Dexamethasone-Free Antiemetic Prophylaxis for Children and Adolescents Receiving Highly Emetogenic Chemotherapy: A Multicenter, Phase III, Noninferiority Trial (CIVIC POD)

In the phase 3 CIVIC POD noninferiority trial, replacing dexamethasone with olanzapine controlled vomiting no worse than standard prophylaxis in 310 children and adolescents aged 4-18 receiving highly emetogenic chemotherapy. Complete response for vomiting over the whole 0-120 hour period was 63.5% with olanzapine versus 56.9% with dexamethasone (absolute difference 6.6%, 95% CI -4.5 to 17.7), meeting the prespecified noninferiority margin of -15%. Control of nausea was similar in both arms. The trade-off is sedation: any-grade somnolence occurred in 50.7% of children on olanzapine versus 17.2% on dexamethasone.