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ARTICLE

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 Chang; Daniel Galvin; Nan E. Hart, Ondansetron Study Group*

15 March 1993 | Volume 118 Issue 6 | Pages 407-413

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.

* For current author addresses and the members of the study group, see end of text.

Author and Article Information

From the Mountain States Tumor Institute, Boise, Idaho; Glaxo, Inc. Research Institute, Research Triangle Park, North Carolina; Baylor University Medical Center, Dallas, Texas. Ondansetron Study Group.
Requests for Reprints: Thomas M. Beck, MD, Mountain States Tumor Institute, 151 E. Bannock Street, Boise, ID 83712.
Grant Support: By Glaxo, Inc. Research Triangle Park, North Carolina.

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