85O_PRPatient-reported symptoms and impact of treatment with osimertinib vs chemotherapy for advanced non-small cell lung cancer

Background: We assessed self-reported symptoms of advanced non-small cell lung cancer patients treated with osimertinib 80mg or chemotherapy in the AURA3 phase III clinical trial (NCT02151981). Methods: Patients completed the European Organisation for Research and Treatment of Cancer QLQ-LC13 questionnaire on disease-specific symptoms and QLQ-C30 on general cancer symptoms, functioning and global health status. QLQ-LC13 was completed at baseline, weekly for 6 weeks, then 3-weekly up to end of study, and at progression. QLQ-C30 was completed at baseline, then 6-weekly up to end of study, and at progression. We compared for differences between treatments in time to deterioration and odds of improvement of symptoms (two assessments ≥18 days apart). A deterioration or improvement was defined as a change in score from baseline of ≥ +/-10. Hazard ratios (HR) and 95% confidence intervals (CI) were calculated using a log-rank test stratified by ethnicity. Odds ratios (OR) and 95% CIs were calculated using logistic regression adjusted for ethnicity. Results: At baseline, 215 − 228 of 279 (77 − 82%) patients on osimertinib and 106 − 114 of 140 (76 − 81%) on chemotherapy had QLQ-LC13 scores ≤90 (cut-off to have potential for deterioration) for cough, chest pain and dyspnoea. Time to deterioration of key symptoms was longer with osimertinib than with chemotherapy (Table). The proportion of patients with improvement in global health status was higher with osimertinib (80/215 [37%]) than with chemotherapy (23/105 [22%]; OR: 2.11; 95% CI: 1.24, 3.67; p = 0.007), as it was for appetite loss (OR: 2.50; 95% CI: 1.31, 4.84) and fatigue (OR: 1.96; 95% CI: 1.20, 3.22). Conclusions: Time to deterioration of key symptoms was longer and more patients had an improvement in global health status with osimertinib treatment than with chemotherapy, demonstrating improved patient outcomes with osimertinib. Clinical trial identification: NCT02151981 Legal entity responsible for the study: AstraZeneca Funding: AstraZeneca Disclosure: C.K. Lee: Served on advisory boards for AstraZeneca. S. Novello: Served on speaker bureaux for AstraZeneca, Boehringer Ingelheim, Bristol-Myers Squibb, Eli Lilly, Merck Sharp & Dohme Limited and Roche. A. Rydén, H. Mann, S. Ghiorghiu: Employees of AstraZeneca and are AstraZeneca shareholders. A. Templeton, K. Rüdell: Former employees of AstraZeneca and former shareholders. T. Mok: Grant/Research Support from AstraZeneca, BI, Pfizer, Novartis, SFJ, Roche, MSD, Clovis Oncology, BMS, Eisai, Taiho; Speaker’s fees with: AstraZeneca, Roche/Genentech, Pfizer, Eli Lilly, BI, MSD, Novartis, BMS; Major Stock Shareholder in: Sanomics Ltd.; Advisory Board for: AstraZeneca, Roche/Genentech, Pfizer, Eli Lilly, BI, Clovis Oncology, Merck Serono, MSD, Novartis, SFJ Pharmaceutical, ACEA Biosciences, Inc., Vertex Pharmaceuticals, BMS, geneDecode Co., Ltd., OncoGenex Technologies Inc., Celgene, Ignyta, Inc.; Board of Directors: IASLC, Chinese Lung Cancer Research Foundation Ltd., Chinese Society of Clinical Oncology (CSCO), Hong Kong Cancer Therapy Society (HKCTS).Table85O_PR Time to deterioration of selected key symptomsSymptomTreatmentNumber (%) of patients with eventHR (95% CI)p-valueCoughO99 (46.0)0.74 (0.53, 1.05)0.090C58 (54.7)Chest painO99 (43.8)0.52 (0.37, 0.73)<0.001C66 (58.4)DyspnoeaO122 (53.5)0.42 (0.31, 0.58)<0.001C84 (73.7)C, chemotherapy; O, osimertinib. Open table in a new tab C, chemotherapy; O, osimertinib.