Efficacy and safety of mitomycin gel (UGN-101) as an adjuvant therapy after complete endoscopic management of Upper Tract Urothelial Carcinoma. Journal Article

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Authors: Labbate, C; Woldu, S; Murray, K; Rose, K; Sexton, W; Tachibana, I; Kaimakliotis, H; Jacob, J; Dickstein, R; Linehan, J; Nieder, A; Bjurlin, M; Humphreys, M; Ghodoussipor, S; Quek, M; O'Donnell, M; Eisner, B; Feldman, A; Lotan, Y; Matin, SF
Article Title: Efficacy and safety of mitomycin gel (UGN-101) as an adjuvant therapy after complete endoscopic management of Upper Tract Urothelial Carcinoma.
Abstract: PURPOSE: To describe a novel application of the reverse thermal polymer gel of mitomycin C (UGN-101) as adjuvant therapy after complete endoscopic ablation of upper tract urothelial carcinoma (UTUC). MATERIALS AND METHODS: We retrospectively reviewed patients treated with UGN-101 from 15 high-volume centers. Adjuvant therapy was defined as treatment administered following visually complete endoscopic ablation. Response at primary endoscopic evaluation was defined as no visual tumor or negative biopsy. Ipsilateral disease free and progression free survival were estimated by the Kaplan Meier method. Ureteral stenosis and other adverse events were abstracted from the medical records. Ureteral stenosis was defined as a condition requiring ureteral stent or nephrostomy or would typically warrant stent or nephrostomy. RESULTS: Adjuvant use of UGN-101 after complete endoscopic ablation was used in 52 of 115 (45%) renal units in the oncologic analysis. At first endoscopic evaluation, 36/52 (69%) were without visible disease. At 6.8 months median follow up, the ipsilateral disease-free rate was 63%. Recurrence after adjuvant UGN101 therapy was more likely in multifocal tumors compared to unifocal (HR 3.3 95%CI 1.07-9.91). Compared with UGN-101 treatment for chemoablation of measurable disease, there were significantly fewer disease detections with adjuvant therapy (p.001). Ureteral stenosis after UGN 101 was diagnosed in 10 patients (19%) undergoing adjuvant therapy compared to 17 (29%) undergoing chemoablative therapy (p=0.28). CONCLUSIONS: In patients being considered for UGN-101, maximal endoscopic ablation prior to UGN-101 treatment may result in fewer patients with disease at first endoscopy and possibly fewer adverse events than primary chemoablative therapy. Longer follow up is needed to determine if UGN-101 after complete endoscopic ablation will lead to durable disease-free interval.
Journal Title: The Journal of urology
ISSN: 1527-3792; 0022-5347
Publisher: Unknown  
Date Published: 2023