.png){kind=icon}
.png){kind=icon}
Return
Prospective comparative evaluation of clinical efficacy and safety of Intravesical gemcitabine-docetaxel versus BCG in adjuvant management of BCG-naive non-muscle invasive urothelial bladder cancer in Indian population
.png){kind=icon}
PRE
AI
A
S
S
U
L
S
A
S
DOI：10.1007/s11255-026-05067-7.png)
.png){kind=icon}
Original request for help.png){kind=icon}
Share.png){kind=icon}
Save
Abstract
En 中文
Background Intravesical Bacillus Calmette-Gu & eacute;rin (BCG) is the standard adjuvant therapy for intermediate/high-risk non-muscle-invasive bladder cancer (NMIBC) but is limited by failure, toxicity, and global supply constraints. Sequential Intravesical gemcitabine-docetaxel (Gem/Doce) can offer a rational chemotherapy alternative. Methods In this prospective randomized, parallel-arm interventional study comparing efficacy and safety of Gem/Doce versus BCG in BCG-na & iuml;ve intermediate/high-risk NMIBC, patients aged 18-80 years with complete TURBT of primary localised bladder lesion(s) were included. Gem/Doce induction comprised weekly gemcitabine (1000 mg) and docetaxel (40 mg) Intravesical instillations for 6 weeks, with monthly maintenance per risk group. BCG induction (weekly 80 mg OncoBCG for 6 weeks) was followed by risk-based maintenance as per SWOG protocol. Outcomes (RFS, high-grade RFS, PFS, CSS, OS) were evaluated post-induction, and at 6 and 12 months. Adverse events were graded by CTCAE v5.0. Results 91 patients (Gem/Doce n = 43; BCG n = 48) were evaluated. At 6 and 12 months, RFS was 95.35% and 90.71% in Gem/Doce versus 83.33% and 77.08% in BCG. Intermediate-risk category had higher 12 month RFS with Gem/Doce (93.55% vs 81.82%, p = 0.041). High-grade RFS was higher with Gem/Doce (97.67% and 93.02%) than BCG (93.75% and 89.58%). At 12 months, PFS, CSS, and OS were superior with Gem/Doce: PFS 97.67% vs 95.83%, CSS 100% vs 97.92%, and OS 100% vs 95.83%. Fewer patients reported AEs with Gem/Doce (13.95% vs 35.42%), with fewer Grade 1-2 events (p < 0.01) and no Grade >= 3 events vs. three in BCG. Dysuria, bladder spasm, and frequency were higher with BCG. Conclusions Sequential Gem/Doce is an effective and better-tolerated alternative to BCG in BCG-na & iuml;ve NMIBC, demonstrating superior intermediate-risk RFS and comparable survival outcomes. Long-term validation through larger multi-centre studies is warranted.
Keywords:
NMIBC
Urothelial carcinoma
BCG
Gemcitabine
Docetaxel
TURBT
Journal
I
IF:
1.9
Papers:
349
Citations:
7.0K