BJU international · 2026
Outcomes of maintenance BCG versus gemcitabine/docetaxel following BCG induction in NMIBC.
СтатьяСравнительное исследованиеНазвание и аннотация: Перевод в очереди
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Gabriel Pierre-Etienne, Zhu Alec, Karim Christopher G, Eraky Ahmed, Gupta Raghav, Ben-David Reuben, Mehrazin Reza, Wiklund Peter, Sfakianos John P
Аннотация
OBJECTIVES: To compare the oncologic outcomes and safety profiles of Bacillus Calmette-Guérin (BCG) versus gemcitabine/docetaxel (Gem/Doce) maintenance following BCG induction in treatment-naïve non-muscle-invasive bladder cancer (NMIBC).
METHODS: We identified patients with treatment-naive NMIBC who received induction BCG followed by maintenance BCG per the Southwest Oncology Group Cancer Research Network protocol or Gem/Doce monthly for 1 year (2016-2026). Oncological outcomes included recurrence-free survival (RFS), high-grade RFS, progression-free survival, and metastasis-free survival. Adverse events were systematically assessed to evaluate treatment tolerability.
RESULTS: Overall, 128 patients received BCG induction followed by either BCG maintenance (n = 98; 76.6%) or Gem/Doce maintenance (n = 30; 23.4%). After a median follow-up of 75.0 months (interquartile range [IQR] 66.7-86.5) in the BCG group and 22.5 months (IQR 14.8-42.9) in the Gem/Doce group (P < 0.001), 3-year RFS (80.0% vs. 83.8%; P = 0.8), 3-year high-grade RFS (83.4% vs. 92.2%; P = 0.7), 3-year progression-free survival (90.0% vs. 96.6%; P = 0.4), and 3-year metastasis-free survival (96.8% vs. 100.0%; P = 0.3) were comparable between the BCG and Gem/Doce maintenance groups, respectively. Multivariable Cox regression analysis confirmed that Gem/Doce versus BCG maintenance was not associated with disease recurrence (hazard ratio 1.04; 95% confidence interval 0.39-2.83; P > 0.9). Overall, Gem/Doce maintenance was better tolerated, with fewer patients reporting adverse events (6.7% vs. 28%, P = 0.02) and no severe events observed during the maintenance phase. Limitations of the study include its retrospective design and the relatively small sample size of the Gem/Doce cohort.
CONCLUSION: Sequential Gem/Doce maintenance following BCG induction achieved oncologic outcomes comparable to those with BCG maintenance, with improved tolerability, highlighting its feasibility as an alternative in cases of BCG intolerance or shortage.
METHODS: We identified patients with treatment-naive NMIBC who received induction BCG followed by maintenance BCG per the Southwest Oncology Group Cancer Research Network protocol or Gem/Doce monthly for 1 year (2016-2026). Oncological outcomes included recurrence-free survival (RFS), high-grade RFS, progression-free survival, and metastasis-free survival. Adverse events were systematically assessed to evaluate treatment tolerability.
RESULTS: Overall, 128 patients received BCG induction followed by either BCG maintenance (n = 98; 76.6%) or Gem/Doce maintenance (n = 30; 23.4%). After a median follow-up of 75.0 months (interquartile range [IQR] 66.7-86.5) in the BCG group and 22.5 months (IQR 14.8-42.9) in the Gem/Doce group (P < 0.001), 3-year RFS (80.0% vs. 83.8%; P = 0.8), 3-year high-grade RFS (83.4% vs. 92.2%; P = 0.7), 3-year progression-free survival (90.0% vs. 96.6%; P = 0.4), and 3-year metastasis-free survival (96.8% vs. 100.0%; P = 0.3) were comparable between the BCG and Gem/Doce maintenance groups, respectively. Multivariable Cox regression analysis confirmed that Gem/Doce versus BCG maintenance was not associated with disease recurrence (hazard ratio 1.04; 95% confidence interval 0.39-2.83; P > 0.9). Overall, Gem/Doce maintenance was better tolerated, with fewer patients reporting adverse events (6.7% vs. 28%, P = 0.02) and no severe events observed during the maintenance phase. Limitations of the study include its retrospective design and the relatively small sample size of the Gem/Doce cohort.
CONCLUSION: Sequential Gem/Doce maintenance following BCG induction achieved oncologic outcomes comparable to those with BCG maintenance, with improved tolerability, highlighting its feasibility as an alternative in cases of BCG intolerance or shortage.