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Exploring Recurrence After Initial Response to UGN-101 Induction in Expanded Settings
Adam S. Feldman, MD, MPH1, Solomon Woldu, MD2, Brett Johnson, MD2, Katie Murray, DO3, Hiroko Miyagi, MD4, Wade Sexton, MD4, Isamu Tachibana, MD5, Hristos Kaimakliotis, MD5, Joseph Jacob, MD6, Rian Dickstein, MD7, Jennifer Linehan, MD8, Alan Nieder, MD9, Marc Bjurlin, MD10, Daniel Hidenberg, MD11, Mitchell Humprheys, MD11, Saum Ghodoussipor, MD12, Marcus Quek, MD13, Michael O'Donnell, MD14, Brian Eisner, MD1, Yair Lotan, MD2, Surena Matin, MD15
1Massachusetts General Hospital, Boston, MA, USA, 2UT Southwestern, Dallas, TX, USA, 3New York University, New York, NY, USA, 4Moffitt Cancer Center, Tampa, FL, USA, 5Indiana University Medical Center, Indianapolis, IN, USA, 6State University of New York Upstate Medical Center, Syracuse, NY, USA, 7University of Maryland Medical Center, Baltimore, MD, USA, 8Providence Specialty Medical Group, Santa Monica, CA, USA, 9Mount Sinai Medical Center, Miami Beach, FL, USA, 10University of North Carolina at Chapel Hill, Chapel Hill, NC, USA, 11Mayo Clinic Cancer Center, Phoenix, AZ, USA, 12Rutgers Cancer Institute of New Jersey, New Brunswick, NJ, USA, 13Loyola University Medical Center, Maywood, IL, USA, 14University of Iowa Health Care, Iowa City, IA, USA, 15University of Texas MD Anderson Cancer Center, Houston, TX, USA

BACKGROUND: UGN-101 is a novel therapeutic for the treatment of upper tract urothelial cancer (UTUC) that was originally approved for chemoablative use in low-volume, low-grade disease of the pelvicalyceal system. In practice, UGN-101 is being utilized more broadly - including for bulky tumors, in the adjuvant setting, and in cases of ureteral involvement. This study aims to evaluate recurrence in these settings. METHODS: Data was collected from 15 centers on patients treated with UGN-101 for UTUC. Recurrence free survival (RFS) was calculated only patients who had no evidence of disease following UGN-101 induction. Chemoablative use was defined as receipt of UGN-101 induction in the setting of known residual UTUC, while adjuvant use was defined as receipt of UGN-101 following visually complete endoscopic ablation. Exploratory analyses were performed to assess impact of size of tumor, presence of ureteral involvement, and multifocality of UTUC prior UGN-101 induction. RESULTS: There were 136 cases of UTUC treated with UGN-101 with a cumulative median (IQR) follow up of 22 (12-27) months including 107 cases of LGTa UTUC. After initial treatment, 74% of adjuvant and 39% of chemoablative patients were disease free totaling 53 cases with LGTa UTUC without evidence of disease following UGN-101 induction. Median recurrence-free survival was not reached and RFS at 24-months was 86%. Among these patients, there was no difference in RFS based on initial disease characteristics (size, location, multifocality) and treatments according to chemoablative vs. adjuvant intent of UGN-101 induction (log rank 0.597). CONCLUSIONS: UGN-101 treatment appears to demonstrate favorable recurrence free survival rates for patients with LGTa UTUC who respond to initial induction. There does not appear to be a recurrence difference according to the intent of UGN-101 induction, original tumor size, multifocality or tumor location.



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