Rolapitant improves quality of life of patients receiving highly or moderately emetogenic chemotherapy

Abstract

PurposeAddition of rolapitant to standard antiemetic therapy improved protection against chemotherapy-induced nausea and vomiting (CINV) in phase 3 trials of patients receiving highly emetogenic chemotherapy (HEC) or moderately emetogenic chemotherapy (MEC). Here, we assessed the impact of CINV on the daily lives of patients receiving HEC or MEC using the Functional Living Index-Emesis (FLIE).MethodsIn three double-blind phase 3 studies, patients receiving HEC or MEC were randomized 1:1 to receive oral rolapitant 180 mg or placebo prior to chemotherapy plus 5-hydroxytryptamine type 3 receptor antagonist and dexamethasone therapy. Patients completed the FLIE questionnaire on day 6 of cycle 1. Endpoints included FLIE total score, nausea and vomiting domain scores, and the proportion of patients with no impact on daily life (total score >108 [range 18–126]). We performed a prespecified analysis of the MEC/anthracycline-cyclophosphamide (AC) study and a post hoc analysis of two pooled cisplatin-based HEC studies.ResultsIn the pooled HEC studies, rolapitant significantly improved the FLIE total score (114.5 vs 109.3, p < 0.001), nausea score (55.3 vs 53.5, p < 0.05), and vomiting score (59.2 vs 55.8, p < 0.001) versus control; similar results were observed in the MEC/AC study for FLIE total score (112.7 vs 108.6, p < 0.001), nausea score (54.1 vs 52.3, p < 0.05), and vomiting score (58.6 vs 56.3, p < 0.001). A higher proportion of patients reported no impact on daily life with rolapitant than with control in the MEC/AC study (73.2 vs 67.4, p = 0.027).ConclusionsCompared with control, rolapitant improved quality of life in patients receiving HEC or MEC.

Differential clinical pharmacology of rolapitant in delayed chemotherapy-induced nausea and vomiting (CINV)

“… 27 , 28 A prespecified analysis on the MEC data and a post hoc on the pooled analysis of HEC trials was done to explore the impact of rolapitant on QOL. 42 The endpoints explored were FLIE total score, emesis domain scores, and the proportion of patients with no impact on daily life. A significant improvement was observed in QOL in both HEC pooled analysis and MEC study.…”

Differential pharmacology and clinical utility of rolapitant in chemotherapy-induced nausea and vomiting

“…A pooled analysis of Phase III trials (HEC 1, HEC 2, and MEC) demonstrated that rolapitant significantly improved QoL in patients receiving both HEC and MEC compared with active control. 56 , 57 In the HEC studies, the mean (±SD) FLIE total score was 114 (±17) for the rolapitant group and 109 (±24) for the active control group ( P <0.001); in the MEC study, it was 113 (±20) for the rolapitant group and 109 (±23) for the active control group ( P >0.001). Overall, these Phase III clinical trials demonstrated that a single oral administration of rolapitant significantly improved patient QoL.…”

Getting it right the first time: recent progress in optimizing antiemetic usage

“…Interestingly, rolapitant did not demonstrate a significant benefit in prevention of nausea in the primary analysis of the MEC trial [ 27 ]. A prespecified analysis of quality of life (QoL) in the MEC trial and a post hoc analysis of the HEC trials also showed that rolapitant improved the Functional Living Index-Emesis score, including both individual nausea and vomiting scores [ 29 ]. Rolapitant also significantly increased the proportion of patients in the MEC trial who reported that CINV had no impact on their daily lives.…”