Efficacy of oral ondansetron in the prevention of emesis in outpatients receiving cyclophosphamide-based chemotherapy

Thomas M. Beck, Arthur A. Ciociola, Stephen E. Jones, Walter H. Harvey, N. Simon Tchekmedyian, Alex Y Chang, Daniel Galvin, Nan E. Hart

Research output: Contribution to journalArticle

Abstract

Objective: To evaluate the efficacy and safety of oral ondansetron (Zofran) as an antiemetic in patients receiving cyclophosphamide-based chemotherapy. Design: A multicenter, randomized, double-blind, stratified, placebo-controlled trial conducted between March 1989 and January 1990. Setting: Twenty-seven oncology centers including university hospitals, community cancer centers, and private medical oncology practices. Patients: A total of 349 chemotherapy-naive patients having their first cycle of cyclophosphamide (≥ 450 mg/m2-based chemotherapy. Patients also received methotrexate (≥ 30 mg/m2) or doxorubicin (≥ 35 mg/ m2). All patients were evaluated for safety and 318 (91%) were evaluated for efficacy. Interventions: Patients were randomly assigned to one of four treatment groups: placebo, 1 mg, 4 mg, or 8 mg of ondansetron. Assigned study medication was taken three times per day for 3 consecutive days. Measurements: Time and number of emetic episodes as well as degree of nausea were recorded by patients for each of the 3 study days. Results: Compared with placebo, all three doses of ondansetron were superior (P <0.001) in preventing vomiting and controlling nausea. A complete response (no emetic episodes) was observed in 19%, 57%, 65%, and 66% of patients in the placebo, 1-mg, 4-mg, and 8-mg ondansetron groups, respectively. For patients who received higher-dose cyclophosphamide and doxorubicin, a dose-related trend in antiemetic efficacy of ondansetron was observed. Mild headache and constipation were the most frequently reported adverse events. No extrapyramidal reactions were observed. Conclusion: Oral ondansetron is a safe and effective antiemetic that is more efficacious than placebo for patients receiving cyclophosphamide-based chemotherapy.

Original languageEnglish (US)
Pages (from-to)407-413
Number of pages7
JournalAnnals of Internal Medicine
Volume118
Issue number6
StatePublished - Mar 1 1993
Externally publishedYes

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Ondansetron
Cyclophosphamide
Vomiting
Outpatients
Drug Therapy
Placebos
Antiemetics
Emetics
Doxorubicin
Nausea
Safety
Medical Oncology
Constipation
Methotrexate
Headache

ASJC Scopus subject areas

  • Medicine(all)

Cite this

Beck, T. M., Ciociola, A. A., Jones, S. E., Harvey, W. H., Tchekmedyian, N. S., Chang, A. Y., ... Hart, N. E. (1993). Efficacy of oral ondansetron in the prevention of emesis in outpatients receiving cyclophosphamide-based chemotherapy. Annals of Internal Medicine, 118(6), 407-413.

Efficacy of oral ondansetron in the prevention of emesis in outpatients receiving cyclophosphamide-based chemotherapy. / Beck, Thomas M.; Ciociola, Arthur A.; Jones, Stephen E.; Harvey, Walter H.; Tchekmedyian, N. Simon; Chang, Alex Y; Galvin, Daniel; Hart, Nan E.

In: Annals of Internal Medicine, Vol. 118, No. 6, 01.03.1993, p. 407-413.

Research output: Contribution to journalArticle

Beck, TM, Ciociola, AA, Jones, SE, Harvey, WH, Tchekmedyian, NS, Chang, AY, Galvin, D & Hart, NE 1993, 'Efficacy of oral ondansetron in the prevention of emesis in outpatients receiving cyclophosphamide-based chemotherapy', Annals of Internal Medicine, vol. 118, no. 6, pp. 407-413.
Beck, Thomas M. ; Ciociola, Arthur A. ; Jones, Stephen E. ; Harvey, Walter H. ; Tchekmedyian, N. Simon ; Chang, Alex Y ; Galvin, Daniel ; Hart, Nan E. / Efficacy of oral ondansetron in the prevention of emesis in outpatients receiving cyclophosphamide-based chemotherapy. In: Annals of Internal Medicine. 1993 ; Vol. 118, No. 6. pp. 407-413.
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abstract = "Objective: To evaluate the efficacy and safety of oral ondansetron (Zofran) as an antiemetic in patients receiving cyclophosphamide-based chemotherapy. Design: A multicenter, randomized, double-blind, stratified, placebo-controlled trial conducted between March 1989 and January 1990. Setting: Twenty-seven oncology centers including university hospitals, community cancer centers, and private medical oncology practices. Patients: A total of 349 chemotherapy-naive patients having their first cycle of cyclophosphamide (≥ 450 mg/m2-based chemotherapy. Patients also received methotrexate (≥ 30 mg/m2) or doxorubicin (≥ 35 mg/ m2). All patients were evaluated for safety and 318 (91{\%}) were evaluated for efficacy. Interventions: Patients were randomly assigned to one of four treatment groups: placebo, 1 mg, 4 mg, or 8 mg of ondansetron. Assigned study medication was taken three times per day for 3 consecutive days. Measurements: Time and number of emetic episodes as well as degree of nausea were recorded by patients for each of the 3 study days. Results: Compared with placebo, all three doses of ondansetron were superior (P <0.001) in preventing vomiting and controlling nausea. A complete response (no emetic episodes) was observed in 19{\%}, 57{\%}, 65{\%}, and 66{\%} of patients in the placebo, 1-mg, 4-mg, and 8-mg ondansetron groups, respectively. For patients who received higher-dose cyclophosphamide and doxorubicin, a dose-related trend in antiemetic efficacy of ondansetron was observed. Mild headache and constipation were the most frequently reported adverse events. No extrapyramidal reactions were observed. Conclusion: Oral ondansetron is a safe and effective antiemetic that is more efficacious than placebo for patients receiving cyclophosphamide-based chemotherapy.",
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AU - Harvey, Walter H.

AU - Tchekmedyian, N. Simon

AU - Chang, Alex Y

AU - Galvin, Daniel

AU - Hart, Nan E.

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N2 - Objective: To evaluate the efficacy and safety of oral ondansetron (Zofran) as an antiemetic in patients receiving cyclophosphamide-based chemotherapy. Design: A multicenter, randomized, double-blind, stratified, placebo-controlled trial conducted between March 1989 and January 1990. Setting: Twenty-seven oncology centers including university hospitals, community cancer centers, and private medical oncology practices. Patients: A total of 349 chemotherapy-naive patients having their first cycle of cyclophosphamide (≥ 450 mg/m2-based chemotherapy. Patients also received methotrexate (≥ 30 mg/m2) or doxorubicin (≥ 35 mg/ m2). All patients were evaluated for safety and 318 (91%) were evaluated for efficacy. Interventions: Patients were randomly assigned to one of four treatment groups: placebo, 1 mg, 4 mg, or 8 mg of ondansetron. Assigned study medication was taken three times per day for 3 consecutive days. Measurements: Time and number of emetic episodes as well as degree of nausea were recorded by patients for each of the 3 study days. Results: Compared with placebo, all three doses of ondansetron were superior (P <0.001) in preventing vomiting and controlling nausea. A complete response (no emetic episodes) was observed in 19%, 57%, 65%, and 66% of patients in the placebo, 1-mg, 4-mg, and 8-mg ondansetron groups, respectively. For patients who received higher-dose cyclophosphamide and doxorubicin, a dose-related trend in antiemetic efficacy of ondansetron was observed. Mild headache and constipation were the most frequently reported adverse events. No extrapyramidal reactions were observed. Conclusion: Oral ondansetron is a safe and effective antiemetic that is more efficacious than placebo for patients receiving cyclophosphamide-based chemotherapy.

AB - Objective: To evaluate the efficacy and safety of oral ondansetron (Zofran) as an antiemetic in patients receiving cyclophosphamide-based chemotherapy. Design: A multicenter, randomized, double-blind, stratified, placebo-controlled trial conducted between March 1989 and January 1990. Setting: Twenty-seven oncology centers including university hospitals, community cancer centers, and private medical oncology practices. Patients: A total of 349 chemotherapy-naive patients having their first cycle of cyclophosphamide (≥ 450 mg/m2-based chemotherapy. Patients also received methotrexate (≥ 30 mg/m2) or doxorubicin (≥ 35 mg/ m2). All patients were evaluated for safety and 318 (91%) were evaluated for efficacy. Interventions: Patients were randomly assigned to one of four treatment groups: placebo, 1 mg, 4 mg, or 8 mg of ondansetron. Assigned study medication was taken three times per day for 3 consecutive days. Measurements: Time and number of emetic episodes as well as degree of nausea were recorded by patients for each of the 3 study days. Results: Compared with placebo, all three doses of ondansetron were superior (P <0.001) in preventing vomiting and controlling nausea. A complete response (no emetic episodes) was observed in 19%, 57%, 65%, and 66% of patients in the placebo, 1-mg, 4-mg, and 8-mg ondansetron groups, respectively. For patients who received higher-dose cyclophosphamide and doxorubicin, a dose-related trend in antiemetic efficacy of ondansetron was observed. Mild headache and constipation were the most frequently reported adverse events. No extrapyramidal reactions were observed. Conclusion: Oral ondansetron is a safe and effective antiemetic that is more efficacious than placebo for patients receiving cyclophosphamide-based chemotherapy.

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