The efficacy of granisetron as a prophylactic anti-emetic and intervention agent in high-dose cisplatin-induced emesis.
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.
Cupissol
D R
DR
Hôpital Val D'Aurelle II, Hospitalisation de Jour, Montpelier, France.
Serrou
B
B
Caubel
M
M
D000328:Adult; D000368:Aged; D002945:Cisplatin / Q000009:adverse effects*; D004311:Double-Blind Method; D005260:Female; D017829:Granisetron; D006801:Humans; D007191:Indazoles / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D009325:Nausea / Q000517:prevention & control; D009369:Neoplasms / Q000188:drug therapy; D012702:Serotonin Antagonists / Q000627:therapeutic use*; D012737:Sex Factors; D013997:Time Factors; D014839:Vomiting / Q000139:chemically induced / Q000517:prevention & control*
D002945:Cisplatin; D017829:Granisetron; D007191:Indazoles; D012702:Serotonin Antagonists