Urothelial carcinoma, also known as bladder carcinoma or bladder cancer, is a type of cancer that occurs in the bladder. Radical nephrectomy is the routine treatment given to patients with low-grade upper tract urothelial cancer. This study aimed to evaluate the efficacy of a non-surgical treatment using UGN-101, a mitomycin-containing reverse thermal gel in patients with low-grade upper tract urothelial cancer.
This single-arm, phase 3, open-label trial included a total of 71 patients with primary or recurrent biopsy-proven, low-grade upper tract urothelial cancer. The patients were assigned to receive six installations of once-weekly once-weekly UGN-101. The primary outcome of the study was disease eradication.
During the median follow-up of 11.0 months, 42 patients had a complete response at the primary disease evaluation visit. The most commonly occurring adverse events were ureteric stenosis (44%), urinary tract infection (32%), haematuria (31%), flank pain (30%), and nausea (24%). Drug-related or treatment-related adverse events were reported in 19 of 71 patients (24%), though no treatment-related deaths occurred.
The research concluded that primary chemoblatation with UGN-101 in patients with low-grade upper tract urothelial cancer resulted in clinically significant disease eradication. The treatment also had a good safety profile, making it a potential kidney -sparing treatment alternative for patients.