Phase III Study of Weekly High-Dose Infusional Fluorouracil Plus Folinic Acid With or Without Irinotecan in Patients With Metastatic Colorectal Cancer: European Organisation for Research and Treatment of Cancer Gastrointestinal Group Study 40986
| Autor: | M.P. Lutz, E. van Cutsem, T. Langenbuch, H.-G. Mergenthaler, B. Genicot, U. Vanhoefer, R. Fuchs, Ö. Anak, P. Reichardt, P. Rougier, C.-H. Köhne, M. El-Serafi, B. Nordlinger, M. Lorenz, Jacques Wils, N. Frickhofen, C. Bokemeyer, H. Rückle-Lanz, L. Müller, R. Voigtmann |
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| Rok vydání: | 2005 |
| Předmět: |
Cancer Research
medicine.medical_specialty business.industry medicine.drug_class Colorectal cancer Cancer medicine.disease Antimetabolite Gastroenterology Surgery Irinotecan Folinic acid Oncology Fluorouracil Internal medicine medicine Gastrointestinal cancer business Survival analysis medicine.drug |
| Zdroj: | Journal of Clinical Oncology. 23:4856-4865 |
| ISSN: | 1527-7755 0732-183X |
| Popis: | Purpose To demonstrate that adding irinotecan to a standard weekly schedule of high-dose, infusional fluorouracil (FU) and leucovorin (folinic acid [FA]) can prolong progression-free survival (PFS). Patients and Methods Four hundred thirty patients with measurable or assessable metastatic colorectal cancer were randomly assigned to receive either FA 500 mg/m2 as a 2-hour infusion and FU 2.6 g/m2 by intravenous 24-hour infusion, both administered weekly for 6 weeks, followed by a 2-week rest (Arbeitsgemeinschaft für Internistische Onkologie [AIO] arm, n = 216), or a similar schedule but with FU 2.3 or 2.0 g/m2 preceded by irinotecan 80 mg/m2 administered over 30 minutes (experimental group, n = 214). Results The median PFS time in the experimental group was 8.5 months (95% CI, 7.6 to 9.9 months) compared with 6.4 months (95% CI, 5.3 to 7.2 months) in the AIO arm (P < .0001). The median overall survival time was increased from 16.9 to 20.1 months (P = .2779). The objective response rate was 62.2% (95% CI, 55.0% to 69.5%) in the experimental group and 34.4% (95% CI, 27.5% to 41.3%) in the AIO arm (P < .0001). Conclusion The addition of irinotecan to the standard AIO FU/FA regimen was associated with a highly significant improvement in PFS and response rate and was well tolerated. The results of this study confirm that irinotecan in combination with high-dose infusional FU/FA is a reference first-line treatment. |
| Databáze: | OpenAIRE |
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