Comparative treatment burden of BCG versus sequential gemcitabine and docetaxel for non-muscle-invasive bladder cancer: A time toxicity analysis.

Abstract

730 Background: BCG shortages have necessitated alternative therapies for intermediate- and high-risk non-muscle-invasive bladder cancer (NMIBC). Sequential intravesical gemcitabine and docetaxel (Gem/Doce) has emerged as a promising alternative. However, the comparative treatment burden and resource utilization between these regimens remains unknown. Time toxicity is the total time that patients spend interacting with the healthcare system, which impacts patient’s quality of life. Herein, we aimed to calculate and compare the cumulative time toxicity of BCG and Gem/Doce. Methods: After IRB approval was obtained, we performed a retrospective analysis of patients with NMIBC treated with BCG or Gem/Doce between 2022 and 2025. Electronic medical records were reviewed to calculate time for intravesical therapy instillations, office visits including cystoscopies, transurethral resection of bladder tumor operations, and emergency department encounters. Time measurements were between facility arrival and discharge. Data was censored at the 5th-95th percentiles to minimize outlier impact. Continuous variables were compared using the Wilcoxon rank-sum test with Hodges–Lehmann estimates. Categorical variables were analyzed using chi-square or Fisher's exact tests. Sensitivity analyses assessed treatment-naïve patients. Results: There were 133 patients, of whom 86 received BCG (65%) and 47 received Gem/Doce (35%). Median age was 73 years for BCG and 74 years for Gem/Doce patients. There were 26% female patients. There were 47% of patients with T1, 28% with Ta and 24% with Tis disease. Sixty-six (77%) of BCG patients had treatment-naïve disease compared to 26 (55%) Gem/Doce patients (p = 0.016). The median time per instillation was 179 minutes for BCG compared to 192 minutes for Gem/Doce (Hodges-Lehmann shift +27 minutes, CI 4-57; p = 0.02). The median TURBT time per procedure was 431 minutes for BCG and 400 minutes for Gem/Doce (p = 0.071). The median office visit time was 82 minutes for BCG and 83 minutes for Gem/Doce (p = 0.44). Thirty-seven patients (28%) sought care at emergency departments during treatment, with similar rates between groups (p = 0.40). Treatment completion rates as defined by completion of at least 5 instillations were comparable: 91% BCG vs 96% Gem/Doce, p = 0.29. In standardized early treatment analysis (TURBT #1, office visit #1, and instillations 1-6), Gem/Doce added 284 minutes (+4.7 hours, p = 0.0008). Conclusions: To our knowledge, this is the first comparison of time toxicity between BCG and Gem/Doce. Gem/Doce is associated with increased instillation times and resultant increased patient time toxicity. This data can aid in tradeoff calculations. As available NMIBC therapies increase, time toxicity should be evaluated along with traditional oncologic and quality of life metrics.