Abstract
Context
There are no prospective pediatric trials evaluating olanzapine for chemotherapy-induced nausea and vomiting (CINV) prevention.
Objective
This study evaluated the feasibility of a trial of olanzapine to evaluate the contribution of olanzapine to CINV control in pediatric oncology patients.
Methods
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.
Results
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.
Conclusion
A pediatric trial of olanzapine for CINV control is feasible. Our findings will inform the design of a future study.
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Acknowledgements
This research was supported by the Pediatric Oncology Group of Ontario Research Unit. We are sincerely grateful to the children who participated in this study and their parents. We also thank the clinical staff of each participating institution for their support of the study and Ms. Mila Khanna, Clinical Research Coordinator, SickKids, for logistical support.
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The authors declare that they have no conflict of interest.
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This multi-center, prospective, open-label study was approved by Health Canada and the Research Ethics Board of each participating institution (SickKids; Children’s Hospital, London Health Sciences Centre (CH-LHS); and Children’s Hospital of Eastern Ontario (CHEO)).
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Flank, J., Schechter, T., Gibson, P. et al. Olanzapine for prevention of chemotherapy-induced nausea and vomiting in children and adolescents: a multi-center, feasibility study. Support Care Cancer 26, 549–555 (2018). https://doi.org/10.1007/s00520-017-3864-8
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DOI: https://doi.org/10.1007/s00520-017-3864-8