Segawa, Y., Aogi, K., Inoue, K., Sano, M., Sekine, I., Tokuda, Y., … Atagi, S. (2009). A phase II dose-ranging study of palonosetron in Japanese patients receiving moderately emetogenic chemotherapy, including anthracycline and cyclophosphamide-based chemotherapy. Annals of Oncology, 20, 1874–1880.
To identify the most effective dose of palonosetron when combined with fixed doses of dexamethasone in patients receiving chemotherapy of emetogenicity level 3 or 4 on the National Comprehensive Cancer Network (NCCN) 2004 guidelines
Patients were randomly assigned to receive a single IV dose of palonosetron of 0.075, 0.25 or 0.75 mg over 30 seconds administered 30 minutes before the first dose of chemotherapy on day one. Daily episodes of vomiting, severity of nausea, and patient satisfaction were recorded daily in patient diaries. Care providers recorded the use of rescue medications. All patients received 8 mg IV dexamethasone 45 minutes prior to the palonosetron. Patients had to be hospitalized for the first two days. Follow-up assessment was done on days 6–10 and days 14–20.
The study was conducted at multisite, inpatient settings in Japan.
All patients were in active treatment.
This was a randomized, double-blind trial.
Palonosetron in single doses from 0.075 to 0.75 mg appeared to be well tolerated. Optimal dosages for prevention and management of chemotherapy-induced nausea and vomiting (CINV) in these patients remain unclear.
The optimal dosage of palonosetron in patients who are receiving moderately emetogenic chemotherapy (MEC) remains unclear. A range of doses appears to be well tolerated.