Granisetron compared with prednisolone plus metopimazine as anti-emetic prophylaxis during multiple cycles of moderately emetogenic chemotherapy

This randomized, double-blind, double-dummy parallel study compared the ant i-emetic efficacy and tolerability of the serotonin antagonist granisetron with prednisolone plus the dopamine D-2 antagonist metopimazine during nine cycles of moderately emetogenic chemotherapy. Chemotherapy naive women wit h stage I or II breast cancer scheduled to intravenous cyclophosphamide, fl uorouracil and methotrexate or cyclophosphamide, epirubicin and fluorouraci l every 3 weeks were included. Patients received a single intravenous dose of granisetron 3 mg or a 3-day oral treatment with prednisolone 25 mg once a day plus metopimazine 30 mg four times a day. A total of 223 women were e nrolled and 218 patients (97.8%) were evaluable for efficacy. Granisetron ( n = 109) was superior to prednisolone plus metopimazine (n = 109) in the pr ophylaxis of acute nausea and vomiting during the first cycle of chemothera py (P < 0.001) and prednisolone plus metopimazine was superior on days 2-5 (P = 0.002). Overall, granisetron was superior on days 1-5 (P = 0.009). The median number of cycles completed with granisetron was five (95% confidenc e interval 4-6) compared with two (95% confidence interval 2-2) for prednis olone plus metopimazine (P = 0.0019). Constipation and rash were reported m ore frequently with granisetron (P < 0.001 and P = 0.043 respectively) and palpitations more frequently with prednisolone plus metopimazine (P = 0.015 ). In conclusion, the number of cycles completed with granisetron was signi ficantly higher than the number completed with prednisolone plus metopimazi ne, but the anti-emetic efficacy of both treatments declined during multipl e cycles of moderately emetogenic chemotherapy.