Cetuximab in Combination with Single Agent Daily Cisplatin Chemotherapy Concurrent with Radiotherapy in Locally Advanced Nonsmall Cell Lung Carcinoma: A Feasibility Study.

INTRODUCTION Despite the benefits from concurrent chemoradiotherapy (CCRT) regimens in patients with locally advanced non-small cell lung cancer (NSCLC), more efficacious treatment options are needed. Cetuximab, a monoclonal antibody that selectively binds to the epidermal growth factor receptor, has demonstrated activity in patients with metastatic NSCLC. This study assessed whether combining cetuximab with CCRT is feasible. METHODS Patients with inoperable locally advanced NSCLC received cetuximab (400 mg/m2 on day 1, 250 mg/m2 q1w in weeks 2-6) in addition to radiotherapy (66 Gy in 24 fractions weeks 2-6) and cisplatin (6 mg/m2 q1d during weeks 2-6) daily. Early response was monitored using FDG PET/CT-scans performed 4 weeks after treatment and response was evaluated by a CT scan 6 weeks after the last fraction of radiotherapy RESULTS Between March and July 2008, 12 consecutive patients were enrolled. Ten patients completed protocol treatment. Although generally well tolerated, two patients were unable to complete protocol treatment. Acneiform rash and dysphagia were the most common side effects (grade ⩽3 according to CTCAE v 3.0). No unexpected toxicities were observed. Early response monitoring revealed a metabolic response in 8 (out of 10) patients. The CT scan evaluation showed a partial response in 8 patients. Four (out of 12) patients showed progressive disease after 12 months of follow-up. CONCLUSIONS The addition of cetuximab to CCRT in patients with NSCLC was generally well tolerated and early clinical responses were observed with this new therapy combination. A randomized phase II study comparing CCRT with CCRT and cetuximab is ongoing. [ABSTRACT FROM AUTHOR]