title: FOLFIRINOX for locally advanced pancreatic adenocarcinoma: results of an AGEO multicenter prospective observational cohort.
abstract: BACKGROUND
  First-line treatment with FOLFIRINOX significantly increases overall survival (OS) in patients with metastatic pancreatic adenocarcinoma (PA) compared with gemcitabine. The aim of this observational cohort was to evaluate the tolerability and efficacy of this regimen in unresectable locally advanced PA (LAPA).
  
  
  METHODS
  From February 2010 to February 2012, all consecutive patients from 11 French centers treated by FOLFIRINOX for a histologically proven LAPA were prospectively enrolled. Unresectability was defined independently by each center's multidisciplinary staff at diagnosis. Absence of metastatic disease was confirmed by chest-abdomen-pelvis computed tomography scan. FOLFIRINOX was delivered every 2 weeks as previously reported until progressive disease, major toxicity, or consolidation treatment by radiotherapy and/or surgery.
  
  
  RESULTS
  Seventy-seven patients were enrolled. They received a median number of five cycles (1-30). Grade 3-4 toxicities were neutropenia (11 %), nausea (9 %), diarrhea (6 %), fatigue (6 %), and anemia (1 %). Grade 2-3 sensory neuropathy occurred in 25 % of patients. No toxic death was reported and only 6 % of patients had to stop treatment because of toxicity. Disease control rate was 84 with 28 % of objective response (Response Evaluation Criteria in Solid Tumors). Seventy-five percent of patients received a consolidation therapy: 70 % had radiotherapy and 36 % underwent a surgical resection, with a curative intent. Within the whole cohort, 1-year OS rate was 77 % (95 % CI 65-86) and 1-year progression-free survival rate was 59 % (95 % CI 46-70).
  
  
  CONCLUSIONS
  First-line FOLFIRINOX for LAPA seems to be effective and have a manageable toxicity profile. These promising results will have to be confirmed in a phase III randomized trial.
authors.affiliation: Department of Gastroenterology, Kremlin Bicêtre Hospital, Assistance publique-Hôpitaux de Paris (AP-HP), Paris Sud University, Le Kremlin Bicêtre, France.
authors.forename: L
authors.initials: L
authors.lastname: Marthey
authors.forename: A
authors.initials: A
authors.lastname: Sa-Cunha
authors.forename: J F
authors.initials: JF
authors.lastname: Blanc
authors.forename: M
authors.initials: M
authors.lastname: Gauthier
authors.forename: A
authors.initials: A
authors.lastname: Cueff
authors.forename: E
authors.initials: E
authors.lastname: Francois
authors.forename: I
authors.initials: I
authors.lastname: Trouilloud
authors.forename: D
authors.initials: D
authors.lastname: Malka
authors.forename: J B
authors.initials: JB
authors.lastname: Bachet
authors.forename: R
authors.initials: R
authors.lastname: Coriat
authors.forename: E
authors.initials: E
authors.lastname: Terrebonne
authors.forename: C
authors.initials: C
authors.lastname: De La Fouchardière
authors.forename: S
authors.initials: S
authors.lastname: Manfredi
authors.forename: D
authors.initials: D
authors.lastname: Solub
authors.forename: C
authors.initials: C
authors.lastname: Lécaille
authors.forename: A
authors.initials: A
authors.lastname: Thirot Bidault
authors.forename: F
authors.initials: F
authors.lastname: Carbonnel
authors.forename: J
authors.initials: J
authors.lastname: Taieb
mesh_terms: D000230:Adenocarcinoma / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D002166:Camptothecin / Q000008:administration & dosage / Q000031:analogs & derivatives; D002945:Cisplatin / Q000008:administration & dosage; D003841:Deoxycytidine / Q000008:administration & dosage / Q000031:analogs & derivatives; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage; D005500:Follow-Up Studies; D006801:Humans; D000077146:Irinotecan; D002955:Leucovorin / Q000008:administration & dosage; D008297:Male; D020714:Maximum Tolerated Dose; D008875:Middle Aged; D009361:Neoplasm Invasiveness; D009364:Neoplasm Recurrence, Local / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D009367:Neoplasm Staging; D010190:Pancreatic Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D011379:Prognosis; D011446:Prospective Studies; D015996:Survival Rate; D000093542:Gemcitabine
chemical_list: D003841:Deoxycytidine; D000077146:Irinotecan; D002945:Cisplatin; D002955:Leucovorin; D005472:Fluorouracil; D002166:Camptothecin; D000093542:Gemcitabine