Patient-Reported Outcomes in FLAURA2: Osimertinib with or without Chemotherapy in Patients with Previously Untreated EGFR-Mutated Advanced Non-Small Cell Lung Cancer.

Authors

Jhanelle E Gray, Konstantin Laktionov, Sang-We Kim, Terufumi Kato, Jialei Wang, Zhigang Han, Paul Mitchell, Shoichi Kuyama, Jerry Tan Chun Bing, Juan Cundom, Gustavo Pinto, Frances A Shepherd, Lynne Poole, Rachel Lai, Muna Albayaty, Neha P Amin, Kunihiko Kobayashi, Chee Khoon Lee

Published in

Clinical cancer research : an official journal of the American Association for Cancer Research. Mar 09, 2026. Epub Mar 09, 2026.

Abstract

In FLAURA2, first-line osimertinib plus platinum-pemetrexed induction, with osimertinib plus pemetrexed maintenance improved progression-free survival versus osimertinib alone in EGFR-mutated, advanced non-small cell lung cancer (NSCLC) (HR, 0.62; P < 0.001). Combining osimertinib with chemotherapy increased induction grade ≥3 adverse event rates, which reduced during maintenance. We report FLAURA2 patient-reported outcomes (PROs).
Health-related quality of life (HRQoL) was measured using EORTC QLQ-C30 (baseline, Week [W] 4, W7, W10, then 6-weekly until progression) and QLQ-LC13 (baseline, weekly until W10, then 3-weekly until progression). Score changes (baseline to progression/19 months) were analyzed by mixed models for repeated measures. Within-patient ≥10-point changes from baseline were considered clinically meaningful. Tolerability was assessed by PRO-CTCAE.
Patients had intermediate-to-high baseline functioning and global health status (GHS)/QoL (mean scores ≥63), with mild symptomology (≤35). Most key scales showed non-clinically meaningful improvements; average least-squares mean [LSM] changes (95% CI) for GHS/QoL and physical function, respectively, were 3.32 (1.67-4.98) and 2.37 (0.70-4.04) with combination and 7.38 (5.70-9.07) and 6.74 (5.04-8.43) with monotherapy. Improvements in cough were clinically meaningful with combination and monotherapy from W5 (except monotherapy at W73); average LSM change (95% CI) -13.23 (-14.85 - -11.62) and -11.19 (-12.83 - -9.55), respectively. Non-clinically meaningful deteriorations in fatigue and appetite loss were seen with the combination during induction. Both treatments were similarly well tolerated (PRO-CTCAE).
In FLAURA2, osimertinib monotherapy and combination with platinum-pemetrexed as first-line treatment for EGFR-mutated advanced NSCLC had non-clinically meaningful impacts on HRQoL in mildly symptomatic patients.

PMID:
41801128
Bibliographic data and abstract were imported from PubMed on 09 Mar 2026.

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