title: A phase I study of concurrent chemoradiotherapy and cetuximab for locally advanced esophageal cancer.
abstract: OBJECTIVE
  To determine the maximum tolerated dose (MTD) and dose-limiting toxicities (DLTs) of concurrent chemoradiotherapy and cetuximab in patients with non-resectable locally advanced esophageal cancer.
  
  
  METHODS
  Escalating doses of oxaliplatin every second week and daily tegafur/uracil were given concurrently with radiotherapy, 59.4 Gy in 33 fractions. Cetuximab was given on day 15 (400 mg/m(2)) and weekly (250 mg/m(2)) during radiotherapy. Fixed doses of oxaliplatin (130 mg/m(2)) and tegafur/uracil (300 mg/m(2)) were administered before, and after radiotherapy.
  
  
  RESULTS
  Eleven patients were included in the study; two were excluded due to allergic reactions to cetuximab. In DL2 (tegafur/uracil 300 mg/m(2), oxaliplatin 30 mg/m(2)) two grade 3/4 fistula and one grade 3 neuropathy were observed. Six patients were enrolled in DL1 (tegafur/uracil 150 mg/m(2)/, oxaliplatin 30 mg/m(2)) with no DLTs. Four out of 9 patients had complete response.
  
  
  CONCLUSIONS
  Concomitant chemoradiotherapy and cetuximab had significant activity. DL1 was established as the MTD.
authors.affiliation: Department of Oncology, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark. c.hollaender@gmail.com
authors.forename: Cecilie
authors.initials: C
authors.lastname: Holländer
authors.forename: Lene
authors.initials: L
authors.lastname: Baeksgaard
authors.forename: Morten
authors.initials: M
authors.lastname: Sorensen
authors.forename: Per
authors.initials: P
authors.lastname: Albertsson
authors.forename: Lars
authors.initials: L
authors.lastname: Damstrup
authors.forename: Ulrik
authors.initials: U
authors.lastname: Lassen
mesh_terms: D000328:Adult; D000368:Aged; D000911:Antibodies, Monoclonal / Q000008:administration & dosage / Q000009:adverse effects; D061067:Antibodies, Monoclonal, Humanized; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage* / Q000009:adverse effects*; D000068818:Cetuximab; D059248:Chemoradiotherapy / Q000009:adverse effects / Q000379:methods; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D004938:Esophageal Neoplasms / Q000188:drug therapy* / Q000532:radiotherapy*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009944:Organoplatinum Compounds / Q000008:administration & dosage / Q000009:adverse effects; D000077150:Oxaliplatin; D005641:Tegafur / Q000008:administration & dosage / Q000009:adverse effects; D014498:Uracil / Q000008:administration & dosage / Q000009:adverse effects
chemical_list: D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D009944:Organoplatinum Compounds; D000077150:Oxaliplatin; D005641:Tegafur; D014498:Uracil; D000068818:Cetuximab