Ondansetron plus metopimazine compared with ondansetron plus metopimazine plus prednisolone as antiemetic prophylaxis in patients receiving multiple cycles of moderately emetogenic chemotherapy

Purpose: To compare the antiemetic efficacy and tolerability of ondansetron plus metopimazine with ondansetron plus metopimazine plus prednisolone dur ing nine cycles of moderately emetogenic chemotherapy. Patients and Methods: A total of 221 women with stage I or II breast cancer and no prior chemotherapy who were scheduled to receive adjuvant chemother apy with intravenous cyclophosphamide, fluorouracil and methotrexate or cyc lophosphamide, epirubicin, and fluorouracil given every 3 weeks were includ ed in a double-blind parallel trial. Patients were randomized to 3 days of oral treatment with ondansetron plus metopimazine, or ondansetron plus meto pimazine plus prednisolone. Ondansetron was administered as 8 mg bid, metop imazine as 30 mg qid, and prednisolone as 50 mg qd. Results: In all, 216 patients (97.7%) were assessable for efficacy during a total of 1,462 cycles. In cycle 1, complete protection from emetic episode s/nausea day 1, days 2 through 5, and days 1 through 5 wets achieved in 84. 4%/51.4%, 82.6%/41.3%, and 79.8%/ 34.9% with ondansetron plus metopimazine and in 84.1%/57.0%, 86.8%/53.8%, and 79.4%/43.0% with ondansetron plus meto pimazine plus prednisolone, respectively. In cycle 1, the three-drug combin ation was superior only in the treatment of nausea on days 2 through 5 (P = .0497). The cumulative emetic protection rate after nine cycles wets 0.52 with ondansetron plus metapimazine and 0.75 with ondansetron plus metapimaz ine plus prednisolone. Side effects were generally few and mild with both t reatments. Constipation was the only adverse event significantly more frequ ent with the three-drug combination (P = .029). Conclusion: Ondansetron plus metopimazine plus prednisolone is highly effec tive and superior to ondansetron plus metopimazine during nine cycles of mo derately emetogenic chemotherapy. (C) 2001 by American Society of Clinical Oncology.