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静脉推注 HTX-019 用于癌症患者的安全性特征:回顾性研究。

Safety profile of HTX-019 administered as an intravenous push in cancer patients: a retrospective review.

机构信息

Division of Hematology Oncology, University of Alabama at Birmingham, Birmingham, AL, USA.

出版信息

Expert Opin Drug Saf. 2020 Feb;19(2):205-210. doi: 10.1080/14740338.2020.1691521. Epub 2019 Nov 14.

DOI:10.1080/14740338.2020.1691521
PMID:31709853
Abstract

: HTX-019 (Cinvanti®) is a novel injectable emulsion formulation of the neurokinin 1 receptor antagonist (RA) aprepitant, approved (as 30-min infusion and 2-min injection) for preventing acute and delayed chemotherapy-induced nausea and vomiting (CINV). This retrospective analysis evaluated the safety of HTX-019 administered by 2-min injection in patients with cancer.: At a single center, HTX-019 was evaluated as a 2-min injection within a guideline-recommended three-drug regimen for CINV prophylaxis in patients receiving highly (HEC) or moderately emetogenic chemotherapy (MEC). Treatment-emergent adverse events (TEAEs) were assessed 0-60 minutes following initiation of HTX-019 administration, focusing on infusion-site adverse events and hypersensitivity reactions.: Among 600 patients (78 MEC, 522 HEC), the most common diagnoses were lung (172) and breast (129) cancer. Patients received a 2-min injection of HTX-019, followed by a 5-hydroxytryptamine type 3 RA intravenously (IV) (palonosetron or ondansetron), dexamethasone IV, and chemotherapy regimen (most common was cisplatin-containing) via a central (76%) and peripheral line (24%). No TEAEs occurred within 60 min after start of HTX-019 administration.: HTX-019 administered by 2-min injection has a tolerable safety profile in patients with cancer, representing a viable method of HTX-019 administration for CINV prevention.

摘要

: HTX-019(Cinvanti®)是一种新型的神经激肽 1 受体拮抗剂(NK1RA)阿瑞匹坦注射用乳剂,已被批准(作为 30 分钟输注和 2 分钟注射)用于预防急性和延迟性化疗引起的恶心和呕吐(CINV)。这项回顾性分析评估了 HTX-019 作为 2 分钟注射剂在接受高(HEC)或中度致吐性化疗(MEC)的癌症患者中进行三药方案预防 CINV 的安全性。: 在一个单中心,HTX-019 被评估为 2 分钟注射剂,作为三药方案的一部分,用于预防接受高(HEC)或中度致吐性化疗(MEC)的癌症患者的 CINV。在开始 HTX-019 治疗后 0-60 分钟评估治疗中出现的不良事件(TEAEs),重点关注输注部位不良事件和过敏反应。: 在 600 名患者(78 例 MEC,522 例 HEC)中,最常见的诊断是肺癌(172 例)和乳腺癌(129 例)。患者接受了 HTX-019 的 2 分钟注射,随后静脉注射(IV)给予 5-羟色胺 3 受体拮抗剂(帕洛诺司琼或昂丹司琼)、地塞米松 IV 和化疗方案(最常见的是含顺铂),通过中央(76%)和外周线(24%)。HTX-019 给药后 60 分钟内未发生 TEAEs。: 在癌症患者中,HTX-019 经 2 分钟注射给药具有可耐受的安全性,为预防 CINV 提供了一种可行的 HTX-019 给药方法。

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