Rolapitant in combination with a 5-HT3 receptor and dexamethasone is well tolerated and showed superiority over active control for the prevention of chemotherapy-induced vomiting and nausea after the administration of moderately emetogenic chemotherapy or an anthracycline and cyclophosphamide, according to a study published online ahead of print in the The Lancet Oncology.
Investigators conducted a global, randomized, double-blind active-controlled, phase 3 study at 170 cancer centers in 23 countries.
Patients qualified if they had not received moderately or highly emetogenic chemotherapy, with a Karnofsky performance score of 60 or higher, and a predicted life expectancy of 4 months or longer.
Between March 5, 2012, and September 6, 2013, 1,369 patients were randomized to receive either 180 mg rolapitant (n=684) or placebo (n=685) 1 to 2 hours before administration of the moderately emetogenic agent.
All patients received 2 mg granisetron and 20 mg dexamethasone on day 1 (except for those receiving taxanes as part of moderately emetogenic chemotherapy, who received dexamethasone according to the package insert) and granisetron (2 mg orally) on days 2 to 3.
A greater proportion of patients receiving rolapitant had complete responses in the delayed phase than did those receiving active control 71% versus 62%, respectively; P=0.0002.
With regard to safety, the incidence of adverse events was similar between the rolapitant and control groups, with the most frequently reported treatment-related treatment-emergent adverse events being fatigue, constipation, and headache.
For the first cycle, the most common grade3-4 adverse events in the rolapitant versus placebo was neutropenia 5% versus 3%. No serious adverse event was treatment-related, and no treatment-related treatment-emergent adverse event resulted in death.
- Shwartzberg LS, Modiano MR, Rapoport B, et al. Safety and Efficacy of rolapitant for prevention of chemotherapy-induced nausea and vomiting after administration of moderately emetogenic chemotherapy or anthracycline and cyclophosphamide regimens in paitents with cancer: a randomised, active-controlled, double-blind phase 3 trial. The Lancet Oncol. 2015. [epub ahead of print]. doi: 10.1016/S1470-2045(15)00034-0.