Journal of Clinical Oncology, Vol 10, 1969-1975, Copyright © 1992 by American Society of Clinical Oncology
Stratified, randomized, double-blind comparison of intravenous ondansetron administered as a multiple-dose regimen versus two single- dose regimens in the prevention of cisplatin-induced nausea and vomiting
TM Beck, PJ Hesketh, S Madajewicz, RM Navari, K Pendergrass, EP Lester, JA Kish, WK Murphy, JD Hainsworth and DR Gandara
Mountain States Tumor Institute, Boise, ID 82712-6297.
PURPOSE: This study compares the efficacy and safety of two single-dose
regimens with the approved three-dose regimen of ondansetron in the
prevention of cisplatin-induced emesis. PATIENTS AND METHODS: This
multicenter study was a stratified, randomized, double-blind, and parallel
group design. Chemotherapy-naive inpatients were randomized to receive
intravenous (IV) ondansetron (Zofran; Glaxo Inc, Research Triangle Park,
NC) 0.15 mg/kg times three doses, every 4 hours or a single 8-mg or 32-mg
dose followed by two saline doses that began 30 minutes before cisplatin
administration. Cisplatin (high-dose > or = 100 mg/m2 or medium-dose 50
to 70 mg/m2) was given as a single infusion (< or = 3 hours). Patients
were monitored for emetic episodes, adverse events, and laboratory safety
parameters for 24 hours after cisplatin administration. RESULTS: A total of
699 patients (359 high-dose, 340 medium-dose) were enrolled. Of these, 618
were assessable for efficacy (15 ineligible, 66 protocol deviations). The
32-mg dose was superior to the 8-mg single dose with regard to total number
of emetic episodes (high-dose, P = .015; medium-dose, P < .001),
complete response (no emetic episodes: high-dose, 48% v 35%; P = .048;
medium-dose, 73% v 50%; P = .001) and failure rate (> 5 emetic episodes,
withdrawn or rescued: high-dose, 20% v 34%; P = .018; medium-dose, 9% v
23%; P = .005). The 32-mg single dose was also superior to the 0.15 mg/kg
times three dose regimen with regard to total number of emetic episodes
(medium-dose, P = .033) and failure rate (high-dose, 20% v 36%; P = .009;
medium-dose, 9% v 22%; P = .011). Ondansetron was well tolerated. The most
common adverse event was headache. An approximate 10-fold increase in the
incidence of clinically significant transaminase elevations was observed in
the high-dose versus medium-dose cisplatin strata (aspartate
aminotransferase [AST], 6.5% v 0.7%; serum alanine aminotransferase [ALT],
5.0% v 0.3%). CONCLUSION: A 32-mg single dose of ondansetron is more
effective than a single 8-mg dose and is at least as effective as the
standard regimen of 0.15 mg/kg times three doses in the prevention of
cisplatin-induced acute emesis.
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