Antiemetic treatment with oral granisetron in patients receiving moderately emetogenic chemotherapy: a dose-ranging study.
The antiemetic efficacy and tolerability of four different oral doses of granisetron (0.25, 0.5, 1, and 2 mg twice daily [BID]) were compared in a randomized, double-blind, parallel-group, multicenter study involving 930 patients with malignant disease receiving moderately emetogenic chemotherapy over a 7- or 14-day period. On the first day of granisetron treatment, a statistically significant association between complete response and dose was seen (P = 0.001), with the maximum response (81.1%) achieved at a dose of 1 mg BID. The 24-hour complete response rate with granisetron 1 mg BID was significantly higher than with 0.25 mg BID (61.1%) or 0.5 mg BID (70.2%) (P < 0.009). The complete response rate for days 0 to 6 was significantly higher with granisetron at 1 mg BID (58.8%) than with 0.25 mg BID (43.7%) or 0.5 mg BID (53.6%) (P < 0.009). No advantage in terms of complete response rate was shown for 2 mg BID over 1 mg BID. Granisetron was well tolerated, and few patients required additional treatment with other antiemetics.
Bleiberg
H H
HH
Institut Bordet, Brussels, Belgium.
Spielmann
M
M
Falkson
G
G
Romain
D
D
D000284:Administration, Oral; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D004361:Drug Tolerance; D005260:Female; D017829:Granisetron / Q000008:administration & dosage*; D006801:Humans; D008297:Male; D008875:Middle Aged; D009325:Nausea / Q000139:chemically induced / Q000188:drug therapy; D009369:Neoplasms / Q000188:drug therapy*; D014839:Vomiting / Q000139:chemically induced / Q000188:drug therapy*
D017829:Granisetron