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Clinical Study

Neoadjuvant Treatment with Weekly High-Dose 5-Fluorouracil as 24-Hour Infusion, Folinic Acid and Oxaliplatin in Patients with Primary Resectable Liver Metastases of Colorectal Cancer

Wein A.a · Riedel C.a · Brückl W.a · Merkel S.b · Ott R.b · Hanke B.a · Baum U.c · Fuchs F.a · Günther K.b · Reck T.b · Papadopoulos T.d · Hahn E.G.a · Hohenberger W.b

Author affiliations

Departments of aInternal Medicine I, bSurgery, cRadiology and dPathology, Friedrich Alexander University of Erlangen-Nuremberg, Erlangen, Germany

Related Articles for ""

Oncology 2003;64:131–138

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Article / Publication Details

First-Page Preview
Abstract of Clinical Study

Published online: February 03, 2003
Issue release date: January 2003

Number of Print Pages: 8
Number of Figures: 3
Number of Tables: 4

ISSN: 0030-2414 (Print)
eISSN: 1423-0232 (Online)

For additional information: http://www.karger.com/OCL

Abstract

Purpose: To evaluate the efficacy and safety of neoadjuvant treatment comprising weekly high-dose 5-fluorouracil (5-FU) as a 24-hour infusion, folinic acid (FA) and biweekly oxaliplatin (L-OHP), followed by metastatic resection in patients with primarily resectable liver metastases of colorectal cancer (CRC). Patients and Methods: 20 patients with primarily resectable liver metastases of CRC were enrolled in a prospective phase II study. On an outpatient basis, the patients received a treatment regimen comprising biweekly 85 mg/m2 L-OHP in the form of a 2-hour intravenous infusion and 500 mg/m2 FA as a 1- to 2-hour intravenous infusion, followed by 2,600 mg/m2 5-FU administered as a 24-hour intravenous infusion once weekly. A single treatment cycle comprised one infusion per week during a period of 6 weeks followed by a 2-week rest. Two cycles were administered, with a third being added when the treatment was well tolerated. Thereafter, curative resection of the liver metastases was attempted, and the patients were followed up. Results: After neoadjuvant therapy, 2 of the original 20 patients showed complete remission (CR; 10%) and 18 patients partial remission (PR; 90%). As the main symptom of toxicity, diarrhea (CTC toxicity grade 3–4) was observed in 6 patients (30%), followed by vomiting in 3 patients (15%). The curative resectability rate was 80% (16 of 20). In 9 of 18 patients (50%) undergoing surgical intervention, mild postoperative complications, mainly wound healing disturbances (n = 5), occurred. No postoperative mortality was observed. Over a median follow-up of 23 months (12–38) 6 of 16 curatively resected patients developed distant metastases and 1 patient a local pelvic recurrence. The 2-year disease-free survival rate was 52% and the 2-year cancer-related survival rate 80%. Conclusion: The neoadjuvant treatment with weekly high-dose 5-FU in the form of a 24-hour infusion combined with FA and L-OHP is very effective and well tolerated. Surgical morbidity does not appear to be increased by the neoadjuvant treatment.

© 2003 S. Karger AG, Basel


Article / Publication Details

First-Page Preview
Abstract of Clinical Study

Published online: February 03, 2003
Issue release date: January 2003

Number of Print Pages: 8
Number of Figures: 3
Number of Tables: 4

ISSN: 0030-2414 (Print)
eISSN: 1423-0232 (Online)

For additional information: http://www.karger.com/OCL


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Drug Dosage: The authors and the publisher have exerted every effort to ensure that drug selection and dosage set forth in this text are in accord with current recommendations and practice at the time of publication. However, in view of ongoing research, changes in government regulations, and the constant flow of information relating to drug therapy and drug reactions, the reader is urged to check the package insert for each drug for any changes in indications and dosage and for added warnings and precautions. This is particularly important when the recommended agent is a new and/or infrequently employed drug.
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