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

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

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

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 LotanRian J Dickstein

Research output: Contribution to journal › Article

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.

Original language	Undefined/Unknown
Journal	Articles, Abstracts, and Reports
State	Published - Jul 28 2023

Access to Document

http://digitalcommons.providence.org/publications/7828

Cite this

Jacob, J. M., Woldu, S. L., Linehan, J., Labbate, C., Rose, K. M., Sexton, W. J., Tachibana, I., Kaimakliotis, H., Nieder, A., Bjurlin, M. A., Humphreys, M., Ghodoussipor, S., Quek, M. L., Johnson, B., O'Donnell, M., Eisner, B. H., Feldman, A. S., Murray, K. S., Matin, S. F., ... Dickstein, R. J. (2023). First analysis of the safety and efficacy of UGN-101 in the treatment of ureteral tumors. Articles, Abstracts, and Reports. http://digitalcommons.providence.org/publications/7828

@article{c07b48d16c414c1e85f5e7d831d24802,

title = "First analysis of the safety and efficacy of UGN-101 in the treatment of ureteral tumors.",

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.",

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

year = "2023",

month = jul,

day = "28",

language = "Undefined/Unknown",

journal = "Articles, Abstracts, and Reports",

}

Jacob, JM, Woldu, SL, Linehan, J, Labbate, C, Rose, KM, Sexton, WJ, Tachibana, I, Kaimakliotis, H, Nieder, A, Bjurlin, MA, Humphreys, M, Ghodoussipor, S, Quek, ML, Johnson, B, O'Donnell, M, Eisner, BH, Feldman, AS, Murray, KS, Matin, SF, Lotan, Y & Dickstein, RJ 2023, 'First analysis of the safety and efficacy of UGN-101 in the treatment of ureteral tumors.', Articles, Abstracts, and Reports. <http://digitalcommons.providence.org/publications/7828>

TY - JOUR

T1 - First analysis of the safety and efficacy of UGN-101 in the treatment of ureteral tumors.

AU - Jacob, Joseph M

AU - Woldu, Solomon L

AU - Linehan, Jennifer

AU - Labbate, Craig

AU - Rose, Kyle M

AU - Sexton, Wade J

AU - Tachibana, Isamu

AU - Kaimakliotis, Hristos

AU - Nieder, Alan

AU - Bjurlin, Marc A

AU - Humphreys, Mitchell

AU - Ghodoussipor, Saum

AU - Quek, Marcus L

AU - Johnson, Brett

AU - O'Donnell, Michael

AU - Eisner, Brian H

AU - Feldman, Adam S

AU - Murray, Katie S

AU - Matin, Surena F

AU - Lotan, Yair

AU - Dickstein, Rian J

PY - 2023/7/28

Y1 - 2023/7/28

N2 - 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.

AB - 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.

M3 - Article

JO - Articles, Abstracts, and Reports

JF - Articles, Abstracts, and Reports

ER -