Takahashi, T., Hoshi, E., Takagi, M., Katsumata, N., Kawahara, M., & Eguchi, K. (2010). Multicenter, phase II, placebo-controlled, double-blind, randomized study of aprepitant in Japanese patients receiving high-dose cisplatin. Cancer Science, 101, 2455–2461.doi: 10.1111/j.1349-7006.2010.01689.x
To evaluate the efficacy and safety of aprepitant plus standard therapy (granisetron and dexamethasone) in the prevention of chemotherapy-induced nausea and vomiting (CINV) in Japanese patients with cancer undergoing treatment with chemotherapy including a highly emetogenic cisplatin-based regimen (≥ 70 mg/m2)
Patients were allocated to three groups.
All patients received standard therapy consisting of 40 µg/kg IV granisetron on day 1 and dexamethasone. Concomitant use of other antiemetics was prohibited from 48 hours before day 1 to the morning of day 6, except for rescue therapy for CINV.
The study was conducted at multiple sites in Japan.
Study participants were in active treatment.
This was a phase II, placebo-controlled, double-blind, randomized parallel comparative study.
In the three study groups, the percentage of patients with complete response (no emesis and no rescue therapy) was 50.3% (standard therapy), 66.4% (aprepitant 40/25 mg), and 70.5% (aprepitant 125/80 mg). Efficacy was significantly higher in the aprepitant 40⁄25 mg and 125/80 mg groups than in the standard therapy group (p = 0.0053 and p = 0.0004, respectively), and efficacy was the highest is the aprepitant 125/80 mg group. The delayed phase efficacy was similar to the overall phase efficacy, indicating that aprepitant is effective in the delayed phase when standard therapy is not very effective. Aprepitant was generally well tolerated.
Aprepitant was shown to be more effective in the overall phase, including both acute and delayed, when compared to the standard group, irrespective of sex, age, or previous treatment with cisplatin.
Aprepitant used in combination with 5-HT3 receptor antagonists and a corticosteroid is effective in preventing CINV associated with highly emetogenic agents.