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Purpose <p>Sequential gemcitabine and docetaxel (Gem/Doce) therapy is increasingly regarded as a promising substitute for Bacillus Calmette-Guérin (BCG) for non–muscle-invasive bladder cancer (NMIBC). This study compares the efficacy of Gem/Doce and BCG in managing Ta high-grade (TaHG) NMIBC.</p> Methods <p>Patients with TaHG NMIBC treated with Gem/Doce or BCG therapy following transurethral resection of the bladder tumor (TURBT) were analyzed. A one-year maintenance protocol when applicable. Recurrence-free survival (RFS) and progression-free survival (PFS) were assessed using Kaplan-Meier analysis, and multivariate Cox regression identified predictors for recurrence and progression.</p> Results <p>A total of 172 patients (99 BCG, 73 Gem/Doce) were included, with longer median follow-up in the BCG group (47 vs. 20 months, <i>p</i> &lt; 0.001). Progression was more frequent in the Gem/Doce group (18% vs. 4%, <i>p</i> = 0.003). BCG demonstrated superior 2-year RFS for any recurrence (62.3% vs. 37.9%, p = 0.018), high-grade recurrence (72.7% vs. 61.3%, p = 0.049), and 2-year PFS (97.4% vs. 83.3%, p &lt; 0.0001). Maintenance therapy improved high-grade RFS (p = 0.019) and PFS (p = 0.033) in the Gem/Doce group but had no significant impact in the BCG group. On multivariate analysis, Gem/Doce was an independent risk factor for any recurrence (HR = 2.03, p &lt; 0.001), high-grade recurrence (HR = 1.95, p = 0.03), and progression (HR = 13.55, p &lt; 0.001).</p> Conclusion <p>BCG appears to provide superior recurrence and progression control over Gem/Doce in TaHG NMIBC with a one-year maintenance protocol. Future studies should explore extended maintenance regimens, particularly for Gem/Doce.</p>

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Efficacy of Bacillus Calmette-Guérin compared to sequential gemcitabine and docetaxel in Ta high-grade non-muscle invasive bladder cancer

  • 期刊论文

  • 发表日期：

    2025年4月28日

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  • Ahmed Eraky,
  • Brenda Hug,
  • Reuben Ben-David,
  • Kaushik P. Kolanukuduru,
  • Nikhil Waingankar,
  • Kyrollis Attalla,
  • Peter Wiklund,
  • Reza Mehrazin,
  • John P. Sfakianos

摘要

Purpose

Sequential gemcitabine and docetaxel (Gem/Doce) therapy is increasingly regarded as a promising substitute for Bacillus Calmette-Guérin (BCG) for non–muscle-invasive bladder cancer (NMIBC). This study compares the efficacy of Gem/Doce and BCG in managing Ta high-grade (TaHG) NMIBC.

Methods

Patients with TaHG NMIBC treated with Gem/Doce or BCG therapy following transurethral resection of the bladder tumor (TURBT) were analyzed. A one-year maintenance protocol when applicable. Recurrence-free survival (RFS) and progression-free survival (PFS) were assessed using Kaplan-Meier analysis, and multivariate Cox regression identified predictors for recurrence and progression.

Results

A total of 172 patients (99 BCG, 73 Gem/Doce) were included, with longer median follow-up in the BCG group (47 vs. 20 months, p < 0.001). Progression was more frequent in the Gem/Doce group (18% vs. 4%, p = 0.003). BCG demonstrated superior 2-year RFS for any recurrence (62.3% vs. 37.9%, p = 0.018), high-grade recurrence (72.7% vs. 61.3%, p = 0.049), and 2-year PFS (97.4% vs. 83.3%, p < 0.0001). Maintenance therapy improved high-grade RFS (p = 0.019) and PFS (p = 0.033) in the Gem/Doce group but had no significant impact in the BCG group. On multivariate analysis, Gem/Doce was an independent risk factor for any recurrence (HR = 2.03, p < 0.001), high-grade recurrence (HR = 1.95, p = 0.03), and progression (HR = 13.55, p < 0.001).

Conclusion

BCG appears to provide superior recurrence and progression control over Gem/Doce in TaHG NMIBC with a one-year maintenance protocol. Future studies should explore extended maintenance regimens, particularly for Gem/Doce.