Schmoll, H.J., Aapro, M.S., Poli-Bigelli, S., Kim, H.K., Park, K., Jordan, K., et al. (2006). Comparison of an aprepitant regimen with a multiple-day ondansetron regimen, both with dexamethasone, for antiemetic efficacy in high-dose cisplatin treatment. Annals of Oncology, 17(6), 1000-1006.

To compare the effectiveness of adding an aprepitant regimen to an ondansetron and dexamethasone regimen for chemotherapy-induced nausea and vomiting (CINV)

Patients were randomized to receive the treatment arm (aprepitant, ondansetron, and dexamethasone on day 1; aprepitant and dexamethasone on days 2–3; dexamethasone on day 4) or the control arm (ondansetron plus dexamethasone on days 1–4).

The study looked at 489 patients with solid malignancies receiving chemotherapy (patients were cisplatin-naïve). The treatment arm had 231 participants, and the comparison group had 229 participants.

The study was a prospective, randomized, double-blind trial with sponsor blinding.

Measurement instruments were

• Patient diaries used to record number of episodes of vomiting
• Use of rescue medication
• Nausea visual analogue scale (VAS).

Patients were considered treatment failures if they needed to take rescue medication.

• Complete response (CR) was defined as no vomiting and no rescue medication in the overall period (days 1-5 after cisplatin infusion).
• The aprepitant regimen was superior to the control arm in the overall treatment period (CR = 72% versus 61%, p = 0.003).
• No significant difference was observed among groups in control of nausea.
• The aprepitant group had higher rates of drug-related adverse events.

Efficacy might be further improved if ondansetron is given on days 1-4 as well (as per guidelines), rather than only on day 1 as done in this study.

The addition of aprepitant to prevention of CINV provides an objective improvement in control of vomiting as compared to ondansetron and dexamethasone alone; however, the triple-drug combination is recommended for practice.