A Phase 3, randomized, double-blind study of single-dose fosaprepitant for prevention of cisplatin-induced nausea and vomiting: Results of an Indian population subanalysis.
Indian J Cancer
; 2013 Oct-Dec; 50(4): 285-291
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| IMSEAR
| ID: sea-154279
ABSTRACT
Context Currently, there is limited data on the prevention of chemotherapy-induced nausea and vomiting (CINV) in Indian patients. Aims:
This post hoc study assessed the efficacy and safety of fosaprepitant compared with aprepitant for prevention of CINV in the Indian population. A subgroup analysis was performed from data collected in a phase 3 study of intravenous (IV) fosaprepitant or oral aprepitant, plus the 5-HT 3 antagonist ondansetron and the corticosteroid dexamethasone, in cisplatin-naοve patients with solid malignancies. Materials andMethods:
Patients scheduled to receive cisplatin (≥70 mg/m 2 ) were administered a single IV dose of fosaprepitant dimeglumine (150 mg) on day 1 or a 3-day dosing regimen of oral aprepitant (day 1125 mg, days 2 and 380 mg) with standard doses of ondansetron and dexamethasone. Patients recorded nausea and/or vomiting episodes and their use of rescue medication and were monitored for adverse events (AEs) and tolerability. Statistical Analysis Used Differences in response rates between fosaprepitant and aprepitant were calculated using the Miettinen and Nurminen method.Results:
In the Indian subpopulation (n = 372), efficacy was similar for patients in both the fosaprepitant or aprepitant groups; complete response in the overall, acute, and delayed phases and no vomiting in all phases were approximately 4 percentage points higher in the fosaprepitant group compared with the aprepitant group. Fosaprepitant was generally well-tolerated; common AEs were similar to oral aprepitant.Conclusions:
IV fosaprepitant is as safe and effective as oral aprepitant in the Indian subpopulation and offers an alternative to the oral formulation.
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IMSEAR
Sujet Principal:
Vomissement
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Sujet âgé
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Femelle
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Humains
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Mâle
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Indiens d'Amérique Nord
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Morpholines
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Méthode en double aveugle
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Cisplatine
/
Adulte
Type d'étude:
Clinical_trials
langue:
En
Texte intégral:
Indian J Cancer
Année:
2013
Type:
Article