Efficacy and Safety of Mitomycin Gel (UGN-101) as an Adjuvant Therapy After Complete Endoscopic Management of Upper Tract Urothelial Carcinoma
PURPOSE: We 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.
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 that would typically warrant stent or nephrostomy.
RESULTS: Adjuvant 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 UGN-101 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 = .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.
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| Medienart: |
E-Artikel |
| Erscheinungsjahr: |
2023 |
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| Erschienen: |
2023 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:209 |
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| Enthalten in: |
The Journal of urology - 209(2023), 5 vom: 01. Mai, Seite 872-881 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Labbate, Craig [VerfasserIn] |
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50SG953SK6 |
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| Anmerkungen: |
Date Completed 10.04.2023 Date Revised 06.02.2024 published: Print-Electronic CommentIn: J Urol. 2023 May;209(5):880-881. - PMID 36815349 Citation Status MEDLINE |
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| doi: |
10.1097/JU.0000000000003185 |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
NLM351677909 |
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| 041 | |a eng | ||
| 100 | 1 | |a Labbate, Craig |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a Efficacy and Safety of Mitomycin Gel (UGN-101) as an Adjuvant Therapy After Complete Endoscopic Management of Upper Tract Urothelial Carcinoma |
| 264 | 1 | |c 2023 | |
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| 500 | |a Date Completed 10.04.2023 | ||
| 500 | |a Date Revised 06.02.2024 | ||
| 500 | |a published: Print-Electronic | ||
| 500 | |a CommentIn: J Urol. 2023 May;209(5):880-881. - PMID 36815349 | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a PURPOSE: We 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 | ||
| 520 | |a 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 that would typically warrant stent or nephrostomy | ||
| 520 | |a RESULTS: Adjuvant 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 UGN-101 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 = .28) | ||
| 520 | |a 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 | ||
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Research Support, N.I.H., Extramural | |
| 650 | 4 | |a carcinoma, transitional cell | |
| 650 | 4 | |a chemotherapy, adjuvant | |
| 650 | 4 | |a endoscopy | |
| 650 | 4 | |a mitomycin | |
| 650 | 4 | |a topical drug administration | |
| 650 | 7 | |a Mitomycin |2 NLM | |
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| 700 | 1 | |a Woldu, Solomon |e verfasserin |4 aut | |
| 700 | 1 | |a Murray, Katie |e verfasserin |4 aut | |
| 700 | 1 | |a Rose, Kyle |e verfasserin |4 aut | |
| 700 | 1 | |a Sexton, Wade |e verfasserin |4 aut | |
| 700 | 1 | |a Tachibana, Isamu |e verfasserin |4 aut | |
| 700 | 1 | |a Kaimakliotis, Hristov |e verfasserin |4 aut | |
| 700 | 1 | |a Jacob, Joseph |e verfasserin |4 aut | |
| 700 | 1 | |a Dickstein, Rian |e verfasserin |4 aut | |
| 700 | 1 | |a Linehan, Jennifer |e verfasserin |4 aut | |
| 700 | 1 | |a Nieder, Alan |e verfasserin |4 aut | |
| 700 | 1 | |a Bjurlin, Marc |e verfasserin |4 aut | |
| 700 | 1 | |a Humphreys, Mitchell |e verfasserin |4 aut | |
| 700 | 1 | |a Ghodoussipour, Saum |e verfasserin |4 aut | |
| 700 | 1 | |a Quek, Marcus |e verfasserin |4 aut | |
| 700 | 1 | |a O'Donnell, Michael |e verfasserin |4 aut | |
| 700 | 1 | |a Eisner, Brian |e verfasserin |4 aut | |
| 700 | 1 | |a Feldman, Adam |e verfasserin |4 aut | |
| 700 | 1 | |a Lotan, Yair |e verfasserin |4 aut | |
| 700 | 1 | |a Matin, Surena F |e verfasserin |4 aut | |
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