Efficacy and safety of bevacizumab-based combination regimens in patients with previously untreated metastatic colorectal cancer: Final results from a randomised phase ii study of bevacizumab plus 5-fluorouracil,leucovorin plus irinotecan versus bevacizumab plus capecitabine plus irinotecan (FNCLCC ACCORD 13/0503 study) |
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| Authors: | M Ducreux A Adenis J-P Pignon E François B Chauffert JL Ichanté E Boucher M Ychou J-Y Pierga C Montoto-Grillot T Conroy |
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| Institution: | 1. Department of Medicine, Institut Gustave Roussy, Villejuif, Université Paris-Sud, Le Kremlin Bicêtre, France;2. Centre Oscar Lambret, Lille, France;3. Department of Biostatistics and Epidemiology, Institut Gustave Roussy, Villejuif, France;4. Centre Antoine Lacassagne, Nice, France;5. Centre Georges-François Leclerc, Dijon, France;6. Centre Eugène Marquis, Rennes, France;7. Centre Val d’Aurelle, Montpellier, France;8. Institut Curie, Paris, France;9. Unicancer, Paris, France;10. Centre Alexis Vautrin, Nancy, France, France |
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| Abstract: | BackgroundThe combination of bevacizumab and bolus 5-fluorouracil, leucovorin and irinotecan is highly effective in patients with metastatic colorectal cancer (mCRC). This randomised, multicenter, non-comparative phase II trial assessed the efficacy and safety of bevacizumab plus oral capecitabine plus irinotecan (XELIRI) or infusional 5-fluorouracil, leucovorin plus irinotecan (FOLFIRI) as first-line therapy for patients with mCRC.Patients and MethodsPatients received bevacizumab 7.5 mg/kg on day 1 plus XELIRI (irinotecan 200 mg/m2 on day 1 and oral capecitabine 1000 mg/m2 bid on days 1–14) every 3 weeks or bevacizumab 5 mg/kg on day 1 plus FOLFIRI (5-fluorouracil 400 mg/m2 on day 1 plus 2400 mg/m2 as a 46-h infusion, leucovorin 400 mg/m2 on day 1, and irinotecan 180 mg/m2 on day 1) every 2 weeks. Patients aged ?65 years received a lower dose of capecitabine (800 mg/m2 twice daily). The primary endpoint was 6-month progression-free survival (PFS) rate.ResultsA total of 145 patients were enrolled (bevacizumab–XELIRI, n = 72; bevacizumab–FOLFIRI, n = 73). The 6-month PFS rate was 82% (95% confidence intervals (CI) 71–90%) in the bevacizumab–XELIRI arm and 85% (95% CI 75–92%) in the bevacizumab–FOLFIRI arm. In both the bevacizumab–XELIRI and bevacizumab–FOLFIRI arms, median PFS and overall survival (OS) were 9 and 23 months, respectively. The most frequent toxicities were grade 3/4 neutropenia (bevacizumab–XELIRI 18%; bevacizumab–FOLFIRI 26%) and grade 3 diarrhoea (12% and 5%, respectively).ConclusionsThis randomised non-comparative study demonstrates that bevacizumab–XELIRI and bevacizumab–FOLFIRI are effective regimens for the first-line treatment of patients with mCRC with manageable toxicity profiles. |
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