Balloon Cryoablation Non-inferior to Single Instillation of Chemotherapy in NMIBC

Endoscopic balloon cryoablation (EBCA) is a safe and effective adjuvant therapy for transurethral resection (TUR) of non-muscle invasive bladder cancer (NMIBC), according to results of a phase-II study comparing it with single instillation (SI) of pirarubicin after TUR.

“The immediate single instillation of intravesical chemotherapy is recommended as a class I level A adjuvant treatment after TUR by 2016 European Association of Urology/American Urological Association/National Comprehensive Cancer Network guidelines,” study researchers wrote in Cancer. “In China, it has been one of the most common adjuvant therapies in preventing NMIBC recurrence inside the urinary bladder.”

This multicenter study was designed to see whether EBCA was non-inferior to SI. The researchers enrolled 205 patients and randomly assigned them to EBCA or a SI of pirarubicin after TUR. Repeat TUR or a repeat biopsy was performed at 4 to 6 weeks after treatment.

The researchers noted that liquid nitrogen was used as a freeze source in this study and that the cost of liquid nitrogen is acceptable in developing countries.

In the per-protocol analysis of 163 patients, local control rate was 91.5% for EBCA plus TUR compared with 76.5% for pirarubicin plus TUR (P<.001). Similar results were seen in a modified intention-to-treat analysis (80.6% vs. 71.3%; P=.01).

Follow-up showed that patients who received EBCA plus TUR had better recurrence-free and progression-free survival.

Looking at safety, there were no significant differences in indwelling catheter duration between the study groups. The most common treatment-emergent adverse events for EBCA were urinary tract infections (15%), fever (9.9%), and hematuria (6.9%). Three patients assigned EBCA had serious adverse events.

The authors concluded that based on these results, “endoscopic cryoablation can eradicate residual tumor inside the urinary bladder with no inferiority to the standardized treatment of single intravesical instillation of chemotherapy.”