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
Discuss this preprint
Start a discussion What are Sciety discussions?Listed in
This article is not in any list yet, why not save it to one of your lists.Abstract
Objective Prospective efficacy and safety comparison of Intravesical Gemcitabine-Docetaxel (Gem/Doce) with Intravesical BCG in BCG-naïve intermediate/high-risk NMIBC. Methods In eligible patients, 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 (80 mg for 6 weeks) was followed by SWOG protocol-based maintenance. Outcomes (RFS, high-grade RFS, PFS, CSS, OS) were evaluated post-induction, 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 effective and better-tolerated alternative to BCG in BCG-naïve NMIBC, demonstrating superior intermediate-risk RFS and comparable survival outcomes. Validation through larger multi-centre studies is warranted.
