1261P - Erlotinib as Neoadjuvant Treatment in Patients with IIIA-N2 Non-Small Cell Lung Cancer(NSCLC) With Activating Epidermal Growth Factor Receptor (EGFR) Mutation (NCT01217619, ESTERN)

Abstract

ABSTRACT Background Patients with stage IIIA N2 NSCLC have poor outcomes with 5-year survival rate of approximately 15% after treatment with surgical resection or chemo-radiotherapy. Tyrosine kinase inhibitor monotherapy have been demonstrated a significant improvement in tumor response rate and progression free survival as the first line treatment for metastatic NSCLC patients with activating EGFR mutation. The objective of this trial is to explore the efficacy and safety profile of erlotinib as neoadjuvant treatment in patients of stage IIIA-N2 NSCLC with activating EGFR mutation. Material and methods This is a single arm, one center, phase II study of erlotinib as neoadjuvant treatment in patients with Endobronchial Ultrasound (EBUS) confirmed stage IIIA-N2 NSCLC with activating EGFR mutation in exon 19 or 21. The primary endpoint is to evaluate radical resection rate. A total of 44 patients will be enrolled. Major inclusion criteria: IIIA-N2 NSCLC Patients with pathologically confirmed ipsilateral mediastinal metastasis by EBUS. The biopsy specimen shows activating EGFR mutation in exon 19 or 21. Treatment schedule All the recruitment patients will be treated by erlotinib 150mg orally per day for 56 days for neoadjuvant period. Patients will be assessed by Chest CT for the efficacy evaluation in day 29 and right after day 56. All the post-operative patients will receive standard adjuvant treatment which will be decided by the investigator. Current enrollment 48 patients have been screened, and 7 patients met the inclusion criteria and were enrolled. 2 patients are still on neoadjuvant treatment, 5 patients have completed the neoadjuvant therapy, and RECIST evaluation showed partial response in 2 patients, disease progression in 2 patients, and disease stable in 1 patient. Due to active hepatitis and technical infeasibility, 2 patients with PR didn't receive surgery, only one SD patient received R0 surgery. Disclosure All authors have declared no conflicts of interest.