In a single-center Indian phase III trial reported in the Journal of Clinical Oncology, Naik et al found that the addition of olanzapine to standard antiemetic treatment significantly increased the rate of complete response (CR; defined as no vomiting or use of rescue medication) among children and adolescents receiving highly emetogenic chemotherapy.
Study Details
The investigator-initiated open-label trial included 231 patients aged 5–18 years (modified intent-to-treat population) scheduled to receive a first cycle of highly emetogenic chemotherapy at a tertiary care hospital in New Delhi. They were randomly assigned to receive aprepitant, ondansetron, and dexamethasone during the chemotherapy block and for 2 days after chemotherapy with (n = 115) or without (n = 116) oral olanzapine. Olanzapine was given at 0.14 mg/kg/d (rounded to the nearest 2.5 mg; to a maximum of 10 mg) during chemotherapy and for 3 days postchemotherapy. The primary objective was to compare rates of CR in the acute (after initiation up to 24 hours after completion of the chemotherapy block), delayed (24–120 hours after completion), and overall periods (after initiation up to 120 hours postchemotherapy).
KEY POINTS
- For the olanzapine vs control groups, CR rates were 78% vs 59% in the acute period, 74% vs 47% in the delayed period, and 64% vs 38% in the overall period.
- For the olanzapine vs control groups, the proportions of patients with no nausea were 74% vs 52% in the acute period, 74% vs 47% in the delayed period, and 64% vs 37% in the overall period.
- Rescue medication was received by 13% vs 21% of patients.
Key Findings
For the olanzapine vs control groups, CR rates were 78% vs 59% (P = .001) in the acute period, 74% vs 47% (P < .001) in the delayed period, and 64% vs 38% (P < .001) in the overall period.
For the olanzapine vs control groups, the proportions of patients with no nausea were 74% vs 52% (P < .001) in the acute period, 74% vs 47% (P < .001) in the delayed period, and 64% vs 37% (P < .001) in the overall period.
Rescue medication was received by 13% vs 21% of patients (P = .12).
Grade 3 or 4 adverse events occurred in four patients in the olanzapine group (abdominal pain in 2, diarrhea in 2) vs two in the control group (abdominal pain and mucositis in 1 each). The frequency of grade 1 or 2 somnolence was greater in the olanzapine group (35% vs 11%, P < .001).
The investigators concluded, “Olanzapine significantly improved CR rates for vomiting in children receiving the first cycle of highly emetogenic chemotherapy.”
Sameer Bakhshi, MD, of the Department of Medical Oncology, All India Institute of Medical Sciences, New Delhi, is the corresponding author for the Journal of Clinical Oncology article.
Disclosure: For full disclosures of the study authors, visit ascopubs.org.
