Patient-reported Outcomes from the LAURA Study: Osimertinib in Patients with Unresectable Stage III EGFR-mutated Non-Small Cell Lung Cancer after Definitive Chemoradiotherapy

BACKGROUND:The LAURA study in unresectable stage III EGFR-mutated NSCLC without progression during/after chemoradiotherapy demonstrated significantly improved progression-free survival (PFS) with osimertinib versus placebo after definitive chemoradiotherapy. We report patient-reported outcomes (PROs) from LAURA. PATIENTS AND METHODS:Score changes from baseline (mixed model for repeated measures analysis) and time to confirmed deterioration in health-related quality of life (HRQoL), functioning and symptoms per EORTC QLQ-C30/LC13 questionnaires were analyzed. Tolerability was assessed using the PRO-CTCAE v1.0. RESULTS:Baseline EORTC scores were comparable between treatment arms. Risk of confirmed deterioration in key scales was generally not substantially different between arms (HR [95% CI], global health status/QoL 1.14 [0.74-1.78]; physical function 1.06 [0.65-1.71]; fatigue 1.23 [0.85-1.80]; appetite loss 1.00 [0.63-1.58]; dyspnea 1.30 [0.91-1.86]; coughing 1.17 [0.81-1.71]; pain in chest 1.46 [0.95-2.23]). Over 40 weeks, minimal changes from baseline were observed for key functioning/symptoms in both arms. PRO-CTCAE responses indicated similar tolerability of osimertinib versus placebo for symptom frequency and severity, except for loose/watery stools ("never"/"rarely" frequency vs. "never") and dry skin ("mild" severity vs. "none"). CONCLUSIONS:PRO scores were maintained during osimertinib treatment of unresectable stage III EGFR-mutated NSCLC after definitive chemoradiotherapy. Together with significant PFS benefit and expected, manageable safety, the PRO data support osimertinib treatment in this setting. TRIAL REGISTRATION NUMBER:NCT03521154.