Osimertinib as neoadjuvant therapy for resectable non-small cell lung cancer: a single-center real-world study

Background: Evidence of osimertinib as neoadjuvant therapy for resectable non-small cell lung cancer (NSCLC) are currently lacking. This real-world study aimed to assess the safety and feasibility of neoadjuvant osimertinib therapy followed by surgery for resectable NSCLC. Methods: Patients with clinical stage Ib-IIIb resectable NSCLC with EGFR mutation who received osimertinib as neoadjuvant therapy followed by surgery were included. Demographic features, assessment of response, surgery-related details and complications, toxicity profiles, and prognostic outcomes were extracted. Results: A total of 13 patients were included. The median age was 57 years and eight (61.5%) patients were female. The objective response rate was 69.2% (9/13) and complete resection rate was 100%. The rates of pathologic and lymph node downstaging were 100% (13/13) and 66.7% (6/9), respectively. There were no perioperative deaths and only three (23.1%) patients had postoperative complications. Seven (53.8%) and 13 (100%) patients experienced grade 1 treatment-related adverse reactions and laboratory abnormalities, respectively. No patients experienced drug withdrawal or surgical delays due to the adverse events. No patients showed grade 2 or worse toxicity profiles. One patient was lost to follow-up. The other 12 were alive and free of disease recurrence with a follow-up time of 10.2 months. Conclusions: Neoadjuvant osimertinib therapy was safe and feasible for resectable EGFR-mutated NSCLC. Future large prospective studies are warranted to confirm whether osimertinib as neoadjuvant therapy outperforms standard tyrosine kinase inhibitors or chemoimmunotherapy for resectable EGFR-mutated NSCLC.