Abstract
BackgroundModest benefits from concurrent chemoradiotherapy in patients with locally advanced NSCLC warrant further clinical investigations to identify more effective treatment regimens. Cetuximab, a monoclonal antibody against the epidermal growth factor receptor has shown activity in NSCLC. We report on the safety and efficacy of the combination of daily dose Cisplatin and concurrent radiotherapy with or without weekly Cetuximab. Patients and methodsPatients received high dose accelerated radiotherapy (66Gy in 24 fractions) and concurrent daily Cisplatin (6mg/m2) without (Arm A) or with (Arm B) weekly Cetuximab (400mg/m2 loading dose one week prior to radiotherapy followed by weekly 250mg/m2). The primary endpoint of the trial was objective local control rate (OLCR) determined at 6–8weeks after treatment. Toxicity was reported as well. ResultsBetween February 2009 and May 2011, 102 patients were randomized. Median follow up was 29months. The OLCR was 84% in Arm A and 92% in Arm B (p=0.36). The one-year local progression free interval (LPFI) and overall survival (OS) were 69% and 82% for Arm A and 73% and 71% for Arm B, respectively (LPFI p=0.39; OS p=0.99). Toxicity compared equally between both groups. ConclusionThe addition of Cetuximab to radiotherapy and concurrent Cisplatin did not improve disease control in patients with locally advanced NSCLC but increased treatment related toxicity.
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