背景:尽管化疗引起的恶心和呕吐(CINV)在急性期可以得到很好的控制,延迟CINV的发生率仍然很高。在这项研究中,我们打算研究除5-HT3RA和地塞米松(DEX)外,长期使用NK-1受体拮抗剂(RA)是否更有效地预防延迟的CINV.
方法:这是随机的,开放标签,对照研究旨在比较接受高致吐性化疗(HEC)的患者在第1、3天(延长组)和第1天(常规组)给予福沙匹坦150mg的疗效和安全性。所有患者也在第1天接受帕洛诺司琼治疗,在第1-3天接受DEX治疗。主要终点是迟发性恶心和呕吐的发生率。第二个终点是AE。所有上述终点均根据CTCAE5.0定义。
结果:77名患者被随机分配到延长组,79名患者被随机分配到常规组。延长组在控制延迟CINV方面优于常规组,具有统计学意义的较低的恶心发生率(6.17%vs12.66%,P=0.0056),1级呕吐的发生率略低(1.62%vs3.80%,P=0.0953)在延迟阶段。此外,长期使用福沙吡坦是安全的.两组在便秘方面无显著差异,腹泻,咳嗽,疲劳,心悸和头痛在延迟期。
结论:在接受HEC的患者中,长期使用福沙吡坦可以有效且安全地预防延迟的CINV。
BACKGROUND: Even though chemotherapy-induced nausea and vomiting (CINV) can be well controlled in the acute phase, the incidence of delayed CINV remains high. In this study, we intend to investigate whether
prolonged use of NK-1 receptor antagonist (RA) in addition to 5-HT3 RA and dexamethasone (DEX) was more effective in preventing delayed CINV.
METHODS: This randomised, open-label, controlled study was designed to compare the efficacy and safety of fosaprepitant 150 mg given on days 1,3 (prolonged group) versus on day 1 (regular group) in patients receiving highly emetogenic chemotherapy (HEC). All patients also treated with palonosetron on day 1 and DEX on days 1-3. The primary endpoint was the incidence of delayed nausea and vomiting. The second endpoint was AEs. All the above endpoints were defined according to CTCAE 5.0.
RESULTS: Seventy-seven patients were randomly assigned to
prolonged group and seventy-nine to regular group.
Prolonged group demonstrated superiority in controlling delayed CINV to regular group, with statistically significant lower incidence of nausea (6.17% vs 12.66%, P = 0.0056), and slightly lower incidence of grade 1 vomiting (1.62% vs 3.80%, P = 0.0953) in the delayed phase. In addition,
prolonged use of fosaprepitant was safe. No significant difference was found between the two groups regarding constipation, diarrhea, hiccough, fatigue, palpitation and headache in delayed phase.
CONCLUSIONS: Prolonged use of fosaprepitant can effectively and safely prevent delayed CINV in patients receiving HEC.