title: Adding preoperative radiotherapy plus cetuximab to perioperative chemotherapy for resectable esophageal adenocarcinoma: a single-center prospective phase II trial.
abstract: BACKGROUND
  Local and systemic recurrence are important sources of treatment failure following surgical resection of esophageal adenocarcinoma. We hypothesized that adding preoperative cetuximab and radiotherapy (cetux-RT) to perioperative chemotherapy would increase treatment efficacy with acceptable toxicity.
  
  
  METHODS
  In this prospective phase II trial, patients were treated with three cycles of epirubicin, cisplatin, and capecitabine (ECX), followed by cetux-RT. After surgery with curative intent, patients received three more cycles of ECX. Primary endpoints were efficacy, determined by histopathological complete response (pCR) rate, and safety, which was assessed with resectability rate.
  
  
  RESULTS
  Of the 12 patients enrolled in this trial, six received at least one dose of cetux-RT. In five patients, cetux-RT was not started because of adverse events (AEs) related to preoperative chemotherapy; one patient had progressive disease. Addition of cetux-RT was well tolerated and did not interfere with the resectability rate (100%). However, the pCR rate was 0, and 50% of patients experienced serious adverse events (SAEs) postoperatively.
  
  
  CONCLUSIONS
  With 12 patients enrolled, the lack of initial signs of efficacy and a high incidence of postoperative SAEs prompted us to end this study prematurely. Perioperative ECX was associated with considerable toxicity, and further treatment intensification is problematic.
authors: Departments of Medical Oncology.
authors: Inge
authors: I
authors: Ubink
authors: Pieter
authors: P
authors: van der Sluis
authors: Marguerite
authors: M
authors: Schipper
authors: Onne
authors: O
authors: Reerink
authors: Emile
authors: E
authors: Voest
authors: Inne
authors: I
authors: Borel-Rinkes
authors: Harm
authors: H
authors: Wijrdeman
authors: Frank
authors: F
authors: Vleggaar
authors: Marriete
authors: M
authors: Agterof
authors: Esther
authors: E
authors: Overkleeft
authors: Peter
authors: P
authors: Siersema
authors: Richard
authors: R
authors: van Hillegersberg
authors: M P
authors: MP
authors: Lolkema
mesh_terms: D000230:Adenocarcinoma / Q000188:drug therapy / Q000532:radiotherapy / Q000601:surgery / Q000628:therapy*; D000368:Aged; D061067:Antibodies, Monoclonal, Humanized / Q000008:administration & dosage / Q000009:adverse effects; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D000069287:Capecitabine; D000068818:Cetuximab; D059248:Chemoradiotherapy; D002945:Cisplatin / Q000008:administration & dosage; D003841:Deoxycytidine / Q000008:administration & dosage / Q000031:analogs & derivatives; D015251:Epirubicin / Q000008:administration & dosage; D004938:Esophageal Neoplasms / Q000188:drug therapy / Q000532:radiotherapy / Q000601:surgery / Q000628:therapy*; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage / Q000031:analogs & derivatives; D006801:Humans; D008297:Male; D008875:Middle Aged; D020360:Neoadjuvant Therapy; D009364:Neoplasm Recurrence, Local / Q000517:prevention & control; D019990:Perioperative Care / Q000379:methods; D011300:Preoperative Care / Q000379:methods; D011446:Prospective Studies; D017741:Survivors
chemical_list: D061067:Antibodies, Monoclonal, Humanized; D003841:Deoxycytidine; D015251:Epirubicin; D000069287:Capecitabine; D000068818:Cetuximab; D002945:Cisplatin; D005472:Fluorouracil