Ondansetron Compared with Granisetron in the Prophylaxis of Cisplatin-lnduced Acute Emesis: A Multicentre Double-Blind, Randomised, Parallel-Group Study

Abstract

This is the first international, multi-centre, double-blind, randomised, parallel group study to directly compare the efficacy and safety profile of a single intravenous dose of ondansetron (8 or 32 mg) with granisetron (3 mg) in the control of cisplatin-induced acute emesis. A total of 496 patients were randomised to receive one of three anti-emetic treatments prior to cisplatin chemotherapy (≥50 mg/m²). Of these, 165 and 162 patients received 8 and 32 mg of ondansetron, respectively, and 169 patients received 3 mg of granisetron. Complete control of emesis (0 emetic episodes) over 24 h was reported in 59% of patients in the 8-mg ondansetron group, 51% of patients in the 32-mg ondansetron group and 56% of patients in the granisetron group. Complete or major control (≤2 emetic episodes) was achieved in 76 and 74% of patients in the 8- and 32-mg ondansetron group, respectively, compared with 78% of patients in the granisetron group. Nausea graded none or mild 24 h after the start of cisplatin infusion was reported in 71 and 69% of patients in the 8- and 32-mg ondansetron groups, respectively, and in 73% of patients in the granisetron group. There were no significant differences between the treatment groups when global satisfaction scores were compared. Logistic regression models were fitted to assess any interaction between treatments and prognostic factors (age, gender, alcohol use, cisplatin dose or concomitant chemotherapy) on complete or major response, but there was no evidence of interaction for any factor. All three anti-emetic treatments were well tolerated and no severe or unexpected drug-related adverse events were observed with ondansetron or granisetron. Headache, the most reported drug-related adverse event for all three treatment groups, occurred in 9% of all patients. In summary, no significant difference was observed between any of the treatment groups with respect to emesis, nausea or drug-related adverse events.

Chemotherapy-Induced Nausea and Vomiting: The Importance of Acute Antiemetic Control

“…5-HT 3 -receptor antagonists have become the agents of choice in preventing acute CINV following both moderately and highly emetogenic chemotherapy [11,51]. Complete response and total control rates seen with specific drugs range from 60%-80% for moderately emetogenic chemotherapy [4,[52][53][54], 40%-60% for cisplatin-containing therapy [4,33,55,56], and 25%-60% for high-dose cisplatin regimens [33,35,47,57,58].…”

Granisetron vs ondansetron for prevention of nausea and vomiting in hematopoietic stem cell transplant patients: results of a prospective, double-blind, randomized trial

“…Outside of the HSCT setting, numerous studies have concluded that these agents provide equivalent control of N/V induced by highly emetogenic chemotherapy when administered at equipotent doses. [2][3][4][5][6][7][8] Although three of these agents have been extensively studied in HSCT patients over the last 8 years, [9][10][11][12][13][14][15][16][17][18][19][20][21][22][23] limited data directly comparing these agents is available. [21][22][23] Ondansetron, the first 5-HT 3 receptor antagonist approved in the United States, has been the most widely studied and is most effectively used in combination with corticosteroids for prevention of CINV; granisetron's effects are also enhanced with the use of corticosteroids.…”

Impact of tumour burden on chemotherapy-induced nausea and vomiting

“…To our knowledge no previous report has shown age differences in delayed nausea or vomiting (Carmichael et al, 1994;du Bois et al, 1992;Gandara et al, 1993;Italian Group for Antiemetic Research, 1994;Kaizer et al, 1994;Lindley et al, 1989;Roila et al, 1991). Interestingly, in more recent studies, the evidence provided for an inverse relationship between age and emesis in the acute phase has not been consistent (de Wet et al, 1993;Heron et al, 1994;Italian Group for Antiemetic Research, 1993;Ruff et al, 1994). This may be related to the introduction of new anti-emetic regimens.…”