Docetaxel combined with irinotecan or 5-fluorouracil in patients with advanced oesophago-gastric cancer: a randomised phase II study
| Autor: | Joseph Kerger, F. Lofts, Halfdan Sorbye, Patrick Schöffski, O. Rixe, D K Hossfeld, J Aparicio, Robert E. Hawkins, A Schalhorn, J.-L. Misset, David Cunningham, J Cassinello, Lionel D'Hondt, M Mousseau, Marianne Nicolson, J-L Canon, C Garcia Giron, E Fonseca, Amitesh Roy, R Rodriguez, C Castanon, J-R Barcelo, Antoine Adenis, Gail K. Adler, Guillermo Lopez-Vivanco |
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| Rok vydání: | 2012 |
| Předmět: |
Adult
Male Oncology Cancer Research medicine.medical_specialty Esophageal Neoplasms Phases of clinical research Docetaxel Irinotecan oesophago-gastric cancer Capecitabine Stomach Neoplasms Internal medicine Antineoplastic Combined Chemotherapy Protocols medicine Humans 5-fluorouracil Aged business.industry Cancer Combination chemotherapy Middle Aged medicine.disease Regimen Fluorouracil Clinical Study Disease Progression Camptothecin Female Taxoids business medicine.drug |
| Zdroj: | British Journal of Cancer |
| ISSN: | 1532-1827 0007-0920 |
| Popis: | 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). 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. |
| Databáze: | OpenAIRE |
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