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

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. © 2012 Cancer Research UK All rights reserved.