title: FOLFOX as second-line chemotherapy in patients with pretreated metastatic pancreatic cancer from the FIRGEM study.
abstract: BACKGROUND
  FOLFOX second-line treatment seems to be a validated option for patients with pancreatic cancer (PC) progressing after gemcitabine chemotherapy. However, other therapeutics strategy has developed in first-line therapy, as the FIRGEM phase II study that evaluated gemcitabine alone versus FOLFIRI.3 alternating with gemcitabine every two months. The present study assessed the efficacy and safety of FOLFOX after failure of the first-line therapy used in the FIRGEM study.
  
  
  METHODS
  In this prospective observational cohort study, we analysed all consecutive patients who received second-line chemotherapy with FOLFOX among 98 patients with metastatic PC included in the FIRGEM study. Progression-free survival (PFS) and overall survival (OS) were estimated from the start of second-line chemotherapy using the Kaplan-Meier method.
  
  
  RESULTS
  Among 46 patients who received second-line chemotherapy, 27 patients (male, 55%; median age, 61 years; performance status (PS) 0-1, 44%) were treated with FOLFOX after progression to first-line gemcitabine alone (n = 20) or FOLFIRI.3 alternating with gemcitabine (n = 7). Grade 3 toxicity was observed in 33% of patients (no grade 4 toxicity). At the end of follow-up, all patients had progressed and 25 had died. No objective response was observed, and disease control rate was 36%. Median PFS and OS were 1.7 and 4.3 months, respectively. In multivariate analysis, PS was the only independent prognostic factor. For patients PS 0-1 versus 2-3, median PFS was 3.0 versus 1.2 months (log rank, p = 0.002), and median OS was 5.9 versus 2.6 months (log rank, p = 0.001).
  
  
  CONCLUSIONS
  This study suggests that FOLFOX second-line therapy offered interesting efficacy results with an acceptable toxicity profile in metastatic PC patients with a good PS.
authors.forename: Aziz
authors.initials: A
authors.lastname: Zaanan
authors.forename: Isabelle
authors.initials: I
authors.lastname: Trouilloud
authors.forename: Theofano
authors.initials: T
authors.lastname: Markoutsaki
authors.forename: Mélanie
authors.initials: M
authors.lastname: Gauthier
authors.forename: Anne-Claire
authors.initials: AC
authors.lastname: Dupont-Gossart
authors.forename: Thierry
authors.initials: T
authors.lastname: Lecomte
authors.forename: Thomas
authors.initials: T
authors.lastname: Aparicio
authors.forename: Pascal
authors.initials: P
authors.lastname: Artru
authors.forename: Anne
authors.initials: A
authors.lastname: Thirot-Bidault
authors.forename: Fanny
authors.initials: F
authors.lastname: Joubert
authors.forename: Daniella
authors.initials: D
authors.lastname: Fanica
authors.affiliation: Department of Gastroenterology and Digestive Oncology, Georges Pompidou European Hospital, AP-HP, 20 rue Leblanc, 75015 Paris, France. julien.taieb@egp.aphp.fr.
authors.forename: Julien
authors.initials: J
authors.lastname: Taieb
mesh_terms: D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D005472:Fluorouracil / Q000009:adverse effects / Q000627:therapeutic use; D006801:Humans; D002955:Leucovorin / Q000009:adverse effects / Q000627:therapeutic use; D008297:Male; D008875:Middle Aged; D009362:Neoplasm Metastasis; D009944:Organoplatinum Compounds / Q000009:adverse effects / Q000627:therapeutic use; D010190:Pancreatic Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology*; D011379:Prognosis; D016896:Treatment Outcome
chemical_list: D009944:Organoplatinum Compounds; D002955:Leucovorin; D005472:Fluorouracil