Radiochemoimmunotherapy with intensity-modulated concomitant boost: interim analysis of the REACH trial

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• 作者：Alexandra D Jensen (1) (4)
  Jürgen Krauss (2)
  Karin Potthoff (1)
  Christian Simon (3)
  Anna V Nikoghosyan (1)
  Karen Lossner (1)
  Jürgen Debus (1)
  Marc W Münter (1)
  
• 关键词：Radiochemotherapy ; Radioimmunotherapy ; Cetuximab ; IMRT ; Concomitant boost ; Squamous cell head and neck cancer ; SCCHN
• 刊名：Radiation Oncology
• 出版年：2012
• 出版时间：December 2012
• 年：2012
• 卷：7
• 期：1
• 全文大小：1139KB
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• 作者单位：Alexandra D Jensen (1) (4)
  Jürgen Krauss (2)
  Karin Potthoff (1)
  Christian Simon (3)
  Anna V Nikoghosyan (1)
  Karen Lossner (1)
  Jürgen Debus (1)
  Marc W Münter (1)
  
  1. Dept of Radiation Oncology, University of Heidelberg, INF 400, 69120, Heidelberg, Germany
  4. Dept of Head and Neck Surgery, INF 400, 69120, Heidelberg, Germany
  2. Dept of Radiation Oncology, INF 400, 69120, Heidelberg, Germany
  3. National Centre for Tumour Disease (NCT), INF 460, 69120, Heidelberg, Germany
  

文摘

Purpose To evaluate efficacy and toxicity clinical in the intensified treatment of locally advanced squamous cell carcinoma of the head and neck (SCCHN) with the combination of chemotherapy, the EGFR antibody cetuximab, and intensity-modulated radiation therapy (IMRT) in a concomitant boost concept. Methods REACH is a prospective, bi-centric phase II trial of carboplatin/5-FU and cetuximab weekly combined with IMRT. Primary endpoint is locoregional control, secondary endpoints include acute radiation effects and adverse events. Evaluation of disease response is carried out according to the Response Evaluation Criteria in Solid Tumors (RECIST); toxicity is assessed using NCI CTC v 3.0. Results Treatment was tolerated moderately well, acneiforme erythema occurred in 74.1% (grade II/III), mucositis grade III in 28.6%, and radiation dermatitis grade III in 14.3%. Higher-grade side-effects resolved quickly until the first follow-up post treatment. Objective response rates were promising with 28.6% CR at first follow-up and 92.9% thereafter. Conclusion The combination of standard carboplatin/5-FU and cetuximab is feasible and results in promising objective response rates. The use of an IMRT concomitant boost is practicable in a routine clinical setting resulting in only moderate overall toxicity of the regimen. Trial Registration Number ISRCTN87356938.