First analysis of the safety and efficacy of UGN-101 in the treatment of ureteral tumors.

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.

Urologic oncology. 2023 Jul 28 [Epub ahead of print]

Joseph M Jacob, Solomon L Woldu, Jennifer Linehan, Craig Labbate, Kyle M Rose, Wade J Sexton, Isamu Tachibana, Hristos Kaimakliotis, Alan Nieder, Marc A Bjurlin, Mitchell Humphreys, Saum Ghodoussipor, Marcus L Quek, Brett Johnson, Michael O'Donnell, Brian H Eisner, Adam S Feldman, Katie S Murray, Surena F Matin, Yair Lotan, Rian J Dickstein

State University of New York Upstate Medical Center, Syracuse, NY., University of Texas Southwestern Medical Center, Dallas, TX. Electronic address: ., Providence Specialty Medical Group, Santa Monica, CA., University of Texas M.D. Anderson Cancer Center, Houston, TX., Moffitt Cancer Center, Tampa, FL., Indiana University Medical Center, Indianapolis, IN., Mount Sinai Medical Center, Miami Beach, FL., University of North Carolina Medical Center, Chapel Hill, NC., Mayo Clinic Cancer Center, Phoenix, AZ., Rutgers Cancer Institute of New Jersey, New Brunswick, NJ., Loyola University Medical Center, Maywood, IL., University of Texas Southwestern Medical Center, Dallas, TX., University of Iowa Health Care, Iowa City, IA., Massachusetts General Hospital, Boston, MA., University of Missouri, Columbia, MO., University of Maryland Baltimore Washington Medical Center, Glen Burnie, MD; Chesapeake Urology, Baltimore, MD.