title: The efficiency and adverse events of radiotherapy with cetuximab for Japanese head and neck cancer patients.
abstract: OBJECTIVE
  Radiotherapy with cisplatin (Chemoradiotherapy, CRT) has long been one of the standard treatments for head and neck squamous cell cancer (HNSCC). Approval of cetuximab for the treatment of HNSCC has made radiotherapy with cetuximab (Bioradiotherapy, BRT) a new treatment option for HNSCC. Reports of BRT in the Japanese written in English up to now is only the phase II study, though it includes only 22 patients. Also on the nature of the clinical Phase II trial, sampling bias of cases may exist. Here we report the treatment completion rate, response rate and frequency of adverse events of BRT in Japanese patients with HNSCC in English for the first time. In association with this, we examine the issues related to BRT in Japanese patients.
  
  
  METHODS
  The subjects consisted of patients with HNSCC who underwent BRT as the first curative treatment (45 cases). Their treatment completion rate, response rate and frequency of adverse events were examined.
  
  
  RESULTS
  Of the 45patients, 42 were male and 3 were female. The mean age of the patients was 64 (range from 40 to 86). Adverse events of Grade3 or more were 12 cases (27%) of dermatitis, 31 cases (69%) of mucositis/stomatitis, 6 cases (13%) of interstitial pneumonia. The complication rate of pulmonary emphysema in those who developed interstitial pneumonia and those who did not were 83% and 21%, respectively. The BRT completion rate was 78%, and the response rate was 84%.
  
  
  CONCLUSIONS
  BRT is sufficiently tolerable and have high response rate even for the Japanese, but we should recognize that BRT is not a minimally invasive and easily manageable treatment.
authors.affiliation: Department of Otorhinolaryngology, Head and Neck Surgery, Tokyo Medical University, Tokyo, Japan.
authors.forename: Kazuhiro
authors.initials: K
authors.lastname: Hirasawa
authors.affiliation: Department of Otorhinolaryngology, Head and Neck Surgery, Tokyo Medical University, Tokyo, Japan.
authors.forename: Isaku
authors.initials: I
authors.lastname: Okamoto
authors.affiliation: Department of Otorhinolaryngology, Head and Neck Surgery, Tokyo Medical University, Tokyo, Japan.
authors.forename: Ray
authors.initials: R
authors.lastname: Motohashi
authors.affiliation: Department of Otorhinolaryngology, Head and Neck Surgery, Tokyo Medical University, Tokyo, Japan.
authors.forename: Hiroki
authors.initials: H
authors.lastname: Sato
authors.affiliation: Department of Otorhinolaryngology, Head and Neck Surgery, Tokyo Medical University, Tokyo, Japan.
authors.forename: Soichiro
authors.initials: S
authors.lastname: Takase
authors.affiliation: Department of Otorhinolaryngology, Head and Neck Surgery, Tokyo Medical University, Tokyo, Japan.
authors.forename: Ayumi
authors.initials: A
authors.lastname: Agata
authors.affiliation: Department of Otorhinolaryngology, Head and Neck Surgery, Tokyo Medical University, Tokyo, Japan.
authors.forename: Atsuo
authors.initials: A
authors.lastname: Takeda
authors.affiliation: Department of Otorhinolaryngology, Head and Neck Surgery, Tokyo Medical University, Tokyo, Japan. Electronic address: tsuka@tokyo-med.ac.jp.
authors.forename: Kiyoaki
authors.initials: K
authors.lastname: Tsukahara
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000074322:Antineoplastic Agents, Immunological / Q000627:therapeutic use*; D002294:Carcinoma, Squamous Cell / Q000628:therapy*; D000068818:Cetuximab / Q000627:therapeutic use*; D059248:Chemoradiotherapy / Q000009:adverse effects / Q000379:methods*; D005260:Female; D006258:Head and Neck Neoplasms / Q000628:therapy*; D006801:Humans; D007564:Japan; D017563:Lung Diseases, Interstitial / Q000209:etiology; D008297:Male; D008875:Middle Aged; D052016:Mucositis / Q000209:etiology; D011656:Pulmonary Emphysema / Q000209:etiology; D011855:Radiodermatitis / Q000209:etiology; D000077195:Squamous Cell Carcinoma of Head and Neck; D013280:Stomatitis / Q000209:etiology; D016896:Treatment Outcome
chemical_list: D000074322:Antineoplastic Agents, Immunological; D000068818:Cetuximab
keywords: Bioradiotherapy; Cetuximab; Interstitial pneumonia; Mucositis/stomatitis