Cancer Res Treat.  2004 Dec;36(6):372-376.

Open-label, Randomized Comparison of the Efficacy of Intravenous Dolasetron Mesylate and Ondansetron in the Prevention of Acute and Delayed Cisplatin-induced Emesis in Cancer Patients

• Kim JS
• Baek JY
• Park SR
• Choi IS
• Kim SI
• Kim DW
• Im SA
• Kim TY
• Heo DS
• Bang YJ
• Kim NK

Abstract

PURPOSE
The aim of this study is to compare the antiemetic efficacy and tolerability of intravenous dolasetron mesylate and ondansetron in the prevention of acute and delayed emesis. MATERIAL AND METHODS: From April 2002 through October 2002, a total of 112 patients receiving cisplatin- based combination chemotherapy were randomized to receive a single i.v. dose of dolasetron 100 mg or ondansetron 8 mg, 30 minutes before the initiation of chemotherapy. In the ondansetron group, two additional doses of ondansetron 8 mg were given at intervals of 2 to 4 hours. To prevent delayed emesis, dolasetron 200 mg p.o. daily or ondansetron 8 mg p.o. bid was administered from the 2nd days to a maximum of 5 days. The primary end point was the proportion of patients that experienced no emetic episodes and required no rescue medication (complete response, CR) during the 24 hours (acute period) and during Day 2 to Day 5 2 days (delayed period), after chemotherapy. The secondary end points included the incidence and severity of emesis. RESULTS: 105 patients were evaluable for efficacy. CR rates during the acute period were 36.0% for a single dose of dolasetron 100 mg, and 43.6% for three doses of ondansetron 8 mg. CR rates during the delayed period were 8.0% and 10.9%, respectively. There was no significant difference in the efficacy between the two groups. Adverse effects were mostly mild to moderate and not related to study medication. CONCLUSIONS: A single i.v. dose of dolasetron 100 mg is as effective as three i.v. doses of ondansetron 8 mg in preventing acute and delayed emesis after cisplatin- based chemotherapy, with a comparable safety profile.

Keyword

Dolasetron mesylate; 5-HT3 receptor antagonist; Antiemetics; Nausea; Vomiting; Ondansetron

MeSH Terms

Antiemetics
Drug Therapy
Drug Therapy, Combination
Humans
Incidence
Mesylates*
Nausea
Ondansetron*
Vomiting*
Antiemetics
Mesylates
Ondansetron

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