title: Multicentre phase II study of leucovorin plus pharmacokinetic modulating chemotherapy for metastatic colorectal cancer.
abstract: The optimal administration of 5-fluorouracil (5-FU)/leucovorin (LV) for colorectal cancer (CRC) has yet to be fully defined although evidence of the combination has already been established. In a multicentre phase II study, pharmacokinetic modulating chemotherapy (PMC), which is based on the concept that continuous intravenous 5-FU infusion can be enhanced by low-dose oral uracil/tegafur, was combined with LV and administered. Thirty-seven patients were enrolled. The objective response rate was 31.4% and the tumour stabilization rate was 85.7%. The most common toxic effects were neutropenia and hand-foot skin reactions although no life-threatening grade 3-4 toxicities were noted. Grade 3 toxicities such as neutropenia, nausea, diarrhoea and oesophagitis occurred in one patient each. We identified the usefulness of a new type of infusional 5-FU combined with LV for the treatment of CRC. The combination of PMC and LV is active with an acceptable rate of toxicity as a first-line treatment of advanced CRC.
authors.affiliation: Department of Gastrointestinal and Paediatric Surgery, Division of Reparative Medicine, Institute of Life Sciences, Mie University Graduate School of Medicine, Mie 514-8507, Japan.
authors.forename: Yasuhiro
authors.initials: Y
authors.lastname: Inoue
authors.forename: Koji
authors.initials: K
authors.lastname: Tanaka
authors.forename: Junichiro
authors.initials: J
authors.lastname: Hiro
authors.forename: Yuji
authors.initials: Y
authors.lastname: Toiyama
authors.forename: Chikao
authors.initials: C
authors.lastname: Miki
authors.forename: Masato
authors.initials: M
authors.lastname: Kusunoki