Inlexzo(吉西他滨膀胱系统):有希望的数据,但关键问题仍然存在。

IF 2.9 2区 医学 Q2 UROLOGY & NEPHROLOGY
Zarmeen Azhar, Zehra Sadia
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引用次数: 0

摘要

FDA批准Inlexzo(吉西他滨膀胱内系统,前身为ar -200)治疗bcg难治性非肌肉浸润性膀胱癌(NMIBC)原位癌是保膀胱治疗的里程碑式成就。SunRISe-1试验的结果显示,3个月的完全缓解率达到82%,超过一半的应答者在12个月时可以持续治疗。然而,热情必须与重要的警告相平衡:缺乏比较组,不成熟的长期生存数据,膀胱内留置分娩的实际问题,感染风险,以及在低资源环境下的可及性。虽然Inlexzo在缺乏替代药物的人群中很有希望,但它的地位必须通过长期随访、与全身和体内治疗的随机比较以及实际经验来明确。在此之前,临床医生必须利用公开咨询和共同决策。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Inlexzo (gemcitabine intravesical system): promising data but key questions remain.

The FDA approval of Inlexzo (gemcitabine intravesical system, formerly TAR-200) for BCG-refractory non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ is a milestone achievement in bladder-sparing therapy. Outcomes from the SunRISe-1 trial showed an outstanding 3-month complete response rate of 82%, and sustainability in more than half of responders at 12 months. Yet enthusiasm must be balanced with significant cautions: lack of comparator arm, immature long-term survival data, and practical issues with indwelling intravesical delivery, risk of infection, and access in low-resource environments. While Inlexzo is promising in a population where alternatives are scarce, its place must be clarified by longer-term follow-up, randomized comparisons versus systemic and intravesical therapies, and real-world experience. Prior to that, clinicians must utilize open counseling and shared decision-making.

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来源期刊
World Journal of Urology
World Journal of Urology 医学-泌尿学与肾脏学
CiteScore
6.80
自引率
8.80%
发文量
317
审稿时长
4-8 weeks
期刊介绍: The WORLD JOURNAL OF UROLOGY conveys regularly the essential results of urological research and their practical and clinical relevance to a broad audience of urologists in research and clinical practice. In order to guarantee a balanced program, articles are published to reflect the developments in all fields of urology on an internationally advanced level. Each issue treats a main topic in review articles of invited international experts. Free papers are unrelated articles to the main topic.
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