Abstract
A phase I study was undertaken in order to establish the maximum tolerated dose of intra-hepatic arterial 5-fluorouracil (5-FU) when given in combination with systemic folinic acid. Patients with colorectal liver metastases (n = 10) received escalating doses of 5-FU as a 24 h infusion with a fixed dose (400 mg m-2) of intravenous folinic acid once per week. Dose limiting toxicity (WHO grade greater than 2) was encountered at 2 g m-2 5-FU. Principal adverse effects were diarrhoea, vomiting and oral ulceration. The recommended dose for phase II studies is 1.5 g m-2 week-1 24 h 5-FU regional infusion with 400 mg m-2 week-1 intravenous folinic acid.
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Anderson, J., Kerr, D., Cooke, T. et al. A phase I study of regional 5-fluorouracil and systemic folinic acid for patients with colorectal liver metastases. Br J Cancer 65, 913–915 (1992). https://doi.org/10.1038/bjc.1992.191
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DOI: https://doi.org/10.1038/bjc.1992.191
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