奥氮平预防接受高度致吐性化疗的儿童和青少年呕吐：研究者发起的、随机、开放标签试验。
Olanzapine for Prevention of Vomiting in Children and Adolescents Receiving Highly Emetogenic Chemotherapy: Investigator-Initiated, Randomized, Open-Label Trial.
机构信息
Department of Medical Oncology, All India Institute of Medical Sciences, New Delhi, India.
Department of Biostatistics, All India Institute of Medical Sciences, New Delhi, India.
出版信息
J Clin Oncol. 2020 Nov 10;38(32):3785-3793. doi: 10.1200/JCO.20.00871. Epub 2020 Sep 15.
PURPOSE
Chemotherapy-induced nausea and vomiting (CINV) is a significant toxicity of chemotherapy. Olanzapine is recommended in adult patients for the prevention of CINV but has not been prospectively investigated in children.
METHODS
This investigator-initiated, randomized, open-label trial evaluated olanzapine in children (ages 5-18 years) scheduled to receive the first cycle of highly emetogenic chemotherapy (HEC). All participants received aprepitant, ondansetron, and dexamethasone during and 2 days after chemotherapy. Participants in the study group additionally received oral olanzapine 0.14 mg/kg/day (rounded to the nearest 2.5 mg; maximum, 10 mg) during the chemotherapy block and 3 days postchemotherapy. The primary objective was to compare complete response (CR) rates (no vomiting and no rescue medication) between the groups in the acute, delayed, and overall periods. Nausea comparison and safety evaluation were secondary and additional objectives, respectively. The collection of outcomes and adverse events was performed daily until the completion of the overall period.
RESULTS
A total of 240 patients underwent randomization. We performed a modified intention-to-treat analysis on 231 patients (116 in the control group and 115 in the study group). A higher proportion of patients in the olanzapine group achieved CR in the acute period (78% 59%; = .001), delayed period (74% 47%; < .001) and overall period (64% 38%; < .001) than in the control group. The proportion of patients with no nausea was significantly higher in the olanzapine group in the acute period (74% 52%; < .001), delayed period (74% 47%; < .001), and overall period (64% 37%; < .001). Grade 1/2 somnolence was greater in the olanzapine group (35% 11%; < .001). There was no grade 3/4 somnolence reported.
CONCLUSION
Olanzapine significantly improved CR rates for vomiting in children receiving the first cycle of HEC.
目的
化疗引起的恶心和呕吐（CINV）是化疗的一种严重毒性。奥氮平被推荐用于预防成人的 CINV，但尚未在儿童中进行前瞻性研究。
方法
本项由研究者发起的、随机、开放标签试验评估了奥氮平在接受高度致吐性化疗（HEC）第一周期的儿童（5-18 岁）中的作用。所有参与者在化疗期间和化疗后 2 天内接受阿瑞匹坦、昂丹司琼和地塞米松。研究组的参与者还在化疗期间和化疗后 3 天内接受奥氮平 0.14mg/kg/天（四舍五入至最接近的 2.5mg；最大剂量 10mg）。主要目标是比较两组在急性、延迟和总体期的完全缓解（CR）率（无呕吐且无解救药物）。恶心比较和安全性评估分别是次要和额外的目标。在整个期间结束之前，每天进行结局和不良事件的采集。
结果
共 240 名患者接受了随机分组。我们对 231 名患者（对照组 116 名，研究组 115 名）进行了意向治疗的改良分析。奥氮平组在急性期（78% 59%； =.001）、延迟期（74% 47%； <.001）和总体期（64% 38%； <.001）的 CR 比例均高于对照组。奥氮平组在急性期（74% 52%； <.001）、延迟期（74% 47%； <.001）和总体期（64% 37%； <.001）的无恶心患者比例显著更高。奥氮平组 1/2 级嗜睡的发生率更高（35% 11%； <.001）。没有报告 3/4 级嗜睡。
结论
奥氮平可显著提高接受 HEC 第一周期化疗的儿童的呕吐 CR 率。
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