To reduce side-effects of corticosteroid-containing antiemetic regimens, tailoring
antiemetic schedules to specific requirements of different patients could be of benefit.
We evaluated the possibility to reduce the total dose of corticosteroids when palonosetron,
a long-acting second-generation 5-hydroxytryptamine-3 (5-HT(3)) receptor antagonist,
Double-blind, multicentre, noninferiority study of chemotherapy-naive breast cancer
patients receiving 0.25 mg palonosetron and 8 mg dexamethasone on day 1, randomly
assigned to receive placebo (n = 151) or 4 mg b.i.d. dexamethasone (n = 149) on days
2 and 3. Primary end point was complete response (CR) rate (no emesis, no rescue medication)
in the overall (days 1-5) period. Secondary end points were CR rates in the acute
(day 1) and delayed (days 2-5) periods, rates of no emesis and no nausea and impact
on daily functioning (Functional Living Index-Emesis).
Noninferiority between the two treatments was demonstrated by similar CR rates (P
= 0.487) in the overall period. Most parameters showed that palonosetron and dexamethasone
on day 1 only offer chemotherapy-induced nausea and vomiting protection similar to
multiple-day dexamethasone administration.
In patients treated with a single injection of palonosetron on day 1, reducing dexamethasone
is an option that is not associated with significant reduction in antiemetic control
during the 5-day period or an impact on patient functioning.