Background: Rolapitant is a novel NK-1 receptor antagonist with a half-life of 180h, and does not inhibit CYP3A4 as other drugs do in the class, and therefore requires no dose modifications of concomitant steroids. Rolapitant demonstrated efficacy for prevention of CINV in phase 3 trials (HEC1, HEC2, and MEC). This pooled analysis examined the effect of rolapitant on QoL. Methods: In 3 double-blind, active-controlled studies, pts were randomized to oral rolapitant 200 mg or placebo 1–2 h before chemotherapy. All pts received active control: granisetron 2 mg oral or 10 mcg/kg IV and oral dexamethasone 20 mg. In the MEC study, granisetron was continued on Days 2 and 3. QoLwas assessed on Day 6 using the Functional Living Index-Emesis (FLIE) Questionnaire, and reported as a total score and by nausea and vomiting domains. Pts with a valid questionnaire from the MITT population (all randomized pts who received at least 1 dose of study drug) in the 2 pooled HEC studies and one MEC study were analyzed. Results: Baseline characteristics were comparable across treatment groups. Most common cancers were breast for MEC and lung for HEC studies. At Day 6, significant improvements (P < 0.05) were observed with rolapitant vs. active control for FLIE total, nausea, and vomiting domain scores (Table). Conclusions: Rolapitant improved QoLin pts receiving both HEC and MEC compared with active control, in addition to providing significant protection from CINV. Clinical trial information: NCT01500213; NCT01499849; NCT01500226

*ANCOVA with study and gender as covariates; **FLIE total score >108