title: Reirradiation with cetuximab in locoregional recurrent and inoperable squamous cell carcinoma of the head and neck: feasibility and first efficacy results.
abstract: OBJECTIVE
  To report our experience with a prospective protocol of external beam reirradiation (Re-RT) combined with cetuximab for patients with inoperable, recurrent squamous cell carcinoma of the head and neck (SCCHN).
  
  
  METHODS
  Between August 2008 and June 2010, 18 patients with inoperable recurrence of SCCHN after adjuvant or definitive radiotherapy (RT) and simultaneous or sequential cisplatin-based chemotherapy for primary SCCHN were enrolled. Acute and late toxicity from the experimental regimen were recorded every week during RT and every 3 months thereafter. Efficacy was assessed with repeated imaging using response evaluation criteria in solid tumors and clinical examinations 8-12 weeks after completion of the treatment and every 3 months thereafter.
  
  
  RESULTS
  Median follow-up time for all patients was 9.4 (range: 3.85-31.7) months and for patients alive 30.4 (range: 15.7-31.7) months. Acute toxicity was generally mild or moderate. Five patients developed a grade 3 acneiform rash related to cetuximab. Late toxicity occurred as grade 3 trismus in five and as grade 3 abacterial salivary gland inflammation in one patient, respectively. Overall response rate was 47%. Median overall and progression-free survival for all patients was 8.38 months and 7.33 months, respectively. The overall survival rate was 44% at 1 year, with a 1 year local control rate of 33%.
  
  
  CONCLUSIONS
  Notwithstanding the limitations of our preliminary data Re-RT combined with cetuximab for recurrent and inoperable SCCHN is feasible and the integration of newer targeted agents seems to be less toxic compared to conventional chemotherapy with encouraging response rates at least for a subset of patients.
authors.affiliation: Department of Radiation Therapy and Oncology, Goethe University, Frankfurt am Main, Germany.
authors.forename: Panagiotis
authors.initials: P
authors.lastname: Balermpas
authors.forename: Christian
authors.initials: C
authors.lastname: Keller
authors.forename: Markus
authors.initials: M
authors.lastname: Hambek
authors.forename: Jens
authors.initials: J
authors.lastname: Wagenblast
authors.forename: Oliver
authors.initials: O
authors.lastname: Seitz
authors.forename: Claus
authors.initials: C
authors.lastname: Rödel
authors.forename: Christian
authors.initials: C
authors.lastname: Weiss
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000911:Antibodies, Monoclonal / Q000009:adverse effects / Q000627:therapeutic use*; D061067:Antibodies, Monoclonal, Humanized; D000970:Antineoplastic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D002294:Carcinoma, Squamous Cell / Q000401:mortality / Q000628:therapy*; D000068818:Cetuximab; D003131:Combined Modality Therapy / Q000379:methods; D018572:Disease-Free Survival; D003875:Drug Eruptions / Q000209:etiology; D005240:Feasibility Studies; D005260:Female; D006258:Head and Neck Neoplasms / Q000401:mortality / Q000628:therapy*; D006801:Humans; D008297:Male; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000401:mortality / Q000473:pathology / Q000628:therapy*; D016609:Neoplasms, Second Primary / Q000401:mortality / Q000473:pathology / Q000628:therapy*; D010865:Pilot Projects; D011446:Prospective Studies; D011880:Radiotherapy Planning, Computer-Assisted; D019233:Retreatment / Q000379:methods; D012793:Sialadenitis / Q000209:etiology; D000077195:Squamous Cell Carcinoma of Head and Neck; D015996:Survival Rate; D014313:Trismus / Q000209:etiology; D047368:Tumor Burden
chemical_list: D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D000970:Antineoplastic Agents; D000068818:Cetuximab