Comparison of an aprepitant regimen with a multiple-day ondansetron regimen, both with dexamethasone, for antiemetic efficacy in high-dose cisplatin treatment.
BACKGROUND
We compared an aprepitant regimen with a control regimen of ondansetron + dexamethasone given for 4 days.


METHODS
Patients scheduled to receive cisplatin > or =70 mg/m(2) were randomized to either the aprepitant regimen (aprepitant, ondansetron and dexamethasone on day 1; aprepitant and dexamethasone on days 2-3; dexamethasone on day 4) or control regimen (ondansetron + dexamethasone on days 1-4). Patients recorded vomiting, nausea and rescue therapy use. The primary end point was complete response (no vomiting and no use of rescue therapy) in the overall phase (days 1-5 post-cisplatin).


RESULTS
Complete response rates were higher in the aprepitant than control group in the overall (72% versus 61%; P = 0.003), acute (day 1; 88% versus 79%; P = 0.005) and delayed phases (days 2-5; 74% versus 63%; P = 0.004), as were rates of no vomiting (overall 77% versus 62%, P < or = 0.001; acute 89% versus 81%, P = 0.004; delayed 79% versus 64%, P < or = 0.001). Rates of no rescue therapy were similar between groups.


CONCLUSIONS
Compared with an antiemetic regimen in which ondansetron + dexamethasone were given for 4 days, the aprepitant regimen was superior in the acute, delayed and overall phases of chemotherapy-induced nausea and vomiting. The aprepitant regimen should be considered a new standard of antiemetic therapy for cisplatin-treated patients. www.ClinicalTrials.gov Identifier: NTC00090207.
Schmoll
H J
HJ
Martin Luther University Halle/Wittenberg, Halle/Saale, Germany. hans-joachim.schmoll@medizin.uni-halle.de
Aapro
M S
MS
Poli-Bigelli
S
S
Kim
H-K
HK
Park
K
K
Jordan
K
K
von Pawel
J
J
Giezek
H
H
Ahmed
T
T
Chan
C Y
CY
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000932:Antiemetics / Q000627:therapeutic use*; D000970:Antineoplastic Agents / Q000009:adverse effects / Q000627:therapeutic use; D000077608:Aprepitant; D002945:Cisplatin / Q000009:adverse effects* / Q000627:therapeutic use*; D003907:Dexamethasone / Q000627:therapeutic use*; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009025:Morpholines / Q000627:therapeutic use*; D009369:Neoplasms / Q000188:drug therapy*; D017294:Ondansetron / Q000627:therapeutic use*; D018579:Patient Selection
D000932:Antiemetics; D000970:Antineoplastic Agents; D009025:Morpholines; D000077608:Aprepitant; D017294:Ondansetron; D003907:Dexamethasone; D002945:Cisplatin