Induction erlotinib therapy in stage IIIA-N2 non-small cell lung cancer.

Abstract

TPS284 Background: Stage IIIA non-small cell lung cancer (NSCLC) is seen in a relatively heterogeneous group of patients with ipsilateral mediastinal (N2) lymph node involvement. The relative roles of different treatment modalities are not clear. Epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors (TKIs) may result in dramatic responses in patients with pulmonary adenocarcinoma carrying EGFR activating mutations. In case reports, the efficacy of perioperative EGFR-TKI therapy in patients with locally advanced NSCLC harboring EGFR gene mutations was satisfactory. Although no prospective data support the use of EGFR-TKIs as induction therapy in stage IIIA-N2 NSCLC, their low toxicity profile and the possibility of a rapid tumor response suggests that prospective trials are required. Therefore, this study evaluated the value of induction erlotinib therapy in IIIA-N2 NSCLC selected by EGFR gene analysis and explored a new treatment strategy for this subset. Erlotinib specifically targets the EGFR TK domain, which is highly expressed and occasionally mutated in various forms of cancer. It binds in a reversible fashion to the adenosine triphosphate (ATP) binding site of the receptor. Methods: A two-stage phase II trial of induction EGFR-TKI therapy is currently recruiting participants (ClinicalTrials.gov identifier: NCT00600587). Patients with resectable stage IIIA-N2 NSCLC confirmed by mediastinoscopy or PET/CT were assigned to the induction erlotinib therapy arm (150 mg erlotinib taken once daily and continued uninterrupted for 42 d before evaluation and thoracotomy/radiotherapy) or the induction gemcitabine/carboplatin (GC) arm based on the EGFR mutation analysis. Study type: Interventional. Study Design: Active control, factorial assignment, nonrandomized, open label, safety/efficacy study, treatment. Primary outcome measures: Response to induction therapy, disease-free survival. Estimated enrollment: Fifteen cases in the erlotinib arm are needed in the first stage, and 46 cases in the second stage. At present, six patients have been assigned to the induction erlotinib therapy arm and seven to the induction GC arm. No significant financial relationships to disclose.