title: Phase II study of first-line FOLFIRI for progressive metastatic well-differentiated pancreatic endocrine carcinoma.
abstract: BACKGROUND
  Pancreatic endocrine carcinomas are rare and heterogeneous. Published results concerning treatment of advanced tumours are inconsistent and responses to standard chemotherapy remain unsatisfactory.
  
  
  OBJECTIVE
  To investigate the ability of the FOLFIRI regimen to manage progressive unresectable metastatic well-differentiated endocrine carcinomas of the pancreas as first-line chemotherapy.
  
  
  METHODS
  20 patients with metastatic or advanced well-differentiated endocrine carcinomas of the pancreas and progressive disease were enrolled in a prospective multicentre phase II trial to receive chemotherapy with FOLFIRI schedule (irinotecan 180mg/m(2) infusion combined with simplified LV5FU2) every 14 days. The primary end point was the non-progression rate at 6 months.
  
  
  RESULTS
  The 6-month non-progression rate was 80% (95% confidence interval [56-94%]), with stabilisation in 15 patients and 1 objective response. Overall survival at 24 months was 65% [40-82%]. Median progression-free survival was 9.1 months [6.5-17.3 months]. The median number of administered cycles was 12 [range 1-28]. Grade 3/4 haematologic toxicity occurred in 5 patients (25%) and grade 3 digestive toxicity in 11.
  
  
  CONCLUSIONS
  The FOLFIRI regimen, as first-line chemotherapy, achieved stabilisation in most patients whose tumours had been progressing and was well-tolerated. It could be an alternative therapy for advanced well-differentiated endocrine carcinomas of the pancreas.
authors.affiliation: Service d'Hépato-Gastroentérologie et d'Oncologie Digestive, CHU de Reims, Hôpital Robert-Debré, Reims F-51092 Cedex, France.
authors.forename: Hedia
authors.initials: H
authors.lastname: Brixi-Benmansour
authors.forename: Jean-Louis
authors.initials: JL
authors.lastname: Jouve
authors.forename: Emmanuel
authors.initials: E
authors.lastname: Mitry
authors.forename: Franck
authors.initials: F
authors.lastname: Bonnetain
authors.forename: Bruno
authors.initials: B
authors.lastname: Landi
authors.forename: Olivia
authors.initials: O
authors.lastname: Hentic
authors.forename: Laurent
authors.initials: L
authors.lastname: Bedenne
authors.forename: Guillaume
authors.initials: G
authors.lastname: Cadiot
mesh_terms: D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D002166:Camptothecin / Q000008:administration & dosage / Q000031:analogs & derivatives; D002277:Carcinoma / Q000188:drug therapy* / Q000556:secondary*; D018572:Disease-Free Survival; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage; D005767:Gastrointestinal Diseases / Q000209:etiology; D006402:Hematologic Diseases / Q000209:etiology; D006801:Humans; D053208:Kaplan-Meier Estimate; D002955:Leucovorin / Q000008:administration & dosage; D008297:Male; D008875:Middle Aged; D009362:Neoplasm Metastasis; D018358:Neuroendocrine Tumors / Q000188:drug therapy* / Q000556:secondary*; D010190:Pancreatic Neoplasms / Q000188:drug therapy* / Q000473:pathology*; D016896:Treatment Outcome
chemical_list: D002955:Leucovorin; D005472:Fluorouracil; D002166:Camptothecin