Results of a Double Blind Placebo Controlled Study of Ondansetron as an Antiemetic During Total Body Irradiation in Patients Undergoing Bone Marrow Transplantation

Abstract

Total body irradiation (TBI) is a highly emetogenic component of the majority of conditioning regimens in use for bone marrow transplantation. Conventional antiemetic therapy fails to control nausea and vomiting induced by single fraction TBI in as many as 50% of patients. In a double blind study of 20 patients undergoing marrow transplantation, a single 8 mg ondansetron dose was compared with placebo given immediately prior to TBI. Our routine premedication of phenobarbitone and corticosteroid was also administered to all patients. All patients had received high dose melphalan the previous evening. Only 1 of the 10 patients in the ondansetron group experienced an emetic event compared with 5 of the 10 in the comparison group (p = 0.029). No significant adverse events were observed. Ondansetron appears to have extremely useful antiemetic activity during single fraction low dose rate TBI.

Radiotherapy-induced nausea and vomiting (RINV): MASCC/ESMO guideline for antiemetics in radiotherapy: update 2009

“…Also, in patients treated with TBI or HBI, 5-HT 3 receptor antagonists provided as expected, significantly better protection for RINV than placebo or conventional antiemetics (Table 2; [34,[39][40][41]43]. Furthermore, Spitzer [40] showed in his randomized trial that granisetron (GRAN) and OND are equally effective in controlling emesis during TBI.…”

Oral dolasetron mesilate (MDL 73,147EF) for the control of emesis during fractionated total-body irradiation and high-dose cyclophosphamide in patients undergoing allogeneic bone marrow transplantation

“…Without antiemetic prophylaxis the mean time to the first emetic episode was 1.5 h and 90% of patients had three or more emetic episodes on the day of TBI [10]. After antiemetic prophylaxis with dexamethasone and sedation with phenobarbitone, 60% of patients vomited after single-fraction irradiation with 4 cGy/min to a total lung dose of 8 Gy [11], and complete response for the first 24 h after pretreatment with metoclopramide, dexamethasone and lorazepam was as low as 13% [4]. The complete response rate achieved with oral dolasetron mesilate in this pilot study for the TBI period indicates efficacy of oral dolasetron mesilate for acute emesis induced by repeated doses of cytotoxic radiotherapy (2!2 Gy per day).…”

“…The antiemetic protection on days 1, 2 and 3 for the combined doses used in this part of the study compares favourably with published studies of i.v. [2,9] and oral [11] ondansetron and i.v. granisetron [5], particularly when the proportion of patients without vomiting and no more then mild nausea for the entire TBI period (11 of 20, 55%) is considered.…”

Protección gastrointestinal y antieméticos en radioterapia: II. Antieméticos

“…El papel de los esteroides asociados a los antagonistas de la 5 HT3 no ha sido estudiado. Existen trabajos 43,44 que demuestran mayor efectividad de los antagonistas de la 5HT3 frente a metoclopramida ó fenotiacinas.…”

“…La incidencia de emesis en este grupo es del 30-90%. Al parecer es mejor la profilaxis que el tratamiento en sí, y que el antagonista de la 5HT3 supera a la metoclopramida y fenotiazinas en este grupo de pacientes 43,44 debido a las escasas diferencias entre los antagonistas de la 5HT3 y dopaminérgicos, algunos autores recomiendan estos últimos especialmente en pacientes sometidos a irradiación craneoespinal o irradiación hemicorporal inferior 45 . Otros autores 46 sugieren que la eficacia de los antagonistas de la 5 HT3 disminuye tras la primera semana de la irradiación.…”