Cetuximab in combination with concurrent chemoradiotherapy (CRT) in locally advanced non-small cell lung carcinoma (NSCLC): A feasibility study

7540 Background: Despite modest benefits from CRT regimens in patients with locally advanced 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 trial was initiated to assess the feasibility of combining cetuximab with concurrent CRT. Methods: Patients with non-operable locally advanced NSCLC received cetuximab (400 mg/m2 on day 1, 250 mg/m2 q1w from weeks 2–6) in combination with cisplatin (6 mg/m2 q1d from weeks 2–6), and RT (66 Gy in 24 fractions from weeks 2–6). Results: Between April and July 2008, 12 consecutive, eligible patients entered the study. The mean age was 61 years (range: 43–77) and 50% were male. Baseline NSCLC staging was: IIb (1 patient), IIIa (5 patients), and IIIb (6 patients). Treatment was generally well tolerated. Acne-like rash and radiation esophagitis were the most common side effects (grade ≤3 according to CTCAE v 3.0) (see table). No unexpected toxicities were observed. Early-response monitoring using PET-CT scans was performed 4 weeks after the last fraction of RT in 10/12 patients. A metabolic response was seen in 50% (complete: 3 patients; partial: 2 patients) of patients. One patient showed progressive disease. Conclusions: Cetuximab added to CRT in patients with NSCLC was generally well tolerated and produced promising early clinical responses. A randomized phase II study comparing CRT with CRT and cetuximab is ongoing. [Table: see text] [Table: see text]