Yahata, H., Kobayashi, H., Sonoda, K., Shimokawa, M., Ohgami, T., Saito, T., . . . Kato, K. (2016). Efficacy of aprepitant for the prevention of chemotherapy-induced nausea and vomiting with a moderately emetogenic chemotherapy regimen: A multicenter, placebo-controlled, double-blind, randomized study in patients with gynecologic cancer receiving paclitaxel and carboplatin. International Journal of Clinical Oncology, 21, 491–497. 

To evaluate the efficacy of aprepitant in the prevention of chemotherapy-induced nausea and vomiting (CINV) and hypersensitivity reactions in patients with gynecologic cancer who are receiving paclitaxel and carboplatin

All patients received either 1 mg of granisetron or 4 mg of ondansetron and 20 mg of dexamethasone IV on day 1. Patients in the placebo group received a placebo on days 1–3, and patients in the aprepitant group received 125 mg of aprepitant PO on day 1 and 80 mg of aprepitant PO on days 2 and 3.

• N = 297   
• MEAN AGE = 59 years
• AGE RANGE = 24–79 years
• FEMALES: 100%
• CURRENT TREATMENT: Chemotherapy
• KEY DISEASE CHARACTERISTICS: Ovarian cancer, endometrial cancer, cervical cancer, peritoneal cancer, tubal cancer

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

PHASE OF CARE: Active antitumor treatment

This was a randomized, double-blind, placebo-controlled study.

Hypersensitivity reactions were graded using the Common Toxicity Criteria for Adverse Events (CTCAE), version 4.0. From days 1–5, patients recorded the highest level of nausea severity each day (absent, mild, moderate, severe), number of episodes of emesis, and time of each episode. Patients also recorded the date and time of each rescue antiemetic and responses to questions about appetite. Adverse effects were graded using CTCAE, version 4.0.

The rates of hypersensitivity reactions were similar in the control and test groups. Patients who received aprepitant, when compared to the control group, had higher rates of no vomiting in the overall phase and during the acute and delayed phases (p < 0.0001, p < 0.0001, p = 0.0495). The rate of \"no significant nausea\" was also significantly higher in the aprepitant group in the overall phase and delayed phase (p = 0.0143, p = 0.0274). Complete response (no vomiting and no rescue medication) was significantly higher in the aprepitant group in the overall and delayed phases (p = 0.0073, p = 0.0072).

Aprepitant is beneficial when used in combination with a 5-HT₃ receptor antagonist and dexamethasone in patients with gynecologic cancer receiving paclitaxel and carboplatin.

Aprepitant may be given as CINV prophylaxis for patients receiving paclitaxel and carboplatin for the treatment of gynecologic cancer.