The efficacy of granisetron as a prophylactic anti-emetic and intervention agent in high-dose cisplatin-induced...

A single-centre, double-blind, placebo-controlled study was carried out in 28 patients with malignant disease, naive to chemotherapy, receiving cisplatin at a mean dose in excess of 80 mg/m2. Patients were randomized into two groups, receiving either granisetron (40 micrograms/kg) or placebo. Patients in both groups who experienced symptoms of vomiting and nausea were given up to a further three 40 micrograms/kg doses of granisetron on an open-label basis, allowing the assessment of granisetron as an intervention anti-emetic in the placebo group. Following granisetron administration, 13 (93%) patients had no vomiting or nausea in the first 24 h, a significant difference compared with the one patient in the placebo group who remained free from vomiting and had only mild nausea in the same period (P less than 0.001). As a single intervention agent, granisetron achieved control or improvement of existing symptoms in the remaining members of the placebo group.