Randomized open-label trial of dolasetron for the control of nausea and vomiting associated with high-dose chemotherapy with hematopoietic stem cell transplantation
Y. Bubalo et al., Randomized open-label trial of dolasetron for the control of nausea and vomiting associated with high-dose chemotherapy with hematopoietic stem cell transplantation, BIOL BLOOD, 7(8), 2001, pp. 439-445
A prospective open-label trial was performed to compare the efficacy of dol
asetron with that of ondansetron or granisetron (standard therapy) for prev
ention of nausea and vomiting associated with high-dose chemotherapy with o
r without total body irradiation followed by hematopoietic stem cell transp
lantation (HSCT). In a university teaching hospital setting, 62 patients we
re randomized to receive either dolasetron 100 mg daily or standard doses o
f ondansetron or granisetron. In addition to objective data such as number
of episodes of emesis and quantity of rescue antiemetics required, 100 nun
visual analogue scales were used to rate nausea, appetite, and changes in t
aste. A post-hoc subgroup analysis was performed between groups of patients
that were matched for conditioning regimens. Sixty-five percent of the dol
asetron-treated patients and 87% of patients in the standard therapy group
achieved a major or complete response (P<.05) based on emetic episodes and
nausea score. Patients in the standard therapy group used fewer rescue anti
emetics and also rated more favorably on selected questions of the visual a
nalogue scale. No differences in safety parameters or adverse effects were
reported. At doses prescribed in this study, dolasetron was less effective
than granisetron or ondansetron in preventing nausea and vomiting associate
d with high-dose chemotherapy/total body irradiation followed by HSCT.