Ondansetron was given as
anti-emetic prophylaxis to 429 children receiving a variety of emetogenic
cancer treatments for up to 8 days, in three, open, multicentre, European studies. Children aged between 6 months and 17 years with a variety of tumours and receiving
chemotherapy or
chemotherapy plus total body irradiation (TBI) were studied.
Ondansetron was given intravenously, 5 mg/m2 or 8 mg, according to the surface area of the child, immediately before
chemotherapy. Intravenous or oral treatment (2, 4 or 8 mg, according to surface area) was continued 3 times a day during
chemotherapy or TBI, and for a further 2 days (non-
cisplatin chemotherapy or TBI) or 5 days (
cisplatin chemotherapy). The number of vomits and retches (each counting as an
emetic episode) were recorded daily, as was an assessment of
nausea, which was graded as none (not feeling sick at all), mild (feeling sick) or severe (feeling very sick). Responses were graded according to the number of
emetic episodes during the worst 24-hour period. In addition, response was expressed in terms of
emesis-free days as a proportion of all
ondansetron treatment days. During
chemotherapy, 66% of children experienced less than 3
emetic episodes on their 'worst day' and 88% had none or mild
nausea. Sixty-eight percent of all
ondansetron treatment days (2,131) were free of
emesis. Of the patients who were poorly controlled with 'customary'
anti-emetics, at least 81% experienced better control with
ondansetron. When analysed according to the most emetogenic agent given 36, 59 and 75% of children reported less than 3
emetic episodes on their 'worst day' respectively, during
cisplatin,
ifosfamide and other less emetogenic
chemotherapy. During conditioning for
bone marrow transplantation with
cyclophosphamide and TBI, 80 and 57% of patients, respectively, experienced less than 3
emetic episodes. The overall incidence of adverse events was low and
headache (reported in 4% of patients) was the only event reported by more than 1% of patients. These studies show that
ondansetron is a safe, well tolerated and an effective
anti-emetic in the treatment of children receiving a wide variety of
chemotherapy regimens.