The addition of single-dose fosaprepitant, the intravenous formulation of aprepitant, to a 5-HT3 receptor antagonist and dexamethasone was well tolerated and demonstrated superior control of chemotherapy-induced nausea and vomiting (CINV) associated with non-anthracycline and cyclophosphamide (AC)-based moderately emetogenic chemotherapy (MEC), a new study published online ahead of print in the journal Annals of Oncology has shown.1
For the international, double-blind, phase 3 trial, researchers randomly assigned adult patients scheduled to receive non-AC MEC on day 1 to a regimen consisting of fosaprepitant 150 mg intravenously or placebo in addition to ondansetron plus dexamethasone on day 1. Those in the control group received ondansetron on days 2 and 3 as well.
Results showed that the single-dose fosaprepitant regimen significantly improved complete response in the delayed (78.9% vs 68.5%; P<0.001) and overall (77.1% vs 66.9%; P<0.001) phases; however, complete response was not improved in the acute phase (93.2% vs 91.0%; P=0.184) compared with control.
Researchers found that fosaprepitant also improved the proportion of patients with no vomiting (82.7% vs 72.9%; P<0.001) and no significant nausea (83.2% vs 77.9%; P=0.030) vs placebo.
In regard to safety, the fosaprepitant regimen was generally well tolerated.
This is the first study to assess a neurokinin-1 receptor antagonist as an intravenous formulation in a population receiving non-AC MEC.
- Weinstein C, Jordan K, Green S, et al. Single-dose fosaprepitant for the prevention of chemotherapy-induced nausea and vomiting associated with moderately emetogenic chemotherapy: results of a randomized, double-blind phase III trial [published online ahead of print in the journal Annals of Oncology]. Ann Oncol. doi: 10.1093/annonc/mdv482.