Phillip M Pierorazio, Nir Kleinmann, Ahmad Shabsigh, Brian Hu, Jay D Raman, Hristos Kaimakliotis, Alexander Sankin, Nirmish Singla, Andrew Meads, Brent Burger, Sunil Raju, Michael J Louie, Karim Chamie, Alon Weizer, Mark Schoenberg
{"title":"使用 UGN-101（一种丝裂霉素逆向热凝胶）对低级别上尿路上皮癌（LG UTUC）进行初次化疗的长期疗效。","authors":"Phillip M Pierorazio, Nir Kleinmann, Ahmad Shabsigh, Brian Hu, Jay D Raman, Hristos Kaimakliotis, Alexander Sankin, Nirmish Singla, Andrew Meads, Brent Burger, Sunil Raju, Michael J Louie, Karim Chamie, Alon Weizer, Mark Schoenberg","doi":"10.1097/JU.0000000000004331","DOIUrl":null,"url":null,"abstract":"<p><strong>Purpose: </strong>To evaluate long-term outcomes of primary chemoablation using a mitomycin reverse thermal gel (UGN-101) in patients with low-grade upper tract urothelial carcinoma.</p><p><strong>Materials and methods: </strong>Patients who participated in the OLYMPUS trial (TC-UT-03, NCT02793128) and achieved a complete response after 6 weekly doses of UGN-101 were followed up to 12 months after initial complete response. Those with complete response at study completion were eligible for long-term follow-up for up to 5 years or until disease recurrence, progression, or death.</p><p><strong>Results: </strong>Of the 71 patients enrolled in the OLYMPUS trial, 42 patients achieved complete response 4-6 weeks after completing ≥1 instillation of UGN-101. Amongst the 41 patients followed after initial complete response, median follow-up was 28.1 months (95% CI 13.1, 57.5), and median duration of response was 47.8 months (95% CI 13.0, not estimable).Twenty patients (49%) had long-term follow-up (median 53.3 months [95% CI 27.9, 65.3]). Seventy-five percent of patients had no evidence of recurrence at last follow-up, with median duration of response not estimable (95% CI 43.5, not estimable) due to a low event rate.</p><p><strong>Conclusions: </strong>Primary intracavitary chemoablation with UGN-101 for low-grade upper tract urothelial carcinoma is associated with favorable long-term durability.</p>","PeriodicalId":17471,"journal":{"name":"Journal of Urology","volume":" ","pages":"101097JU0000000000004331"},"PeriodicalIF":5.9000,"publicationDate":"2024-11-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Long-Term Outcomes of Primary Chemoablation of Low-Grade Upper Tract Urothelial Carcinoma (LG UTUC) with UGN-101, A Mitomycin Reverse Thermal Gel.\",\"authors\":\"Phillip M Pierorazio, Nir Kleinmann, Ahmad Shabsigh, Brian Hu, Jay D Raman, Hristos Kaimakliotis, Alexander Sankin, Nirmish Singla, Andrew Meads, Brent Burger, Sunil Raju, Michael J Louie, Karim Chamie, Alon Weizer, Mark Schoenberg\",\"doi\":\"10.1097/JU.0000000000004331\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Purpose: </strong>To evaluate long-term outcomes of primary chemoablation using a mitomycin reverse thermal gel (UGN-101) in patients with low-grade upper tract urothelial carcinoma.</p><p><strong>Materials and methods: </strong>Patients who participated in the OLYMPUS trial (TC-UT-03, NCT02793128) and achieved a complete response after 6 weekly doses of UGN-101 were followed up to 12 months after initial complete response. Those with complete response at study completion were eligible for long-term follow-up for up to 5 years or until disease recurrence, progression, or death.</p><p><strong>Results: </strong>Of the 71 patients enrolled in the OLYMPUS trial, 42 patients achieved complete response 4-6 weeks after completing ≥1 instillation of UGN-101. Amongst the 41 patients followed after initial complete response, median follow-up was 28.1 months (95% CI 13.1, 57.5), and median duration of response was 47.8 months (95% CI 13.0, not estimable).Twenty patients (49%) had long-term follow-up (median 53.3 months [95% CI 27.9, 65.3]). Seventy-five percent of patients had no evidence of recurrence at last follow-up, with median duration of response not estimable (95% CI 43.5, not estimable) due to a low event rate.</p><p><strong>Conclusions: </strong>Primary intracavitary chemoablation with UGN-101 for low-grade upper tract urothelial carcinoma is associated with favorable long-term durability.</p>\",\"PeriodicalId\":17471,\"journal\":{\"name\":\"Journal of Urology\",\"volume\":\" \",\"pages\":\"101097JU0000000000004331\"},\"PeriodicalIF\":5.9000,\"publicationDate\":\"2024-11-19\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Journal of Urology\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1097/JU.0000000000004331\",\"RegionNum\":2,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q1\",\"JCRName\":\"UROLOGY & NEPHROLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Journal of Urology","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1097/JU.0000000000004331","RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"UROLOGY & NEPHROLOGY","Score":null,"Total":0}
引用次数: 0
摘要
目的：评估使用丝裂霉素逆向热凝胶（UGN-101）对低级别上尿路上皮癌患者进行初次化疗的长期疗效：参加 OLYMPUS 试验（TC-UT-03，NCT02793128）并在每周服用 6 次 UGN-101 后获得完全反应的患者在首次完全反应后随访 12 个月。研究结束时获得完全应答的患者有资格接受长达5年的长期随访，或随访至疾病复发、进展或死亡：在71名参加OLYMPUS试验的患者中，42名患者在完成≥1次UGN-101注射4-6周后获得完全应答。在首次完全应答后随访的 41 名患者中，中位随访时间为 28.1 个月（95% CI 13.1，57.5），中位应答持续时间为 47.8 个月（95% CI 13.0，无法估计）。20 名患者（49%）接受了长期随访（中位 53.3 个月 [95% CI 27.9，65.3]）。75%的患者在最后一次随访时无复发迹象，由于事件发生率较低，中位反应持续时间无法估计（95% CI 43.5，无法估计）：结论：使用UGN-101对低级别上尿路上皮癌进行原发性腔内化消融治疗具有良好的长期耐受性。
Long-Term Outcomes of Primary Chemoablation of Low-Grade Upper Tract Urothelial Carcinoma (LG UTUC) with UGN-101, A Mitomycin Reverse Thermal Gel.
Purpose: To evaluate long-term outcomes of primary chemoablation using a mitomycin reverse thermal gel (UGN-101) in patients with low-grade upper tract urothelial carcinoma.
Materials and methods: Patients who participated in the OLYMPUS trial (TC-UT-03, NCT02793128) and achieved a complete response after 6 weekly doses of UGN-101 were followed up to 12 months after initial complete response. Those with complete response at study completion were eligible for long-term follow-up for up to 5 years or until disease recurrence, progression, or death.
Results: Of the 71 patients enrolled in the OLYMPUS trial, 42 patients achieved complete response 4-6 weeks after completing ≥1 instillation of UGN-101. Amongst the 41 patients followed after initial complete response, median follow-up was 28.1 months (95% CI 13.1, 57.5), and median duration of response was 47.8 months (95% CI 13.0, not estimable).Twenty patients (49%) had long-term follow-up (median 53.3 months [95% CI 27.9, 65.3]). Seventy-five percent of patients had no evidence of recurrence at last follow-up, with median duration of response not estimable (95% CI 43.5, not estimable) due to a low event rate.
Conclusions: Primary intracavitary chemoablation with UGN-101 for low-grade upper tract urothelial carcinoma is associated with favorable long-term durability.
期刊介绍：
The Official Journal of the American Urological Association (AUA), and the most widely read and highly cited journal in the field, The Journal of Urology® brings solid coverage of the clinically relevant content needed to stay at the forefront of the dynamic field of urology. This premier journal presents investigative studies on critical areas of research and practice, survey articles providing short condensations of the best and most important urology literature worldwide, and practice-oriented reports on significant clinical observations.
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