Rapoport, B.L., Chasen, M.R., Gridelli, C., Urban, L., Modiano, M.R., Schnadig, I.D., . . . Navari, R.M. (2015). Safety and efficacy of rolapitant for prevention of chemotherapy-induced nausea and vomiting after administration of cisplatin-based highly emetogenic chemotherapy in patients with cancer: Two randomised, active-controlled, double-blind, phase 3 trials. Lancet Oncology, 16, 1079–1089.
To assess the safety and efficacy of 180 mg rolapitant for the prevention of chemotherapy-induced nausea and vomiting (CINV) in patients with cancer who receive moderately or highly emetogenic chemotherapy (HEC)
Patients who had a KPS of 60 or higher, were expected to live at least four months, and had adequate bone marrow and liver and kidney function were randomly assigned to receive 180 mg of rolapitant versus placebo, which looked exactly like the rolapitant.
PHASE OF CARE: Active antitumor treatment
This article describes two randomized, double-blind, active-control studies.
In both studies (and in the pooled results), treatment with rolapitant resulted in a significantly increased number of patients experiencing a complete response in the delayed phase. The pooled studies found significant difference in the acute phase (first 24 hours). In the overall phase, complete response was significantly more frequent in the first study and in the results of the pooled studies. No significant differences were observed between study groups with respect to daily living as measured by the FLI-E questionnaire.
Oral rolapitant taken once daily before chemotherapy in combination with a 5-HT3 receptor antagonist and dexamethasone is superior to 5-HT3 receptor antagonist and corticosteroid alone.
The study participants were enrolled prior to recommendations for the addition of an NK1 receptor antagonist to standard care and the use of dexamethasone to HEC.
As now accepted, the addition of an NK1 receptor antagonist reduces CINV experienced by patients receiving HEC. Patient education regarding adherence to medications and correct timing can help them prevent what is often the most worrisome side effect.