Fabi, A., Ciccarese, M., Metro, G., Savarese, A., Giannarelli, D., Nuzzo, C.M., … Cognetti, F. (2008). Oral ondansetron is highly active as rescue antiemetic treatment for moderately emetogenic chemotherapy: Results of a randomized phase II study. Supportive Care in Cancer, 16, 1375–1380.
To test the efficacy and safety of two different schedules of ondansetron as rescue antiemetic treatment in patients who were refractory to standard antiemetic prophylaxis for delayed emesis following moderately emetogenic chemotherapy (MEC)
Patients were randomly allocated to one of two treatment groups for rescue antiemetic treatment: intramuscular ondansetron 8 mg or oral ondansetron 16 mg for days two to six (antiemetic prophylaxis was provided by ondansetron 8 mg IV plus dexamethasone 8 mg IV for acute emesis and dexamethasone 8 mg for four days for delayed emesis).
The study was conducted at a single site, outpatient setting.
All patients were in active treatment.
The study design was a prospective trial (open label, phase II, randomly assigned to treatment group).
Oral ondansetron 16 mg was significantly superior to intramuscular ondansetron 8 mg for nausea and vomiting control during days two to six (p < 0.01). The two arms had a similar adverse event profile. A higher degree of personal satisfaction was found with oral ondansetron.
Because of its high efficacy and excellent tolerability, oral ondansetron is an important option in the management of MEC-related delayed emesis refractory to standard antiemetic prophylaxis.
The oral form of ondansetron could provide satisfactory rescue for breakthrough delayed emesis when compared to the Intramuscular form of ondansetron, with a similar adverse event profile.