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厄达替尼治疗转移性尿路上皮癌:一项真实世界分析。

Erdafitinib treatment in metastatic urothelial carcinoma: a real-world analysis.

作者信息

Rouvinov Keren, Levanon Eran, Peer Avivit, Sarfaty Michal, Sarid David, Neiman Victoria, Grikshtas Eduard, Rosenbaum Eli, Kushnir Igal, Talmor Barak, Friger Michael, Zarbiv Yonaton, Gez Eli, Dresler Hadas, Shalata Walid, Meirovitz Amichay, Shrem Noa Shani, Yakobson Alexander, Mermershtain Wilmosh, Keizman Daniel

机构信息

The Legacy Heritage Oncology Center & Dr. Larry Norton Institute, Soroka Medical Center, Beer Sheva, Israel.

Ben-Gurion University of the Negev, Beer Sheva, Israel.

出版信息

Front Oncol. 2023 May 24;13:1151701. doi: 10.3389/fonc.2023.1151701. eCollection 2023.

Abstract

BACKGROUND

Erdafitinib, a fibroblast growth factor receptor (FGFR) inhibitor is a standard post chemotherapy advanced treatment line for metastatic urothelial carcinoma harboring FGFR2/3 genomic alterations. It was approved based on a phase 2 clinical trial, revealing a 40% response rate, and 13.8 months overall survival. These FGFR genomic alterations are uncommon. Thus, real-world data on erdafitinb use is scant. We herein describe erdafitinib treatment outcome in a real world patient cohort.

METHODS

We retrospectively reviewed the data of patients treated with erdafitinib from 9 Israeli medical centers.

RESULTS

Twenty-five patients with metastatic urothelial carcinoma (median age 73, 64% male, 80% with visceral metastases) were treated with erdafitinib between January 2020 to October 2022. A clinical benefit (complete response 12%, partial response 32%, stable disease 12%) was seen in 56%. Median progression-free survival was 2.7 months, and median overall survival 6.73 months. Treatment related toxicity ≥ grade 3 occurred in 52%, and 32% discontinued therapy due to adverse events.

CONCLUSIONS

Erdafitinib therapy is associated with a clinical benefit in the real world setting, and associated with similar toxicity as reported in prospective clinical trials.

摘要

背景

厄达替尼是一种成纤维细胞生长因子受体(FGFR)抑制剂,是治疗携带FGFR2/3基因组改变的转移性尿路上皮癌的标准化疗后晚期治疗方案。它基于一项2期临床试验获得批准,该试验显示缓解率为40%,总生存期为13.8个月。这些FGFR基因组改变并不常见。因此,关于厄达替尼使用的真实世界数据很少。我们在此描述了厄达替尼在一个真实世界患者队列中的治疗结果。

方法

我们回顾性分析了来自9家以色列医疗中心接受厄达替尼治疗的患者数据。

结果

2020年1月至2022年10月期间,25例转移性尿路上皮癌患者(中位年龄73岁,64%为男性,80%有内脏转移)接受了厄达替尼治疗。56%的患者出现临床获益(完全缓解12%,部分缓解32%,病情稳定12%)。中位无进展生存期为2.7个月,中位总生存期为6.73个月。52%的患者发生≥3级治疗相关毒性,32%的患者因不良事件停药。

结论

在真实世界中,厄达替尼治疗具有临床获益,且毒性与前瞻性临床试验报告的相似。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6e2d/10244774/bfcf38e6ad02/fonc-13-1151701-g001.jpg

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