KEY TAKEAWAYS
- The phase 3 study compared outcomes among patients with ureteral tumors, patients with a combination of ureteral and renal pelvis tumors, and patients exclusively affected by renal pelvis tumors.
- The study evaluated various effectiveness measures and adverse events.
- UGN-101 demonstrated safety and efficacy in treating low-grade urothelial carcinoma of the ureter.
UGN-101 has received approval for the chemoablation of low-grade upper tract urothelial cancer (UTUC) that affects the renal pelvis and calyces. The first group of patients (pts) with ureteral tumors who underwent treatment utilizing UGN-101 were considered in this retrospective analysis conducted across 15 prominent medical facilities. The study aimed to compare outcomes between pts with ureteral tumors with or without renal pelvis tumors and those exclusively affected by renal pelvis tumors. Investigators evaluated effectiveness measures based on initial endoscopic assessments, recurrence, and progression rates. Adverse events were scrutinized, with particular attention given to the incidence of ureteral stenosis.
Within a group of 132 pts and 136 renal units, 47 instances exhibited ureteral tumor engagement, with 12 ureteral tumors (8.8%), while 35 cases featured a combination of ureteral and renal pelvic tumors (25.7%). No discernible outcome disparity was observed during the initial endoscopic assessment between cases involving the ureter and those without ureteral involvement (p=0.644). Similarly, no variance emerged regarding recurrence rate or progression based on tumor location. Notably, 37.8% of pts (n=14) with ureteral tumors displayed significant ureteral stenosis during the primary post-treatment evaluation; nonetheless, when excluding pts with pre-existing hydronephrosis or ureteral stenosis, the incidence of new clinically significant stenosis was 5.4%.
UGN-101 demonstrated comparable safety and effectiveness in addressing low-grade urothelial carcinoma of the ureter when compared to its performance in treating renal pelvic tumors.
Source: https://www.auajournals.org/doi/10.1097/JU.0000000000003302.07
Clinical Trial: https://classic.clinicaltrials.gov/ct2/show/NCT04006691
Jacob, Joseph; Woldu, Solomon; Linehan, Jennifer; Labbate, Craig; Rose, Kyle; Sexton, Wade; Tachibana, Isamu; Kaimakliotis, Hristos; Nieder, Alan; Bjurlin, Marc; Humphreys, Mitchell; Ghodoussipor, Saum; Quek, Marcus; O’Donell, Michael; Eisner, Brian; Feldman, Adam; Murray, Katie; Matin, Serena; Lotan, Yair; Dickstein, Rian PD24-07 FIRST ANALYSIS OF THE SAFETY AND EFFICACY OF UGN-101 IN THE TREATMENT OF URETERAL TUMORS, Journal of Urology: April 2023 – Volume 209 – Issue Supplement 4 doi: 10.1097/JU.0000000000003302.07
