Purpose: In a prospective crossover study, we evaluated the safety and antiemetic activity of granisetron, a 5-hydroxytryptamine3 (5-HT3) receptor antagonist, compared with conventional antiemetics regimen, including metoclopramide, in pediatric cancer patients.
Patients and methods: Twenty-two children with malignant diseases were enrolled. The chemotherapy included cytarabine 3 g/m2 (regimen A), cisplatin 90 mg/m2 (regimen B), and actinomycin D 900 micrograms/m2 plus ifosfamide 3 g/m2 (regimen C). Granisetron 40 micrograms/kg was infused over 30 min just before each chemotherapy treatment.
Results: A complete response was obtained more often with granisetron than with conventional antiemetics (59.1% vs. 0%, p < 0.001). In terms of efficacy by chemotherapy type, complete response with granisetron was obtained in eight of 10 patients with regimen A, three of eight with regimen B, and two of four with regimen C. Major efficacy (vomiting fewer than two times) was also obtained more with granisetron than with conventional antiemetics (81.8% vs. 4.6%, p < 0.001). The number of vomiting episodes in the first 24 h was less with granisetron than with conventional antiemetics (1.1 +/- 1.46 vs. 9.0 +/- 4.97, p < 0.001). Normal appetite and activity were retained in more patients with granisetron than with conventional antiemetics. Extrapyramidal reactions, akathisia, and sedation were not seen in any case with granisetron.
Conclusions: Granisetron 40 micrograms/kg is well tolerated and more effective than are conventional antiemetic regimens containing metoclopramide for children receiving cancer chemotherapy.