title: Severe gastrointestinal bleeding in patients with locally advanced head and neck squamous cell carcinoma treated by concurrent radiotherapy and Cetuximab.
abstract: OBJECTIVE
  Concurrent administration of Cetuximab with radiotherapy (Cetuximab-radiation) has been accepted as an alternative option for locally advanced head and neck squamous cell carcinoma (HNSCC). The purpose of this study was to retrospectively compare complications of Cetuximab-radiation with those of concurrent chemoradiation (cCRT) with a special concern on gastrointestinal (GI) hemorrhage associated with Cetuximab-radiation.
  
  
  METHODS
  Indication of Cetuximab-radiation/cCRT for locally advanced HNSCC was primary, postoperative adjuvant, or salvage after recurrence. Our first choice for patients with advanced HNSCC was cCRT; however, if patients did not have enough organ function but with a favorable performance status, Cetuximab-radiation was applied.
  
  
  RESULTS
  From April 2013 to March 2014, 30 patients were identified who were treated with Cetuximab-radiation or cCRT and each cohort consisted of 15 patients. Patients in Cetuximab-radiation cohort suffered from a statistically higher rate of G3/4 dermatitis compared with cCRT cohort (80 vs. 13.3%, respectively, p < 0.001). More patients required unexpected hospitalization due to deterioration of their general condition and total parenteral nutrition in Cetuximab-radiation cohort (p = 0.011 and p = 0.025, respectively). While none experienced GI bleeding in cCRT cohort, four patients experienced GI bleeding including two grade 4 bleeding in Cetuximab-radiation cohort (p = 0.05).
  
  
  CONCLUSIONS
  It is probable that there exists a group of patients who are susceptible for Cetuximab-radiation not only in terms of well-known dermatitis and mucositis but also of gastrointestinal complications.
authors.affiliation: Department of Radiation Oncology, National Cancer Center Hospital, 5-1-1 Tsukiji, Chuo-ku, Tokyo, 104-0045, Japan, ore-murakami@hotmail.co.jp.
authors.forename: Naoya
authors.initials: N
authors.lastname: Murakami
authors.forename: Seiichi
authors.initials: S
authors.lastname: Yoshimoto
authors.forename: Fumihiko
authors.initials: F
authors.lastname: Matsumoto
authors.forename: Takao
authors.initials: T
authors.lastname: Ueno
authors.forename: Yoshinori
authors.initials: Y
authors.lastname: Ito
authors.forename: Satoru
authors.initials: S
authors.lastname: Watanabe
authors.forename: Kazuma
authors.initials: K
authors.lastname: Kobayashi
authors.forename: Ken
authors.initials: K
authors.lastname: Harada
authors.forename: Mayuka
authors.initials: M
authors.lastname: Kitaguchi
authors.forename: Shuhei
authors.initials: S
authors.lastname: Sekii
authors.forename: Kana
authors.initials: K
authors.lastname: Takahashi
authors.forename: Kotaro
authors.initials: K
authors.lastname: Yoshio
authors.forename: Koji
authors.initials: K
authors.lastname: Inaba
authors.forename: Madoka
authors.initials: M
authors.lastname: Morota
authors.forename: Minako
authors.initials: M
authors.lastname: Sumi
authors.forename: Yutaka
authors.initials: Y
authors.lastname: Saito
authors.forename: Jun
authors.initials: J
authors.lastname: Itami
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D061067:Antibodies, Monoclonal, Humanized / Q000008:administration & dosage; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects*; D002294:Carcinoma, Squamous Cell / Q000150:complications* / Q000473:pathology / Q000628:therapy; D000068818:Cetuximab; D059248:Chemoradiotherapy / Q000009:adverse effects*; D002945:Cisplatin / Q000008:administration & dosage; D005260:Female; D005500:Follow-Up Studies; D006471:Gastrointestinal Hemorrhage / Q000175:diagnosis / Q000209:etiology*; D006258:Head and Neck Neoplasms / Q000150:complications* / Q000473:pathology / Q000628:therapy; D006801:Humans; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D011379:Prognosis; D012189:Retrospective Studies
chemical_list: D061067:Antibodies, Monoclonal, Humanized; D000068818:Cetuximab; D002945:Cisplatin