Docetaxel combined with irinotecan or 5-fluorouracil in patients with advanced oesophago-gastric cancer: A randomised phase II study

Amitesh Roy, David Cunningham, Robert Hawkins, Halfdan Sörbye, Antoine Adenis, Jose Barcelo, Guillermo Lopez-Vivanco, Guido Adler, Jean-Luc Canon, Fiona Lofts, Carmen Castanon, Emilio Fonseca, Olivier Rixe, Jorge Aparicio, Javier Cassinello, Marianne Nicolson, Mireille Mousseau, Andreas Schalhorn, Lionel D'Hondt, Joseph KergerDieter Hossfeld, Carlos Garcia Giron, R. Rodriguez, Patrick Schoffski, Jean-Louis Misset

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    16 Citations (Scopus)


    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-nave patients with advanced oesophago-gastric cancer were randomised to receive either 3-weekly DI (docetaxel 60 mg m2 plus irinotecan 250 mg m2 (Day 1)) or 3-weekly DF (docetaxel 85 mg m2 (Day 1) followed by 5-fluorouracil 750 mg m2 per day as a continuous infusion (Days 1-5)).Results:A total of 85 patients received DI (n42) or DF (n43). The primary endpoint was overall response rate (ORR). The ORR and time to progression (TTP) in the evaluable population (n65) 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).Conclusion: 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.

    Original languageEnglish
    Pages (from-to)435-441
    Number of pages7
    JournalBritish Journal of Cancer
    Issue number3
    Publication statusPublished - 24 Jul 2012


    • 5-fluorouracil
    • docetaxel
    • irinotecan
    • oesophago-gastric cancer


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