EAU 2024: Subsequent Therapies After Intravesical BCG in Patients with Bladder Cancer: Analysis of Real-World Treatment Patterns

(UroToday.com) The 2024 European Association of Urology (EAU) annual meeting featured a session on navigating urothelial carcinoma from innovative diagnostics to therapeutic strategies, and a presentation by Dr. Bolan Linghu discussing real-world treatment patterns of subsequent therapies after intravesical BCG in patients with bladder cancer. Intravesical BCG is the recommended first-line treatment option for patients with high-risk non-muscle-invasive bladder cancer.


Despite initial activity, BCG eventually fails in up to 50% of patients, with half of these failures occurring within the first 6 months. Bladder cancer treatment patterns after BCG treatment are not well understood and are dependent on patient and disease characteristics. The objective of this study presented at EAU 2024 was to analyze real-world subsequent treatment patterns after BCG failure, including informing subsequent treatment options at different disease and clinical status (ie. patients with CIS vs non-CIS, patients starting subsequent treatment early versus late).

This retrospective, observational cohort study utilized comprehensive claims and electronic health records in the US HealthVerity dataset between 2014 2019. This analysis included patients who received first BCG treatment within 90 days of their bladder cancer diagnosis, with a follow-up period of ≥ 3 years post BCG treatment. The index date was defined as the date of first BCG treatment within 3 months of any prior bladder cancer diagnosis. BCG failure was defined as initiation of a new line of bladder cancer therapy (including surgical treatment) after BCG discontinuation (a gap of > 1 year from the last BCG dose). This included intravesical therapies, radical cystectomy, radiation, systemic chemotherapy, and systemic immunotherapy. A descriptive analysis was conducted to evaluate BCG treatment patterns and characterize subsequent therapy post BCG.

This study identified 13,525 patients with non-muscle-invasive bladder cancer diagnosis who were treated with BCG:analysis was conducted to evaluate BCG treatment patterns and characterize subsequent therapy post BCG population
Patients received a median of 7 BCG doses (IQR: 5, 14) with a median treatment duration of 156 days (IQR: 36, 489). Overall, 6,182 (45.7%) patients received subsequent treatment after BCG. The median time from the last BCG dose to initiation of the next treatment was 217 days (IQR: 50, 569). Overall, intravesical chemotherapy (41.9%) was the most frequent subsequent treatment after BCG failure:
 intravesical chemotherapy (41.9%) was the most frequent subsequent treatment after BCG failure
There were 3,550 (57.4%) patients that initiated the next treatment ≤ 1 year after their last BCG dose, with intravesical chemotherapy being the most frequent subsequent therapy (61%). Additionally, there were 2,632 (42.6%) patients with BCG failure that started subsequent treatment > 1 year after the last BCG dose, with retreatment with BCG being the most frequent treatment (59%).

There were 772 (12%) patients with BCG failure that had CIS when initiating subsequent treatment. For both CIS and non-CIS patients, intravesical chemotherapy was the most frequent subsequent treatment, regardless of treatment starting less than or greater than 1 years since last dose of BCG (both >41%). Additionally, CIS patients were associated with a higher rate of radical cystectomy than non-CIS patients (15.3% vs 6.6%, p < 0.001), and CIS patients had a lower rate of systemic chemotherapy than non-CIS patients (10.6% vs 17.9%, p < 0.001).

Dr. Linghu concluded his presentation discussing real-world treatment patterns of subsequent therapies after intravesical BCG in patients with bladder cancer with the following statements:

  • In this real world data analysis, nearly half of patients with non-muscle-invasive bladder cancer treated with intravesical BCG experienced treatment failure, with most of these patients starting subsequent therapy ≤ 1 year from their last BCG dose
  • Overall, intravesical chemotherapy was the most frequently administered treatment after BCG failure
  • Findings suggest that different therapies were used to treat patients with BCG failure and treatment choice may depend on CIS status and timing of BCG failure
  • Further research is warranted to evaluate the types of recurrences, subsequent therapies and outcomes in patients with high-risk non-muscle invasive bladder cancer treated with BCG in the real-world setting

Presented by: Bolan Linghu, PhD, Johnson and Johnson Innovative Medicine, Boston, MA

Written by: Zachary Klaassen, MD, MSc - Urologic Oncologist, Associate Professor of Urology, Georgia Cancer Center, WellStar MCG Health, @zklaassen_md on Twitter during the 2024 European Association of Urology (EAU) annual congress, Paris, France, April 5th - April 8th, 2024