Bladder-Preserving Trimodality Treatment for High-Grade T1 Bladder Cancer: Results From Phase II Protocol NRG...

Area of Science:

• Uro-oncology
• Radiation oncology
• Medical oncology

Background:

• Radical cystectomy is the standard treatment for muscle-invasive bladder cancer.
• For patients with T1 bladder cancer that has failed Bacillus Calmette-Guerin (BCG) treatment, radical cystectomy is often recommended.
• There is a need for effective bladder-sparing alternatives to radical cystectomy.

Purpose of the Study:

• To evaluate trimodality therapy (radiation with radiosensitizing chemotherapy following transurethral resection) as an alternative to radical cystectomy.
• To assess the efficacy and safety of trimodality therapy in patients with recurrent T1 bladder cancer after BCG failure.

Main Methods:

• A single-arm phase II study enrolled 37 patients with recurrent T1 bladder cancer who had failed BCG and were candidates for cystectomy.
• Patients were treated with trimodality therapy.
• The primary endpoint was 3-year freedom from cystectomy; secondary endpoints included distant metastasis, local recurrence, survival, and safety.

Main Results:

• The 3-year freedom from cystectomy rate was 88%, meeting the primary study goal.
• Overall survival at 3 and 5 years was 69% and 56%, respectively.
• Grade 3 adverse events occurred in 18 patients, primarily hematological; one patient experienced grade 4 neutropenia.

Conclusions:

• Trimodality therapy is a viable and effective alternative to radical cystectomy for patients with recurrent high-grade T1 urothelial cancer.
• The treatment demonstrated a high rate of cystectomy-free survival at three years.
• The safety profile was acceptable, with manageable adverse events.