1. First analysis of the safety and efficacy of UGN-101 in the treatment of ureteral tumors.
- Author
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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, and Dickstein RJ
- Subjects
- Humans, Constriction, Pathologic, Mitomycins, Retrospective Studies, Ureteral Neoplasms surgery, Carcinoma, Transitional Cell drug therapy, Carcinoma, Transitional Cell pathology, Urinary Bladder Neoplasms pathology, Pelvic Neoplasms, Ureter surgery, Ureter pathology, Kidney Neoplasms pathology
- Abstract
Objective: 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., Patients and Methods: 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., Results: 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., Conclusions: 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., Competing Interests: Declaration of Competing Interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Solomon Woldu receives honoraria for consulting for UroGen Pharma Ltd. Yair Lotan is involved in research with Pacific Edge Inc., Cepheid Inc., MDx Health and received honoraria for consulting for Nanorobotics, C2I genomics, Photocure, Astra-Zeneca, Merck, Fergene, Abbvie, Nucleix, Ambu, Seattle Genetics, Hitachi, Ferring Research, Verity Pharmaceutics, Virtuoso Surgical, Stimit, Urogen Pharma Ltd, Vessi medical, CAPs medical, Xcures, BMS, Nonagen, Aura Biosciences, Inc., Convergent Genomics, Pacific Edge, Pfizer, Phinomics Inc, CG oncology, Uroviu, On target lab., (Copyright © 2023 Elsevier Inc. All rights reserved.)
- Published
- 2024
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