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A randomised phase II study of OSI-7904L versus 5-fluorouracil (FU)/leucovorin (LV) as first-line treatment in patients with advanced biliary cancers

Ciuleanu, T
Diculescu, M
Hoepffner, N M
Trojan, J
Sailer, V
Zalupski, M
Herrmann, T
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Published in Investigational New Drugs. 2007, vol. 25, no. 4, p. 385-90
Abstract The prognosis of advanced biliary tract carcinoma is poor with chemotherapy limited to a palliative role. This randomised study was designed to evaluate the effectiveness of a new liposomal thymidylate synthase inhibitor (TSI), OSI-7904L, in parallel with a modified de Gramont regimen of 5-FU/LV in patients with advanced biliary cancer. Patients with previously untreated advanced or metastatic carcinoma of the biliary tract were randomised to receive either OSI-7904L 12 mg/m2 intravenously every 21 days or a modified de Gramont schedule of 5-FU/LV (intravenous l-LV 200 mg/m2, bolus 5-FU 400 mg/m2 and a 46-h infusion of 5-FU 2,400 mg/m2) every 14 days. Twenty-two patients were randomised, 11 to each group. No patients responded in the OSI-7904L arm, while one patient achieved a partial response in the 5-FU/LV arm. The rates of disease stabilisation were 4/11 (OSI-7904L) and 10/11 (5-FU/LV). Both treatment arms were generally well tolerated. These results show that the activity of OSI-7904L is below a level of clinical relevance in advanced biliary tract cancer, providing only a small degree of disease stabilisation. A simplified de Gramont schedule appears to have marginally more activity. Both treatments were well tolerated.
Keywords Adenocarcinoma/drug therapy/secondaryAntineoplastic Agents/therapeutic useAntineoplastic Combined Chemotherapy Protocols/therapeutic useBiliary Tract Neoplasms/drug therapy/pathologyFemaleFluorouracil/administration & dosageGlutarates/therapeutic useHumansIsoindolesLeucovorin/administration & dosageMaleMiddle AgedQuinazolines/therapeutic useSurvival AnalysisThymidylate Synthase/antagonists & inhibitorsTreatment Outcome
PMID: 17364234
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Research group Groupe Roth Arnaud (oncologie) (285)
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CIULEANU, T et al. A randomised phase II study of OSI-7904L versus 5-fluorouracil (FU)/leucovorin (LV) as first-line treatment in patients with advanced biliary cancers. In: Investigational New Drugs, 2007, vol. 25, n° 4, p. 385-90. doi: 10.1007/s10637-007-9040-0 https://archive-ouverte.unige.ch/unige:34789

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