Maemondo, M., Masuda, N., Sekine, I., Kubota, K., Segawa, Y., Shibuya, M., … PALO Japanese Cooperative Study Group. (2009). A phase II study of palonosetron combined with dexamethasone to prevent nausea and vomiting induced by highly emetogenic chemotherapy. Annals of Oncology, 20, 1860–1866.
To evaluate the safety, efficacy, and pharmacokinetics of palonosetron, in combination with dexamethasone in patients receiving highly emetogenic chemotherapy (HEC)
Patients were randomized to 1 of 3 single doses of palonosetron, IV bolus (0.075, 0.25, or 0.75 mg), before administration of HEC. Subjects also received dexamethasone (12–16 mg IV on day 1, 8 mg on day 2, and 4–8 mg on day 3). All patients were hospitalized at least one day after palonosetron administration. Patients were followed up to five days. Patients used a diary to record episodes of vomiting, degree of nausea, and use of rescue medication.
The study was conducted at multiple sites in Japan.
All patients were in active treatment.
This was a randomized, double blind, dose-ranging study.
Palonosetron at doses of 0.25 mg and 0.75 mg was shown to be effective in preventing chemotherapy-induced nausea and vomiting (CINV) in the acute phase in patients treated with HEC. CR rates in the delayed phase were less than 60% overall.
Increasing the dose of palonosetron on day one could contribute to better control of CINV during the delayed and overall phases of HEC.