Open-label, randomized comparison of the efficacy of intravenous dolasetron mesylate and ondansetron in the prevention of acute and delayed cisplatin-induced emesis in cancer patients.
OBJECTIVE
The aim of this study is to compare the antiemetic efficacy and tolerability of intravenous dolasetron mesylate and ondansetron in the prevention of acute and delayed emesis.


METHODS
From April 2002 through October 2002, a total of 112 patients receiving cisplatin- based combination chemotherapy were randomized to receive a single i.v. dose of dolasetron 100 mg or ondansetron 8 mg, 30 minutes before the initiation of chemotherapy. In the ondansetron group, two additional doses of ondansetron 8 mg were given at intervals of 2 to 4 hours. To prevent delayed emesis, dolasetron 200 mg p.o. daily or ondansetron 8 mg p.o. bid was administered from the 2(nd) days to a maximum of 5 days. The primary end point was the proportion of patients that experienced no emetic episodes and required no rescue medication (complete response, CR) during the 24 hours (acute period) and during Day 2 to Day 5+/-2 days (delayed period), after chemotherapy. The secondary end points included the incidence and severity of emesis.


RESULTS
105 patients were evaluable for efficacy. CR rates during the acute period were 36.0% for a single dose of dolasetron 100 mg, and 43.6% for three doses of ondansetron 8 mg. CR rates during the delayed period were 8.0% and 10.9%, respectively. There was no significant difference in the efficacy between the two groups. Adverse effects were mostly mild to moderate and not related to study medication.


CONCLUSIONS
A single i.v. dose of dolasetron 100 mg is as effective as three i.v. doses of ondansetron 8 mg in preventing acute and delayed emesis after cisplatin-based chemotherapy, with a comparable safety profile.
Kim
Jin-Soo
JS
Department of Internal Medicine, Seoul National University College of Medicine, Seoul, Korea.
Baek
Ji Yeon
JY
Park
Sook Ryun
SR
Choi
In Sil
IS
Kim
Sang-Il
SI
Kim
Dong-Wan
DW
Im
Seock-Ah
SA
Kim
Tae-You
TY
Heo
Dae Seog
DS
Bang
Yung-Jue
YJ
Kim
Noe Kyeong
NK