Svanberg, A., & Birgegard, G. (2015). Addition of aprepitant (Emend®) to standard antiemetic regimen continued for 7 days after chemotherapy for stem cell transplantation provides significant reduction of vomiting. Oncology, 89, 31–36. 

DOI Link

Study Purpose

To evaluate the effectiveness of adding aprepitant to standard antiemetic treatment in patients receiving high-dose chemotherapy prior to stem cell transplantation

Intervention Characteristics/Basic Study Process

Ninety-six patients were randomized to the experiment group to receive Emend® plus standard antiemetics or to the control group receiving standard antiemetics plus a placebo. Emend or placebo treatment started one hour before the first high-dose chemotherapy prior to stem cell transplantation and ended seven days after high-dose chemotherapy. The standard antiemetic therapy evaluated in this trial was 5HT3 and hydrocortisone.
 
Prior to hospital admission, patients received information regarding the study. On admission to the hospital, they were asked if they agreed to participate on the study. Patients were stratified for diagnoses as well as mild ablative regimen. The nurse caring for the patients was unaware if the study drug or placebo was being administered. Nausea and vomiting episodes were recorded by the patient in a personal diary from the start of chemotherapy through 10–17 days after the end of the study. This range was because of differences in mild ablative regimens used. The primary efficacy en point was complete response during chemotherapy and in the delayed phase.

Sample Characteristics

  • N = 96  
  • MEAN AGE = 58.1 years (experimental), 56.5 years (control)
  • MALES: 70%, FEMALES: 30%
  • KEY DISEASE CHARACTERISTICS: Lymphoma (38 patients) and myeloma (58 patients)
  • OTHER KEY SAMPLE CHARACTERISTICS: Chemotherapy regimens, high-dose melphelan, BEAM, BEAC, and BBM

Setting

  • SITE: Single site
  • SETTING TYPE: Inpatient    
  • LOCATION: Sweden

Phase of Care and Clinical Applications

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

Study Design

This was a randomized, blinded study.

Measurement Instruments/Methods

Patient diaries were used to record nausea and vomiting. An analysis was made on an intention-to-treat basis, and differences between the groups were then analyzed. Days at the hospital, weight, and use of total parenteral nutrition also were analyzed.

Results

Thirty-eight patients (83%) in the experimental group experienced no vomiting compared to 16 patients (36%) in the control group. This finding was statistically significant. The number of vomiting episodes was also significantly lower in the experimental arm compared to the control arm up to 17 days post chemotherapy. There were no significant differences regarding days of nausea or use of antiemetic rescue medications between the two groups. There were no significant differences noted in days at the hospital, weight and use of TPN between the two groups.

The results also showed that there was a significant difference between patients who expected nausea and those who did not. Patients who did not expect nausea had lower rates of vomiting as well as fewer days of nausea.

Conclusions

The addition of aprepitant to the antiemetic regimen in this patient population was well-tolerated and demonstrated a statistically significant reduction in the rate of delayed vomiting.

Limitations

  • Small sample (< 100)

Nursing Implications

Delayed CINV is an issue of critical importance for this patient population, and ongoing research to identify and improve symptom control and quality of life is necessary. These findings provide a springboard to conduct additional research with a larger sample size to confirm the positive impact of aprepitant on delayed vomiting.