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