Comparison of antiemetic efficacy of granisetron and ondansetron in Oriental patients: a randomized crossover study

Abstract

Summary A double-blind randomized crossover trial was performed to compare the antiemetic efficacy of two 5-HT3 receptor antagonists, granisetron and ondansetron, in Chinese patients receiving adjuvant chemotherapy (cyclophosphamide, methotrexate and 5-fluorouracil) for breast cancer. Twenty patients were randomized to receive chemotherapy with either granisetron on day 1 and ondansetron on day 8 of the first cycle followed by the reverse order in the second cycle, or vice versa. The number of vomiting episodes and the severity of nausea in the first 24 h (acute vomiting/nausea) and the following 7 days (delayed vomiting/nausea) were studied. Acute vomiting was completely prevented in 29 (72.5%) cycles with granisetron and 27 (67.5%) cycles with ondansetron, and treatment failure (>5 vomiting episodes) occurred in two (5%) cycles with each agent (P = NS). Acute nausea was completely controlled in 15 (37.5%) cycles with granisetron and 14 (35%) cycles with ondansetron, whereas severe acute nausea occurred in four (10%) cycles with each agent (P = NS). However, complete response for delayed vomiting was observed in only 21 (52.5%) cycles with granisetron and 22 (55%) cycles with ondansetron (P = NS), and delayed nausea was completely controlled in only 11 (27.5%) and ten (25%) cycles respectively (P = NS). In conclusion, both granisetron and ondansetron are effective in controlling acute nausea and vomiting in Chinese patients, with equivalent antiemetic efficacy. Control of delayed nausea and vomiting is less satisfactory.Keywords: nausea; vomiting; chemotherapy; granisetron; ondansetron; Chinese Nausea and vomiting are the most common side-effects of chemotherapy. Traditional antiemetic agents such as metoclopramide, anxiolytics and steroids have limited antiemetic efficacy. 5-HT3 receptor antagonists are a new class of more effective antiemetic agents. Granisetron, ondansetron and tropisetron are the currently available 5-HT3 receptor antagonists, and they differ significantly in their pharmacokinetic properties such as dose-response profile, receptor affinity, potency and duration of action (Andrews et al, 1992). However, not until recently have these agents been compared directly in their antiemetic efficacy in randomized clinical trials.Comparison of granisetron with ondansetron in Western studies showed that the former had either equal or greater efficacy (Jantunen et al, 1993;Gebbia et al, 1994;Noble et al, 1994;Ruff et al, 1994;Navari et al, 1995;Mantovani et al, 1996). To our knowledge, no study comparing these two agents in Oriental patients has been reported before. Both drugs are mainly metabolized in the liver by the cytochrome P450 enzymes (Bloomer et al, 1994;Fischer et al, 1994). Ethnic differences in drug metabolism by the cytochrome P450 enzymes between Caucasians and Orientals are well recognized (Kalow, 1982;Vetticaden, 1988;Relling, 1989;Johansson et al, 1994 MATERIALS AND METHODS Study designA prospective double-blind randomized crossover trial was carried out in 20 consecutive female patie...

Granisetron is equivalent to ondansetron for prophylaxis of chemotherapy-induced nausea and vomiting

“…However, the number of studies and eligible patients are heterogeneous within the different scenarios. Therefore, more studies may be necessary to firmly establish this issue, especially regarding the DHV and DHN settings that were ad- 15 Ͻ 25 patients per arm Kalaycio et al 16 Ͻ 25 patients per arm and bone marrow transplant patients Pellier et al 17 Not enough information to exclude for complete control of emesis in the first 24 hours or after 24 hours of chemotherapy administration Poon and Chow 18 Ͻ 25 patients per arm Perez et al 13 No data regarding antiemetics for the first cycle before the crossover to the other antiemetic Zeidman et al 19 Although the study included 60 patients, it included both highly and moderately emetogenic regimens having Ͻ 25 patients for each of these groups Because both arms of granisetron and of ondansetron had equivalent antiemetic efficacy in these three studies they were combined for the meta-analysis calculations.…”

Randomized Double Blind Trial to Compare the Efficacy of Granisetron And Ondansetron in Controlling Emesis in Children with Acute Lymphoblastic Leukemia

“…Two different studies conducted by Poon et al in 1998 andLuis et al, 2006, observed the response to nausea and vomiting had achieved 70% in the patient who had received granisetron and the value was statistically significant 21,15 . Our observational findings are also consistent with their study.…”

An analysis of the antiemetic protection of metoclopramide plus dexamethasone in Chinese patients receiving moderately high emetogenic chemotherapy

“…More effective antiemetic protection should be considered for Chinese patients receiving chemotherapy, including the use of 5‐HT 3 receptor antagonists. In a study of Chinese patients receiving CMF for breast cancer, Poon and Chow (1998) showed that granisetron (at day 1) and ondansetron (at day 8), or the reverse, were equally effective in controlling nausea and vomiting. Acute vomiting was completely prevented in 67.5–72.5%, and acute nausea was completely prevented in 35–37.5%, depending on the order of the antiemetics (Poon & Chow 1998).…”

“…In a study of Chinese patients receiving CMF for breast cancer, Poon and Chow (1998) showed that granisetron (at day 1) and ondansetron (at day 8), or the reverse, were equally effective in controlling nausea and vomiting. Acute vomiting was completely prevented in 67.5–72.5%, and acute nausea was completely prevented in 35–37.5%, depending on the order of the antiemetics (Poon & Chow 1998). Delayed emesis was, however, less satisfactorily controlled (complete control in 52.5% of patients).…”