Warr, D.G., Street, J.C., & Carides, A.D. (2011). Evaluation of risk factors predictive of nausea and vomiting with current standard-of-care antiemetic treatment: analysis of phase 3 trial of aprepitant in patients receiving adriamycin-cyclophosphamide-based chemotherapy. Supportive Care in Cancer, 19, 807–813.

DOI Link

Study Purpose

Whether prognostic factors in nausea and vomiting can be used to identify a low-risk group for whom ondansetron plus dexamethasone alone would provide a high level of protection (defined as 80% or less of no emesis) and to evaluate the impact of the neurokinin 1 (NK1) receptor antagonist aprepitant on chemotherapy-induced nausea and vomiting (CINV), regardless of the antiemetic risk 

Sample Characteristics

  • The study reported on 866 patients.
  • Mean age was 53.1 years.
  • The sample was 99.5% female and 0.5% male.
  • All patients had been diagnosed with breast cancer, and 99% of the sample was receiving anthrocycline-based chemotherapy.
  • To be included in the study, patients had to provide Informed consent, be naïve to emetogenic chemotherapy, have a predicted life expectancy of at least four months, and have a Karnofsky score of 60 or greater.

Setting

This was a multisite study.

Phase of Care and Clinical Applications

All patients were in active treatment.

Study Design

This was a phase III, multicenter, randomized, double-blind, parallel-group, placebo-controlled trial evaluating women with breast cancer who were receiving their first anthracycline plus cyclophosphamide-based chemotherapy regimen.

Measurement Instruments/Methods

  • Patients used diaries to record occurrence of emetic episodes, use of rescue therapy, and daily ratings of nausea severity using a visual analog scale.
  • The authors used logistical regression models to evaluate the impact of the number of risk factors on treatment outcomes.

Results

The most significant factor that had an impact on incidence of vomiting was treatment with aprepitant (p = 0.0001). Age over 55 years (p = 0.006), alcohol use (p = 0.005), and no history of morning sickness (p = 0.0007) were all associated with decreased risk. Motion sickness was not predictive of emesis.

The study's overall recommendation was to use the best available antiemetic regimen from the first cycle to maximize control of CINV and minimize anticipatory nausea and vomiting in subsequent cycles.

Conclusions

Aprepitant use ameliorated the risk of emesis associated with age, alcohol use, and previous history of morning sickness. 

Limitations

The study only looked at patients with breast cancer receiving anthrocycline-containing chemotherapy regimens with cyclophosphamide. Only two men were included in the study. The results are not generalizable to all patients with cancer.

Nursing Implications

Expansion of this study to include all cancer types and evaluate emetogenic potential with consideration of risk factors would be useful. This study demonstrates the importance of risk analysis when choosing antiemetics, but it also shows the clear benefit of using aprepitant in this group.