Celio, L., Denaro, A., Agustoni, F., & Bajetta, E. (2012). Palonosetron plus 1-day dexamethasone for the prevention of nausea and vomiting due to moderately emetogenic chemotherapy: Effect of established risk factors on treatment outcome in a phase III trial. The Journal of Supportive Oncology, 10(2), 65–71.
To verify whether the noninferiority hypothesis of a dexamethasone sparing regimen can be demonstrated even after adjustment for known risk factors for developing CINV and to assess the impact of the risk factors studied on antiemetic outcome
Chemotherapy-naïve patients received 0.25 mg IV palonosetron and 8 mg IV dexamethasone on day 1. Patients were randomly assigned to no additional dexamethasone (1 day dexamethasone regimen) or 8 mg oral dexamethasone on days 2–3 (3-day dexa regimen). After chemotherapy, rescue medication, including dexamethasone or metoclopramide, were permitted on an as-needed basis.
The study was conducted at multiple sites (not specified) in Italy.
This was a prespecified, posthoc analysis of a randomized, multicenter, phase III trial.
The analysis confirmed that the palonosetron plus one-day dexamethasone regimen provides a valid treatment option for prevention of CINV in delayed, non-AC-based MEC. However, these findings are not applicable to younger patients undergoing AC-based chemotherapy as the palonosetron plus three-day dexamethasone regimen achieved statistically better nausea control in this population.
Younger patients were mostly women undergoing AC chemotherapy and, primarily, no history of alcohol consumption. A 15% margin was set for the noninferiority analysis, which is still a highly clinically relevant difference.
Administration of palonosetron with single-day dexamethasone could be recommended for the patients undergoing non-AC-based MEC for the control of delayed CINV, considering the side effects of dexamethasone. This was a noninferiority analysis, meaning that researchers accepted a 15% difference in rate of control as no real difference. Nurses need to be aware of the implications of this type of trial and judge whether lack of CINV control in 15% of patients is acceptable. As the study demonstrated, the palonosetron with three-day dexamethasone regimen is still recommended for the control of nausea, especially for younger patients receiving AC-based chemotherapy.