THE COMBINATION OF METOCLOPRAMIDE, METHYLPREDNISOLONE AND ONDANSETRONAGAINST ANTIBLASTIC-DELAYED EMESIS - A RANDOMIZED PHASE-II STUDY

The aim of the study was to verify whether the combination of an antis erotoninergic, metoclopramide, and a steroid could improve the complet e control (CC) of delayed emesis, a contraversial issue. 105 patients undergoing highly-emetogenic chemotherapy, receiving Ondansetron (O) 8 mg + Dexamethasone 20 mg i.v. for the prevention of acute emesis, wer e randomly treated p.o for three further days with a) Metoclopramide 1 0 mg x 3 b) the same as a) + Methylprednisolone 4 mg c) the same as b) + O 8mg x 3. CC (acute + delayed emesis) over three cycles was: a) 0. b) 12.5%, c) 38.5% (p=0.02). Days with nausea/vomiting: 59%, 51%, 29. 7% of the total observed period respectively (b vs c p=0.0000). CC of acute emesis was similar in the first cycle (about 85%), remained unch anged in the following cycles (c) and decreased to 30% and 68% in the third cycle (a and b) (p=0.01). The three drug combination significant ly improved complete control of acute and delayed emesis over successi ve chemotherapy cycles.