Abstract | PURPOSE: PATIENTS AND METHODS: Patients receiving cisplatin > or = 70 mg/m2 were blindly assigned to receive one of the following three regimens: (1) aprepitant 375 mg 1 hour before cisplatin on day 1 and aprepitant 250 mg on days 2 to 5 (n = 35); (2) aprepitant 125 mg before cisplatin and aprepitant 80 mg on days 2 to 5 (n = 81); or (3) placebo before cisplatin on days 2 to 5 (n = 86). All groups received ondansetron 32 mg and dexamethasone 20 mg before cisplatin, and dexamethasone 8 mg on days 2 to 5. The primary end point was complete response (no emesis and no rescue therapy) over 5 days following cisplatin in up to six cycles. A cumulative probability analysis using a model for transitional probabilities was used to analyze the data. The aprepitant 375/250-mg regimen was discontinued early in light of new pharmacokinetic data. RESULTS: In the first cycle, 64% of patients in the aprepitant group and 49% in the standard therapy group had a complete response. Thereafter, complete response rates for the aprepitant group were still 59% by cycle 6, but decreased to 34% by cycle 6 for the standard therapy group. Reasons for discontinuation were similar across treatment groups. CONCLUSION:
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Authors | R de Wit, J Herrstedt, B Rapoport, A D Carides, G Carides, M Elmer, C Schmidt, J K Evans, K J Horgan |
Journal | Journal of clinical oncology : official journal of the American Society of Clinical Oncology
(J Clin Oncol)
Vol. 21
Issue 22
Pg. 4105-11
(Nov 15 2003)
ISSN: 0732-183X [Print] United States |
PMID | 14559891
(Publication Type: Clinical Trial, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
- Antiemetics
- Antineoplastic Agents
- Morpholines
- Neurokinin-1 Receptor Antagonists
- Aprepitant
- Dexamethasone
- Cisplatin
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Topics |
- Administration, Oral
- Adolescent
- Adult
- Aged
- Aged, 80 and over
- Antiemetics
(therapeutic use)
- Antineoplastic Agents
(adverse effects)
- Aprepitant
- Cisplatin
(adverse effects)
- Dexamethasone
(therapeutic use)
- Double-Blind Method
- Drug Therapy, Combination
- Female
- Humans
- Male
- Middle Aged
- Morpholines
(therapeutic use)
- Nausea
(chemically induced, prevention & control)
- Neoplasms
(drug therapy, pathology)
- Neurokinin-1 Receptor Antagonists
- Treatment Outcome
- Vomiting
(chemically induced, prevention & control)
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