Köhne, C. H., Schöffski, P., Wilke, H., Käufer, C., Andreesen, Reinhard, Ohl, U., Klaasen, U., Westerhausen, M., Hiddemann, W., Schott, G., Harstick, A., Bade, J., Horster, A., Schubert, U., Hecker, H., Dörken, B. and Schmoll, H. J.
(1998)
Effective biomodulation by leucovorin of high-dose infusion fluorouracil given as a weekly 24-hour infusion: results of a randomized trial in patients with advanced colorectal cancer.
Journal of clinical oncology : official journal of the American Society of Clinical Oncology 16 (2), pp. 418-26.
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at PubMed
Abstract
PURPOSE: To determine whether high-dose infusional fluorouracil (FU) is effectively modulated by leucovorin (LV), interferon (IFN) alpha-2b, or both when given to patients with metastatic colorectal cancer. PATIENTS AND METHODS: Patients (n = 236) with progressive, measurable disease were randomized to three groups and received FU 2,600 mg/m2 as a 24-hour continuous infusion (CI) weekly for 6 ...
Abstract
PURPOSE: To determine whether high-dose infusional fluorouracil (FU) is effectively modulated by leucovorin (LV), interferon (IFN) alpha-2b, or both when given to patients with metastatic colorectal cancer. PATIENTS AND METHODS: Patients (n = 236) with progressive, measurable disease were randomized to three groups and received FU 2,600 mg/m2 as a 24-hour continuous infusion (CI) weekly for 6 weeks with 2 weeks rest (FU24h) and LV 500 mg/m2 as a 2-hour infusion before FU or IFN 3 x 10(6) U subcutaneously 3 times weekly or both. Treatment continued until progressive disease or unacceptable toxicity was observed. Pairs of treatment arms were analyzed sequentially to detect equivalence or a 25% difference in response rates. RESULTS: The rate of objective remission in patients who received FU24h/LV (44%; 40 of 91) was significantly higher than in patients who received FU24h/IFN (18%; 16 of 90; P < .05). The response rates of patients who received FU24h/LV versus FU24h/LV/IFN (27%; 13 of 49) were statistically equivalent. Significant differences were observed for time to tumor progression (TTP) (FU24h/LV, 7.1 months; FU24h/IFN, 3.9 months; FU24h/LV/IFN, 6.3 months; global P value < .009) and survival (16.6 months, 12.7 months, 19.6 months, respectively; global P value < .04). Unpredictable and life-threatening toxicity in the FU24h/LV/IFN arm required dose reduction of FU to 2,000 mg/m2/day and early stoppage of this arm. Toxicity was manageable in patients who received both FU24h/LV (grade 3 to 4 diarrhea, 21%) and FU24h/IFN (grade 3 to 4 diarrhea, 15%). CONCLUSION: Response rate, TTP, and overall survival were superior for LV-containing regimens compared with IFN modulation alone. The addition of IFN to high-dose infusional FU plus LV offers no advantage and may increase toxicity. The regimen of high-dose infusional FU24h/LV warrants further evaluation in patients with metastatic colorectal cancer.
Export bibliographical data
| Item type: | Article |
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| Date: | 1998 |
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| Institutions: | Medicine > Lehrstuhl für Innere Medizin III (Hämatologie und Internistische Onkologie) |
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| Identification Number: | | Value | Type |
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| 10334556 | PubMed ID |
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| Classification: | | Notation | Type |
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| Adult | MESH | | Aged | MESH | | Antimetabolites, Antineoplastic/adverse effects | MESH | | Colorectal Neoplasms/pathology | MESH | | Disease Progression | MESH | | Drug Administration Schedule | MESH | | Female | MESH | | Fluorouracil/adverse effects | MESH | | Humans | MESH | | Immunologic Factors/administration & dosage | MESH | | Infusions, Intravenous | MESH | | Interferon Alfa-2b/administration & dosage | MESH | | Leucovorin/administration & dosage | MESH | | Male | MESH | | Middle Aged | MESH | | Prospective Studies | MESH | | Survival Rate | MESH |
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| Dewey Decimal Classification: | 600 Technology > 610 Medical sciences Medicine |
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| Status: | Published |
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| Refereed: | Yes, this version has been refereed |
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| Created at the University of Regensburg: | Yes |
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| Item ID: | 14324 |
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