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首次分析 UGN-101 在治疗输尿管肿瘤中的安全性和疗效。

First analysis of the safety and efficacy of UGN-101 in the treatment of ureteral tumors.

机构信息

State University of New York Upstate Medical Center, Syracuse, NY.

University of Texas Southwestern Medical Center, Dallas, TX.

出版信息

Urol Oncol. 2024 Jan;42(1):20.e17-20.e23. doi: 10.1016/j.urolonc.2023.07.004. Epub 2023 Jul 28.

DOI:10.1016/j.urolonc.2023.07.004
PMID:37517898
Abstract

OBJECTIVE

UGN-101 has been approved for the chemoablation of low-grade upper tract urothelial cancer (UTUC) involving the renal pelvis and calyces. Herein is the first reported cohort of patients with ureteral tumors treated with UGN-101.

PATIENTS AND METHODS

We performed a retrospective review of patients treated with UGN-101 for UTUC at 15 high-volume academic and community centers focusing on outcomes of patients treated for ureteral disease. Patients received UGN-101 with either adjuvant or chemo-ablative intent. Response rates are reported for patients receiving chemo-ablative intent. Adverse outcomes were characterized with a focus on the rate of ureteral stenosis.

RESULTS

In a cohort of 132 patients and 136 renal units, 47 cases had tumor involvement of the ureter, with 12 cases of ureteral tumor only (8.8%) and 35 cases of ureteral plus renal pelvic tumors (25.7%). Of the 23 patients with ureteral involvement who received UGN-101 induction with chemo-ablative intent, the complete response was 47.8%, which did not differ significantly from outcomes in patients without ureteral involvement. Fourteen patients (37.8%) with ureteral tumors had significant ureteral stenosis at first post-treatment evaluation, however, when excluding those with pre-existing hydronephrosis or ureteral stenosis, only 5.4% of patients developed new clinically significant stenosis.

CONCLUSIONS

UGN-101 appears to be safe and may have similar efficacy in treating low-grade urothelial carcinoma of the ureter as compared to renal pelvic tumors.

摘要

目的

UGN-101 已获准用于肾盂和肾盏低级别上尿路尿路上皮癌(UTUC)的化学消融。本文报告了首例采用 UGN-101 治疗输尿管肿瘤的患者队列。

患者和方法

我们对 15 个高容量学术和社区中心的 132 例患者和 136 个肾脏单位进行了 UGN-101 治疗 UTUC 的回顾性研究,重点关注治疗输尿管疾病的患者的结局。患者接受 UGN-101 辅助或化学消融治疗。报告了接受化学消融治疗的患者的反应率。对不良结局进行了特征描述,重点关注输尿管狭窄的发生率。

结果

在 132 例患者和 136 个肾脏单位中,47 例患者输尿管受累,其中 12 例仅输尿管肿瘤(8.8%),35 例输尿管加肾盂肿瘤(25.7%)。23 例接受 UGN-101 诱导性化学消融治疗的输尿管受累患者中,完全缓解率为 47.8%,与无输尿管受累患者的结局无显著差异。14 例(37.8%)有输尿管肿瘤的患者在首次治疗后评估时出现明显的输尿管狭窄,但在排除存在肾盂积水或输尿管狭窄的患者后,仅有 5.4%的患者出现新的有临床意义的狭窄。

结论

与肾盂肿瘤相比,UGN-101 似乎安全,且在治疗低级别输尿管尿路上皮癌方面可能具有相似的疗效。

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