EQ-5D-5L is a standardized patient reported outcome instrument to capture a patient's health state. EQ-5D-5L consists of a descriptive health system covering five dimensions (mobility, self-care, usual activities, pain/discomfort and anxiety/depression) with five levels each (no problems, slight problems, moderate problems, severe problems, and extreme problems) and a visual analogue scale (VAS) assessing overall health. It also provides a health state utility value frequently used in economic evaluations. To our knowledge this is the first EQ-5D data published for T790M EGFRm NSCLC. EQ-5D-5L was included as an exploratory endpoint in AURA2, a Phase II single arm study of osimertinib for the treatment of advanced EGFR T790M NSCLC (NTC02094261).
AURA2 recruited 210 patients to osimertinib 80mg QD tablet. EQ-5D-5L was included to explore the impact of osimertinib on health state utility. It was collected electronically at first dose and every 6w including during follow-up post-progression. Using the EQ-5D-5L crosswalk value set for the UK, mean utility values for progression-free (PF) and progressive disease (PD) health-state were calculated.
A total of 175 patients completed the questionnaire at baseline. The main improvements in health state observed were reduced depression/anxiety and pain/discomfort. Mean utility at baseline was 0.745. At 6w post treatment initiation, the utility had increased to 0.819, and the improvement maintained above baseline values until 60w of treatment (0.798). The same trend was observed in the VAS (at baseline 65, rising to 72 at 6w, falling to below baseline only after progression). The mean health-state utilities for PF and PD were 0.812 and 0.751, respectively. Pre-progression, patients with complete or partial response (defined by objective response) showed a higher utility (0.883) than those with stable disease (0.754).
Patients treated with osimertinib experienced a numerical improvement in health dimensions and associated health state utility values, which increased from baseline to 6w and were maintained above baseline values for nearly 14 months. EQ-5D will be explored further in an ongoing Phase III study (AURA3).
Clinical trial identification
Legal entity responsible for the study
C. Bodnar: Employee of AstraZeneca. J. Ryan, M. Green: Employee of and shareholder in AstraZeneca