Real-world description of patients with resected epidermal growth factor receptor mutation positive non-small cell lung carcinoma treated with adjuvant osimertinib in an early access program in Italy: the ELBA observational study

Background Following the ADAURA study results, showing that adjuvant osimertinib was associated with significant improvement in disease-free survival among patients with stage IB-IIIA epidermal growth factor receptor mutation positive (EGFRm+) non-small cell lung carcinoma (NSCLC), an Early Access Program (EAP) was activated in Italy to provide preapproval access to osimertinib. Methods The ELBA observational retrospective cohort study aims to describe the characteristics, diagnostic workup, mutation testing, and treatment patterns of the patients included in the ADAURA EAP. The retrospective observation period was from the day of the first procedure leading to the pathological diagnosis of NSCLC (index date) to osimertinib initiation and data were obtained from medical records or other original documents available at the sites. Results Overall, 71 patients were evaluable, mainly females (73.2%), with mean (SD) age of 67.5 (8.7) years. Age-adjusted Charlson Comorbidity Index scored 2 or 3 for 74.7% of patients without considering lung cancer. Forty-six (66.7%) out of 69 evaluable patients with available data were discussed at the multi-disciplinary team meeting. The median (25 th -75 th percentiles) time from the initial diagnostic suspicion to the index date was 52.0 (30.0-67.0) days and from index date to EGFR test prescription 20.0 (0.0-42.0) days. Among patients with available data (N = 69), the tests were mostly single-gene polymerase chain reaction mutation-specific test (63.8%) and next-generation sequencing (33.3%). Primary tumor surgery was mostly lobectomy (n/N=63/71, 88.7%). Pathological staging was IB for 21.1% of patients, II for 43.7% and III for 35.2%. Adjuvant chemotherapy prior to osimertinib was administered in 32.4% of patients. Osimertinib was started after a median (25 th -75 th percentiles) time from tumor resection of 2.9 (2.1-4.9) months. Conclusions The ELBA Study showed an evolving landscape in biomarker-driven and molecular targeted therapies in early-stage NSCLC management towards the integration of mutational testing into clinical practice, with a growing focus on an optimal definition of adjuvant treatment.