INTEREST IN USING ORAL ONDANSETRON COMBINED WITH METHYLPREDNISOLONE IN MODERATELY EMETOGENIC CHEMOTHERAPY

This multicentre randomized single-blind parallel group study compared the efficacy of oral ondansetron plus methylprednisolone (OND + MPS) with conventional antiemetic strategies (TH) over 4 consecutive course s in moderately emetogenic chemotherapy. This study was conducted in n aive patients receiving a minimum of 3 cytotoxics including adriamycin (greater than or equal to 35 mg/m(2)) and cyclophosphamide (greater t han or equal to 500 mg/m(2)) plus an other alkylating agent. Of the 36 4 patients included in the study, 70% had a breast cancer and 30% a ly mphoma. Patients were divided into two groups. On day 1, one group of patients received OND (8 mg, po) 2 hours before chemotherapy, followed by a slow intravenous injection of MPS (120 mg) 30 minutes before che motherapy. Eight hours after the start of chemotherapy, patients recei ved OND (8 mg, po) and MPS (16 mg, po). On days 2-4, patients received OND (8 mg, po) and MPS (16 mg, po) twice daily. The second group of p atients received conventional antiemetic treatment (benzamide plus cor ticosteroids with or without benzodiazepins). The primary efficacy par ameter was defined as complete control of emesis (0 emetic episodes) o ver 4 consecutive courses of chemotherapy. In the OND + MPS group, 63% of patients experienced complete control of emesis versus 33% in the TH group (p < 0.001). The secondary parameters (percentage of days wit h no emetic episodes, control of emetic episodes, grade of nausea at e ach course, patient preference and quality of life evaluation) were al ways significantly better in the OND + MPS treated group. The percenta ge of days without any emetic episode over the 4 courses of chemothera py was 91% in the OND + MPS group and 75% in the TH group (p < 0.001). Ninety-two percent of patients from OND + MPS group preferred to cont inue their treatment versus 76% in the TH group (p < 0,001). Concernin g the quality of life assessed by FLIC and FLIE questionnaires, the an alysis showed a significant difference at the end of the treatment in favor of OND + MPS (p = 0.037 and 0.0075 respectively). This study sho wed the interest in using the combination OND + MPS right from the fir st course of moderately emetogenic chemotherapy.