Sequential intravesical gemcitabine and docetaxel (Gem/Doce) are increasingly used for nonmuscle-invasive bladder cancer (NMIBC), especially in the setting of Bacillus Calmette-Guérin (BCG) shortage or failure. However, the contribution of docetaxel to gemcitabine remains unquantified. We compared the effectiveness of gemcitabine alone vs. Gem/Doce in high-risk NMIBC.
We conducted a retrospective study of 296 patients treated with gemcitabine (n = 173) or Gem/Doce (n = 123) at 3 Mayo Clinic sites between 2018 and 2023. The primary outcome was high-grade recurrence-free survival (HGRFS). Secondary outcomes included recurrence-free, progression-free, cystectomy-free, cancer-specific, and overall survival and adverse events. Analyses included Kaplan-Meier and Cox regression with 2-stage residual inclusion to adjust for confounding.
Median HGRFS was similar between groups (gemcitabine: 22.6 months; Gem/Doce: 19.5 months [P = 0.25]). Among patients with BCG-unresponsive carcinoma in situ (n = 49), median HGRFS was comparable (gemcitabine: 12.2 months; Gem/Doce: 7.6 months [P = 0.12]). No significant differences were observed for secondary outcomes. In the 2-stage residual inclusion analysis, Gem/Doce was not associated with improved HGRFS (hazard ratio [HR], 1.09; 95% CI, 0.65-1.82; P = 0.80), including among patients with BCG-unresponsive disease (HR, 2.24; 95% CI, 0.96-5.24 [P = .06]). Low-grade adverse events were common (gemcitabine: 63%; Gem/Doce: 55% [P = 0.19]), but grade ≥3 adverse events were rare (2.3% vs. 2.4%). Limitations included imbalances in maintenance utilization (gemcitabine: 19%; Gem/Doce: 40%), baseline characteristics, gemcitabine dosing, and follow-up duration between cohorts.
In this multicenter study, Gem/Doce was not associated with improved outcomes compared with gemcitabine alone. Prospective trials are needed to quantify the specific contribution of docetaxel in NMIBC.
Urologic oncology. 2026 Jul 09 [Epub ahead of print]
Jacob A Moyer, Mahnoor Ashraf, Lanyu Mi, Andrew J Zganjar, Timothy D Lyon, Paras H Shah, Stephen A Boorjian, Mark D Tyson
Department of Urology, Mayo Clinic School of Graduate Medical Education, Mayo Clinic College of Medicine and Science, Scottsdale, Arizona., Department of Urology, Mayo Clinic, Phoenix, Arizona., Division of Clinical Trials and Biostatistics, Mayo Clinic, Scottsdale, Arizona., Department of Urology, Mayo Clinic, Jacksonville, Florida., Department of Urology, Mayo Clinic, Rochester, Minnesota., Department of Urology, Mayo Clinic, Phoenix, Arizona. Electronic address: .