Prophylaxis of nausea and vomiting in pts receiving hyperfractionated total body irradiation

In this study, the efficacy and safety of granisetron and ondansetron for the prophylaxis of nausea and vomiting resulting from hyperfractioned total body irradiation (TBI) were assessed.

Thirty-four patients randomly received double-blind, oral granisetron (2 mg, 1 h before first daily fraction of radiation) or ondansetron (8 mg, 1.5 h prior to each fraction of TBI). Ninety patients who received the same TBI regimen prior to bone marrow transplantation (BMT), but no 5-HT3-receptor antagonist, were identified and comprised the historical control group. By design, this study was only powered to show a difference between each of the active treatment groups and the historical control group. Significantly more patients given granisetron (33.3%) or ondansetron (26.7%) had zero emetic episodes over 4 days, the primary efficacy end point, than those in the historical control group (0%) (P<0.01; intent-to-treat). Secondary efficacy end points were also evaluated. During the first 24 h, significantly more patients taking granisetron (61.%) or ondansetron (46.7%) had zero emetic episodes than patients in the historical control group (6.7%) (P<0.01). Complete emetic control (no emesis or rescue antiemetic) over 4 days was more frequent in patients taking granisetron (27.8%) or ondansetron (26.7%) compared with the historical control group (0%) (P<0.01). Significantly fewer patients taking granisetron (18/18), but those not taking ondansetron (12/15), experienced more than five emetic episodes during the 4 days of the study compared with the historical control group (40/90;P<0.01). Researchers concluded that oral granisetron and ondansetron are safe and effective for the prevention of nausea and vomiting resulting from TBI. (Source: Bone Marrow Transplantation (2000) 26, 203-210.)