title: Phase 2 trial of induction gemcitabine, oxaliplatin, and cetuximab followed by selective capecitabine-based chemoradiation in patients with borderline resectable or unresectable locally advanced pancreatic cancer.
abstract: OBJECTIVE
  To evaluate, in a phase 2 study, the safety and efficacy of induction gemcitabine, oxaliplatin, and cetuximab followed by selective capecitabine-based chemoradiation in patients with borderline resectable or unresectable locally advanced pancreatic cancer (BRPC or LAPC, respectively).
  
  
  METHODS
  Patients received gemcitabine and oxaliplatin chemotherapy repeated every 14 days for 6 cycles, combined with weekly cetuximab. Patients were then restaged; "downstaged" patients with resectable disease underwent attempted resection. Remaining patients were treated with chemoradiation consisting of intensity modulated radiation therapy (54 Gy) and concurrent capecitabine; patients with borderline resectable disease or better at restaging underwent attempted resection.
  
  
  RESULTS
  A total of 39 patients were enrolled, of whom 37 were evaluable. Protocol treatment was generally well tolerated. Median follow-up for all patients was 11.9 months. Overall, 29.7% of patients underwent R0 surgical resection (69.2% of patients with BRPC; 8.3% of patients with LAPC). Overall 6-month progression-free survival (PFS) was 62%, and median PFS was 10.4 months. Median overall survival (OS) was 11.8 months. In patients with LAPC, median OS was 9.3 months; in patients with BRPC, median OS was 24.1 months. In the group of patients who underwent R0 resection (all of which were R0 resections), median survival had not yet been reached at the time of analysis.
  
  
  CONCLUSIONS
  This regimen was well tolerated in patients with BRPC or LAPC, and almost one-third of patients underwent R0 resection. Although OS for the entire cohort was comparable to that in historical controls, PFS and OS in patients with BRPC and/or who underwent R0 resection was markedly improved.
authors.affiliation: Department of Surgery, Hollings Cancer Center, Medical University of South Carolina, Charleston, South Carolina.
authors.forename: Nestor F
authors.initials: NF
authors.lastname: Esnaola
authors.affiliation: Division of Hematology and Oncology, Department of Internal Medicine, Hollings Cancer Center, Medical University of South Carolina, Charleston, South Carolina.
authors.forename: Uzair B
authors.initials: UB
authors.lastname: Chaudhary
authors.affiliation: Division of Hematology and Oncology, Department of Internal Medicine, Hollings Cancer Center, Medical University of South Carolina, Charleston, South Carolina.
authors.forename: Paul
authors.initials: P
authors.lastname: O'Brien
authors.affiliation: Division of Biostatistics and Epidemiology, Department of Internal Medicine, Hollings Cancer Center, Medical University of South Carolina, Charleston, South Carolina.
authors.forename: Elizabeth
authors.initials: E
authors.lastname: Garrett-Mayer
authors.affiliation: Department of Surgery, Hollings Cancer Center, Medical University of South Carolina, Charleston, South Carolina.
authors.forename: E Ramsay
authors.initials: ER
authors.lastname: Camp
authors.affiliation: Division of Hematology and Oncology, Department of Internal Medicine, Hollings Cancer Center, Medical University of South Carolina, Charleston, South Carolina.
authors.forename: Melanie B
authors.initials: MB
authors.lastname: Thomas
authors.affiliation: Department of Surgery, Hollings Cancer Center, Medical University of South Carolina, Charleston, South Carolina.
authors.forename: David J
authors.initials: DJ
authors.lastname: Cole
authors.affiliation: Division of Hematology and Oncology, Department of Internal Medicine, Hollings Cancer Center, Medical University of South Carolina, Charleston, South Carolina.
authors.forename: Alberto J
authors.initials: AJ
authors.lastname: Montero
authors.affiliation: Division of Gastroenterology and Hepatology, Department of Internal Medicine, Hollings Cancer Center, Medical University of South Carolina, Charleston, South Carolina.
authors.forename: Brenda J
authors.initials: BJ
authors.lastname: Hoffman
authors.affiliation: Division of Gastroenterology and Hepatology, Department of Internal Medicine, Hollings Cancer Center, Medical University of South Carolina, Charleston, South Carolina.
authors.forename: Joseph
authors.initials: J
authors.lastname: Romagnuolo
authors.affiliation: Department of Radiation Oncology, Hollings Cancer Center, Medical University of South Carolina, Charleston, South Carolina.
authors.forename: Kelly P
authors.initials: KP
authors.lastname: Orwat
authors.affiliation: Department of Radiation Oncology, Hollings Cancer Center, Medical University of South Carolina, Charleston, South Carolina. Electronic address: marshadt@musc.edu.
authors.forename: David T
authors.initials: DT
authors.lastname: Marshall
mesh_terms: D000230:Adenocarcinoma / Q000401:mortality / Q000473:pathology / Q000628:therapy*; D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D000069287:Capecitabine; D059248:Chemoradiotherapy / Q000009:adverse effects / Q000379:methods* / Q000401:mortality; D003841:Deoxycytidine / Q000008:administration & dosage / Q000031:analogs & derivatives; D004334:Drug Administration Schedule; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage / Q000031:analogs & derivatives; D006801:Humans; D060828:Induction Chemotherapy / Q000009:adverse effects / Q000379:methods* / Q000401:mortality; D008297:Male; D008875:Middle Aged; D009944:Organoplatinum Compounds / Q000008:administration & dosage; D000077150:Oxaliplatin; D010190:Pancreatic Neoplasms / Q000401:mortality / Q000473:pathology / Q000628:therapy*; D011879:Radiotherapy Dosage; D050397:Radiotherapy, Intensity-Modulated / Q000379:methods*; D000093542:Gemcitabine
chemical_list: D009944:Organoplatinum Compounds; D000077150:Oxaliplatin; D003841:Deoxycytidine; D000069287:Capecitabine; D005472:Fluorouracil; D000093542:Gemcitabine