title: Preoperative treatment with capecitabine, cetuximab and radiotherapy for primary locally advanced rectal cancer--a phase II clinical trial.
abstract: OBJECTIVE
  To investigate the feasibility and safety of preoperative capecitabine, cetuximab and radiation in patients with MRI-defined locally advanced rectal cancer (LARC, cT3/T4).
  
  
  METHODS
  31 patients with LARC were treated with cetuximab and capecitabine concomitantly with 45 Gy radiotherapy and resected by total mesorectal excision. Histopathological response and association with KRAS status was evaluated.
  
  
  RESULTS
  R0-resection was possible in 27 of 31 (86%) patients. No complete pathological remission was observed. Radiochemotherapy with capecitabine and cetuximab was safe to administer and diarrhea was the main toxicity. KRAS-status did not correlate to down-staging or pathological response concerning T- or N-stage.
  
  
  CONCLUSIONS
  Neoadjuvant therapy with capecitabine and cetuximab in combination with radiotherapy did not lead to complete pathological remission. Treatment tolerability was excellent and toxicity remained low. KRAS status did not influence treatment outcomes. Capecitabine in combination with radiotherapy remains a standard therapy for locally advanced rectal cancer.
authors.affiliation: Department of Internal Medicine V, Medical University, Innsbruck, Austria wolfgang.eisterer@i-med.ac.at.
authors.forename: Wolfgang
authors.initials: W
authors.lastname: Eisterer
authors.affiliation: Department of Radiotherapy and Radio-oncology, Feldkirch Hospital, Feldkirch, Austria.
authors.forename: Alexander
authors.initials: A
authors.lastname: De Vries
authors.affiliation: Department of Surgery, Paracelsus Medical University, Salzburg, Austria.
authors.forename: Dietmar
authors.initials: D
authors.lastname: Öfner
authors.affiliation: Department of Surgery, Leoben Hospital, Leoben, Austria.
authors.forename: Hans
authors.initials: H
authors.lastname: Rabl
authors.affiliation: Department of Internal Medicine IV, Hospital Wels-Grieskirchen, Wels, Austria.
authors.forename: Renate
authors.initials: R
authors.lastname: Koplmüller
authors.affiliation: Department of Internal Medicine III, Paracelsus Medical University, Salzburg, Austria.
authors.forename: Richard
authors.initials: R
authors.lastname: Greil
authors.affiliation: Department of Surgery, St. Veit Hospital, Sankt Veit an de Glan, Austria.
authors.forename: Jöerg
authors.initials: J
authors.lastname: Tschmelitsch
authors.affiliation: Department of Radio-oncology, Medical University of Vienna, Vienna, Austria.
authors.forename: Rainer
authors.initials: R
authors.lastname: Schmid
authors.affiliation: Department of Radio-oncology, Medical University, Graz, Austria.
authors.forename: Karin
authors.initials: K
authors.lastname: Kapp
authors.affiliation: Department of Radio-oncology, Medical University, Innsbruck, Austria.
authors.forename: Peter
authors.initials: P
authors.lastname: Lukas
authors.affiliation: Department of Radio-oncology, Paracelsus Medical University, Salzburg, Austria.
authors.forename: Felix
authors.initials: F
authors.lastname: Sedlmayer
authors.affiliation: Department of Pathology, Medical University, Graz, Austria.
authors.forename: Gerald
authors.initials: G
authors.lastname: Höfler
authors.affiliation: Department of Surgery, Medical University of Vienna, Vienna, Austria Comprehensive Cancer Center, Medical University of Vienna, Vienna, Austria.
authors.forename: Michael
authors.initials: M
authors.lastname: Gnant
authors.affiliation: Department of Internal Medicine IV, Hospital Wels-Grieskirchen, Wels, Austria.
authors.forename: Josef
authors.initials: J
authors.lastname: Thaler
mesh_terms: D000230:Adenocarcinoma / Q000473:pathology / Q000601:surgery / Q000628:therapy*; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D061067:Antibodies, Monoclonal, Humanized / Q000008:administration & dosage; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D000069287:Capecitabine; D000068818:Cetuximab; D059248:Chemoradiotherapy; D003131:Combined Modality Therapy; D003841:Deoxycytidine / Q000008:administration & dosage / Q000031:analogs & derivatives; D005240:Feasibility Studies; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage / Q000031:analogs & derivatives; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D020360:Neoadjuvant Therapy; D009367:Neoplasm Staging; D011300:Preoperative Care; D011379:Prognosis; D012004:Rectal Neoplasms / Q000473:pathology / Q000601:surgery / Q000628:therapy*; D012074:Remission Induction; D015996:Survival Rate
chemical_list: D061067:Antibodies, Monoclonal, Humanized; D003841:Deoxycytidine; D000069287:Capecitabine; D000068818:Cetuximab; D005472:Fluorouracil
keywords: Rectal cancer; capecitabine; cetuximab; phase II trial; radiochemotherapy