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

Hee Yeon Lee, Hoon Kyo Kim, Kyung Hee Lee, Bong Seog Kim, Hong Suk Song, Sung Hyun Yang, Joon Hee Kim, Yeul Hong Kim, Jong Gwang Kim, Sang We Kim, Dong Wan Kim, Si Young Kim, Hee Sook Park

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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.

Original languageEnglish
Pages (from-to)19-26
Number of pages8
JournalCancer Research and Treatment
Volume46
Issue number1
DOIs
Publication statusPublished - 2014 Feb 20

Fingerprint

Ondansetron
Nausea
Multicenter Studies
Vomiting
Safety
Drug Therapy
Dexamethasone
Placebos
Hiccup
azasetron
Constipation
Korea
Drug-Related Side Effects and Adverse Reactions
Confidence Intervals

Keywords

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

ASJC Scopus subject areas

  • Cancer Research
  • Oncology

Cite this

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, Hee Yeon; Kim, Hoon Kyo; Lee, Kyung Hee; Kim, Bong Seog; Song, Hong Suk; Yang, Sung Hyun; Kim, Joon Hee; Kim, Yeul Hong; Kim, Jong Gwang; Kim, Sang We; Kim, Dong Wan; Kim, Si Young; Park, Hee Sook.

In: Cancer Research and Treatment, Vol. 46, No. 1, 20.02.2014, p. 19-26.

Research output: Contribution to journalArticle

Lee, Hee Yeon ; Kim, Hoon Kyo ; Lee, Kyung Hee ; Kim, Bong Seog ; Song, Hong Suk ; Yang, Sung Hyun ; Kim, Joon Hee ; Kim, Yeul Hong ; Kim, Jong Gwang ; Kim, Sang We ; Kim, Dong Wan ; Kim, Si Young ; Park, Hee Sook. / 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. In: Cancer Research and Treatment. 2014 ; Vol. 46, No. 1. pp. 19-26.
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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.",
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AU - Kim, Hoon Kyo

AU - Lee, Kyung Hee

AU - Kim, Bong Seog

AU - Song, Hong Suk

AU - Yang, Sung Hyun

AU - Kim, Joon Hee

AU - Kim, Yeul Hong

AU - Kim, Jong Gwang

AU - Kim, Sang We

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AU - Kim, Si Young

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AB - 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.

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