Comparison of single-dose oral granisetron versus intravenous ondansetron in the prevention of nausea and vomiting induced by moderately emetogenic chemotherapy: A multicenter, double-blind, randomized parallel study

E. A. Perez, P. Hesketh, J. Sandbach, J. Reeves, S. Chawla, M. Markman, J. Hainsworth, W. Bushnell, C. Friedman

Research output: Contribution to journalArticle

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Abstract

Purpose: The antiemetic effectiveness and safety of single-dose oral granisetron were compared with intravenous (IV) ondansetron in chemotherapy- naive patients who received moderately emetogenic chemotherapy. Patients and Methods: In this double-blind, parallel-group study, patients naive to emetogenic chemotherapy (N = 1,085) who were scheduled to receive cyclophosphamide-(500 to 1,200 mg/m2) or carboplatin-(≤300 mg/m2) based chemotherapy, were randomized to receive either oral granisetron (n = 542) or IV ondansetron (n = 543). Efficacy assessments included the proportion of patients in each treatment group with total control over the 24 and 48 hours following chemotherapy initiation, as well as incidence and severity of nausea and emesis and use of antiemetic rescue medication. Prophylactic corticosteroids were allowed. Safety assessment was based on patients' reports of adverse experiences. Results: Approximately 80% of patients received prophylactic corticosteroids. Single-dose oral granisetron (2 mg) and IV ondansetron (32 mg) resulted in equivalent levels of total emetic control during the first 48 hours after chemotherapy. The proportion of nausea-and emesis-free patients at 24 and 48 hours were also approximately equivalent. The most commonly reported adverse experiences were headache, asthenia, and constipation. More patients who received ondansetron than granisetron reported dizziness (9.6% v 5.4%, respectively; P = .011) and abnormal vision (4.2% v 0.6%, respectively; p < .001). Conclusion: A single oral dose of granisetron (2 mg) resulted in equivalent levels of antiemetic protection as IV ondansetron (32 mg). Both agents were well tolerated, although more dizziness and abnormal vision were reported with ondansetron. Because the two antiemetic regimens exhibited equivalent efficacies, additional factors such as convenience and cost of therapy should be considered.

Original languageEnglish (US)
Pages (from-to)754-760
Number of pages7
JournalJournal of Clinical Oncology
Volume16
Issue number2
StatePublished - Feb 1998

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Granisetron
Ondansetron
Nausea
Vomiting
Drug Therapy
Antiemetics
Dizziness
Adrenal Cortex Hormones
Emetics
Safety
Asthenia
Carboplatin
Constipation
Double-Blind Method
Cyclophosphamide
Headache
Costs and Cost Analysis

ASJC Scopus subject areas

  • Cancer Research
  • Oncology

Cite this

Comparison of single-dose oral granisetron versus intravenous ondansetron in the prevention of nausea and vomiting induced by moderately emetogenic chemotherapy : A multicenter, double-blind, randomized parallel study. / Perez, E. A.; Hesketh, P.; Sandbach, J.; Reeves, J.; Chawla, S.; Markman, M.; Hainsworth, J.; Bushnell, W.; Friedman, C.

In: Journal of Clinical Oncology, Vol. 16, No. 2, 02.1998, p. 754-760.

Research output: Contribution to journalArticle

Perez, E. A. ; Hesketh, P. ; Sandbach, J. ; Reeves, J. ; Chawla, S. ; Markman, M. ; Hainsworth, J. ; Bushnell, W. ; Friedman, C. / Comparison of single-dose oral granisetron versus intravenous ondansetron in the prevention of nausea and vomiting induced by moderately emetogenic chemotherapy : A multicenter, double-blind, randomized parallel study. In: Journal of Clinical Oncology. 1998 ; Vol. 16, No. 2. pp. 754-760.
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abstract = "Purpose: The antiemetic effectiveness and safety of single-dose oral granisetron were compared with intravenous (IV) ondansetron in chemotherapy- naive patients who received moderately emetogenic chemotherapy. Patients and Methods: In this double-blind, parallel-group study, patients naive to emetogenic chemotherapy (N = 1,085) who were scheduled to receive cyclophosphamide-(500 to 1,200 mg/m2) or carboplatin-(≤300 mg/m2) based chemotherapy, were randomized to receive either oral granisetron (n = 542) or IV ondansetron (n = 543). Efficacy assessments included the proportion of patients in each treatment group with total control over the 24 and 48 hours following chemotherapy initiation, as well as incidence and severity of nausea and emesis and use of antiemetic rescue medication. Prophylactic corticosteroids were allowed. Safety assessment was based on patients' reports of adverse experiences. Results: Approximately 80{\%} of patients received prophylactic corticosteroids. Single-dose oral granisetron (2 mg) and IV ondansetron (32 mg) resulted in equivalent levels of total emetic control during the first 48 hours after chemotherapy. The proportion of nausea-and emesis-free patients at 24 and 48 hours were also approximately equivalent. The most commonly reported adverse experiences were headache, asthenia, and constipation. More patients who received ondansetron than granisetron reported dizziness (9.6{\%} v 5.4{\%}, respectively; P = .011) and abnormal vision (4.2{\%} v 0.6{\%}, respectively; p < .001). Conclusion: A single oral dose of granisetron (2 mg) resulted in equivalent levels of antiemetic protection as IV ondansetron (32 mg). Both agents were well tolerated, although more dizziness and abnormal vision were reported with ondansetron. Because the two antiemetic regimens exhibited equivalent efficacies, additional factors such as convenience and cost of therapy should be considered.",
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T1 - Comparison of single-dose oral granisetron versus intravenous ondansetron in the prevention of nausea and vomiting induced by moderately emetogenic chemotherapy

T2 - A multicenter, double-blind, randomized parallel study

AU - Perez, E. A.

AU - Hesketh, P.

AU - Sandbach, J.

AU - Reeves, J.

AU - Chawla, S.

AU - Markman, M.

AU - Hainsworth, J.

AU - Bushnell, W.

AU - Friedman, C.

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Y1 - 1998/2

N2 - Purpose: The antiemetic effectiveness and safety of single-dose oral granisetron were compared with intravenous (IV) ondansetron in chemotherapy- naive patients who received moderately emetogenic chemotherapy. Patients and Methods: In this double-blind, parallel-group study, patients naive to emetogenic chemotherapy (N = 1,085) who were scheduled to receive cyclophosphamide-(500 to 1,200 mg/m2) or carboplatin-(≤300 mg/m2) based chemotherapy, were randomized to receive either oral granisetron (n = 542) or IV ondansetron (n = 543). Efficacy assessments included the proportion of patients in each treatment group with total control over the 24 and 48 hours following chemotherapy initiation, as well as incidence and severity of nausea and emesis and use of antiemetic rescue medication. Prophylactic corticosteroids were allowed. Safety assessment was based on patients' reports of adverse experiences. Results: Approximately 80% of patients received prophylactic corticosteroids. Single-dose oral granisetron (2 mg) and IV ondansetron (32 mg) resulted in equivalent levels of total emetic control during the first 48 hours after chemotherapy. The proportion of nausea-and emesis-free patients at 24 and 48 hours were also approximately equivalent. The most commonly reported adverse experiences were headache, asthenia, and constipation. More patients who received ondansetron than granisetron reported dizziness (9.6% v 5.4%, respectively; P = .011) and abnormal vision (4.2% v 0.6%, respectively; p < .001). Conclusion: A single oral dose of granisetron (2 mg) resulted in equivalent levels of antiemetic protection as IV ondansetron (32 mg). Both agents were well tolerated, although more dizziness and abnormal vision were reported with ondansetron. Because the two antiemetic regimens exhibited equivalent efficacies, additional factors such as convenience and cost of therapy should be considered.

AB - Purpose: The antiemetic effectiveness and safety of single-dose oral granisetron were compared with intravenous (IV) ondansetron in chemotherapy- naive patients who received moderately emetogenic chemotherapy. Patients and Methods: In this double-blind, parallel-group study, patients naive to emetogenic chemotherapy (N = 1,085) who were scheduled to receive cyclophosphamide-(500 to 1,200 mg/m2) or carboplatin-(≤300 mg/m2) based chemotherapy, were randomized to receive either oral granisetron (n = 542) or IV ondansetron (n = 543). Efficacy assessments included the proportion of patients in each treatment group with total control over the 24 and 48 hours following chemotherapy initiation, as well as incidence and severity of nausea and emesis and use of antiemetic rescue medication. Prophylactic corticosteroids were allowed. Safety assessment was based on patients' reports of adverse experiences. Results: Approximately 80% of patients received prophylactic corticosteroids. Single-dose oral granisetron (2 mg) and IV ondansetron (32 mg) resulted in equivalent levels of total emetic control during the first 48 hours after chemotherapy. The proportion of nausea-and emesis-free patients at 24 and 48 hours were also approximately equivalent. The most commonly reported adverse experiences were headache, asthenia, and constipation. More patients who received ondansetron than granisetron reported dizziness (9.6% v 5.4%, respectively; P = .011) and abnormal vision (4.2% v 0.6%, respectively; p < .001). Conclusion: A single oral dose of granisetron (2 mg) resulted in equivalent levels of antiemetic protection as IV ondansetron (32 mg). Both agents were well tolerated, although more dizziness and abnormal vision were reported with ondansetron. Because the two antiemetic regimens exhibited equivalent efficacies, additional factors such as convenience and cost of therapy should be considered.

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