title: [Locally advanced unresectable pancreatic cancer: Induction chemoradiotherapy followed by maintenance gemcitabine versus gemcitabine alone: Definitive results of the 2000-2001 FFCD/SFRO phase III trial].
abstract: OBJECTIVE
  To compare chemoradiation with systemic chemotherapy to chemotherapy alone in locally advanced pancreatic cancer.
  
  
  METHODS
  One hundred and nineteen patients with locally advanced pancreatic cancer, with World Health Organization performance status of zero to two were randomly assigned to either the induction chemoradiation group (60 Gy, 2 Gy/fraction; concomitant 5-fluoro-uracil infusion, 300 mg/m(2) per day, days 1-5 for 6 weeks; cisplatin, 20 mg/m(2) per day, days 1-5 during weeks 1 and 5) or the induction gemcitabine group (GEM: 1000 mg/m(2) weekly for 7 weeks). Maintenance gemcitabine (1000 mg/m(2) weekly, 3/4 weeks) was given in both arms until disease progression or toxicity.
  
  
  RESULTS
  Overall survival was shorter in the chemoradiation than in the gemcitabine arm (median survival 8.6 [99% confidence interval 7.1-11.4] and 13 months [8,9,9-18], p=0.03). One-year survival was, respectively, 32 and 53%. These results were confirmed in a per-protocol analysis for patients who received 75% or more of the planned dose of radiotherapy. More overall grades 3-4 toxic effects were recorded in the chemoradiation arm, both during induction (36 versus 22%) and maintenance (32 versus 18%).
  
  
  CONCLUSIONS
  This intensive induction schedule of chemoradiation was more toxic and less effective than gemcitabine alone.
authors.affiliation: EA, département de radiothérapie-oncologie, centre hospitalier Lyon-Sud, Pierre-Bénite, France. barhoumi.maha@yahoo.fr
authors.forename: M
authors.initials: M
authors.lastname: Barhoumi
authors.forename: F
authors.initials: F
authors.lastname: Mornex
authors.forename: F
authors.initials: F
authors.lastname: Bonnetain
authors.forename: P
authors.initials: P
authors.lastname: Rougier
authors.forename: C
authors.initials: C
authors.lastname: Mariette
authors.forename: O
authors.initials: O
authors.lastname: Bouché
authors.forename: J-F
authors.initials: JF
authors.lastname: Bosset
authors.forename: T
authors.initials: T
authors.lastname: Aparicio
authors.forename: L
authors.initials: L
authors.lastname: Mineur
authors.forename: A
authors.initials: A
authors.lastname: Azzedine
authors.forename: P
authors.initials: P
authors.lastname: Hammel
authors.forename: J
authors.initials: J
authors.lastname: Butel
authors.forename: N
authors.initials: N
authors.lastname: Stremsdoerfer
authors.forename: P
authors.initials: P
authors.lastname: Maingon
authors.forename: L
authors.initials: L
authors.lastname: Bedenne
authors.forename: B
authors.initials: B
authors.lastname: Chauffert
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000964:Antimetabolites, Antineoplastic / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D021441:Carcinoma, Pancreatic Ductal / Q000188:drug therapy* / Q000532:radiotherapy; D002945:Cisplatin / Q000008:administration & dosage; D003131:Combined Modality Therapy / Q000009:adverse effects; D003841:Deoxycytidine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D018450:Disease Progression; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage; D005767:Gastrointestinal Diseases / Q000139:chemically induced; D006402:Hematologic Diseases / Q000139:chemically induced; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D010190:Pancreatic Neoplasms / Q000188:drug therapy* / Q000532:radiotherapy; D016016:Proportional Hazards Models; D020266:Radiotherapy, Conformal / Q000009:adverse effects; D012074:Remission Induction; D000093542:Gemcitabine
chemical_list: D000964:Antimetabolites, Antineoplastic; D003841:Deoxycytidine; D002945:Cisplatin; D005472:Fluorouracil; D000093542:Gemcitabine