Sakurai, M., Mori, T., Kato, J., Koda, Y., Kikuchi, T., Kohashi, S., . . . Okamoto, S. (2014). Efficacy of aprepitant in preventing nausea and vomiting due to high-dose melphalan-based conditioning for allogeneic hematopoietic stem cell transplantation. International Journal of Hematology, 99, 457–462.

DOI Link

Study Purpose

To evaluate the efficacy of aprepitant in addition to standard antiemetic therapy with ondansetron and methylprednisolone in the prevention of chemotherapy-induced nausea and vomiting (CINV) caused by high-dose melphalan given as part of conditioning for allogeneic ​hematopoietic stem cell transplantation (HSCT)

Intervention Characteristics/Basic Study Process

Patients who received conditioning with fludarabine and high-dose melphalan for allogeneic HSCT were enrolled, and patients receiving low-dose ​total body irradiation (TBI) also were included. All patients received ondansetron and methylprednisolone as standard antiemetics. In the control group, oral aprepitant was started one day after the second dose of melphalan for five days. Rescue antiemetics were given at the discretion of each physician.
 
The primary endpoint of the study was to compare the incidence of vomiting after conditioning between the control and aprepitant groups. The observation period began on the first day of melphalan administration and continued for 10 days after the last dose of melphalan (12 days total).

Sample Characteristics

  • N = 60 (20 in the treatment arm, 40 in the control arm)
  • MEDIAN AGE = 47 years (control), 52 years (treatment)
  • MALES: 50% (control); 52.5% (treatment), FEMALES: 50% (control), 47.5% (treatment)
  • KEY DISEASE CHARACTERISTICS: Lymphoma and multiple myeloma
  • OTHER KEY SAMPLE CHARACTERISTICS: Patients received fludarabine and high-dose melphalan conditioning were included. Patients receiving TBI for graft-versus-host disease prophylaxis also were enrolled.

Setting

  • SITE: Single site    
  • SETTING TYPE: Inpatient    
  • LOCATION: Tokyo, Japan

Phase of Care and Clinical Applications

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

Study Design

Retrospective, single-center analysis

Measurement Instruments/Methods

Medical records during the period were analyzed to extract data about CINV and food information. Adverse events were monitored during the observation period, and there were no statistically significant differences in the incidence of grade 2 or greater adverse events between the two groups.

Results

This retrospective study demonstrated that the addition of an aprepitant 5HT3 receptor antagonist and a steroid to a standard antiemetic regimen increased the complete response and complete protection rates (complete protection was measured as no emesis with or without the addition of antiemetic medications). The authors found that the duration of anorexia was significantly shortened by adding aprepitant. 
 
Similar improvements were found in CINV in the aprepitant arm. This was noted when a subanalysis was performed accounting for the use of low-dose TBI.

Conclusions

Aprepitant was well tolerated and positively affected the rates of delayed vomiting in this population. The ability to consume food more quickly after the conditioning regimen was improved with aprepitant.

Limitations

  • Small sample (< 100)
  • Risk of bias (no random assignment)
  • Selective outcomes reporting
  • Measurement validity/reliability questionable
  • Other limitations/explanation: Retrospective design instead of a prospective, randomized, controlled trial

Nursing Implications

This retrospective study did not indicate how the data were categorized from the records. There was no specific information regarding the rescue antiemetics used, and the rescue medications were chosen by the physicians. This impact on CINV was not discussed in the manuscript. The results are intriguing and demonstrate the safety of adding aprepitant, but a prospective, randomized, controlled trial will be needed to change clinical practice.