Division of Medical Oncology, Department of Internal Medicine, College of Medicine, The Catholic University of Korea, Seoul St. Mary's Hospital, Seoul, Korea.
Division of Hemato-Oncology, Department of Internal Medicine, Kangdong Sacred Heart Hospital, Hallym University College of Medicine, Seoul, Korea.
Cancer Res Treat. 2020 Jul;52(3):907-916. doi: 10.4143/crt.2019.713. Epub 2020 Mar 18.
The purpose of this study was to compare ramosetron (RAM), aprepitant (APR), and dexamethasone (DEX) [RAD] with palonosetron (PAL), APR, and DEX [PAD] in controlling highly-emetogenic chemotherapy (HEC)-induced nausea and vomiting.
Patients were randomly assigned (1:1) to receive RAD or PAD:RAM (0.3 mg intravenously) or PAL (0.25 mg intravenously) D1, combined with APR (125 mg orally, D1 and 80 mg orally, D2-3) and DEX (12 mg orally or intravenously, D1 and 8 mg orally, D2-4). Patients were stratified by sex, cisplatin-based chemotherapy, and administration schedule. The primary endpoint was overall complete response (CR), defined as no emesis and no rescue regimen during 5 days of HEC. Secondary endpoints were overall complete protection (CP; CR+nausea score < 25 mm) and total control (TC; CR+nausea score < 5 mm). Quality of life was assessed by Functional Living Index Emesis (FLIE) questionnaire on D0 and D6.
A total of 279 patients receiving RAD (n=137) or PAD (n=142) were evaluated. Overall CR rates in RAD and PAD recipients were 81.8% and 79.6% (risk difference [RD], 2.2%; 95% confidence interval [CI], -7.1 to 11.4), respectively. Overall CP and TC rates for RAD and PAD were 56.2% and 58.5% (RD, -2.3%; 95% CI, -13.9 to 9.4) and 47.5% vs. 43.7% (RD, 3.8%; 95% CI, -7.9 to 15.5), respectively. FLIE total score ≥ 108 (no impact on daily life) was comparable between RAD and PAD (73.9% vs. 73.4%, respectively). Adverse events were similar between the two groups.
In all aspects of efficacy, safety and QOL, RAD is non-inferior to PAD for the control of CINV in cancer patients receiving HEC.
本研究旨在比较雷莫司琼（RAM）、阿瑞匹坦（APR）和地塞米松（DEX）[RAD]与帕洛诺司琼（PAL）、APR 和 DEX[PAD]在控制高度致吐性化疗（HEC）引起的恶心和呕吐方面的效果。
患者按 1:1 随机分配（随机分组）接受 RAD 或 PAD：RAM（静脉内 0.3 mg）或 PAL（静脉内 0.25 mg），D1，联合 APR（口服 125 mg，D1 和 80 mg 口服，D2-3）和 DEX（口服或静脉内 12 mg，D1 和 8 mg 口服，D2-4）。患者按性别、顺铂类化疗和给药方案分层。主要终点是总体完全缓解（CR），定义为 HEC 期间 5 天内无呕吐且无解救方案。次要终点是总体完全保护（CP；CR+恶心评分<25 mm）和总控制（TC；CR+恶心评分<5 mm）。在 D0 和 D6 通过功能性生活指数呕吐（FLIE）问卷评估生活质量。
共评估了 279 例接受 RAD（n=137）或 PAD（n=142）的患者。RAD 和 PAD 组的总体 CR 率分别为 81.8%和 79.6%（风险差[RD]，2.2%；95%置信区间[CI]，-7.1 至 11.4）。RAD 和 PAD 的总体 CP 和 TC 率分别为 56.2%和 58.5%（RD，-2.3%；95%CI，-13.9 至 9.4）和 47.5%与 43.7%（RD，3.8%；95%CI，-7.9 至 15.5）。RAD 和 PAD 的 FLIE 总分≥108（对日常生活无影响）分别为 73.9%和 73.4%。两组的不良事件相似。
在疗效、安全性和生活质量的各个方面，RAD 与 PAD 相比，在控制接受 HEC 的癌症患者的 CINV 方面均不劣效。
