Abstract #301446

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JSM 2003 Abstract #301446
Activity Number: 376
Type: Contributed
Date/Time: Wednesday, August 6, 2003 : 10:30 AM to 12:20 PM
Sponsor: Biopharmaceutical Section
Abstract - #301446
Title: An Evaluation of the Relationship Between Acute and Delayed Efficacy in Two Regimens for Preventing Chemotherapy Induced Nausea and Vomiting: An Oral NK1 Antagonist (Aprepitant) Regimen and a Standard Therapy Regimen
Author(s): Guoguang Ma*+ and Alexandra Carides
Companies: Merck & Company and
Address: 10 Sentry Pkwy., Blue Bell, PA, 19422,
Keywords: aprepitant ; cancer ; NK1 antagonist ; clinical trial ; generalized estimating equation ; alternating logistic regression
Abstract:

In two randomized, double-blind Phase III studies, the NK1 antagonist aprepitant enhanced the efficacy of standard therapy (a 5-HT3 antagonist plus a corticosteroid) in the prevention of chemotherapy-induced nausea and vomiting. For two studies combined, 1044 patients (42% female) receiving their first cisplatin (>=70mg/m2) were given either standard therapy or an aprepitant (A) regimen. Data were analyzed by a modified intent-to-treat approach. Previously, an analysis was performed on complete response (no emesis and no rescue therapy) for the acute phase (Day 1) and delayed phase (Days 2-5), separately, using a logistic regression. The results showed that A was significantly superior in each phase (p< 0.001). To confirm the effect of A, we considered the outcomes from the two phases as repeated measures for each patient.We then used the generalized estimating equation approach and applied an alternating logistic regression (Carey et. al.,1993) to model the association. Both models suggested that A had enhanced efficacy relative to standard therapy in each phase as assessed by the complete response (p< 0.001), even after controlling the association between the two phases.

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