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Aprepitant for the prevention of chemotherapy-induced nausea and vomiting associated with a broad range of moderately emetogenic chemotherapies and tumor types: a randomized, double-blind study
Supportive Care in Cancer, 07/07/09

Rapoport BL et al. - In a study to assess aprepitant in pts receiving a broad range of moderately emetogenic chemotherapy (MEC) regimens with a variety of tumor types, it was reported that the aprepitant regimen provided superior efficacy in treatment of chemotherapy-induced nausea and vomiting (CINV) in a broad range of pts receiving MEC (non-anthracycline and cyclophosphamide [AC] or AC) in both no vomiting and complete response endpoints. Aprepitant was generally well tolerated. These results show the benefit of including aprepitant as part of the standard antiemetic regimen for cancer pts receiving MEC.

Methods

This trial enrolled pts with confirmed malignancies, naïve to MEC or highly emetogenic chemotherapy, who were scheduled to receive a single dose of at least 1 MEC agent.
Pts received an aprepitant triple-therapy regimen (aprepitant, ondansetron, and dexamethasone) or a control regimen (ondansetron and dexamethasone) administered orally.
Primary and key secondary efficacy endpoints were proportions of pts with no vomiting and complete response (no vomiting and no rescue medication), respectively, during 120 hr post-chemotherapy.

Results

Of 848 randomized pts, 77% were female, and 52% received non-AC-based antineoplastic regimens.
More pts in the aprepitant group achieved no vomiting and complete response regardless of whether they received AC or non-AC regimens in 120 hr after chemotherapy.
Incidences of adverse events were generally similar in the aprepitant (62.8%) and control groups (67.2%).

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