A SINGLE-BLIND STUDY OF THE EFFICACY AND SAFETY OF INTRAVENOUS GRANISETRON COMPARED WITH ALIZAPRIDE PLUS DEXAMETHASONE IN THE PROPHYLAXIS AND CONTROL OF EMESIS IN PATIENTS RECEIVING 5-DAY CYTOSTATIC THERAPY

200 cancer patients who were due to receive fractionated chemotherapy (cisplatin greater-than-or-equal-to 15, ifosfamide greater-than-or-equal-to 1.2 or etoposide greater-than-or-equal-to 120, all mg/m2 per day) for 5 days, entered a multicentre study. Patients were randomised single-blind to receive either prophylactic intravenous granisetron (40-mu-g/kg) or alizapride (4 mg/kg followed by 4 mg/kg at 4 and 8 h post-treatment) plus dexamethasone 8 mg. Granistron was superior to the combination in preventing nausea and vomiting (54% vs. 43% complete responders). The differences were in the cisplatin-treated group. The time to first episode of moderate to severe nausea was significantly longer in the granisetron group (P = 0.03). Dosing with granisetron was more simple, with over 85% of patients requiring only a single prophylactic dose. Fewer patients receiving granisetron experienced adverse events (48% vs. 62%, P = 0.047). The frequency of constipation was, as expected, significantly higher in the granisetron group. Extrapyramidal effects, which were not noted by any granisetron patient, occurred in 5.3% of comparator patients.