Multi institutional phase II study of concomitant stereotactic reirradiation and cetuximab for recurrent head and neck cancer

Purpose: Recurrent head and neck cancer is associated to a poor survival prognosis. A high toxicity rate is demonstrated when surgery and/or radiotherapy and/or chemotherapy are combined. Furthermore, the duration of treatment is often not ethically compatible with the expected survival (median survival < 1 year). Normal tissues tolerance limits the use of reirradiation and stereotactic body radiotherapy (SBRT) could offer precise irradiation while sparing healthy tissues. After completion of a feasibility study, results of a multicentric study (Lille, Nancy Sx Nice) using SBRT with cetuximab are reported. The aim of the study was to deliver non toxic short course SBRT (2 weeks) in order to get the same local control as the one demonstrated with longer protocols. Methods and materials: Patients with inoperable recurrent, or new primary tumor in a previously irradiated area, were included (WHO < 3). Reirradiation (RT) dose was 36 Gy in six fractions of 6 Gy to the 85% isodose line covering 95% of the PTV with 5 injections of concomitant cetuximab (CT). All patients had previous radiotherapy, 85% had previous surgery and 48% previous chemotherapy. Results: Between 11/2007 and 08/2010, 60 were included (46 men and 14 women), 56 received CT + RT, 3 were not treated and 1 received only CT. Median age was 60 (42-87)) and all 56 patients had squamous carcinoma and received concomitant cetuximab. Mean time between previous radiotherapy and the start of SBRT was 38 months. Cutaneous toxicity was observed for 41 patients. There was one toxic death from hemorrhage and denutrition. Median follow-up was 11.4 months. At 3 months, response rate was 58.4% (95% CI: 43.2-72.4%) and disease control rate was 91.7% (95% CI: 80.0-97.7%). The one-year OS rate was 47.5% (95% CI: 30.8-62.4). Conclusion: These results suggest that short SBRT with cetuximab is an effective salvage treatment with good response rate in this poor prognosis population with previously irradiated HNC. Treatment is feasible and, with appropriate care to limiting critical structure, acute toxicities are acceptable. This combination may be the reference treatment is this population. (C) 2013 Elsevier Ireland Ltd. All rights reserved.