Hingmire, S., & Raut, N. (2015). Open-label observational study to assess the efficacy and safety of aprepitant for chemotherapy-induced nausea and vomiting prophylaxis in Indian patients receiving chemotherapy with highly emetogenic chemotherapy/moderately emetogenic chemotherapy regimens. South Asian Journal of Cancer, 4, 7–10. 

DOI Link

Study Purpose

To assess the safety and efficacy of aprepitant for chemotherapy-induced nausea and vomiting (CINV) prophylaxis with highly emetogenic cheomtherapy (HEC) or moderately emetogenic chemotherapy (MEC) regimens

Intervention Characteristics/Basic Study Process

Patients received 125 mg aprepitant on day 1 and 80 mg along with palonosetron and dexamethasone

Sample Characteristics

  • N = 75   
  • AGE RANGE = 18-71 years
  • MALES: 10.3%, FEMALES: 89.7%
  • CURRENT TREATMENT: Chemotherapy
  • KEY DISEASE CHARACTERISTICS: Multiple tumor types 
  • OTHER KEY SAMPLE CHARACTERISTICS: Sixty percent were receiving HEC therapy.

Setting

  • SITE: Multi-site   
  • SETTING TYPE: Outpatient    
  • LOCATION: India

Phase of Care and Clinical Applications

PHASE OF CARE: Active antitumor treatment

Study Design

Open-label, prospective, observational

Measurement Instruments/Methods

  • Complete response (CR) defined as no emesis and no use of rescue medicatiton
  • Common Terminology Criteria for Adverse Events (CTCAE), version 4

Results

For all regimens, CR rates were 96.8%, 93.7%, and 92% for acute, delayed, and overall phases. Nine percent reported side effects; the most common was hiccoughs.

Conclusions

Triple drug antiemetic prophylaxis was effective to manage CINV in most patients.

Limitations

  • Small sample (< 100)
  • Risk of bias (no control group)
  • Risk of bias (no blinding)
  • Risk of bias (no random assignment)

 

Nursing Implications

This study adds to the substantial body of evidence for the efficacy of triple drug antiemetic regimens for the prevention of CINV.