Overall health status (HS) in patients (pts) with advanced (adv) non-squamous (NSQ) NSCLC treated with nivolumab (nivo) or docetaxel (doc) in CheckMate 057

Abstract

Background: The CheckMate 057 randomized, open‐label, phase III study evaluated the efficacy and safety of nivo vs doc in previously‐treated pts with adv NSQ NSCLC. Overall survival was significantly improved with nivo vs doc, as were symptoms as assessed by the Lung Cancer Symptom Scale. Here we report the impact of nivo vs doc on overall pt‐reported HS. Methods: The EuroQoL‐5 Dimensions visual analog scale (EQ‐5D VAS) and EQ‐5D utility index (UI) (scaled 0 to 100 and ‐0.594 to +1, respectively) were assessed every other cycle (Q4W) for nivo and every cycle (Q3W) for doc for the first 6 mo on treatment (tx), then every 6 wks and at 2 post‐tx follow‐up visits. Changes from baseline (BL) at individual assessments (asmts), a mixed‐effects model (MMRM) of change from BL over all on‐tx asmts, and time to first deterioration (TTD) in HS were evaluated. The minimally important difference (MID) is ≥7 points for the EQ‐5D VAS and ≥0.08 points for the UI. Results: At on‐tx asmts with >10 pts (through wk 78), EQ‐5D VAS briefly worsened from BL in nivo pts at wk 4 ( MID) at wks 24 and 36. There were no statistically significant changes from BL at any on‐tx asmt in EQ‐5D VAS scores for doc pts or in EQ‐5D UI scores for nivo (apart from a worsening [