Endoscopic balloon cryoablation plus transurethral resection for bladder cancer: A phase 2, multicenter, randomized,...

Area of Science:

• Urology
• Oncology
• Surgical Innovation

Background:

• Cryotherapy is an established ablative technique for solid tumors.
• Endoscopic cryotherapy using liquid nitrogen presents a novel approach for bladder cancer treatment.

Purpose of the Study:

• To evaluate the efficacy and safety of endoscopic balloon cryoablation (EBCA) compared to intravesical chemotherapy after transurethral resection (TUR) for bladder cancer.
• To assess local control rates, tumor recurrence, and adverse events in a Phase 2 randomized trial.

Main Methods:

• A multicenter, randomized, parallel controlled Phase 2 trial compared TUR followed by EBCA versus TUR followed by single instillation (SI) of pirarubicin.
• Patients were assessed for residual tumor via repeat TUR or biopsies 4-6 weeks post-treatment.
• Primary endpoint was local control rate; secondary endpoints included tumor upgrading/upstaging, catheter duration, and adverse events.

Main Results:

• The local control rate was 91.5% for TUR-EBCA versus 76.5% for TUR-SI, demonstrating non-inferiority (p < .001).
• No significant differences were observed in catheter indwelling duration or serious adverse event rates between groups.
• Post hoc analysis with a median follow-up of 31 months indicated better recurrence-free and progression-free survival in the TUR-EBCA group.

Conclusions:

• Endoscopic balloon cryoablation (EBCA) is a safe and effective adjuvant therapy when combined with TUR for non-muscle-invasive bladder cancer.
• EBCA is a promising alternative to standard intravesical chemotherapy, offering improved long-term prognosis.