title: Docetaxel- and 5-FU-concurrent radiotherapy in patients presenting unresectable locally advanced pancreatic cancer: a FNCLCC-ACCORD/0201 randomized phase II trial's pre-planned analysis and case report of a 5.5-year disease-free survival.
abstract: BACKGROUND
  To explore possible improvement in the treatment of locally advanced pancreatic carcinoma (LAPC) we performed a randomized, non-comparative phase II study evaluating docetaxel - plus either daily continuous 5 FU or weekly cisplatin concurrent to radiotherapy. We report here the results of the docetaxel plus 5 FU regimen stopped according to the interim analysis. The docetaxel plus cisplatin arm was continued.
  
  
  METHODS
  Forty (40) chemotherapy-naive patients with unresectable LAPC were randomly assigned (1:1) to either continuous fluorouracil (5-FU) 200 mg/m(2)/day (protracted IV) and docetaxel (DCT) 20 mg/m(2)/week or DCT 20 mg/m2 and cisplatin (CDDP) 20 mg/m(2), plus concurrent radiotherapy for a period of 6 weeks. The radiation dose to the primary tumor was 54 Gy in 30 fractions. The trial's primary endpoint was the 6-month crude non-progression rate (NPR). Secondary endpoints were tolerance, objective response rate, and overall survival. Accrual was to be stopped if at 6 months more than 13 disease progressions were observed in 20 patients.
  
  
  RESULTS
  Eighteen (18) progressions occurred at 6 months in the 5-FU-DCT arm. Six-month NPR was 10% (95%CI: 0-23). Six and 12-month survivals were 85% (95%CI: 64-95) and 40% (95%CI: 22-61); median overall survival was 10.1 months. Median progression-free survival was 4.3 months. We report the case of one patient who was amenable to surgery and has been in complete response (CR) for 5.5 years. Toxicities grade ≥ 3 were reported in 75% of patients; no treatment-related death occurred. Severe toxicities were mainly vomiting (35%), abdominal pain (10%) and fatigue (10%).
  
  
  CONCLUSIONS
  Combination of 5-FU, docetaxel and radiotherapy has inadequate efficacy in the treatment of LAPC despite good tolerance for the 5-FU-DCT regimen.
  
  
  BACKGROUND
  ClinicalTrials.gov: NCT00112697.
authors.affiliation: Institut Gustave Roussy, Villejuif, France.
authors.forename: Lucie
authors.initials: L
authors.lastname: Oberic
authors.forename: Frédéric
authors.initials: F
authors.lastname: Viret
authors.forename: Charlotte
authors.initials: C
authors.lastname: Baey
authors.forename: Marc
authors.initials: M
authors.lastname: Ychou
authors.forename: Jaafar
authors.initials: J
authors.lastname: Bennouna
authors.forename: Antoine
authors.initials: A
authors.lastname: Adenis
authors.forename: Didier
authors.initials: D
authors.lastname: Peiffert
authors.forename: Françoise
authors.initials: F
authors.lastname: Mornex
authors.forename: Jean-Pierre
authors.initials: JP
authors.lastname: Pignon
authors.forename: Patrice
authors.initials: P
authors.lastname: Celier
authors.forename: Jocelyne
authors.initials: J
authors.lastname: Berille
authors.forename: Michel
authors.initials: M
authors.lastname: Ducreux
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use; D002945:Cisplatin / Q000494:pharmacology; D003131:Combined Modality Therapy / Q000379:methods; D018450:Disease Progression; D018572:Disease-Free Survival; D000077143:Docetaxel; D005260:Female; D005472:Fluorouracil / Q000494:pharmacology*; D006801:Humans; D008297:Male; D008875:Middle Aged; D010190:Pancreatic Neoplasms / Q000188:drug therapy* / Q000532:radiotherapy*; D043823:Taxoids / Q000494:pharmacology*; D016896:Treatment Outcome
chemical_list: D043823:Taxoids; D000077143:Docetaxel; D002945:Cisplatin; D005472:Fluorouracil