Wang Lu, Jin Gaowa, Wang Wenjuan, Zhao Jun, Chen Feng, Li Xiaorong, Jiang Ying, Zhang Zewei, Li Quanfu
Ordos Clinical College, Inner Mongolia Medical University, Ordos, 017000, China.
Department of Medical Oncology, Ordos Central Hospital, 23th Yijinhuoluo Western Road, Ordos, 017000, China.
BMC Pharmacol Toxicol. 2025 Jul 1;26(1):126. doi: 10.1186/s40360-025-00964-6.
We aimed to compare the efficacy and safety of fosaprepitant plus triple therapy versus triple therapy alone, in terms of both routine and delayed regimen, in preventing chemotherapy-induced nausea and vomiting (CINV) in patients receiving three-day cisplatin-based treatment.
In a prospective randomized controlled trial, patients undergoing three-day cisplatin-based chemotherapy (25mg/m/day) received fosaprepitant plus triple therapy or triple therapy alone on day 1 (routine regimen). For the evaluation of the delayed regimen, the administration of fosaprepitant and/or olanzapine was delayed for 1 day. Efficacy and safety in overall phase (OP) were evaluated within 5 days after initiation of chemotherapy.
Fosaprepitant plus triple therapy achieved a higher total protection (TP) rate during OP than triple therapy alone (56.9% vs. 40.4%; P = 0.018). Fosaprepitant plus triple therapy also produced a higher TP rate than triple therapy alone during delay phase (DP) (57.8% vs. 40.4%; P = 0.012) but not during acute phase (AP) (88.2% vs. 86.5%; P = 0.714). In addition, fosaprepitant plus triple therapy achieved higher complete response (CR) rates than triple therapy alone during DP, but not during AP. The delayed regimen appeared to have produced higher TP and CR rates than the routine regimen, but the differences were not statistically significant. The Kaplan-Meier curves showed that fosaprepitant plus triple therapy delayed the first vomiting.
Fosaprepitant plus triple therapy demonstrated superiority over triple therapy alone for CINV control in patients receiving three-day cisplatin-based treatment.
This trial was registered in the China Clinical Trials Registry on December 8, 2020 (chiCTR2000040675).
我们旨在比较磷丙泊酚二钠联合三联疗法与单纯三联疗法在常规方案和延迟方案中预防接受为期三天的顺铂化疗患者化疗引起的恶心和呕吐（CINV）的疗效和安全性。
在一项前瞻性随机对照试验中，接受为期三天顺铂化疗（25mg/m²/天）的患者在第1天接受磷丙泊酚二钠联合三联疗法或单纯三联疗法（常规方案）。为评估延迟方案，将磷丙泊酚二钠和/或奥氮平的给药延迟1天。在化疗开始后5天内评估总体阶段（OP）的疗效和安全性。
在OP期间，磷丙泊酚二钠联合三联疗法的总保护（TP）率高于单纯三联疗法（56.9%对40.4%；P = 0.018）。在延迟阶段（DP），磷丙泊酚二钠联合三联疗法的TP率也高于单纯三联疗法（57.8%对40.4%；P = 0.012），但在急性期（AP）并非如此（88.2%对86.5%；P = 0.714）。此外，在DP期间，磷丙泊酚二钠联合三联疗法的完全缓解（CR）率高于单纯三联疗法，但在AP期间并非如此。延迟方案的TP和CR率似乎高于常规方案，但差异无统计学意义。Kaplan-Meier曲线显示，磷丙泊酚二钠联合三联疗法延迟了首次呕吐。
对于接受为期三天顺铂化疗的患者而言，在控制CINV方面，磷丙泊酚二钠联合三联疗法优于单纯三联疗法。
本试验于2020年12月8日在中国临床试验注册中心注册（注册号：chiCTR2000040675）。
