Celio, L., Frustaci, S., Denaro, A., Buonadonna, A., Ardizzoia, A., Piazza, E., … Italian Trials in Medical Oncology Group. (2010). Palonosetron in combination with 1-day versus 3-day dexamethasone for prevention of nausea and vomiting following moderately emetogenic chemotherapy: A randomized, multicenter, phase III trial. Supportive Care in Cancer,19, 1217–1225.
To assess the efficacy of palonosetron plus dexamethasone given once in preventing acute and delayed chemotherapy-induced nausea and vomiting (CINV) with moderately emetogenic chemotherapy (MEC) regimens
All patients received a single IV dose of 0.25 mg palonosetron and 8 mg dexamethasone before chemotherapy on day 1. Patients then were randomized to one of two delayed antiemetic regimens: no additional dexamethasone or 8 mg dexamethasone daily on days 2 and 3. Rescue medication of dexamethasone or metoclopramide was allowed as needed. In patient diaries, participants recorded emetic events, use of rescue medication, and maximum nausea experience.
The study was conducted in multiple sites in Italy.
All patients were in active treatment.
This was a randomized, open-label, parallel group trial.
Patients recorded the number and time of emetic episodes, use of rescue medications, maximum nausea in the previous 24 hours, adverse events, and use of concomitant medication in patient diaries.
The following were measured.
Palonosetron plus single-dose dexamethasone administered before common MEC regimens was not as effective as palonosetron plus dexamethasone for three days in the prevention of CINV.
For patients receiving non-AC MEC chemotherapy, and especially male patients, single-dose palonosetron and dexamethasone could be an option, considering side effects from multiday use of dexamethasone. However, as the study suggested, the need for rescue medication was higher in this group compared with the three-day dexamethasone regimen during the delayed phase.