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泛FGFR抑制剂厄达替尼在晚期尿路上皮癌和其他实体瘤中的安全性和有效性:一项系统评价和荟萃分析。

Safety and efficacy of the pan-FGFR inhibitor erdafitinib in advanced urothelial carcinoma and other solid tumors: A systematic review and meta-analysis.

作者信息

Zheng Xinyi, Wang Hang, Deng Junyue, Yao Minghe, Zou Xiuhe, Zhang Fan, Ma Xuelei

机构信息

West China School of Medicine, Sichuan University, Chengdu, Sichuan, China.

Department of Biotherapy, West China Hospital, Sichuan University, Chengdu, Sichuan, China.

出版信息

Front Oncol. 2023 Jan 26;12:907377. doi: 10.3389/fonc.2022.907377. eCollection 2022.

Abstract

OBJECTIVE

This review aimed to comprehensively analyze the safety and efficacy of erdafitinib in treating advanced and metastatic urothelial carcinoma and other solid tumors.

METHODS

PubMed, Embase, and ClinicalTrials.gov were searched until 10 February 2022. The safety outcome as adverse events and efficacy outcomes, including objective response rate, stable disease rates, and progressive disease rates, were selected and analyzed by comprehensive meta-analysis version 3.0 and STATA 15.0.

RESULTS

The most common all-grade adverse events were hyperphosphatemia, dry mouth, stomatitis, diarrhea, and dysgeusia. The occurrence of ≥3 adverse events was relatively low, and stomatitis and hyponatremia were the most common. Moreover, eye disorders could not be ignored. Efficacy in urothelial carcinoma patients was obviously better than in other solid tumor patients, with a higher objective response rate (0.38 versus 0.10) and lower progressive disease rate (0.26 versus 0.68). All responses occurred in patients with fibroblast growth factor receptor (FGFR) alteration. In those patients, a specific FGFR alteration () was observed to have a maximum response.

CONCLUSION

Erdafitinib has satisfactory clinical activity for metastatic urothelial carcinoma and other solid tumors, while the toxicity is acceptable. With more RCTs and combination therapy trials published, erdafitinib will be applied widely.

摘要

目的

本综述旨在全面分析厄达替尼治疗晚期和转移性尿路上皮癌及其他实体瘤的安全性和疗效。

方法

检索截至2022年2月10日的PubMed、Embase和ClinicalTrials.gov。通过综合荟萃分析3.0版和STATA 15.0选择并分析安全性结果(不良事件)和疗效结果,包括客观缓解率、疾病稳定率和疾病进展率。

结果

最常见的所有级别的不良事件为高磷血症、口干、口腔炎、腹泻和味觉障碍。≥3级不良事件的发生率相对较低,最常见的是口腔炎和低钠血症。此外,眼部疾病也不容忽视。尿路上皮癌患者的疗效明显优于其他实体瘤患者,客观缓解率更高(0.38对0.10),疾病进展率更低(0.26对0.68)。所有缓解均发生在成纤维细胞生长因子受体(FGFR)改变的患者中。在这些患者中,观察到一种特定的FGFR改变有最大反应。

结论

厄达替尼对转移性尿路上皮癌和其他实体瘤具有令人满意的临床活性,同时毒性是可接受的。随着更多随机对照试验和联合治疗试验的发表,厄达替尼将得到广泛应用。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3336/9909824/c9f17a40f449/fonc-12-907377-g001.jpg

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