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Post-Transplant Complications

Double-blind, randomized, parallel-group study on the efficacy and safety of oral granisetron and oral ondansetron in the prophylaxis of nausea and vomiting in patients receiving hyperfractionated total body irradiation

Bone Marrow Transplantation volume 26, pages 203–210 (2000)Cite this article

Abstract

The efficacy and safety of granisetron and ondansetron for the prophylaxis of nausea and vomiting resulting from hyperfractionated 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 (61.1%) 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 not those 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). Oral granisetron and ondansetron are safe and effective for the prevention of nausea and vomiting resulting from TBI. Bone Marrow Transplantation (2000) 26, 203–210.

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Authors and Affiliations

  1. Massachusetts General Hospital, Boston, MA, USA

    TR Spitzer

  2. SmithKline Beecham Pharmaceuticals, Collegeville, PA, USA

    CJ Friedman & W Bushnell

  3. Greenebaum Cancer Center, Baltimore, MD, USA

    SR Frankel

  4. City of Hope National Medical Center, Duarte, CA, USA

    J Raschko

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  5. J Raschko
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Spitzer, T., Friedman, C., Bushnell, W. et al. Double-blind, randomized, parallel-group study on the efficacy and safety of oral granisetron and oral ondansetron in the prophylaxis of nausea and vomiting in patients receiving hyperfractionated total body irradiation. Bone Marrow Transplant 26, 203–210 (2000). https://doi.org/10.1038/sj.bmt.1702479

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