Hu, Z., Cheng, Y., Zhang, H., Zhou, C., Han, B., Zhang, Y., ... Zhang, L. (2014). Aprepitant triple therapy for the prevention of chemotherapy-induced nausea and vomiting following high-dose cisplatin in Chinese patients: A randomized, double-blind, placebo-controlled phase III trial. Supportive Care in Cancer, 22(4), 979–987. 

To determine the efficacy of aprepitant on patients in Asian countries receiving highly emetogenic chemotherapy (HEC)

Patients receiving HEC were stratified by gender and randomized to receive either aprepitant or a standard therapy with a placebo. Placebo medications were matched to aprepitant capsules. Data were collected from the time of chemotherapy (0 hours) to six days (120 hours). Patients recorded vomiting episodes, daily nausea, and rescue medications.

• N = 411
• AGE = > 18 years
• MALES: 66 %, FEMALES: 34% 
• KEY DISEASE CHARACTERISTICS: Solid tumors, cisplatin-naïve, and Karnofsky Performance Status Scale score > 60
• OTHER KEY SAMPLE CHARACTERISTICS: Patients were excluded for current illicit drug use; evidence of alcohol abuse; symptomatic primary or metastatic CNS malignancy; administration of chemotherapy of moderate or high emetogenicity within the prior six days; scheduled administration of abdomen/pelvis radiation therapy within one week; scheduled administration of multiple-day chemotherapy with cisplatin in a single cycle or stem cell rescue therapy with cisplatin chemotherapy; active infection or other uncontrolled disease; or concurrent medical conditions precluding Decadron use.

• SITE: Multi-site  
• SETTING TYPE: Outpatient  
• LOCATION: China, 16 independent centers

• PHASE OF CARE: Active antitumor treatment
• APPLICATIONS: Elder care 

A phase III, randomized, double-blind, placebo-controlled, parallel-group trial

Patients self-reported the times and dates of vomiting or retching episode(s), use of rescue therapy, and daily nausea assessments during the first chemotherapy cycle along with Visual Analog Scale (VAS) overall nausea ratings. Patients were contacted on the mornings of days 2–6 to ensure compliance. Functional Living Index-Emesis (FLIE) questionnaire scoring was self-administered early on day 6 directly following completion of final self-reports.

The addition of aprepitant to standard antiemetic treatment regimens for Chinese patients undergoing HEC provided superior chemotherapy-induced nausea and vomiting prevention and was very well tolerated.

The efficacy and tolerability of aprepitant were studied only for one or two cycles of chemotherapy; further study will be required for multi-cycle treatment. 56.4% of patients in the aprepitant arm used Chinese medicine versus 49% in the control arm.

Aprepitant is well-tolerated and effective in the treatment of CINV in Chinese patients receiving HEC. This is the first study in Chinese chemotherapy patients. Based on nursing knowledge of drug metabolism, this is an important study to assess that aprepitant provides efficacy in this group of chemotherapy patients.