Osimertinib therapy may lead to improved clinical benefits and patient-reported outcomes (PROs) compared with chemotherapy among patients with non-small-cell lung cancer (NSCLC), according to a study published in the Journal of Clinical Oncology.1
Previous studies have demonstrated that osimertinib improves progression-free survival (PFS) — an important outcome measure to assess the clinical benefit of oncologic therapies — compared with first or second generation epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKIs) or chemotherapy. Despite improvements in PFS, NSCLC largely remains incurable and is associated with high symptom burden and reduced quality of life (QoL); PRO and QoL are important measures of therapeutic efficacy.
The phase 3 AURA3 (ClinicalTrials.gov Identifier: NCT02151981) study, in which investigators randomly assigned 419 patients with T790M-mutation positive advanced NSCLC who had failed first-line EGFR-TKI therapy to oral osimertinib or chemotherapy, showed that PFS was significantly improved among patients treated with osimertinib. For the secondary outcome, patients were instructed to complete the European Organisation for Research and Treatment of Cancer 13-item Quality of Life Questionnaire-Lung Cancer Module (EORTC QLQ-LC13) to assess disease-specific symptoms, as well as the Core Quality of Life Questionnaire (EORTC QLQ-C30).
Patients treated with osimertinib had a longer time to deterioration compared with chemotherapy for various symptoms, including cough (hazard ratio [HR], 0.74; 95% CI, 0.53-1.05), chest pain (HR, 0.52; 95% CI, 0.37-0.73), and dyspnea (HR, 0.42; 95% CI, 0.31-0.58).
A significantly larger proportion of symptomatic patients in the osimertinib arm experienced improvements in global health status and quality of life from baseline compared with patients in the chemotherapy arm (37% vs 22%; odds ratio [OR], 2.11; 95% CI, 1.24-3.67; P= .007). A larger proportion of patients treated with osimertinib had improvements in appetite loss (OR, 2.50; 95% CI, 1.31-4.84) and fatigue (OR, 1.96; 95% CI, 1.20-3.22) as well.
The authors concluded that “AURA3 demonstrated substantially improved PROs with osimertinib when compared with chemotherapy together with substantial improvement in PFS. These PRO data further support the role of osimertinib as the new standard of care in the second-line setting for patients with advanced EGFR T790M-positive NSCLC who progressed after first-line EGFR-TKI therapy.”
- Lee CK, Novello S, Ryden A, et al. Patient-reported symptoms and impact of treatment with osimertinib versus chemotherapy in advanced non-small-cell lung cancer: the AURA3 trial[published online May 7, 2018]. J Clin Oncol. doi: 10.1200/JCO.2017.77.2293