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来自1000多名泛癌患者的前瞻性临床证据:对磷丙泊酚在预防化疗引起的恶心和呕吐方面的补充。

Prospective clinical evidence from over 1,000 pan-cancer patients: a complement to fosaprepitant in the prevention of chemotherapy-induced nausea and vomiting.

作者信息

He Lijuan, Wang Jize, Pu Weigao, Li Haiyuan, Liu Ben, Wang Zhuanfang, Han Qinying, Wang Yunpeng, Xu Bo, Hu Jike, Sun Guodong, Chen Hao

机构信息

The Second Hospital & Clinical Medical School, Lanzhou University, Lanzhou, 730030, China.

Department of Surgical Oncology, The Second Hospital & Clinical Medical School, Lanzhou University, Lanzhou, 730030, China.

出版信息

BMC Cancer. 2025 Jan 14;25(1):82. doi: 10.1186/s12885-025-13469-6.

Abstract

BACKGROUND

Chemotherapy-induced nausea and/or vomiting (CINV) is an intractable adverse effect of anticancer drugs. Although prophylactic use of fosaprepitant may be effective in reducing CINV, there is a lack of studies evaluating the application of fosaprepitant in real world.

AIMS AND METHODS

This study prospectively observed the effectiveness and safety for the prophylaxis of CINV in a real-world clinical setting. A single dose fosaprepitant 150 mg was intravenously administered to enrolled patients 30 min prior to the chemotherapy drug. Initial data were recorded and patients were followed for 120 h (5 days). The primary endpoint is the complete response (CR) rate and the incidence of serious adverse events (SAEs). The second endpoint is the use of rescue therapy. We also performed stratified analyses to investigate the impact of different factors on fosaprepitant for the prevention of CINV in the acute phase.

RESULTS

Between March 2021 to August 2021, 1001 patients were enrolled in this study. CR was 77.32%, 93.61%, and 76.72% for vomiting control in 0-24 h, 24-120 h, and 0-120 h respectively, and 97.4%, 99.1%, and 96.9% for nausea control. No SAEs were recorded. 23.48% or 3.1% of patients needed rescue therapy for vomiting or nausea control respectively, most of which occurred in the acute phase. CR rate decreased with increasing emetogenicity of chemotherapeutic agents.

CONCLUSIONS

Single-dose fosaprepitant has shown good performance in real-world clinical practice. This study is the first to prospectively evaluate the efficacy and safety of fosaprepitant for the prevention of CINV in a real-world clinical setting and may be a good complement to the clinical data.

摘要

背景

化疗引起的恶心和/或呕吐(CINV)是抗癌药物难以处理的不良反应。尽管预防性使用磷丙泊酚可能有效降低CINV,但缺乏在现实世界中评估磷丙泊酚应用情况的研究。

目的和方法

本研究在现实世界的临床环境中前瞻性观察预防CINV的有效性和安全性。在化疗药物给药前30分钟,对入选患者静脉注射单剂量150mg磷丙泊酚。记录初始数据并对患者随访120小时(5天)。主要终点是完全缓解(CR)率和严重不良事件(SAE)的发生率。次要终点是救援治疗的使用情况。我们还进行了分层分析,以研究不同因素对磷丙泊酚预防急性期CINV的影响。

结果

2021年3月至2021年8月,1001例患者入选本研究。呕吐控制在0 - 24小时、24 - 120小时和0 - 120小时的CR率分别为77.32%、93.61%和76.72%,恶心控制的CR率分别为97.4%、99.1%和96.9%。未记录到SAE。分别有23.48%或3.1%的患者需要救援治疗以控制呕吐或恶心,其中大部分发生在急性期。CR率随着化疗药物致吐性的增加而降低。

结论

单剂量磷丙泊酚在现实世界的临床实践中表现良好。本研究首次在现实世界的临床环境中前瞻性评估磷丙泊酚预防CINV的疗效和安全性,可能是临床数据的良好补充。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/98a0/11731560/6af7a5230277/12885_2025_13469_Fig1_HTML.jpg

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