JU INSIGHT Mitomycin Gel as Adjuvant Therapy After Complete Endoscopic Management of Upper Tract Urothelial Carcinoma

By: Craig Labbate, MD, University of Texas MD Anderson Cancer Center, Houston; Solomon Woldu, MD, University of Texas Southwestern Medical Center, Dallas; Katie Murray, DO, University of Missouri, Columbus; Kyle Rose, MD, Moffitt Cancer Center, Tampa, Florida; Wade Sexton, MD, Moffitt Cancer Center, Tampa, Florida; Isamu Tachibana, MD, Indiana University Medical Center, Indianapolis; Hristov Kaimakliotis, MD, Indiana University Medical Center, Indianapolis; Joseph Jacob, MD, State University of New York Upstate Medical Center, Syracuse; Rian Dickstein, MD, University of Maryland Medical Center, Baltimore, Chesapeake Urology, Baltimore, Maryland; Jennifer Linehan, MD, Providence Specialty Medical Group, Santa Monica, California; Alan Nieder, MD, Mount Sinai Medical Center, Miami Beach, Florida; Marc Bjurlin, MD, University of North Carolina Medical Center, Chapel Hill; Mitchell Humphreys, MD, Mayo Clinic Cancer Center, Phoenix, Arizona; Saum Ghodoussipor, MD, Rutgers Cancer Institute of New Jersey, New Brunswick; Marcus Quek, MD, Loyola University Medical Center, Maywood, Illinois; Michael O’Donnell, MD, University of Iowa Health Care, Iowa City; Brian Eisner, MD, Massachusetts General Hospital, Boston; Adam Feldman, MD, Massachusetts General Hospital, Boston; Yair Lotan, MD, University of Texas Southwestern Medical Center, Dallas; Surena F. Matin, MD, University of Texas MD Anderson Cancer Center, Houston | Posted on: 18 May 2023

Labbate C, Woldu S, Murray K, et al. Efficacy and safety of mitomycin gel (UGN-101) as an adjuvant therapy after complete endoscopic management of upper tract urothelial carcinoma. J Urol. 2023;209(5):872-881.

Study Need and Importance

Upper tract urothelial carcinoma (UTUC) has high rates of local recurrence after nephron-sparing surgery. UGN-101 was approved by the Food and Drug Administration in 2019 as a chemoablative treatment of low-grade UTUC, but its usage as an adjuvant agent after complete endoscopic ablation has yet to be described. This multicenter experience provides data from the 15 highest UGN-101 utilizing centers post-commercialization in the U.S.

What We Found

At the first endoscopic evaluation, use of UGN-101 as an adjuvant agent (following complete endoscopic ablation) resulted in disease-free status in 69% (36 of 52) of patients, which was greater than the disease-free status of patients undergoing UGN-101 as chemoablative therapy alone (40%, P < .01). Ipsilateral recurrence during follow-up was observed in an additional 4 patients. Disease progression to high-grade or metastatic disease after adjuvant therapy was rare, occurring in 1 patient during follow-up. The rate of ureteral stenosis was not different in patients who underwent adjuvant therapy (19%) or chemoablative therapy (27%, P = .55).

Limitations

As a rare genitourinary malignancy, data were collected across 15 centers and thus are prone to bias introduced by practice pattern variation. In particular, adjuvant UGN-101 was administered by nephrostomy tube in 54% of cases, which may influence adverse event profile. Intensity and duration of ureteroscopic surveillance were not protocolized in this retrospective review.

Interpretations for Patient Care

UGN-101 appears to be well tolerated after complete endoscopic ablation of UTUC. Patients who underwent complete endoscopic ablation followed by UGN-101 were more likely to be disease-free at first endoscopic evaluation than those who underwent chemoablation alone. This highlights the potential benefit of complete up-front endoscopic ablation. The durability of ipsilateral disease-free response requires longer follow-up.