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- 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
- Cancer Res Treat. 2014;46(1):19-26. Published online January 15, 2014
- DOI: https://doi.org/10.4143/crt.2014.46.1.19
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Abstract
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ePub - 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. -
Citations
Citations to this article as recorded by
- Influence of ABCB1 genetic polymorphisms on the antiemetic response to ondansetron-based medication for cisplatin-based chemotherapy in South Indian cancer patients in a tertiary care hospital
Ayyar Porkodi, Deepak Gopal Shewade, Goud Alladi Charanraj
Current Issues in Pharmacy and Medical Sciences.2023; 36(3): 129. CrossRef - Hiccups in Cancer Patients Receiving Chemotherapy: A Cross-Sectional Study
Mevlüde Ergen, Fatma Arikan, Rüya Fırat Çetin
Journal of Pain and Symptom Management.2021; 62(3): e85. CrossRef - A Fast and Validated HPLC Method for the Simultaneous Analysis of Five 5-HT3 Receptor Antagonists via the Quantitative Analysis of Multicomponents by a Single Marker
Fuchao Chen, Baoxia Fang, Peng Li, Sicen Wang, Amr M. Mahmoud
International Journal of Analytical Chemistry.2021; 2021: 1. CrossRef - Antiemetics for adults for prevention of nausea and vomiting caused by moderately or highly emetogenic chemotherapy: a network meta-analysis
Vanessa Piechotta, Anne Adams, Madhuri Haque, Benjamin Scheckel, Nina Kreuzberger, Ina Monsef, Karin Jordan, Kathrin Kuhr, Nicole Skoetz
Cochrane Database of Systematic Reviews.2021;[Epub] CrossRef - Effectiveness of Steroid Rotation in a Japanese Patient with Hiccups Caused by Dexamethasone: a Case Report
Hiroki Hosokawa, Hideaki Shimoda, Takayuki Ishii
YAKUGAKU ZASSHI.2019; 139(4): 647. CrossRef - Stability of azasetron-dexamethasone mixture for chemotherapy-induced nausea and vomiting administration
Bao-Xia Fang, Fu-Chao Chen, Dan Zhu, Jun Guo, Lin-Hai Wang
Oncotarget.2017; 8(63): 106249. CrossRef - Gender Differences in Hiccup Patients: Analysis of Published Case Reports and Case-Control Studies
Gyeong-Won Lee, Rock Bum Kim, Se Il Go, Hyun Seop Cho, Seung Jun Lee, David Hui, Eduardo Bruera, Jung Hun Kang
Journal of Pain and Symptom Management.2016; 51(2): 278. CrossRef - Cheaper Options in the Prevention of Chemotherapy-Induced Nausea and Vomiting
Bishal Gyawali, Bishesh Sharma Poudyal, Mahesh Iddawela
Journal of Global Oncology.2016; 2(3): 145. CrossRef - Recent developments in the prevention of chemotherapy-induced nausea and vomiting (CINV): a comprehensive review
K. Jordan, F. Jahn, M. Aapro
Annals of Oncology.2015; 26(6): 1081. CrossRef
- Influence of ABCB1 genetic polymorphisms on the antiemetic response to ondansetron-based medication for cisplatin-based chemotherapy in South Indian cancer patients in a tertiary care hospital
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- Effect of Granisetron Plus Dexamethasone in the Prevention of Delayed Nausea and Vomiting
- Jeong Woo Shim, Yong Seop Lee, Heung Up Kim, Geong Won Jung, Yeong Ho Park, Se Ho Chang, Jin Yong Whang, Jeong Soon Jang, Jong Seok Lee
- J Korean Cancer Assoc. 1997;29(4):690-699.
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Abstract
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- BACKGROUND
Granisetron, a new 5-HT3 receptor antagonist, was reported as a highly effective antiemetics, especially in combination with dexamethasone, in the prevention of acute emesis induced by cisplatin. But there is lack of data about effectiveness in the prevention of delayed emesis. In this study, the efficacy of granisetron plus dexamethasone in the prevention of delayed emesis induced by cisplatin was evaluated.
MATERIALS AND METHODS
Sixty-four patients who were to receive high-dose cisplatin containing chemotherapy regimen were enrolled in this study. They were received 20 mg of dexamethasone and 3 mg of granisetron at 30 min and 10 minutes prior to cisplatin infusion, respectively. They were monitored for 5 days, first 24 hours for acute nausea/ vomiting and the subsequent 4 days for delayed nausea/vomiting. Antiemetic effect of granisetron was evaluated according to the criteria of Italian Group of Antiemetic Research.
RESULTS
Control of delayed nausea and vomiting was achieved in 58% and 84%, respectively. Eastern Cooperative Oncology Group performance status was a statistically significant prognostic factor for control of acute vomiting and delayed nausea/vomiting. There were no stastically significant differences between control of delayed nausea/ vomiting and other prognostic factors, including sex, age, and prior history of cisplatin therapy. The antiemetic effect was greater in the patients who had controled acute nausea/ vomiting than those who had not.
CONCLUSION
Granisetron plus dexamethasone is an excellent regimen in the control of not only acute emesis but also delayed emesis induced by high-dose cisplatin chemotherapy.
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- 17 Download
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