Efficacy of a triple antiemetic regimen with aprepitant for the prevention of chemotherapy-induced nausea and vomiting: effects of gender, age, and region

Abstract

Objective:

To determine the variability in treatment responses to antiemetic therapy (ondansetron and dexamethasone vs ondansetron and dexamethasone plus aprepitant) given with moderately emetogenic chemotherapy.

Research design and methods:

Post hoc subgroup analysis of data from a phase III, randomized, double-blind clinical trial evaluated whether the efficacy of aprepitant triple therapy (ondansetron and dexamethasone plus aprepitant) versus control (ondansetron and dexamethasone) varies by gender, age, or region in 848 men and women ≥18 years old with histologically confirmed malignancies and who were naïve to moderately or highly emetogenic chemotherapeutic agents. Endpoints compared were the incidences of no vomiting, complete response, and no use of rescue therapy, all during the overall period (0–120 h).

Main outcome measures:

Regardless of age, gender, or region, the aprepitant regimen provided better control for the no-vomiting and complete-response (no vomiting, no rescue therapy) endpoints.

Results:

The aprepitant regimen provided better control for the no-vomiting and complete-response (no vomiting, no rescue therapy) endpoints. Overall response rates were higher in men and in older (≥55 y) patients, but treatment differences were greater among women and younger patients, known to be at increased chemotherapy-induced nausea and vomiting (CINV) risk. Aprepitant showed a benefit versus control across regions, although the between-treatment difference appeared to be smaller for patients in Central/South America versus North America or international regions.

Conclusions:

Although we acknowledge that subset numbers in this post hoc analysis may be too small to allow definitive conclusions, the data suggest that aprepitant triple therapy provides a benefit over control therapy for the prevention of CINV in patients receiving anthracycline and cyclophosphamide (AC)- or non-AC-based moderately emetogenic chemotherapy across age, gender, and region. (Original trial results available at ClinicalTrials.gov: NCT00337727.)

Trial registration: ClinicalTrials.gov identifier: NCT00337727.

Keywords::

• Chemotherapy
• Nausea and vomiting
• Prevention
• Supportive care

Transparency

Declaration of funding

Financial support for this study was provided by Merck & Co. Inc., Whitehouse Station, NJ, USA.

The author conceived the idea for this post hoc analysis and wrote the manuscript.

Declaration of financial/other relationships

B.L.R. has disclosed that he has received honoraria for clinical trials, speaker engagements, and advisory boards from Merck & Co. Inc., Whitehouse Station, NJ, USA, in the past 12 months.

CMRO peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Acknowledgments

The author thanks Amy Yellen-Shaw PhD, of Complete Healthcare Communications Inc. (Chadds Ford, PA, USA), for writing and editorial assistance during the development of this manuscript. Editorial assistance was also provided by Susan Quiñones PhD of Apothecom, Yardley, PA, USA. This assistance was funded by Merck & Co. Inc., Whitehouse Station, NJ, USA. Martha Vollmer MS and Kristen Lewis of Merck & Co. Inc., Whitehouse Station, NJ, USA also provided editorial assistance.