Uchida, M., Ikesue, H., Kato, K., Ichinose, K., Hiraiwa, H., Sakurai, A., … Oishi, R. (2013). Antiemetic effectiveness and safety of aprepitant in patients with hematologic malignancy receiving multiday chemotherapy. American Journal of Health-System Pharmacy, 70, 343-349.

To determine the effectiveness and safety of aprepitant in Japanese patients with hematologic malignancy receiving multiday chemotherapy

All patients were given 3 mg IV granisetron 30 minutes before chemotherapy. Corticosteroids were administered as part of the chemotherapy regimen.  In the aprepitant group, 125 mg was given orally on day 1; on following days, patients received 80 mg aprepitant daily. 

Data were collected via retrospective electronic medical records review for comparison of outcomes between those who received aprepitant versus those who did not. Nausea, vomiting, and adverse events were monitored daily and recorded in the medical record.

• The study consisted of 82 patients.
• The mean age was 47.5.
• The sample was 42.7% male and 57.3% female.
• All participants had hematologic malignancies.  Stem cell transplant patients were excluded.  All patients were receiving moderately or highly emetogenic chemotherapy in multiday regimens.

The study was conducted at a single inpatient site in Japan.

All patients were in active antitumor treatment.

This was a retrospective comparison.

Measurement tools were the Common Terminology for Adverse Events version 4.0 and complete response calculation.

• With aprepitant, the complete response (CR) rate for chemotherapy-induced nausea and vomiting (CINV) control was 76%, compared to 50% in those who did not receive aprepitant (p = 0.013). 
• The percentage of patients without any vomiting was significantly higher with aprepitant (p = 0.002).
• No significant differences were found between groups in prevalence of nausea. 
• Patients treated with regimens containing cytarabine had more CINV (p = 0.028).  In those patients receiving cytarabine 4 g/m² or more per day, CINV was poorly controlled for all patients. 
• Few adverse effects were found with aprepitant with the most common being malaise.

The study showed aprepitant to be safe and effective for CINV prophylaxis in this group of Japanese patients. Analysis suggested that cytarabine at a dosage of 4 g/m² or more per day should be considered highly emetogenic.

• The study had a small sample of fewer than 100 patients.
• A risk of bias exists because no blinding or random assignment was done.

This study adds to the body of evidence that demonstrates the safety and effectiveness of aprepitant for multiday chemotherapy by demonstrating effects in Japanese patients.