title: Chemoradiotherapy with FOLFOX plus cetuximab in locally advanced oesophageal cancer: The GERCOR phase II trial ERaFOX.
abstract: BACKGROUND
  To determine efficacy and toxicity of radiation therapy combined with oxaliplatin, 5-fluorouracil, and folinic acid (FOLFOX) and cetuximab in patients with locally advanced oesophageal cancer.
  
  
  METHODS
  Patients with stage III oesophageal or gastro-oesophageal junction cancer were enrolled in a Simon's two-stage phase II study. Patients received FOLFOX and weekly cetuximab on week 1-10 with concurrent radiotherapy (50.4 Gy in 30 fractions) on week 5-10. Primary end-point was clinical overall response rate (ORR). An ORR rate of more than 50% was expected.
  
  
  RESULTS
  Among the 79 included patients, clinical ORR was 77% with 40% complete responses. Median overall survival and progression-free survival were 21.6 and 11.3 months, respectively. The most common grade III-IV toxicities observed during experimental chemoimmunotherapy followed by chemoradiation included neutropenia (28%), oesophagitis (12%), rash (11%), and allergy (9%). There was one treatment-related death due to oesophagitis with gastrointestinal bleeding.
  
  
  CONCLUSIONS
  Cetuximab-FOLFOX regimen combined with radiotherapy demonstrated its efficacy and was well tolerated. Unfortunately, these results were not confirmed in two recent phase III studies.
authors: Gastroenterology Department, Private Hospital Jean Mermoz, Lyon, France; Groupe Coopérateur Multidisciplinaire en Oncologie (GERCOR), Paris, France. Electronic address: lledogerard@aol.com.
authors: Gérard
authors: G
authors: Lledo
authors: Groupe Coopérateur Multidisciplinaire en Oncologie (GERCOR), Paris, France; Radiation Oncology Department, Tenon Universitary Hospital, Assistance Publique - Hôpitaux Universitaires Paris Est, University Pierre and Marie Curie Paris 6, Institut Universitaire de Cancérologie, Paris, France.
authors: Florence
authors: F
authors: Huguet
authors: Groupe Coopérateur Multidisciplinaire en Oncologie (GERCOR), Paris, France; Medical Oncology Department, Saint-Antoine Universitary Hospital, Paris, France.
authors: Benoist
authors: B
authors: Chibaudel
authors: Digestive Oncology Unit, Hepatogastroenterology Department, University Hospital, Rouen, France.
authors: Frédéric
authors: F
authors: Di Fiore
authors: Radiation Oncology Department, Institut Sainte-Catherine, Avignon, France.
authors: Laurent
authors: L
authors: Mineur
authors: Digestive Oncology Unit, Centre Régional François Baclesse, Caen, France.
authors: Marie-Pierre
authors: MP
authors: Galais
authors: Gastroenterology Department, Private Hospital Jean Mermoz, Lyon, France.
authors: Pascal
authors: P
authors: Artru
authors: Digestive Oncology Unit, Hepatogastroenterology Department, University Hospital, Rouen, France.
authors: Valérie
authors: V
authors: Blondin
authors: Clinique Victor Hugo, Le Mans, France.
authors: Olivier
authors: O
authors: Dupuis
authors: Radiation Oncology Department, Robert Boulin Hospital, Libourne, France.
authors: Menouar Samir
authors: MS
authors: Abdiche
authors: Medical Oncology Department, Institut Jean Godinot, Reims, France.
authors: Nicolas
authors: N
authors: Jovenin
authors: Methodology and Quality of Life Unit in Cancer, EA 3181, Universitary Hospital of Besançon, Besançon, France.
authors: Astrid
authors: A
authors: Pozet
authors: Methodology and Quality of Life Unit in Cancer, EA 3181, Universitary Hospital of Besançon, Besançon, France.
authors: Franck
authors: F
authors: Bonnetain
authors: Groupe Coopérateur Multidisciplinaire en Oncologie (GERCOR), Paris, France.
authors: Mohamed
authors: M
authors: Attia
authors: Digestive Oncology Unit, University Hospital la Timone, Marseille, France.
authors: Laetitia
authors: L
authors: Dahan
authors: Groupe Coopérateur Multidisciplinaire en Oncologie (GERCOR), Paris, France; Medical Oncology Department, Saint-Antoine Universitary Hospital, Paris, France.
authors: Aimery
authors: A
authors: de Gramont
mesh_terms: D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D000068818:Cetuximab / Q000008:administration & dosage* / Q000009:adverse effects; D059248:Chemoradiotherapy / Q000009:adverse effects; D018572:Disease-Free Survival; D004938:Esophageal Neoplasms / Q000401:mortality / Q000473:pathology / Q000628:therapy*; D004943:Esophagogastric Junction / Q000187:drug effects* / Q000473:pathology / Q000528:radiation effects*; D005472:Fluorouracil / Q000008:administration & dosage; D005602:France; D006801:Humans; D053208:Kaplan-Meier Estimate; D002955:Leucovorin / Q000008:administration & dosage; D009367:Neoplasm Staging; D009944:Organoplatinum Compounds / Q000008:administration & dosage; D016016:Proportional Hazards Models; D011446:Prospective Studies; D011879:Radiotherapy Dosage; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D009944:Organoplatinum Compounds; D000068818:Cetuximab; D002955:Leucovorin; D005472:Fluorouracil
keywords: Cetuximab; Chemoradiotherapy; FOLFOX; Oesophageal cancer; Oxaliplatin; Radiotherapy