Research Institute, The Hospital for Sick Children, 555 University Ave, Toronto, ON, M5G 1X8, Canada.
Children's Hospital, London Health Sciences Centre, London, Canada.
Support Care Cancer. 2018 Feb;26(2):549-555. doi: 10.1007/s00520-017-3864-8. Epub 2017 Aug 30.
There are no prospective pediatric trials evaluating olanzapine for chemotherapy-induced nausea and vomiting (CINV) prevention.
This study evaluated the feasibility of a trial of olanzapine to evaluate the contribution of olanzapine to CINV control in pediatric oncology patients.
Patients < 18 years receiving CINV prophylaxis with ondansetron/granisetron/palonosetron ± dexamethasone ± aprepitant were eligible to participate in this prospective, single-arm, open-label study. All patients received olanzapine (0.14 mg/kg/dose; max 10 mg/dose) once daily orally starting before the first chemotherapy dose and continuing for up to four doses after the last chemotherapy administration. A future trial was considered feasible if mean time to enroll 15 patients was ≤ 12 months/site, ≥ 12/15 took at least half of the planned olanzapine doses, and ≤ 3/15 experienced significant sedation or dizziness despite dose reduction. The proportion of children who experienced complete CINV control (no nausea, vomiting, or retching) was described.
Fifteen patients (range 4.1-17.4 years) participated; mean recruitment period was 9.3 months/site. All patients took at least half of the planned olanzapine doses. Six patients experienced sedation which resolved with olanzapine dose reduction (N = 5) or bedtime administration (N = 1). Olanzapine was stopped in one patient with blurry vision and in another with increased plasma GGT values. In both the acute and delayed phases, eight patients experienced complete control of vomiting but almost all (14/15) had nausea.
A pediatric trial of olanzapine for CINV control is feasible. Our findings will inform the design of a future study.
目前尚无评估奥氮平预防化疗引起的恶心和呕吐（CINV）的儿科前瞻性试验。
本研究评估了奥氮平用于儿科肿瘤患者 CINV 控制的试验的可行性。
接受恩丹西酮/格拉司琼/帕洛诺司琼+地塞米松+阿瑞匹坦预防 CINV 的<18 岁患者符合本前瞻性、单臂、开放标签研究的入组条件。所有患者均接受奥氮平（0.14mg/kg/剂量；最大 10mg/剂量），在首次化疗前每日一次口服给药，在末次化疗后最多连续 4 天给药。如果每个研究中心招募 15 名患者的平均时间≤12 个月，≥12/15 名患者至少服用了计划奥氮平剂量的一半，且≤3/15 名患者尽管剂量减少但仍出现明显镇静或头晕，则认为未来的试验是可行的。描述了经历完全 CINV 控制（无恶心、呕吐或干呕）的儿童比例。
共 15 名患者（年龄范围为 4.1-17.4 岁）参与了研究；每个中心的平均招募时间为 9.3 个月。所有患者均至少服用了计划奥氮平剂量的一半。6 名患者出现镇静，通过减少奥氮平剂量（N=5）或睡前给药（N=1）解决。1 名患者因视力模糊和另 1 名患者因血浆 GGT 值升高而停用奥氮平。在急性和迟发性阶段，8 名患者呕吐完全得到控制，但几乎所有患者（14/15）均有恶心。
奥氮平治疗儿科 CINV 控制的试验是可行的。我们的研究结果将为未来的研究设计提供信息。
