Rolapitant in combination with a 5-HT3 receptor antagonist and dexamethasone is well-tolerated and is superior to active control for the prevention of chemotherapy-induced nausea and vomiting after administration of highly emetogenic cisplatin-based chemotherapy.

Researchers reached this conclusion after conducting 2 global, randomized, double-blind, active controlled trials at 155 cancer centers. Both studies included a total of 1,087 patients. They were randomized to receive either oral rolapitant 180 mg or placebo 1 to 2 hours before being given highly emetogenic chemotherapy. Each cycle lasted for a minimum of 14 days.

More patients in the rolapitant groups experienced complete response in the delayed phase vs the control groups. In one study, 73% in the treatment group had complete response (vs 58% in the control group). The other study yielded 70% and 62% rates of complete response, respectively.

Adverse event rates were similar between treatment and control groups in both studies. No serious adverse events were treatment-related, and none resulted in death.

Citation: Rapoport B, Chasen M, Gridelli C. et al. 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 Oncol. 2015;16(9):1079-1089.