In this pilot trial, the antiemetic efficacy and tolerability of an all-ora
l antiemetic combination in the prevention of both acute and delayed nausea
and vomiting following high-dose cisplatin was evaluated. Fifty-two patien
ts receiving cisplatin (median dose 100 mg/m(2)) were entered. Patients rec
eived (1) 60 min prior to cisplatin: prochlorperazine spansule 15 mg, dexam
ethasone 20 mg, granisetron 2 mg; (2) 12 h after cisplatin: prochlorperazin
e spansule 15 mg, dexamethasone 10 mg; (3) on days 2 and 3. prochlorperazin
e spansule 35 mg b.i.d., dexamethasone 8 mg b.i.d,, (4) on days 4 and 5: de
xamethasone 4 mg b.i.d. All antiemetics were administered orally. The study
period was the 120 h after cisplatin administration. The primary efficacy
end-point was complete control (no vomiting, retching or antiemetic rescue)
of delayed emesis (24-120 h after cisplatin), Complete control of delayed
emesis was achieved in 26 patients (53%), Nineteen patients (39%) noted no
delayed nausea. Complete control of acute emesis (24 h after cisplatin) was
attained in 44 patients (86%). The no nausea rate during the first 24 h wa
s 74%. Overall, 39 patients (80%) were satisfied or very satisfied with the
ir outcome, Treatment was well tolerated with infrequent and minor adverse
events. In conclusion, an ail-oral combination of granisetron, dexamethason
e and prochlorperazine is a highly effective and well-tolerated regimen for
preventing acute cisplatin-induced emesis, Control of delayed emesis was n
ot better than with current standard treatment, and more effective approach
es are needed.