Induction erlotinib or gemcitabine/carboplatin factorial assignment therapy in stage IIIA-N2 non-small cell lung cancer.

Abstract

e17512 Background: Stage IIIA-N2 NSCLC represents a heterogeneous group of patients with ipsilateral mediastinal lymph nodes involvement. The epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) may provide dramatic responses in patients with non-small cell lung cancer (NSCLC) carrying EGFR mutations. The purpose of this study is to evaluate the role of induction EGFR-TKI therapy in IIIA-N2 NSCLC. Methods: A Phase II trial conferring induction erlotinib therapy is currently recruiting participants (NCT00600587). Patients with resectable NSCLC of stage IIIA-N2 were assigned to either induction erlotinib arm or induction gemcitabine/carboplatin (GC) arm based on the EGFR mutations analysis. Results: From January 2008 till now, 21 patients with IIIA-N2 NSCLC diagnosed by mediastinoscopy or PET/CT have been enrolled. Ten cases with EGFR mutation were assigned to the erlotinib arm, while 11 cases harboring wild-type EGFR received the GC regimen. In the erlotinib arm, one case suffered from postoperative bleeding, and another case suffered from acute radiotherapy-induced pneumonitis which led to death. In the GC arm, three cases suffered from grade IV thrombocytopenia, among which two cases received transfusion. In the 19 cases with full data up till now, the response rates were 66.7% (6/9) for the erlotinib arm and 40% (4/10) for the GC arm (P=0.31). The pathological N2 complete response rates were 22.2% (2/9) for the erlotinib arm and 30% (3/10) for the GC arm (P=1.0). Five cases received complete resection in the erlotinib arm, while 6 cases received complete resection in the GC arm. In the erlotinib arm, the most common failure model after initial therapy was distant metastases (5/7), especially brain metastases (3/7). The median progression free survival time was 236 days for the erlotinib arm and 271 days for the GC arm (P=0.27). In addition, two cases in the erlotinib arm got partial response to gefitinib therapy after progression to erlotinib induction therapy and the following complete resection. Conclusions: Induction erlotinib therapy in IIIA-N2 NSCLC with EGFR activating mutation is a promising strategy. Brain metastases were major failure model.