European journal of cancer (Oxford, England : 1990) · 2026
Patient-reported outcomes from the LAURA study: osimertinib in patients with unresectable stage III EGFR-mutated non-small cell lung cancer after definitive chemoradiotherapy.
СтатьяРандомизированное исследованиеКлиническое исследование III фазыМногоцентровое исследованиеНазвание и аннотация: Перевод в очереди
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Arriola Edurne, Casarini Ignacio, Özgüroğlu Mustafa, Huang Meijuan, Takahashi Toshiaki, Lai Xiaojing, Goto Koichi, Maneenil Kunlatida, Lee Ki Hyeong, Cobo Manuel, Valdiviezo Natalia, Evans Azura, Bolanos Ana, Huang Xiangning, Lai Rachel, Ramalingam Suresh S
Аннотация
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.
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.
Предметные рубрики MeSH
AdultAgedFemaleHumansMaleMiddle AgedAcrylamidesAniline CompoundsAntineoplastic AgentsCarcinoma, Non-Small-Cell LungChemoradiotherapyDouble-Blind MethodErbB ReceptorsIndolesLung NeoplasmsMutationNeoplasm StagingPatient Reported Outcome MeasuresProgression-Free SurvivalProtein Kinase InhibitorsPyrimidinesQuality of Life