Olver, I.N., Grimison, P., Chatfield, M., Stockler, M.R., Toner, G.C., Gebski, V., … Australian and New Zealand Urogenital and Prostate Cancer Trials Group. (2013). Results of a 7-day aprepitant schedule for the prevention of nausea and vomiting in 5-day cisplatin-based germ cell tumor chemotherapy. Supportive Care in Cancer , 21, 1561-1568.

DOI Link

Study Purpose

To determine the effectiveness of the addition of a seven-day aprepitant dose to standard triple-drug antiemetic therapy for patients receiving multiday, highly emetogenic chemotherapy (HEC)

Intervention Characteristics/Basic Study Process

Patients were given 125 mg of oral apreipitant on day 1 and 80 mg of apreipitant on days 2-7, a 5-HT3 on days 1-5, and 8 mg of dexamethasone on 1-8 for each cycle of chemotherapy.  Assessment of efficacy was performed via daily diaries, and analysis of outcomes was done for each chemotherapy cycle.  Rescue medication was lorazepam, metoclopramide, haloperideol, or prochlorperazine.

Sample Characteristics

  • The study consisted of 50 participants.
  • The median age was 30 with a range of 19-60.
  • The sample was 96% male and 4% female.
  • All patients had germ cell cancer.

 

Setting

The study was conducted at a single outpatient site in Austalia.

Study Design

This was a prospective, observational trial.

Measurement Instruments/Methods

Patients recorded the number of vomiting episodes and severity of nausea and an 11-point numeric scale in diaries.

 

Results

  • The majority of patients (96%) reported no emesis on day 1, and an average of 82% (95% CI 68-91) had no emesis on days 1-7 in cycle 1.  This was maintained over 4 cycles, with more than 80% reporting no emesis on any day.
  • Nausea was not as well controlled. In cycle 1, 71% of patients experienced no nausea on day one but only 27% reported no nausea days 1-7.  The pattern of nausea was similar for all cycles.
  • Authors stated that adherence was good, but they did not report actual adherence to the medications.

Conclusions

This study adds to the current evidence for effectiveness of triple-drug antiemetic therapy for patients receiving HEC. The findings suggested that additional days of neurokinin 1 (NK1) may improve outcomes. The findings showed that nausea continues to be poorly controlled with current regimens.

Limitations

  • The sample size was small with fewer than 100 participants.
  • A risk of bias exists because no control group, blinding, or random assignment was included in the study design.
  • The outcomes reporting was selective.
  • The measurement validity and reliability was questionable.
  • No information on nausea severity or use of rescue medications was provided, so it was not clear how use may have varied and influenced results. 
  • No data was provided on adherence or compliance with diary documentation of symptoms and episodes of vomiting.
  • Findings cannot be directly compared to others because this study did not evaluate and define outcomes in terms of complete control per phase of chemotherapy administration.

Nursing Implications

Triple-drug antiemetic therapy for patients receiving HEC is the current established recommendation for management of chemotherapy-induced nausea and vomiting (CINV).  The addition of further NK1 may improve control. Although current therapies appear to control vomiting well, nausea continues to be a problem for patients.  Ongoing research aimed at nausea control is needed.