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

Abstract

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.

• Authors: Alexandra D Jensen, Jürgen Krauss, Karin Potthoff, Christian Simon, Anna V Nikoghosyan, Karen Lossner, Jürgen Debus, Marc W Münter
• Journal: Radiation oncology (London, England) (Radiat Oncol) Vol. 7 Pg. 57 (Apr 02 2012) ISSN: 1748-717X [Electronic] England
• PMID: 22472064 (Publication Type: Clinical Trial, Phase II, Journal Article, Research Support, Non-U.S. Gov't)

Chemical References

• Antibodies, Monoclonal
• Antibodies, Monoclonal, Humanized
• Carboplatin
• Cetuximab
• Fluorouracil

Topics

• Adult
• Aged
• Antibodies, Monoclonal (administration & dosage, adverse effects)
• Antibodies, Monoclonal, Humanized
• Carboplatin (administration & dosage, adverse effects)
• Carcinoma, Squamous Cell (immunology, therapy)
• Cetuximab
• Chemoradiotherapy (adverse effects, methods)
• Female
• Fluorouracil (administration & dosage, adverse effects)
• Head and Neck Neoplasms (immunology, therapy)
• Humans
• Immunotherapy (adverse effects, methods)
• Male
• Middle Aged
• Neoplasm Grading
• Radiotherapy Planning, Computer-Assisted
• Radiotherapy, Intensity-Modulated
• Squamous Cell Carcinoma of Head and Neck