Kim, J.E., Jang, J.S., Kim, J.W., Sung, Y.L., Cho, C.H., Lee, M.A., . . . Min, K.W. (2017). Efficacy and safety of aprepitant for the prevention of chemotherapy-induced nausea and vomiting during the first cycle of moderately emetogenic chemotherapy in Korean patients with a broad range of tumor types. Supportive Care in Cancer, 25, 801–809.

DOI Link

Study Purpose

The purpose was to evaluate the efficacy of a three-day aprepitant regimen to manage CINV during cycle one of moderately emetogenic chemotherapy.

Intervention Characteristics/Basic Study Process

Three-day regimen of aprepitant plus ondansetron and dexamethasone compared to three-day regimen of placebo plus ondansetron and dexamethasone.

Sample Characteristics

  • N = 480   
  • AGE: Overall mean = 60.3, range = 23-85 years 
  • MALES: 55%
  • FEMALES: 45%
  • CURRENT TREATMENT: Chemotherapy
  • KEY DISEASE CHARACTERISTICS: Any cancer type
  • OTHER KEY SAMPLE CHARACTERISTICS: Receiving cycle one of non-anthracycline plus cyclophosphamide (AC)-based moderately emetogenic chemotherapy (MEC), aged 20 years and older, Eastern Cooperative Oncology Group (ECOG) performance status 0–2 or Karnofsky score of 60 or greater, predicted life expectancy of 4 months or greater. 

Setting

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

Phase of Care and Clinical Applications

PHASE OF CARE: Active anti-tumor treatment

Study Design

Randomized, controlled trial, double-blind.

Measurement Instruments/Methods

Measures of nausea and vomiting were not specifically described but aspects measured were vomiting during the overall phase (0-120 hours), use of rescue therapy during the overall phase, time to first vomiting event during the overall phase, vomiting during the acute (0–24 hours following initiation of chemotherapy) and delayed (25–120 hours following initiation of chemotherapy) phases.

Results

Participants who received the three-day aprepitant regimen did not have statistically significant fewer episode of vomiting or use of rescue medications in the overall phase (0-120 hours after chemotherapy) as compared with those who received the placebo regimen.

Conclusions

The addition of aprepitant to a standard antiemetic regimen for moderately emetogenic chemotherapy did not result in significant improvement in CINV.

Limitations

Measurement/methods not well described

Nursing Implications

For patients receiving moderately emetogenic chemotherapy, adding aprepitant to antiemetic therapy may not provide additional prevention of CINV.