Patient-reported outcomes from the LAURA study: osimertinib in patients with unresectable stage III EGFR-mutated non-small cell lung cancer after definitive chemoradiotherapy

Arriola E.; Casarini I.; Özgüroğlu M.; Huang M.; Takahashi T.; Lai X.; Goto K.; Maneenil K.; Lee K.H.; Cobo M.; Valdiviezo N.; Evans A.; Bolanos A.; Huang X.; Lai R.; Ramalingam S.S. · European Journal of Cancer (2026) · DOI: 10.1016/j.ejca.2026.116744

Resumen

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