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Annals of Oncology 12:321-325, 2001
© 2001 European Society for Medical Oncology

research-article

Phase II study of weekly 24-hour intra-arterial high-dose infusion of 5-fluorouracil and folinic acid for liver metastases from colorectal carcinomas

M. Lorenz1,, H. H. Mueller2, E. Mattes3, H. J. Gassel4, T. Junginger5, H. D. Saeger6, H. Schramm7, E. Staib-Sebler1, G. Vetter1, S. Heinrich1, C. H. Köhne8 and German Cooperative Group on Liver Metastases (Arbeitsgruppe Lebermetastasen und -tumoren (ALM) in der Chirurgischen Arbeitsgemeinschaft Onkologie)

1Department of General and Vascular Surgery, Johann Wolfgang Goethe- University Frankfurt
2Institute of Medical Biometry and Epidemiology, Philipps-University Marburg
3Department of Surgery, General Hospital Esslingen
4Department of General Surgery, Luitpold-Hospital, University Würzburg
5Department of General Surgery, Johannes Gutenberg-University Mainz
6Department of General Surgery, Carl Gustav Carus-University Dresden
7Department of General Surgery, General Hospital Gera
8Department of Hemato-Oncology, University Hospital Rostock, Germany

Prof. Dr M. Lorenz, Department of General and Vascular Surgery, Johann Wolfgang Goethe-University, Theodor-Stern-Kai 7, 60590 Frankfurt am Main, Germany, E-mail: M.Lorenz{at}em.uni-frankfurt.de

Background: A multicenter phase II trial was initiated in order to evaluate the weekly, high-dose 24-hour infusion of 5-fluorouracil (5-FU) plus folinic acid (FA) in patients with unresectable colorectal cancer hepatic metastases.

Patients and methods: A weekly hepatic arterial infusion (HAI) of FA 500 mg/m2followed by a 24-hour infusion of 5-FU 2,600 mg/m2(later reduced to 2,200 mg/m2) was given via a surgically implanted intra-arterial port system. One treatment cycle consisted of six weekly applications followed by a two-week rest period. Toxicity was assessed according to the WHO criteria. Chemotherapy was continued until disease progression or complete response occured.

Results: A total of 50 patients (40 chemonaive, 10 pretreated) entered this trial. An objective tumor response occurred in 28 patients (56%), while 13 patients (26%) had stable disease. The median progression free survival was 12 months, and the median survival 22.3 months. Due to a high rate of gastrointestinal side-effects in the initial phase of the trial, the dosage of 5-FU was reduced to 2, 200 mg/m2 for all subsequent patients. Diarrhea and nausea led to a dose reduction in 40% of applications and 24% of patients, respectively. One patient died of cardiac insufficiency unrelated to chemotherapy before response evaluation.

Conclusions: This HAI approach using high-dose 5-FU was relatively well tolerated when 2,200 mg/m2instead of 2,600 mg/m2was used. The activity of this regimen is promising and warrants further evaluation and modification.

24-hour high-dose 5-FU/FA, colorectal hepatic metastases, hepatic artery infusion, HAI, phase II study


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