A double-blind, randomised, crossover comparison of granisetron and ondansetron in 5-day fractionated chemotherapy: assessment of efficacy, safety and patient preference. The Granisetron Study Group.
We report the first double-blind, randomised, crossover study comparing granisetron and ondansetron as antiemetics in cancer chemotherapy. Patients receiving two cycles of identical chemotherapy fractionated over 5 days were given either granisetron (3 mg/day) or ondansetron (24 mg/day) on each day of chemotherapy, using a double-dummy technique to preserve study blindness. Patients then crossed over to the other therapy. 309 patients (237 male) completed the crossover: 260 received cisplatin (mean dose 19.2 mg/m2/day) and 49 received ifosfamide (mean dose 1415 mg/m2/day). Primary efficacy variables were prospectively defined as complete response (no vomiting and mild or absent nausea) over 5 days, and patient preference. Both agents achieved good control of emetic symptoms with 5-day complete response rates of 44.0% on granisetron and 39.8% on ondansetron [95% confidence interval (CI) for odds ratio 0.8, 1.9]. Complete response rates were very similar in patients receiving either cisplatin (40.8% granisetron, 37.6% ondansetron) or ifosfamide (61.2% granisetron, 51.0% ondansetron). There was a statistically significant difference in patient preference in favour of granisetron, 105 patients preferred granisetron, 79 preferred ondansetron, 121 had no preference (P = 0.048: 95% CI for odds ratio 1.00, 1.84). Single daily doses of granisetron (3 mg/day) appeared similarly effective and well tolerated to three daily doses of ondansetron (8 mg three times daily) in prevention of emesis induced by 5-day fractionated chemotherapy, however, significantly more patients preferred granisetron.
Noble
A
A
Hôpital Castellucio, Ajaccio, France.
Bremer
K
K
Goedhals
L
L
Cupissol
D
D
Dilly
S G
SG
D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D018592:Cross-Over Studies; D004311:Double-Blind Method; D005260:Female; D017829:Granisetron / Q000627:therapeutic use*; D006801:Humans; D008297:Male; D008875:Middle Aged; D009325:Nausea / Q000517:prevention & control*; D009369:Neoplasms / Q000188:drug therapy*; D017294:Ondansetron / Q000627:therapeutic use*; D014839:Vomiting / Q000517:prevention & control*
D017829:Granisetron; D017294:Ondansetron