EFFICACY AND TOLERABILITY OF ORAL ONDANSETRON VERSUS PROCHLORPERAZINEIN THE PREVENTION OF EMESIS ASSOCIATED WITH CYCLOPHOSPHAMIDE-BASED CHEMOTHERAPY AND MAINTENANCE OF HEALTH-RELATED QUALITY-OF-LIFE (VOL 18, PG 508, 1996)

This study compared the efficacy and tolerability of oral ondansetron (8 mg twice daily [BID] for up to 3 days) with those of phenothiazine prochlorperazine (10 mg BID for up to 3 days) in 133 cancer patients r eceiving cyclophosphamide-based chemotherapy. In addition, the study e valuated the impact of these treatments on patients' health-related qu ality of life, measured with both the Functional Living Index-Cancer a nd the Functional Living Index-Emesis questionnaires. The first dose o f study drug was administered 30 minutes before initiation of chemothe rapy. Patients received a rescue antiemetic at their request or if the investigator deemed it necessary. There was a statistically significa nt difference in the number of patients with no emetic episodes over t he S-day study period: 60% in the ondansetron group compared with 21% in the prochlorperazine group. Twenty-five percent of ondansetron-trea ted patients compared with 68% of prochlorperazine-treated patients ex perienced three or more emetic episodes, rescue medication use, or wit hdrawal from the study due to emesis or adverse events. Among patients with at least one emetic episode, the mean time to emesis was signifi cantly longer (13 hours and 37 minutes) in the ondansetron group compa red with the prochlorperazine group (9 hours and 30 minutes). Nausea a nd appetite scores did not differ significantly between groups. The sc ore on the vomiting subscale of the Functional Living Index-Emesis was significantly more favorable in the ondansetron group compared with t he prochlorperazine group, indicating better maintenance of health-rel ated quality of life in ondansetron-treated patients. Both treatments were well tolerated. The most common potentially drug-related adverse event was headache, which occurred in significantly more (16%) ondanse tron-treated patients compared with prochlorperazine-treated patients (3%). The results of this study demonstrate that oral ondansetron 8 mg BID for up to 3 days is more effective than prochlorperazine 10 mg BI D for up to 3 days in the prevention of emesis associated with moderat ely emetogenic chemotherapy.