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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.
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.