Double-blind, randomized comparison of the antiemetic efficacy of intravenous dolasetron mesylate and intravenous ondansetron in the prevention of acute cisplatin-induced emesis in patients with cancer Journal Article


Authors: Hesketh, P.; Navari, R.; Grote, T.; Gralla, R.; Hainsworth, J.; Kris, M.; Anthony, L.; Khojasteh, A.; Tapazoglou, E.; Benedict, C.; Hahne, W.; for the Dolasetron Comparative Chemotherapy-Induced Emesis Prevention Group
Article Title: Double-blind, randomized comparison of the antiemetic efficacy of intravenous dolasetron mesylate and intravenous ondansetron in the prevention of acute cisplatin-induced emesis in patients with cancer
Abstract: Purpose: To assess the comparative antiemetic efficacy of single-dose intravenous (IV) dolasetron mesylate and ondansetron in preventing cisplatin-induced nausea and vomiting. Patients and Methods: Cancer patients (n = 609) receiving first-course cisplatin chemotherapy were randomized to one of three treatments: 1.8 or 2.4 mg/kg dolasetron mesylate salt (equivalent to 1.3 and 1.8 mg/kg dolasetron base, respectively) or 32 mg ondansetron. Each treatment was infused over 15 minutes, 30 minutes before cisplatin administration. Patients were stratified to cisplatin doses of <greater than or equal to greater than or equal to 70 and less than 91 mg/m(2) (n = 368) or greater than or equal to 91 mg/m(2) (n = 241), administered over less than or equal to 3 hours, protocol-defined efficacy criteria included complete response (zero emetic episodes and no rescue medication), major response (1 to 2 emetic episodes and no rescue medication), and patients' report of nausea severity and satisfaction recorded on a 100-mm visual analog scale (VAS). Results: The three treatments met protocol-specified criteria for equivalence, Complete response rates for dolasetron mesylate 1.8 mg/kg, 2.4 mg/kg, and ondansetron, respectively, were 49.2%, 45.6%, and 50.4% for patients in the lower cisplatin stratum (mean, 74.7 mg/m(2)) and 36.8%, 31.3%, and 31.8% in the higher cisplatin stratum (mean, 100.6 mg/m(2)). No significant differences were observed in the extent of nausea with either dolasetron dose compared with ondansetron. Less nausea was noted with 1.8 mg/kg dolasetron compared with the 2.4 mg/kg dose (P = .044) All three antiemetic treatments were well tolerated. Asymptomatic electrocardiogram changes were recorded with both dolasetron and ondansetron. Conclusion: A single IV dose of dolasetron mesylate (1.8 or 2.4 mg/kg) has comparable safety and efficacy to a single 32-mg IV dose of ondansetron in patients receiving cisplatin chemotherapy. (C) 1996 by American Society of Clinical Oncology.
Keywords: granisetron; pharmacokinetics; serotonin; trial; induced nausea; 5-ht3 antagonists
Journal Title: Journal of Clinical Oncology
Volume: 14
Issue: 8
ISSN: 0732-183X
Publisher: American Society of Clinical Oncology  
Date Published: 1996-08-01
Start Page: 2242
End Page: 2249
Language: English
ACCESSION: WOS:A1996VA76700008
DOI: 10.1200/jco.1996.14.8.2242
PROVIDER: wos
PUBMED: 8708713
Notes: Article -- Source: Wos
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MSK Authors
  1. Mark Kris
    581 Kris