Thomas M. Beck, MD; Arthur A. Ciociola, PhD; Stephen E. Jones, MD; Walter H. Harvey, DO; N. Simon Tchekmedyian, MD; Alex Chang, MD; Daniel Galvin, MS; Nan E. Hart, BA; Ondansetron Study Group*
To evaluate the efficacy and safety of oral ondansetron (Zofran) as an antiemetic in patients receiving cyclophosphamide-based chemotherapy.
A multicenter, randomized, double-blind, stratified, placebo-controlled trial conducted between March 1989 and January 1990.
Twenty-seven oncology centers including university hospitals, community cancer centers, and private medical oncology practices.
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.
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.
Time and number of emetic episodes as well as degree of nausea were recorded by patients for each of the 3 study days.
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.
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.
Beck TM, Ciociola AA, Jones SE, Harvey WH, Tchekmedyian NS, Chang A, et al. Efficacy of Oral Ondansetron in the Prevention of Emesis in Outpatients Receiving Cyclophosphamide-based Chemotherapy. Ann Intern Med. ;118:407–413. doi: 10.7326/0003-4819-118-6-199303150-00002
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Published: Ann Intern Med. 1993;118(6):407-413.
Gastroenterology/Hepatology, Hematology/Oncology, Prevention/Screening.
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Print ISSN: 0003-4819 | Online ISSN: 1539-3704
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