M. Marty et al., CURATIVE EFFICACY OF ONDANSETRON AGAINST NAUSEA AND EMESIS INDUCED BYANTICANCER DRUGS - A STUDY VERSUS METOCLOPRAMIDE, La Semaine des hopitaux de Paris, 70(31-32), 1994, pp. 985-988
Twenty-two patients who experienced nausea or vomiting within eight ho
urs after administration of weakly emetogenic anticancer drugs not pre
ceded by prophylactic antiemetic therapy were entered into a double-bl
ind randomized trial of 8 mg ondansetron (OND, n=11) versus 2 mg/kg me
toclopramide (MCP; n=11). Each antiemetic was given as a slow intraven
ous injection. Eight hours later oral therapy with the same antiemetic
was initiated, in a dose of one 8-mg tablet of OND or two 10-mg table
ts of MCP every eight hours for three to five days. The number of vomi
ting episodes (VE) that occurred between the injection of the antiemet
ic drug and the end of the 24th hour after anticancer drug administrat
ion (D1) was recorded. Responses to therapy were categorized as follow
s: complete (0 VEs), major (1 to 2 VEs), minor (3 to 5 VEs), and absen
t (> 5 VEs or rescue therapy). Successful therapy was defined as a maj
or or complete response (0 to 2 VEs). Complete response rates on D1 we
re 55% (6/11) in the OND group and 18% (2/11) in the MCP group. This d
ifference was significant (p = 0.04). The large number of study withdr
awals for inefficacy in the MCP group precluded statistical analysis o
f success rates beyond D1. In conclusion, ondansetron is superior over
metoclopramide in terms of curative antiemetic efficacy in patients w
ith nausea and vomiting induced by weakly emetogenic anticancer agents
.