ONDANSETRON FOR NAUSEA AND VOMITING ASSOCIATED WITH MODERATELY EMETOGENIC CANCER-CHEMOTHERAPY

This multicenter, randomized, double-blind study compared the efficacy and tolerability of ondansetron 8 mg twice daily for 3 days with plac ebo in preventing nausea and vomiting in 81 patients receiving cycloph osphamide-doxorubicin-based chemotherapy. The first dose of study drug was administered 30 minutes before the initiation of chemotherapy. Pa tients received a rescue antiemetic if the investigator deemed it nece ssary or if the patient experienced more than two emetic episodes duri ng the 3-day study. Sixty-one percent of patients treated with ondanse tron compared with 6% of patients receiving placebo (P < 0.001) had no emetic episodes during the 3-day study. Among patients with at least one emetic episode, the mean time to emesis was 24 hours 18 minutes in the ondansetron group compared with 8 hours 1 minute in the placebo g roup (P < 0.001). In the intent-to-treat analysis, 78% of patients in the ondansetron group and 29% of patients in the placebo group complet ed the study with no need for rescue therapy. Clinical laboratory and adverse-event profiles were similar between groups. The most common ad verse event was headache, occurring in 23% of ondansetron patients and 24% of placebo patients. This study is the first double-blind, placeb o-controlled trial to demonstrate that ondansetron 8 mg twice daily is effective in the prevention of nausea and vomiting associated with cy clophosphamide-doxorubicin-based chemotherapy. The twice-daily regimen may encourage patient compliance and may be more cost-effective than regimens that need to be given three times daily.