title: 5-fluorouracil/leucovorin combined with irinotecan and oxaliplatin (FOLFIRINOX) as second-line chemotherapy in patients with metastatic pancreatic adenocarcinoma.
abstract: BACKGROUND
  To evaluate the efficacy and toxicity of irinotecan and oxaliplatin plus 5-fluorouracil (FU) and leucovorin (FOLFIRINOX) as second-line therapy in metastatic pancreatic adenocarcinoma (MPA).
  
  
  METHODS
  We retrospectively analyzed the medical records of 27 patients with MPA treated with FOLFIRINOX as second-line therapy between January 2003 and November 2009 in our hospital. The recommended schedule was oxaliplatin 85 mg/m(2) on day 1 + irinotecan 180 mg/m(2) on day 1 + leucovorin 400 mg/m(2) on day 1 followed by FU 400 mg/m(2) as a bolus on day 1 and 2,400 mg/m(2) as 46-hour continuous infusion biweekly.
  
  
  RESULTS
  The median age of the 27 patients (13 males and 14 females) was 63 years (45-83). All patients had progressive disease after first-line chemotherapy by gemcitabine. A total of 167 cycles were administered, with a median number of 6 cycles (1-29) per patient. One toxic death occurred (sepsis). Tolerance of treatment was acceptable, and the relative dose density delivered per patient was 92.8% for oxaliplatin, 89.1% for irinotecan and 96.4% for FU. Grade 3-4 neutropenia occurred in 55.6% of the patients, including 1 febrile neutropenia. The other toxicities were manageable. Regarding efficacy, 22 of the 27 patients were evaluable (WHO and RECIST criteria). Five patients had partial responses and 12 stable disease, resulting in an overall disease control rate of 63%. Median time to progression was 5.4 months (0.7-25.48), and median event-free survival was 3 months (0.5-24.9). Median overall survival was 8.5 months (0-26). A clinical benefit was reported for 55% of the patients.
  
  
  CONCLUSIONS
  These results confirmed the good safety profile and the efficacy of the FOLFIRINOX regimen as second-line treatment of MPA.
authors.affiliation: Department of Medical Oncology, Centre Hospitalier Universitaire, Groupe Hospitalier Henri Mondor-Albert Chenevier, Assistance Publique-Hôpitaux de Paris et Université Paris XII, 51 Avenue du Maréchal de Lattre de Tassigny, Créteil, France. elias.assaf@hmn.aphp.fr
authors.forename: Elias
authors.initials: E
authors.lastname: Assaf
authors.forename: Muriel
authors.initials: M
authors.lastname: Verlinde-Carvalho
authors.forename: Catherine
authors.initials: C
authors.lastname: Delbaldo
authors.forename: Julien
authors.initials: J
authors.lastname: Grenier
authors.forename: Zineb
authors.initials: Z
authors.lastname: Sellam
authors.forename: Damien
authors.initials: D
authors.lastname: Pouessel
authors.forename: Linda
authors.initials: L
authors.lastname: Bouaita
authors.forename: Isabelle
authors.initials: I
authors.lastname: Baumgaertner
authors.forename: Iradj
authors.initials: I
authors.lastname: Sobhani
authors.forename: Claude
authors.initials: C
authors.lastname: Tayar
authors.forename: Muriel
authors.initials: M
authors.lastname: Paul
authors.forename: Stéphane
authors.initials: S
authors.lastname: Culine
mesh_terms: D000230:Adenocarcinoma / Q000188:drug therapy* / Q000556:secondary / Q000601:surgery; D000368:Aged; D000369:Aged, 80 and over; D000964:Antimetabolites, Antineoplastic / Q000627:therapeutic use; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D002166:Camptothecin / Q000008:administration & dosage / Q000031:analogs & derivatives; D017024:Chemotherapy, Adjuvant; D003841:Deoxycytidine / Q000031:analogs & derivatives / Q000627:therapeutic use; D018450:Disease Progression; D004334:Drug Administration Schedule; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage; D006801:Humans; D000077146:Irinotecan; D002955:Leucovorin / Q000008:administration & dosage; D008297:Male; D008499:Medical Records; D008875:Middle Aged; D009367:Neoplasm Staging; D009944:Organoplatinum Compounds / Q000008:administration & dosage; D000077150:Oxaliplatin; D010190:Pancreatic Neoplasms / Q000188:drug therapy* / Q000473:pathology / Q000601:surgery; D012189:Retrospective Studies; D017211:Treatment Failure; D016896:Treatment Outcome; D000093542:Gemcitabine
chemical_list: D000964:Antimetabolites, Antineoplastic; D009944:Organoplatinum Compounds; D000077150:Oxaliplatin; D003841:Deoxycytidine; D000077146:Irinotecan; D002955:Leucovorin; D005472:Fluorouracil; D002166:Camptothecin; D000093542:Gemcitabine