Please use this identifier to cite or link to this item: https://hdl.handle.net/2440/116470
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Type: Journal article
Title: Additional weekly Cetuximab to concurrent chemoradiotherapy in locally advanced non-small cell lung carcinoma: efficacy and safety outcomes of a randomized, multi-center phase II study investigating
Author: Van Den Heuvel, M.
Uyterlinde, W.
Vincent, A.
De Jong, J.
Aerts, J.
Koppe, F.
Knegjens, J.
Codrington, H.
Kunst, P.
Dieleman, E.
Verheij, M.
Belderbos, J.
Citation: Radiotherapy and Oncology, 2014; 110(1):126-131
Publisher: Elsevier
Issue Date: 2014
ISSN: 0167-8140
1879-0887
Statement of
Responsibility: 
Michel M. van den Heuvel, Wilma Uyterlinde, Andrew D. Vincent, Jeroen de Jong, Joachim Aerts, Frederike Koppe, Joost Knegjens, Henk Codrington, Peter W.E. Kunst, Edith Dieleman, Marcel Verheij, José Belderbos
Abstract: BACKGROUND: Modest 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 METHODS: Patients received high dose accelerated radiotherapy (66 Gy in 24 fractions) and concurrent daily Cisplatin (6 mg/m(2)) without (Arm A) or with (Arm B) weekly Cetuximab (400 mg/m(2) loading dose one week prior to radiotherapy followed by weekly 250 mg/m(2)). The primary endpoint of the trial was objective local control rate (OLCR) determined at 6-8 weeks after treatment. Toxicity was reported as well. RESULTS: Between February 2009 and May 2011, 102 patients were randomized. Median follow up was 29 months. 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. CONCLUSION: The addition of Cetuximab to radiotherapy and concurrent Cisplatin did not improve disease control in patients with locally advanced NSCLC but increased treatment related toxicity.
Keywords: NSCLC; concurrent chemoradiotherapy; cetuximab
Rights: © 2013 Elsevier Ireland Ltd. All rights reserved.
DOI: 10.1016/j.radonc.2013.10.009
Published version: http://dx.doi.org/10.1016/j.radonc.2013.10.009
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