title: Prospective study of cetuximab and gemcitabine in combination with radiation therapy: feasibility and efficacy in locally advanced pancreatic head cancer.
abstract: BACKGROUND
  Radio-chemotherapy is one of the steps of multidisciplinary management in locally advanced pancreatic cancer. The Epidermal Growth Factor Receptor (EGFR) plays an important role in the disease pathway. The purpose of this prospective study is to evaluate the feasibility and the efficacy of radiotherapy in combination with gemcitabine and EGFR targeting therapy for patients with locally advanced disease.
  
  
  METHODS
  From November 2008 through January 2012, 34 patients were included in this study. In all cases an accurate pre-treatment staging including CT scan, Endoscopic Ultra-Sonography (EUS), 18F - fluorodeoxyglucose (18F-FDG) PET-CT and laparoscopy with peritoneal washing was performed. External beam radiation was delivered with a total dose of 50.4 Gy (1.8 Gy per fraction). Patients were treated using 3D- conformal radiotherapy, and the clinical target volume was the primary tumor and involved lymph nodes. Gemcitabine 300 mg/m(2) and Cetuximab were given weekly during radiation therapy.
  
  
  RESULTS
  Ten patients (29.4 %) were excluded from the protocol because of the evidence of metastatic disease at the pre-treatment staging. Three patients refused radiochemotherapy. Twenty-one patients completed the therapy protocol. During the combined therapy grade 3-4 toxicities observed were only haematological (leukopenia 47,6 %, trombocytopenia 4.8 %, elevated gamma-GT 23.8 %, elevated alkaline phosphatase 4,8 %). Non-haematological toxicity grade 3-4 was never reported. Post-treatment workup showed partial response in five patients (24 %), stable disease in 11 patients (52 %) and disease progression in 5 patients (24 %). Two-year Local Control was 49 % (median, 18.6 months), 2-year Metastases Free Survival was 24 % (median, 10.8 months). One and two-year Overall Survival were 66 % and 28 % respectively, with a median survival time of 15.3 months.
  
  
  CONCLUSIONS
  The combination of cetuximab and gemcitabine with concurrent radiation therapy provides a feasible and well tolerated treatment for locally advanced pancreatic cancer. Patients' selection is crucial in order to treat patients appropriately.
authors.affiliation: Radiotherapy Unit, Campus Bio-Medico University, Via A. del Portillo, 21, 00128, Rome, Italy. m.fiore@unicampus.it.
authors.forename: Michele
authors.initials: M
authors.lastname: Fiore
authors.affiliation: Radiotherapy Unit, Campus Bio-Medico University, Via A. del Portillo, 21, 00128, Rome, Italy. l.trodella@unicampus.it.
authors.forename: Lucio
authors.initials: L
authors.lastname: Trodella
authors.affiliation: Department of General Surgery, Campus Bio-Medico University, Rome, Italy. s.valeri@unicampus.it.
authors.forename: Sergio
authors.initials: S
authors.lastname: Valeri
authors.affiliation: Department of General Surgery, Campus Bio-Medico University, Rome, Italy. d.borzomati@unicampus.it.
authors.forename: Domenico
authors.initials: D
authors.lastname: Borzomati
authors.affiliation: Radiotherapy Unit, Campus Bio-Medico University, Via A. del Portillo, 21, 00128, Rome, Italy. b.floreno@unicampus.it.
authors.forename: Barnaba
authors.initials: B
authors.lastname: Floreno
authors.affiliation: Radiotherapy Unit, Campus Bio-Medico University, Via A. del Portillo, 21, 00128, Rome, Italy. e.ippolito@unicampus.it.
authors.forename: Edy
authors.initials: E
authors.lastname: Ippolito
authors.affiliation: Radiotherapy Unit, Campus Bio-Medico University, Via A. del Portillo, 21, 00128, Rome, Italy. p.trecca@unicampus.it.
authors.forename: Pasquale
authors.initials: P
authors.lastname: Trecca
authors.affiliation: Radiotherapy Unit, Campus Bio-Medico University, Via A. del Portillo, 21, 00128, Rome, Italy. luca.trodella@unicampus.it.
authors.forename: Luca Eolo
authors.initials: LE
authors.lastname: Trodella
authors.affiliation: Radiotherapy Unit, Campus Bio-Medico University, Via A. del Portillo, 21, 00128, Rome, Italy. r.dangelillo@unicampus.it.
authors.forename: Rolando Maria
authors.initials: RM
authors.lastname: D'Angelillo
authors.affiliation: Radiotherapy Unit, Campus Bio-Medico University, Via A. del Portillo, 21, 00128, Rome, Italy. s.ramella@unicampus.it.
authors.forename: Sara
authors.initials: S
authors.lastname: Ramella
authors.affiliation: Department of General Surgery, Campus Bio-Medico University, Rome, Italy. r.coppola@unicampus.it.
authors.forename: Roberto
authors.initials: R
authors.lastname: Coppola
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D021441:Carcinoma, Pancreatic Ductal / Q000188:drug therapy* / Q000401:mortality / Q000532:radiotherapy*; D000068818:Cetuximab / Q000008:administration & dosage / Q000009:adverse effects; D059248:Chemoradiotherapy / Q000009:adverse effects / Q000379:methods*; D003841:Deoxycytidine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives; D018572:Disease-Free Survival; D005240:Feasibility Studies; D005260:Female; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D010190:Pancreatic Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000532:radiotherapy*; D020266:Radiotherapy, Conformal; D000093542:Gemcitabine
chemical_list: D003841:Deoxycytidine; D000068818:Cetuximab; D000093542:Gemcitabine