Cancer Res Treat.  2014 Jan;46(1):19-26.

A Randomized Double-Blind, Double-Dummy, Multicenter Trial of Azasetron versus Ondansetron to Evaluate Efficacy and Safety in the Prevention of Delayed Nausea and Vomiting Induced by Chemotherapy

• Lee HY
• Kim HK
• Lee KH
• Kim BS
• Song HS
• Yang SH
• Kim JH
• Kim YH
• Kim JG
• Kim SW
• Kim DW
• Kim SY
• Park HS

Abstract

PURPOSE
This study was conducted to evaluate the efficacy and safety of azasetron compared to ondansetron in the prevention of delayed chemotherapy-induced nausea and vomiting.
MATERIALS AND METHODS
This study was a multi-center, prospective, randomized, double-dummy, double-blind and parallel-group trial involving 12 institutions in Korea between May 2005 and December 2005. A total of 265 patients with moderately and highly emetogenic chemotherapy were included and randomly assigned to either the azasetron or ondansetron group. All patients received azasetron (10 mg intravenously) and dexamethasone (20 mg intravenously) on day 1 and dexamethasone (4 mg orally every 12 hours) on days 2-4. The azasetron group received azasetron (10 mg orally) with placebo of ondansetron (orally every 12 hours), and the ondansetron group received ondansetron (8 mg orally every 12 hours) with placebo of azasetron (orally) on days 2-6.
RESULTS
Over days 2-6, the effective ratio of complete response in the azasetron and ondansetron groups was 45% and 54.5%, respectively (95% confidence interval, -21.4 to 2.5%). Thus, the non-inferiority of azasetron compared with ondansetron in delayed chemotherapy-induced nausea and vomiting was not proven in the present study. All treatments were well tolerated and no unexpected drug-related adverse events were reported. The most common adverse events related to the treatment were constipation and hiccups, and there were no differences in the overall incidence of adverse events.
CONCLUSION
In the present study, azasetron showed inferiority in the control of delayed chemotherapy-induced nausea and vomiting compared with ondansetron whereas safety profiles were similar between the two groups.

Keyword

Vomiting; Vomiting/chemically induced; Vomiting/prevention and control; Antineoplastic agents; Serotonin antagonists; Azasetron; Ondansetron

MeSH Terms

Antineoplastic Agents
Constipation
Dexamethasone
Drug Therapy*
Hiccup
Humans
Incidence
Korea
Nausea*
Ondansetron*
Prospective Studies
Serotonin Antagonists
Vomiting*
Antineoplastic Agents
Dexamethasone
Ondansetron
Serotonin Antagonists

Figure

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  Fig. 1 Trial profile. ITT, intention-to-treat.

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