ORAL ONDANSETRON IN THE PROPHYLAXIS OF NAUSEA AND VOMITING INDUCED BYCYCLOPHOSPHAMIDE, METHOTREXATE AND 5-FLUOROURACIL (CMF) IN WOMEN WITHBREAST-CANCER - RESULTS OF A PROSPECTIVE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY

Background: The combination of cyclophosphamide, methotrexate and 5-fl uorouracil (CMF) is a widely used chemotherapy regimen in breast cance r patients. However, the control of nausea and vomiting induced by ora l CMF is a rarely examined problem. Therefore we felt a randomized, pl acebo controlled study justified in order to improve currently availab le antiemetic therapy. Subjects and methods: In a randomised double-bl ind trial ondansetron given orally, 8 mg three times a day for 15 days , was compared with placebo in 82 breast cancer patients receiving che motherapy with CMF (cyclophosphamide 100 mg/m2 orally days 1-14, metho trexate 40 mg/m2 i.v. days 1 and 8 and 5-fluorourcil 600 mg/m2 i.v. da ys 1 and 8). The patients recorded nausea and the number of vomits and retches daily on diary cards. Forty-two patients received ondansetron and 40 received placebo. Results: Significantly more patients who rec eived ondansetron experienced neither vomiting nor retching (emesis) c ompared to those receiving placebo over a 15 day treatment period (60% vs. 35%, p = 0.027). The difference, with 95% confidence limits, was estimated as 25 (4.45%). Furthermore, there was a trend in favour of o ndansetron in the control of nausea. Ondansetron was well tolerated, w ith 25 patients (59%) reporting at least 1 adverse event compared to 1 8 patients (45%) receiving placebo (p = 0.191). Conclusion: The result s indicate that ondansetron given orally for 15 days is safe and effec tive in the control of emesis induced by CMF. It is however too early to recommend ondansetron as standard antiemetic therapy for oral CMF, as the treatment of nausea and vomiting in this setting has not been s tudied thoroughly enough.