title: Radiochemoimmunotherapy with intensity-modulated concomitant boost: interim analysis of the REACH trial.
abstract: OBJECTIVE
  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.
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  ISRCTN87356938.
authors.affiliation: Dept of Radiation Oncology, University of Heidelberg, Heidelberg, Germany. alexandra.jensen@med.uni-heidelberg.de
authors.forename: Alexandra D
authors.initials: AD
authors.lastname: Jensen
authors.forename: Jürgen
authors.initials: J
authors.lastname: Krauss
authors.forename: Karin
authors.initials: K
authors.lastname: Potthoff
authors.forename: Christian
authors.initials: C
authors.lastname: Simon
authors.forename: Anna V
authors.initials: AV
authors.lastname: Nikoghosyan
authors.forename: Karen
authors.initials: K
authors.lastname: Lossner
authors.forename: Jürgen
authors.initials: J
authors.lastname: Debus
authors.forename: Marc W
authors.initials: MW
authors.lastname: Münter
mesh_terms: D000328:Adult; D000368:Aged; D000911:Antibodies, Monoclonal / Q000008:administration & dosage / Q000009:adverse effects; D061067:Antibodies, Monoclonal, Humanized; D016190:Carboplatin / Q000008:administration & dosage / Q000009:adverse effects; D002294:Carcinoma, Squamous Cell / Q000276:immunology / Q000628:therapy*; D000068818:Cetuximab; D059248:Chemoradiotherapy / Q000009:adverse effects / Q000379:methods*; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage / Q000009:adverse effects; D006258:Head and Neck Neoplasms / Q000276:immunology / Q000628:therapy*; D006801:Humans; D007167:Immunotherapy / Q000009:adverse effects / Q000379:methods*; D008297:Male; D008875:Middle Aged; D060787:Neoplasm Grading; D011880:Radiotherapy Planning, Computer-Assisted; D050397:Radiotherapy, Intensity-Modulated; D000077195:Squamous Cell Carcinoma of Head and Neck
chemical_list: D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D016190:Carboplatin; D000068818:Cetuximab; D005472:Fluorouracil