Source: DGNews  |  Posted 3 years ago

By Jill Stein

STOCKHOLM, Sweden -- September 14, 2008 -- The NK1 receptor antagonist aprepitant improves antiemetic outcome in patients receiving chemotherapy, regardless of their risk factors for chemotherapy-induced nausea and vomiting (CINV), researchers said here at the 33rd European Society for Medical Oncology Congress (ESMO).

Paul Hesketh, MD, Caritas St. Elizabeth Medical Center, Boston, Massachusetts, and colleagues assessed the impact of aprepitant on antiemetic outcome in patients with previously reported risk factors for CINV.

The analysis, presented here in a poster session on September 14, drew 1,043 subjects from 2 phase 3 trials; all subjects had been randomised to an active control group involving ondansetron and dexamethasone or to treatment with aprepitant.

The primary endpoint in the analysis was complete response.

To determine the risk factors for CINV, subjects were broken out into gender, age (<65 or >=65 years), alcohol use (<5 or >=5 drinks/wk) and cisplatin dose (<80 or >=80 mg/m²).

In a multivariate analysis, the inclusion of aprepitant (P < .0001), male gender (P = .023), lower cisplatin dose (P = .001), older age (P = .021), and alcohol use (P = .027) were all significantly associated with an increased likelihood of achieving a complete response.

The relative difference in the complete response rate between high- and low-risk groups for the active control and aprepitant arms were as follows: 30.3 for gender in the active control arm versus 4.4 for aprepitant; 34.4 and 14.9, respectively, for dose; 33.7 and 21.2, respectively, for ethanol use; and 19.4 and 19.1, respectively, for age.

The addition of aprepitant was consistently associated with a significantly improved chance of a complete response, regardless of risk. Complete response rates were improved to a greater degree in high- versus low-risk populations.

While the relative risk associated with female gender, higher cisplatin dose, and light or no alcohol use -- but not younger age -- was reduced for patients receiving an aprepitant-containing regimen compared to an active control, these effects did not reach statistical significance.

Dr. Hesketh said that the results suggest aprepitant should be included in the antiemetic regimen from the first cycle for patients receiving highly or moderately emetogenic chemotherapy regardless of risk profile.

Funding for this study was provided by Merck & Co., Inc.

[Presentation title: Impact of Aprepitant (A) on Antiemetic Outcome in Patients With Adverse Predictive Factors Receiving Cisplatin-Based Chemotherapy. Abstract 891]