: Urinary/Kidney Disorders, STA: Multiple/Other Specialized Treatments