Antiemetic treatment with oral granisetron in patients receiving moderately emetogenic chemotherapy: a dose-ranging...

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.