Quality of life (QOL) evaluation of patients in a phase 3 study comparing NEPA with an aprepitant regimen for prevention of chemotherapy-induced nausea and vomiting (CINV)

Abstract

Background: Suboptimal CINV prevention can negatively impact patients' (pts) QOL by interfering with daily functioning. Antiemetic guidelines recommend coadministration of a NK1 receptor antagonist (RA)/5‐HT3RA/corticosteroid to optimize CINV control in pts at high risk for CINV. NEPA, a fixed combination of the NK1RA netupitant and 5‐HT3RA palonosetron (PALO) has shown superior CINV prevention and improvement in QOL over PALO. A single dose of NEPA recently showed noninferiority to a 3‐day aprepitant/granisetron (APR/GRAN) regimen in preventing CINV in the first head‐to‐head comparison of NK1RA‐containing regimens. The impact of CINV on pts' QOL in this study was explored. Methods: This randomized, double‐blind, Phase 3 study in chemotherapy‐naïve pts receiving cisplatin‐based chemotherapy (CT) assessed the non‐inferiority of NEPA versus APR/GRAN for complete response (CR: no emesis/no rescue medication [RM]) rates during the overall (0‐120 h) phase post‐CT. All pts received dexamethasone on days 1‐4. Secondary endpoints included proportion of pts with no emesis, no significant nausea (NSN: <25mmon 100mm VAS), no RMuse, and no impact on daily life (NIDL) as assessed by the Functional Living Index‐Emesis (FLIE), comprised of vomiting‐ and nausea‐specific questions/domains. The Cochran‐Mantel‐Haenszel test was used for between group comparisons; non‐inferiority testing was not done for secondary endpoints. Results: Treatment groups were similar for the 828 pts analyzed: male (71%); mean age 55 years; lung cancer (58%). NIDL rates were higher for NEPA, particularly during the delayed phase; similar results were seen for no emesis, NSN, and noRM. Conclusions: In this first study comparing NK1RA regimens, NEPA administered only on day 1 was numerically similar to a 3‐day oral APR/GRAN regimen in maintaining functional status in patients receiving highly emetogenic CT.