Annals of Oncology Advance Access published online on March 8, 2006
Annals of Oncology, doi:10.1093/annonc/mdl019
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1 Martin Luther University Halle/Wittenberg, Halle/Saale, Germany
* To whom correspondence should be addressed. Background: We compared an aprepitant regimen with a control regimen of ondansetron + dexamethasone given for 4 days. Patients and methods: Patients scheduled to receive 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 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
Received December 29, 2005
Accepted January 9, 2006
original article
Comparison of an aprepitant regimen with a multiple-day ondansetron regimen, both with dexamethasone, for antiemetic efficacy in high-dose cisplatin treatment
H. J. Schmoll 1 *,
M. S. Aapro 2,
S. Poli-Bigelli 3,
H.-K. Kim 4,
K. Park 5,
K. Jordan 1,
J. von Pawel 6,
H. Giezek 7,
T. Ahmed 8,
and
C. Y. Chan 9
2 IMO Clinique de Genolier, Genolier, Switzerland
3 Instituto de Oncologia Hematologia, Universidad Central de Venezuela, Caracas, Venezuela
4 Medical Oncology, St. Vincent's Hospital, The Catholic University of Korea, Suwon, Korea
5 Division of Hematology/Oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea
6 Asklepios Fachkliniken, Centre for Pneumology and Thoracic Surgery, Gauting, Germany
7 Merck Research Laboratories, Brussels, Belgium
8 Merck Research Laboratories, West Point, Pennsylvania, USA
9 Merck & Co., Inc., Whitehouse Station, New Jersey, USA
H. J. Schmoll, E-mail: hans-joachim.schmoll{at}medizin.uni-halle.de
Abstract 
70 mg/m2 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).
0.001; acute 89% versus 81%, P = 0.004; delayed 79% versus 64%, P 0.001). Rates of no rescue therapy were similar between groups.
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