title: Docetaxel combined with irinotecan or 5-fluorouracil in patients with advanced oesophago-gastric cancer: a randomised phase II study.
abstract: BACKGROUND
  Docetaxel and irinotecan chemotherapy have shown good efficacy in the treatment of advanced oesophago-gastric cancer. This randomised phase II study evaluated the efficacy and toxicity profile of two non-platinum docetaxel-based doublet regimens in advanced oesophago-gastric cancer.
  
  
  METHODS
  Chemotherapy-naïve patients with advanced oesophago-gastric cancer were randomised to receive either 3-weekly DI (docetaxel 60 mg m(-2) plus irinotecan 250 mg m(-2) (Day 1)) or 3-weekly DF (docetaxel 85 mg m(-2) (Day 1) followed by 5-fluorouracil 750 mg m(-2) per day as a continuous infusion (Days 1-5)).
  
  
  RESULTS
  A total of 85 patients received DI (n=42) or DF (n=43). The primary endpoint was overall response rate (ORR). The ORR and time to progression (TTP) in the evaluable population (n=65) were 37.5% (DI) vs 33.3% (DF), and 4.2 months vs 4.4 months, respectively. In the intent-to-treat population, the observed ORR, TTP and median overall survival were similar between the two groups. Grade 3-4 neutropenia, febrile neutropenia and diarrhoea were more frequent in the DI arm as compared with the DF arm (83.3% vs 69.8%, 40.5% vs 18.6%, and 42.9% vs 16.3%, respectively).
  
  
  CONCLUSIONS
  Both docetaxel-based doublet regimens show comparable efficacy; however, the DF regimen was associated with a better toxicity profile and is an alternative treatment option for patients in whom platinum-based regimens are unsuitable.
authors: Department of Medicine, Royal Marsden Hospital, Sutton, London, SM25PT, UK.
authors: A
authors: A
authors: Roy
authors: D
authors: D
authors: Cunningham
authors: R
authors: R
authors: Hawkins
authors: H
authors: H
authors: Sörbye
authors: A
authors: A
authors: Adenis
authors: J-R
authors: JR
authors: Barcelo
authors: G
authors: G
authors: Lopez-Vivanco
authors: G
authors: G
authors: Adler
authors: J-L
authors: JL
authors: Canon
authors: F
authors: F
authors: Lofts
authors: C
authors: C
authors: Castanon
authors: E
authors: E
authors: Fonseca
authors: O
authors: O
authors: Rixe
authors: J
authors: J
authors: Aparicio
authors: J
authors: J
authors: Cassinello
authors: M
authors: M
authors: Nicolson
authors: M
authors: M
authors: Mousseau
authors: A
authors: A
authors: Schalhorn
authors: L
authors: L
authors: D'Hondt
authors: J
authors: J
authors: Kerger
authors: D K
authors: DK
authors: Hossfeld
authors: C
authors: C
authors: Garcia Giron
authors: R
authors: R
authors: Rodriguez
authors: P
authors: P
authors: Schoffski
authors: J-L
authors: JL
authors: Misset
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D002166:Camptothecin / Q000008:administration & dosage / Q000031:analogs & derivatives; D018450:Disease Progression; D000077143:Docetaxel; D004938:Esophageal Neoplasms / Q000188:drug therapy*; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage; D006801:Humans; D000077146:Irinotecan; D008297:Male; D008875:Middle Aged; D013274:Stomach Neoplasms / Q000188:drug therapy*; D043823:Taxoids / Q000008:administration & dosage
chemical_list: D043823:Taxoids; D000077143:Docetaxel; D000077146:Irinotecan; D005472:Fluorouracil; D002166:Camptothecin