A randomised dose-comparison trial of granisetron in preventing emesis in children with leukaemia receiving emetogenic chemotherapy

This randomised study was performed to assess the anti-emetic efficacy and tolerability of two-dose regimens of granisetron in children with leukaemia . 49 children with leukaemia were treated with three consecutive courses of high-dose methotrexate or cytarabine regimen. During the first course, pat ients were evaluated regarding the emetogenicity of each regimen. They were randomised in a crossover manner to receive 20 or 40 mu g/kg of granisetro n before the second and third course of chemotherapy. Neither emesis nor se vere appetite loss were observed in over 80% of patients within the first 2 4h in all treatment groups. There was no significant difference in the anti -emetic efficacy between the two-dose regimens of granisetron. However, com plete protection was achieved less frequently on days 2 and 3. Older childr en and girls appeared to be less well protected. No adverse events attribut able to granisetron were observed. Granisetron dose regimens of 20 and 40 m u g/kg are, comparably, well tolerated and effective in controlling chemoth erapy-induced emesis in the first 24h, though this protection fails thereaf ter, particularly in older patients and girls (C) 1999 Elsevier Science Ltd . All rights reserved.