A Phase 2 Trial of Intravesical Cabazitaxel, Gemcitabine, and Cisplatin for the Treatment of Nonmuscle-Invasive Bacillus Calmette-Guérin-Unresponsive Urothelial Carcinoma of the Bladder.
G Joel DeCastro, Benjamin I Joffe, Mark N Stein et al.
✦ AI-curated · Sources linked
In 30 seconds
This single-center phase 2 trial evaluated sequential intravesical cabazitaxel, gemcitabine, and cisplatin in patients with BCG-unresponsive high-risk nonmuscle-invasive bladder cancer who refused or were ineligible for radical cystectomy. Thirty-three patients received a 6-week induction course, with maintenance offered to responders. The primary outcome was recurrence-free survival (RFS) at 12 months. RFS was 73% (95% CI 57%-87%) at 12 months and 59% (95% CI 42%-76%) at 24 months. No dose-limiting toxicities were reported.
Key findings
- RFS was 82% (95% CI 69%-95%) at 3 months, 73% (95% CI 57%-87%) at 12 months, and 59% (95% CI 42%-76%) at 24 months.
- Restricted mean survival time for RFS at 24 months was estimated to be 18.1 months (95% CI 15-21 months).
- No dose-limiting toxicities occurred during the trial.
Why it matters
BCG-unresponsive high-risk nonmuscle-invasive bladder cancer presents a treatment challenge for patients who cannot or will not undergo radical cystectomy. This trial provides phase 2 evidence on recurrence outcomes and tolerability for a combination of intravesical chemotherapy agents, informing consideration of nonsurgical approaches while larger comparative evidence remains important.
What to keep in mind
The trial was single-center and included 33 patients; the abstract does not report a comparator group.