Ondasetron versus granisetron in the prevention of chemotherapy-induced nausea and vomiting. Results of a prospective randomized trial

Abstract

Background. A single‐institution, prospective, randomized open trial was performed to compare ondansetron and granisetron in the prevention of chemotherapyrelated nausea and vomiting. The effect of antemetic drugs was analyzed indipendently for patients treated with highly emetogenic chemotherapy (Study 1), and those treated with moderately emetogenic regimens (Study 2). Methods. In Study 1. 182 patients treated with chemotherapeutic regimens containing high dose cisplatin (more than 70 mg/m2) were randomized to receive 24 mg of ondasentron intravenously (i. v.) or 3 mg of granisetron i. v. for the control of acute emesis. Patients treated with fractionated chemotherapy and those followed‐up for delayed emesis also received 8 mg of ondansetron orally twice a day or 3 mg of granisetron i. v. on the days after Day 1. In Study 2, 164 patients were randomized to receive either 16 mg of ondansetron i. v. or 3 mg of granisetron i. v. to prevent emesis in the first 24 hours. Results. In the ondansetron group in Study 1, a complete response (CR) (i. e., no vomiting, nausea possible) from acute emesis was achieved in 52% of cases, a major response (MR) in 29%, and a minor response (MiR) in 14%. In the granisetron group in Study 1, a CR was seen in 49% of patients, an MR in 24%, and an MiR in 12% Failure was recorded in 5% and 15% of cases in the ondansetron and granisetron groups, respectively. No statistically significant difference in any response category was seen between the two groups. In the ondansetron group, a complete protection from delayed emesis was recorded in 39% of cases, an MR in 32%, an MiR in 21%. and failure in 16%. In the granisetron arm, 36% of the patients had a CR, 22% had an MR, 14% had an MiR, and 14% experienced treatment failure. Again, these differences did not reach statistical significance. In Study 2, no statistical significant difference was observed between the ondansetron arm and the granisetron arm, both for acute and delayed emesis. Both ondansetron and granisetron were tolerated very well by most patients, with no severe side effects. In the group of patients treated with ondansetron, however, the incidence of headache (9%) was higher than in the group treated with granisetron (4%). Conclusions. These data suggest that although both ondansetron and granisetron are very effective drugs for the control of acute emesis, their efficacy against delayed emesis is still not entirely satisfactory.

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

“…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.…”

“…single dose. Five subsequent randomized trials showed no significant difference in the antiemetic efficacy between intravenous granisetron and ondansetron (Gebbia et al, 1994;Noble et al, 1994;Ruff et al, 1994;Navari et al, 1995;Mantovani et al, 1996). These studies compared the two agents in patients receiving cisplatin-based highly emetogenic regimens, except for the study of Gebbia et al (1994), which also included a comparison of the two agents in moderately emetogenic chemotherapy.…”

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

“…Nausea and vomiting is one of the major adverse effects of cytotoxic drugs and it is most frequently reported by the patients those who are undergoing chemotherapy for hematological and oncological malignancies like, ALL, Hodgkin's lymphoma (HL) and Non-Hodgkin's lymphomas (NHL) 1 .Without appropriate and effective prophylactic measurement severe nausea and protracted vomiting may results in severe dehydration, electrolyte abnormalities, malnutrition and aspiration of food materials leading to aspiration pneumonia and increased frequency of hospital admission. So, a very effective, well tolerated and potent antiemetic drug is mandatory for those patients who are receiving intensive chemotherapeutic agents 2 .…”

“…During the last two decades several drugs likemetochlorpropamide, levosulpride, steroids, phenothiazine and other compounds were randomly used to combat CRNV without any satisfactory results 1 .Moreover, the compounds had moderate efficacy and significant adverse effects, such as sedation and extra pyramidal symptoms 4 . Since mid1980s a major advancement had found in the development of antiemetic drugs 4 .…”

Granisetron compared with prednisolone plus metopimazine as anti-emetic prophylaxis during multiple cycles of moderately emetogenic chemotherapy

“…The efficacy of the serotonin antagonists ondansetron, granisetron and tropisetron has been compared in several trials and no significant differences have been shown (Campora et al, 1994;Gebbia et al, 1994;Stewart et al, 1995).…”