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

P. Hesketh, R. Navari, T. Grote, Richard J. Gralla, J. Hainsworth, M. Kris, L. Anthony, A. Khojasteh, E. Tapazoglou, C. Benedict, W. Hahne

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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 ≤ 70 and less than 91 mg/m2 (n = 368) or ≤ 91 mg/m2 (n = 241), administered over ≤ 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/m2) and 36.8%, 31.3%, and 31.8% in the higher cisplatin stratum (mean, 100.6 mg/m2). 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 bath 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.

Original languageEnglish (US)
Pages (from-to)2242-2249
Number of pages8
JournalJournal of Clinical Oncology
Volume14
Issue number8
StatePublished - 1996
Externally publishedYes

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Ondansetron
Antiemetics
Cisplatin
Vomiting
Nausea
Neoplasms
Emetics
Drug Therapy
dolasetron
Clinical Protocols
Visual Analog Scale
Baths
Electrocardiography
Therapeutics
Salts
Safety

ASJC Scopus subject areas

  • Cancer Research
  • Oncology

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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. / Hesketh, P.; Navari, R.; Grote, T.; Gralla, Richard J.; Hainsworth, J.; Kris, M.; Anthony, L.; Khojasteh, A.; Tapazoglou, E.; Benedict, C.; Hahne, W.

In: Journal of Clinical Oncology, Vol. 14, No. 8, 1996, p. 2242-2249.

Research output: Contribution to journalArticle

Hesketh, P, Navari, R, Grote, T, Gralla, RJ, Hainsworth, J, Kris, M, Anthony, L, Khojasteh, A, Tapazoglou, E, Benedict, C & Hahne, W 1996, '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 of Clinical Oncology, vol. 14, no. 8, pp. 2242-2249.
Hesketh, P. ; Navari, R. ; Grote, T. ; Gralla, Richard J. ; Hainsworth, J. ; Kris, M. ; Anthony, L. ; Khojasteh, A. ; Tapazoglou, E. ; Benedict, C. ; Hahne, W. / 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. In: Journal of Clinical Oncology. 1996 ; Vol. 14, No. 8. pp. 2242-2249.
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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 ≤ 70 and less than 91 mg/m2 (n = 368) or ≤ 91 mg/m2 (n = 241), administered over ≤ 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/m2) and 36.8{\%}, 31.3{\%}, and 31.8{\%} in the higher cisplatin stratum (mean, 100.6 mg/m2). 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 bath 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.",
author = "P. Hesketh and R. Navari and T. Grote and Gralla, {Richard J.} and J. Hainsworth and M. Kris and L. Anthony and A. Khojasteh and E. Tapazoglou and C. Benedict and W. Hahne",
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T1 - 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

AU - Hesketh, P.

AU - Navari, R.

AU - Grote, T.

AU - Gralla, Richard J.

AU - Hainsworth, J.

AU - Kris, M.

AU - Anthony, L.

AU - Khojasteh, A.

AU - Tapazoglou, E.

AU - Benedict, C.

AU - Hahne, W.

PY - 1996

Y1 - 1996

N2 - 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 ≤ 70 and less than 91 mg/m2 (n = 368) or ≤ 91 mg/m2 (n = 241), administered over ≤ 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/m2) and 36.8%, 31.3%, and 31.8% in the higher cisplatin stratum (mean, 100.6 mg/m2). 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 bath 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.

AB - 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 ≤ 70 and less than 91 mg/m2 (n = 368) or ≤ 91 mg/m2 (n = 241), administered over ≤ 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/m2) and 36.8%, 31.3%, and 31.8% in the higher cisplatin stratum (mean, 100.6 mg/m2). 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 bath 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.

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