{Reference Type}: Journal Article {Title}: First analysis of the safety and efficacy of UGN-101 in the treatment of ureteral tumors. {Author}: Jacob JM;Woldu SL;Linehan J;Labbate C;Rose KM;Sexton WJ;Tachibana I;Kaimakliotis H;Nieder A;Bjurlin MA;Humphreys M;Ghodoussipour SB;Quek ML;Johnson B;O'Donnell M;Eisner BH;Feldman AS;Murray KS;Matin SF;Lotan Y;Dickstein RJ; {Journal}: Urol Oncol {Volume}: 42 {Issue}: 1 {Year}: 2024 01 28 {Factor}: 2.954 {DOI}: 10.1016/j.urolonc.2023.07.004 {Abstract}: UGN-101 has been approved for the chemoablation of low-grade upper tract urothelial cancer (UTUC) involving the renal pelvis and calyces. Herein is the first reported cohort of patients with ureteral tumors treated with UGN-101.
We performed a retrospective review of patients treated with UGN-101 for UTUC at 15 high-volume academic and community centers focusing on outcomes of patients treated for ureteral disease. Patients received UGN-101 with either adjuvant or chemo-ablative intent. Response rates are reported for patients receiving chemo-ablative intent. Adverse outcomes were characterized with a focus on the rate of ureteral stenosis.
In a cohort of 132 patients and 136 renal units, 47 cases had tumor involvement of the ureter, with 12 cases of ureteral tumor only (8.8%) and 35 cases of ureteral plus renal pelvic tumors (25.7%). Of the 23 patients with ureteral involvement who received UGN-101 induction with chemo-ablative intent, the complete response was 47.8%, which did not differ significantly from outcomes in patients without ureteral involvement. Fourteen patients (37.8%) with ureteral tumors had significant ureteral stenosis at first post-treatment evaluation, however, when excluding those with pre-existing hydronephrosis or ureteral stenosis, only 5.4% of patients developed new clinically significant stenosis.
UGN-101 appears to be safe and may have similar efficacy in treating low-grade urothelial carcinoma of the ureter as compared to renal pelvic tumors.