Single-dose oral granisetron has equivalent antiemetic efficacy to intravenous ondansetron for highly emetogenic cisplatin-based chemotherapy

Richard J. Gralla, Rudolph M. Navari, Paul J. Hesketh, William Popovic, John Strupp, Jose Noy, Lawrence Einhorn, David Ettinger, William Bushnell, Carl Friedman

Research output: Contribution to journalArticle

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Abstract

Purpose: To compare the antiemetic efficacy of a single dose of an oral antiemetic (granisetron 2 mg) with a single dose of an intravenous (IV) antiemetic (ondansetron 32 mg) given before cisplatin-based chemotherapy. Patients and Methods: This was a multicenter, randomized, double-blind, parallel-group study. Patients (N = 1,054) scheduled to receive cisplatin (≤ 60 mg/m2)-based chemotherapy were randomized to receive either 2 mg of oral granisetron tablets 1 hour before chemotherapy (n = 534) or IV ondansetron (32 mg) 30 minutes before chemotherapy (n = 520). The primary efficacy end point was total control (no emesis, no nausea, and no use of antiemetic rescue medication) over the initial 24 hours after the start of chemotherapy. Dexamethasone or methylprednisolone were permitted, but not required, as concomitant prophylactic antiemetics. Results: Total control was equivalent 24 hours after cisplatin chemotherapy for single-dose oral granisetron (54.7%) and IV ondansetron (58.3%) (95% confidence interval [CI], - 9.6 to 2.4). Similar proportions of patients remained nausea-free in the granisetron group (55.4%) and the ondansetron group (59%) (95% CI, - 9.6 to 2.4). The rate of complete control of emesis was 61.2% in the granisetron group and 67.1% in the ondansetron group (95% CI, - 11.7 to - 0.1). Both treatment regimens were well tolerated, with similar patterns of adverse reactions, generally of a mild degree. The most common side effects included constipation (14%), headache (15%), and diarrhea (10%). Conclusion: Oral granisetron, administered as a single 2-mg dose, provided equivalent total antiemetic control when compared with IV ondansetron (32 mg) in patients who received highly emetogenic, cisplatin-based chemotherapy.

Original languageEnglish (US)
Pages (from-to)1568-1573
Number of pages6
JournalJournal of Clinical Oncology
Volume16
Issue number4
StatePublished - Apr 1998
Externally publishedYes

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Granisetron
Ondansetron
Antiemetics
Cisplatin
Drug Therapy
Confidence Intervals
Nausea
Vomiting
Methylprednisolone
Constipation
Dexamethasone
Tablets
Headache
Diarrhea

ASJC Scopus subject areas

  • Cancer Research
  • Oncology

Cite this

Single-dose oral granisetron has equivalent antiemetic efficacy to intravenous ondansetron for highly emetogenic cisplatin-based chemotherapy. / Gralla, Richard J.; Navari, Rudolph M.; Hesketh, Paul J.; Popovic, William; Strupp, John; Noy, Jose; Einhorn, Lawrence; Ettinger, David; Bushnell, William; Friedman, Carl.

In: Journal of Clinical Oncology, Vol. 16, No. 4, 04.1998, p. 1568-1573.

Research output: Contribution to journalArticle

Gralla, RJ, Navari, RM, Hesketh, PJ, Popovic, W, Strupp, J, Noy, J, Einhorn, L, Ettinger, D, Bushnell, W & Friedman, C 1998, 'Single-dose oral granisetron has equivalent antiemetic efficacy to intravenous ondansetron for highly emetogenic cisplatin-based chemotherapy', Journal of Clinical Oncology, vol. 16, no. 4, pp. 1568-1573.
Gralla, Richard J. ; Navari, Rudolph M. ; Hesketh, Paul J. ; Popovic, William ; Strupp, John ; Noy, Jose ; Einhorn, Lawrence ; Ettinger, David ; Bushnell, William ; Friedman, Carl. / Single-dose oral granisetron has equivalent antiemetic efficacy to intravenous ondansetron for highly emetogenic cisplatin-based chemotherapy. In: Journal of Clinical Oncology. 1998 ; Vol. 16, No. 4. pp. 1568-1573.
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title = "Single-dose oral granisetron has equivalent antiemetic efficacy to intravenous ondansetron for highly emetogenic cisplatin-based chemotherapy",
abstract = "Purpose: To compare the antiemetic efficacy of a single dose of an oral antiemetic (granisetron 2 mg) with a single dose of an intravenous (IV) antiemetic (ondansetron 32 mg) given before cisplatin-based chemotherapy. Patients and Methods: This was a multicenter, randomized, double-blind, parallel-group study. Patients (N = 1,054) scheduled to receive cisplatin (≤ 60 mg/m2)-based chemotherapy were randomized to receive either 2 mg of oral granisetron tablets 1 hour before chemotherapy (n = 534) or IV ondansetron (32 mg) 30 minutes before chemotherapy (n = 520). The primary efficacy end point was total control (no emesis, no nausea, and no use of antiemetic rescue medication) over the initial 24 hours after the start of chemotherapy. Dexamethasone or methylprednisolone were permitted, but not required, as concomitant prophylactic antiemetics. Results: Total control was equivalent 24 hours after cisplatin chemotherapy for single-dose oral granisetron (54.7{\%}) and IV ondansetron (58.3{\%}) (95{\%} confidence interval [CI], - 9.6 to 2.4). Similar proportions of patients remained nausea-free in the granisetron group (55.4{\%}) and the ondansetron group (59{\%}) (95{\%} CI, - 9.6 to 2.4). The rate of complete control of emesis was 61.2{\%} in the granisetron group and 67.1{\%} in the ondansetron group (95{\%} CI, - 11.7 to - 0.1). Both treatment regimens were well tolerated, with similar patterns of adverse reactions, generally of a mild degree. The most common side effects included constipation (14{\%}), headache (15{\%}), and diarrhea (10{\%}). Conclusion: Oral granisetron, administered as a single 2-mg dose, provided equivalent total antiemetic control when compared with IV ondansetron (32 mg) in patients who received highly emetogenic, cisplatin-based chemotherapy.",
author = "Gralla, {Richard J.} and Navari, {Rudolph M.} and Hesketh, {Paul J.} and William Popovic and John Strupp and Jose Noy and Lawrence Einhorn and David Ettinger and William Bushnell and Carl Friedman",
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T1 - Single-dose oral granisetron has equivalent antiemetic efficacy to intravenous ondansetron for highly emetogenic cisplatin-based chemotherapy

AU - Gralla, Richard J.

AU - Navari, Rudolph M.

AU - Hesketh, Paul J.

AU - Popovic, William

AU - Strupp, John

AU - Noy, Jose

AU - Einhorn, Lawrence

AU - Ettinger, David

AU - Bushnell, William

AU - Friedman, Carl

PY - 1998/4

Y1 - 1998/4

N2 - Purpose: To compare the antiemetic efficacy of a single dose of an oral antiemetic (granisetron 2 mg) with a single dose of an intravenous (IV) antiemetic (ondansetron 32 mg) given before cisplatin-based chemotherapy. Patients and Methods: This was a multicenter, randomized, double-blind, parallel-group study. Patients (N = 1,054) scheduled to receive cisplatin (≤ 60 mg/m2)-based chemotherapy were randomized to receive either 2 mg of oral granisetron tablets 1 hour before chemotherapy (n = 534) or IV ondansetron (32 mg) 30 minutes before chemotherapy (n = 520). The primary efficacy end point was total control (no emesis, no nausea, and no use of antiemetic rescue medication) over the initial 24 hours after the start of chemotherapy. Dexamethasone or methylprednisolone were permitted, but not required, as concomitant prophylactic antiemetics. Results: Total control was equivalent 24 hours after cisplatin chemotherapy for single-dose oral granisetron (54.7%) and IV ondansetron (58.3%) (95% confidence interval [CI], - 9.6 to 2.4). Similar proportions of patients remained nausea-free in the granisetron group (55.4%) and the ondansetron group (59%) (95% CI, - 9.6 to 2.4). The rate of complete control of emesis was 61.2% in the granisetron group and 67.1% in the ondansetron group (95% CI, - 11.7 to - 0.1). Both treatment regimens were well tolerated, with similar patterns of adverse reactions, generally of a mild degree. The most common side effects included constipation (14%), headache (15%), and diarrhea (10%). Conclusion: Oral granisetron, administered as a single 2-mg dose, provided equivalent total antiemetic control when compared with IV ondansetron (32 mg) in patients who received highly emetogenic, cisplatin-based chemotherapy.

AB - Purpose: To compare the antiemetic efficacy of a single dose of an oral antiemetic (granisetron 2 mg) with a single dose of an intravenous (IV) antiemetic (ondansetron 32 mg) given before cisplatin-based chemotherapy. Patients and Methods: This was a multicenter, randomized, double-blind, parallel-group study. Patients (N = 1,054) scheduled to receive cisplatin (≤ 60 mg/m2)-based chemotherapy were randomized to receive either 2 mg of oral granisetron tablets 1 hour before chemotherapy (n = 534) or IV ondansetron (32 mg) 30 minutes before chemotherapy (n = 520). The primary efficacy end point was total control (no emesis, no nausea, and no use of antiemetic rescue medication) over the initial 24 hours after the start of chemotherapy. Dexamethasone or methylprednisolone were permitted, but not required, as concomitant prophylactic antiemetics. Results: Total control was equivalent 24 hours after cisplatin chemotherapy for single-dose oral granisetron (54.7%) and IV ondansetron (58.3%) (95% confidence interval [CI], - 9.6 to 2.4). Similar proportions of patients remained nausea-free in the granisetron group (55.4%) and the ondansetron group (59%) (95% CI, - 9.6 to 2.4). The rate of complete control of emesis was 61.2% in the granisetron group and 67.1% in the ondansetron group (95% CI, - 11.7 to - 0.1). Both treatment regimens were well tolerated, with similar patterns of adverse reactions, generally of a mild degree. The most common side effects included constipation (14%), headache (15%), and diarrhea (10%). Conclusion: Oral granisetron, administered as a single 2-mg dose, provided equivalent total antiemetic control when compared with IV ondansetron (32 mg) in patients who received highly emetogenic, cisplatin-based chemotherapy.

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