Uchida, M., Kato, K., Ikesue, H., Ichinose, K., Hiraiwa, H., Sakurai, A., . . . Oishi, R. (2013). Efficacy and safety of aprepitant in allogeneic hematopoietic stem cell transplantation. Pharmacotherapy, 33, 893–901.

DOI Link

Study Purpose

To evaluate the efficacy and safety of aprepitant added to standard antiemetic regimens in high-dose chemotherapy for allogeneic hematopoietic stem cell transplantation

Intervention Characteristics/Basic Study Process

All patients received 3 mg of granisetron intravenously 30 minutes before chemotherapy. Patients in the aprepitant group received 125 mg of aprepitant orally 60–90 minutes before the first moderately to highly emetogenic chemotherapy administration. On the days following chemotherapy, the aprepitant arm received 80 mg of aprepitant orally every morning.
 
The mean administration duration of aprepitant was 3.3 days (range of three to six days).

Sample Characteristics

  • N = 88  
  • AVERAGE AGE = 47 years (control), 53 years (aprepitant)
  • MALES: 57.1% (control); 60.9% (aprepitant), FEMALES: 42.9% (control); 39.1% (aprepitant)
  • KEY DISEASE CHARACTERISTICS: Acute myeloid leukemia, acute lymphoblastic leukemia, T-cell leukemia, lymphoma, myelodysplastic syndrome; sources of stem cells were related donors, placenta stem cells, bone marrow, unrelated donors, and cord blood
  • OTHER KEY SAMPLE CHARACTERISTICS: Chemotherapies included cyclophosphamide, busulfan, fludarabine, and melphan as well as total body irradiation.

Setting

  • SITE: Single site    
  • SETTING TYPE: Inpatient    
  • LOCATION: Kyushu University Hospital in Japan

Phase of Care and Clinical Applications

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

Study Design

Retrospective medical record review of electronic medical records

Measurement Instruments/Methods

  • Adverse effects were recorded by nurses in the medical records.

Results

The overall complete response rate in the aprepitant group was significantly greater than in the control group (47.8% versus 23.8%, p = 0.019. No vomiting was achieved by 67.4% of patients in the aprepitant arm and 35.7% in the control. The number of patients without moderate to severe nausea was significantly lower in the aprepitant group (31% versus 52.2%). The rates of major response, minor response, and failure in the aprepitant group were 39.1%, 8.7%, and 4.3%, respectively. In the control group, these rates were 23.8%, 33.3%, and 19.0%, respectively (p = 0.001).
 
There were no differences between the groups in hematopoietic stem cell transplantation-related adverse effects.

Conclusions

The use of aprepitant with granisetron was highly effective in decreasing vomiting and nausea in patients receiving hematopoietic stem cell transplantations. There was no increase in adverse events. There were therapeutic outcomes.

Limitations

  • Small sample (< 100)
  • Baseline sample/group differences of import
  • Risk of bias (no blinding)
  • Selective outcomes reporting

Nursing Implications

The combination of granisetron and aprepitant was highly effective for chemotherapy-induced nausea and vomiting in patients receiving hematopoietic stem cell transplantations. Nurses should know that the combination did not increase side effects or affect engraftment.