Aridome, K., Mori, S. I., Baba, K., Yanagi, M., Hamanoue, M., Miyazono, F., . . . Natsugoe, S. (2016). A phase II, randomized study of aprepitant in the prevention of chemotherapy-induced nausea and vomiting associated with moderately emetogenic chemotherapies in colorectal cancer patients. Molecular and Clinical Oncology, 4, 393–398. 

To study the efficacy of aprepitant in the prevention of chemotherapy-induced nausea and vomiting (CINV) in patients receiving moderately emetogenic chemotherapy (MEC) for colorectal cancer

Patients with advanced or recurrent colorectal cancer were treated with standard MEC regimens including FOLFOX, XELOX, OR FOLFIRI and received either standard antiemetic therapy with 5-HT₃ receptor antagonist (RA) plus dexamethasone or aprepitant regimen including 5-HT₃ RA plus reduced-dose dexamethasone plus aprepitant. Patients were followed from the initiation of chemotherapy through day 5 using patient diaries to record emetic episodes, nausea, or rescue antiemetics in 24-hour intervals.

• N = 117 Japanese and Australian adults with recurrent or advanced colorectal cancer stratified based on Performance status 
• MEAN AGE = 63.48 years in standard group, 66.46 years in aprepitant group
• MALES: 56%, FEMALES: 44%
• CURRENT TREATMENT: Chemotherapy
• KEY DISEASE CHARACTERISTICS: Patients with dvanced or recurrent colorectal cancer receiving MEC

• SITE: Multi-site   
• SETTING TYPE: Not specified    
• LOCATION: Japan

PHASE OF CARE: Active antitumor treatment

Multicenter, phase II, open-label, randomized, parallel, comparative study

The outcomes in both groups were analyzed using chi-squared tests for primary end points, secondary end points, and patients characteristics by treatment group. Two-sided sample t tests were used when appropriate. P < 0.05 was considered to be a statistically significant difference.

The percentage of patients with complete response in the overall phase was 79.6% in the standard group versus 79.7% in the aprepitant group. The acute phase was 94.9% complete response in both groups, and the delayed phase was 79.6% versus 79.7%. The overall incidence of adverse events were similar in both groups.

No significant differences existed between the standard treatment and aprepitant regimen in terms of complete suppression of vomiting, nausea, and time to treatment failure. This study demonstrates that aprepitant in combination with a 5-HT₃ RA and reduced dose of dexamethasone is well tolerated and effective for preventing CINV associated with MEC in patients with colorectal cancer.

The addition of aprepitant to standard antiemetic therapy for MEC in patients with colorectal cancer is well tolerated and effective for control of CINV, but the lack of significant difference suggests that the added cost of an additional medication is not warranted.