Health-Related Quality of Life Outcomes in Patients with Resected Epidermal Growth Factor Receptor-Mutated Non-Small Cell Lung Cancer who underwent Adjuvant Osimertinib in the phase III ADAURA trial
Mené sur 682 patients atteints d'un cancer du poumon non à petites cellules présentant une mutation EGFR et ayant été totalement réséqué, cet essai de phase III évalue l'intérêt, du point de vue de la qualité de vie, de l'osimertinib en traitement adjuvant
Purpose: In the phase III ADAURA trial, adjuvant treatment with osimertinib versus placebo, with/without prior adjuvant chemotherapy, resulted in a statistically significant and clinically meaningful disease-free survival benefit in completely resected stage IB-IIIA EGFR-mutated (EGFRm) non-small cell lung cancer (NSCLC). We report health-related quality of life (HRQoL) outcomes from ADAURA. Experimental design: Patients randomized 1:1 received oral osimertinib 80 mg or placebo for 3 years or until recurrence/discontinuation. HRQoL (secondary endpoint) was measured using the Short Form-36 (SF-36) health survey at baseline, 12, and 24 weeks, then every 24 weeks until recurrence or treatment completion/discontinuation. Exploratory analyses of SF-36 score changes from baseline until week 96 and time to deterioration (TTD) were performed in the overall population (stage IB-IIIA; N = 682). Clinically meaningful changes were defined using the SF-36 manual. Results: Baseline physical/mental component summary (PCS/MCS) scores were comparable between osimertinib and placebo (range 46-47) and maintained to Week 96, with no clinically meaningful differences between arms; difference in adjusted least squares (LS) mean (95% confidence intervals [CI]): -1.18 (-2.02 - -0.34) and -1.34 (-2.40 - -0.28), for PCS and MCS, respectively. There were no differences between arms for TTD of PCS and MCS; HR (95% CI): 1.17 (0.82-1.67) and 0.98 (0.70-1.39), respectively. Conclusions: HRQoL was maintained with adjuvant osimertinib in patients with stage IB-IIIA EGFRm NSCLC, who were disease-free after complete resection, with no clinically meaningful differences versus placebo, further supporting adjuvant osimertinib as a new treatment in this setting. Trial registration number: NCT02511106