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Research ArticleClinical Studies

Palliative Second-line Treatment with Weekly High-dose 5-Fluorouracil as 24-hour Infusion and Folinic Acid (AIO) plus Oxaliplatin after Pre-treatment with the AIO-Regimen in Colorectal Cancer (CRC)

K. LINK, K. HAPPICH, I. SCHIRNER, B. JÜNGERT, V. BRÜCKL, G. MÄNNLEIN, M. BRÜCKL, S. MERKEL, J. GÖHL, W. HOHENBERGER, E.G. HAHN and A. WEIN
Anticancer Research January 2004, 24 (1) 385-392;
K. LINK
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K. HAPPICH
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I. SCHIRNER
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B. JÜNGERT
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V. BRÜCKL
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G. MÄNNLEIN
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M. BRÜCKL
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S. MERKEL
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J. GÖHL
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W. HOHENBERGER
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E.G. HAHN
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A. WEIN
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Abstract

Background and Aims: The aim of this work was to evaluate the efficacy and safety of second-line treatment with weekly high-dose 5-Fluorouracil (5-FU) as a 24-hour infusion (24-h inf.) and folinic acid (FA) (AIO-regimen) plus Oxaliplatin (L-OHP) after pre-treatment with the AIO regimen, focusing in particular on the efficacy of palliative first- and second-line treatment in colorectal carcinoma (CRC). Patients and Methods: Patients with non-resectable distant CRC metastases were enrolled in a prospective phase II study for palliative second-line treatment after previous palliative first-line treatment in accordance with the AIO regimen. 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 (i.v.) infusion and 500 mg/m2 FA as a 1 to 2-hour i.v. infusion, followed by 2,600 mg/m2 5-FU administered as a 24-h inf. i.v. once weekly. A single treatment cycle comprised 6 weekly infusions followed by 2 weeks of rest. Results: During second-line treatment, a total of 26 patients received 340 chemotherapy applications. As the main symptom of toxicity, diarrhoea (NCI-CTC toxicity grade 3+4) presented in 5 patients (19%; 95% CI: 4-34), followed by nausea (CTC grade 3) in one patient (4%; 95% CI: 0-11). Twenty-three patients were evaluable for treatment response. The remission data can be summarised as follows: Complete remission (CR): n=1 (4%; 95% CI: 0-13); partial remission (PR): n=3 (13%; 95% CI: 0-27); stable disease (SD): n=11 (48%; 95% CI: 27-68) and progressive disease (PD): n=8 (35%; 95% CI: 15-54). The median progression-free survival (PFS) rate (n=26) was 3.3 months (range 0-11.5), the median survival time counted from the start of second-line treatment (n=26) 11.6 months (range 2.1-33.0) and the median survival time counted from the start of first-line treatment (n=26) 19.9 months (range 7.7-49.8). Conclusion: Palliative second-line treatment according to the AIO regimen plus L-OHP is feasible in an outpatient setting and well tolerated by the patients. Tumour control (CR + PR + SD) was achieved in 65% of the patients, the median survival time being 11.6 months. The AIO regimen followed by the ‘AIO regimen plus L-OHP’ therapy sequence led to a promising median survival time of 19.9 months (range 7.7-49.8).

  • Received July 1, 2003.
  • Accepted December 9, 2003.
  • Copyright© 2004 International Institute of Anticancer Research (Dr. John G. Delinassios), All rights reserved
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Anticancer Research: 24 (1)
Anticancer Research
Vol. 24, Issue 1
January-February 2004
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Palliative Second-line Treatment with Weekly High-dose 5-Fluorouracil as 24-hour Infusion and Folinic Acid (AIO) plus Oxaliplatin after Pre-treatment with the AIO-Regimen in Colorectal Cancer (CRC)
K. LINK, K. HAPPICH, I. SCHIRNER, B. JÜNGERT, V. BRÜCKL, G. MÄNNLEIN, M. BRÜCKL, S. MERKEL, J. GÖHL, W. HOHENBERGER, E.G. HAHN, A. WEIN
Anticancer Research Jan 2004, 24 (1) 385-392;

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Palliative Second-line Treatment with Weekly High-dose 5-Fluorouracil as 24-hour Infusion and Folinic Acid (AIO) plus Oxaliplatin after Pre-treatment with the AIO-Regimen in Colorectal Cancer (CRC)
K. LINK, K. HAPPICH, I. SCHIRNER, B. JÜNGERT, V. BRÜCKL, G. MÄNNLEIN, M. BRÜCKL, S. MERKEL, J. GÖHL, W. HOHENBERGER, E.G. HAHN, A. WEIN
Anticancer Research Jan 2004, 24 (1) 385-392;
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