Erlotinib as neoadjuvant treatment in patients with stage IIIA-N2 non-small cell lung cancer (NSCLC) with activating epidermal growth factor receptor (EGFR) mutation (NCT01217619, ESTERN).

Abstract

e17551 Background: Patients with stage IIIA N2 NSCLC have poor outcomes with 5-year survival rate. Tyrosine kinase inhibitor monotherapy have been demonstrated a significant improvement in OR rate and PFS as first-line treatment for metastatic NSCLC patients with EGFR mutation. The objective of trial is to explore the efficacy and safety profile of erlotinib as neoadjuvant treatment in patients of stage IIIA-N2 NSCLC with EGFR mutation. The purpose of this neoadjuvant regime is to down-stage and increase complete resection rate in this patients setting. 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. The secondary endpoint is pathological complete resection rate (pCR), objective response rate (ORR), disease free survival (DFS), overall survival (OS), quality of life (QoL) and safety profile. A total of 44 patients will be enrolled. Patients with IIIA-N2 NSCLC with pathologically confirmed ipsilateral mediastinal metastasis by EBUS. The biopsy specimen shows EGFR mutation in exon 19 or 21. All patients will be treated by erlotinib 150mg orally per day for 56 days. Patients will be assessed by Chest CT for the efficacy evaluation in day 29 and right after day 56. Patients get benefit from neoadjuvant treatment and evaluated as technically resectable will receive surgery. All the post-operative patients will receive standard adjuvant treatment. The adjuvant regime is decided by the investigator for the patients’ benefits. After adjuvant treatment patients will enter nomal follow-up including regular chest CT and ultrasound examination Results: Current enrollment: The study has enrolled 5 patients. One male patient, aged 47, with stable disease after neoadjuvant treatment, got right upper lobe resection on 17 Jan 2012. Conclusions: Erlotinib as neoadjuvant treatment in patients of stage IIIA-N2 NSCLC with activating EGFR mutation is feasible.