Maru, A., Gangadharan, V.P., Desai, C.J., Mohapatra, R.K., & Carides, A.D. (2013). A phase 3, randomized, double-blind study of single-dose fosaprepitant for prevention of cisplatin-induced nausea and vomiting: Results of an Indian population subanalysis. Indian Journal of Cancer, 50, 285–291. 

DOI Link

Study Purpose

To compare the safety and efficacy of fosaprepitant with the safety and efficacy of aprepitant

Intervention Characteristics/Basic Study Process

Patients on cisplatin-based chemotherapy were randomly assigned to receive a single IV dose of fosaprepitant or a three-day dosing regimen of aprepitant. All also were given a dexamethasone regimen and ondansetron on day 1. Both groups could receive rescue therapy. Patients recorded nausea and vomiting episodes for the first 120 hours after chemotherapy.

Sample Characteristics

  • N = 272
  • MEAN AGE =  50.5 years
  • AGE RANGE = 19–79 years
  • MALES: 73.5%, FEMALES: 24.5%
  • KEY DISEASE CHARACTERISTICS: Patients had varied tumor types; lung and gastrointestinal cancers were most prevalent.

Setting

  • SITE: Multi-site  
  • LOCATION: India 

Phase of Care and Clinical Applications

  • PHASE OF CARE: Active antitumor treatment

Study Design

  • Subgroup analysis of a double-blind, randomized controlled trial

Measurement Instruments/Methods

  • Patient diary

Results

No significant differences occurred between groups in complete response (CR) during the acute phase. In the delayed phase, 77.7% of patients on fosaprepitant had CR compared to 73.9% in the aprepitant group. This difference was not statistically significant. No differences existed in need for rescue medication. None of the patients experienced infusion site reactions with fosaprepitant.

Conclusions

The findings showed essentially equivalent efficacy of single dose fosaprepitant and a three-day aprepitant regimen for the prevention of chemotherapy-induced nausea and vomiting (CINV) with highly emetogenic chemotherapy.

Limitations

  • Risk of bias (no blinding)
  • The study states a double-blind design and refers to a placebo, but the use of a placebo is not described in the report.

Nursing Implications

A single dose of fosaprepitant can provide the same essential prevention of CINV as a multiday aprepitant regimen as part of triple-drug therapy. Infusion site reactions have been described with fosaprepitant but were not shown in this particular analysis. Selection of the type of NK1 use can be planned according to individual patient situations.