title: Multi institutional phase II study of concomitant stereotactic reirradiation and cetuximab for recurrent head and neck cancer.
abstract: OBJECTIVE
  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<1year). 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 & Nice) using SBRT with cetuximab are reported. The aim of the study was to deliver non toxic short course SBRT (2weeks) in order to get the same local control as the one demonstrated with longer protocols.
  
  
  METHODS
  Patients with inoperable recurrent, or new primary tumor in a previously irradiated area, were included (WHO<3). Reirradiation (RT) dose was 36Gy in six fractions of 6Gy 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 38months. Cutaneous toxicity was observed for 41 patients. There was one toxic death from hemorrhage and denutrition. Median follow-up was 11.4months. At 3months, 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).
  
  
  CONCLUSIONS
  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.
authors.affiliation: Centre Oscar Lambret, University Lille II & ONCOLille Consortium, France. Electronic address: e-lartigau@o-lambret.fr.
authors.forename: Eric F
authors.initials: EF
authors.lastname: Lartigau
authors.forename: Emmanuelle
authors.initials: E
authors.lastname: Tresch
authors.forename: Juliette
authors.initials: J
authors.lastname: Thariat
authors.forename: Pierre
authors.initials: P
authors.lastname: Graff
authors.forename: Bernard
authors.initials: B
authors.lastname: Coche-Dequeant
authors.forename: Karen
authors.initials: K
authors.lastname: Benezery
authors.forename: Luis
authors.initials: L
authors.lastname: Schiappacasse
authors.forename: Marian
authors.initials: M
authors.lastname: Degardin
authors.forename: Pierre-Yves
authors.initials: PY
authors.lastname: Bondiau
authors.forename: Didier
authors.initials: D
authors.lastname: Peiffert
authors.forename: Jean-Louis
authors.initials: JL
authors.lastname: Lefebvre
authors.forename: Thomas
authors.initials: T
authors.lastname: Lacornerie
authors.forename: Andrew
authors.initials: A
authors.lastname: Kramar
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D061067:Antibodies, Monoclonal, Humanized / Q000627:therapeutic use*; D000970:Antineoplastic Agents / Q000627:therapeutic use*; D000068818:Cetuximab; D003131:Combined Modality Therapy; D066246:ErbB Receptors / Q000037:antagonists & inhibitors*; D005260:Female; D006258:Head and Neck Neoplasms / Q000401:mortality / Q000628:therapy*; D006801:Humans; D008297:Male; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000401:mortality / Q000628:therapy*; D016634:Radiosurgery; D016879:Salvage Therapy
chemical_list: D061067:Antibodies, Monoclonal, Humanized; D000970:Antineoplastic Agents; D066246:ErbB Receptors; D000068818:Cetuximab
keywords: Head and neck tumors; Re-irradiation; Recurrence; Stereotactic radiotherapy