Aapro, M.S., Grunberg, S.M., Manikhas, G.M., Olivares, G., Suarez, T., Tjulandin, S.A. ... Macciocchi, A. (2006). A phase III, double-blind, randomized trial of palonosetron compared with ondansetron in preventing chemotherapy-induced nausea and vomiting following highly emetogenic chemotherapy. Annals of Oncology, 17(9), 1441–1449.

To evaluate the safety and efficacy of palonosetron at two different doses (0.25 mg versus 0.75 mg) compared with a single dose of 32 mg ondansetron in preventing chemotherapy-induced nausea and vomiting (CINV) after highly-emetogenic chemotherapy

Patients were assigned to one of three treatment arms: palonosetron 0.25 mg, palonosetron 0.75 mg, and ondansetron 32 mg.

The  study consisted of 673 patients, and final data were reported on 667 patients.

This was a phase III, multinational, randomized, double-blind, double-dummy, stratified, parallel-group, active-comparator trial.

• Patient diaries were used to record emetic episodes, nausea, and use of rescue medications.
• The Functional Living Index-Emesis (FLIE) was used.

Equal results were reported for palonosetron and ondansetron in the first 24 hours. In the delayed and overall phases, palonosetron (regardless of dose) was associated with higher complete response (CR) rates compared with ondansetron.