Back to Search
Start Over
Bevacizumab in combination with fluorouracil and leucovorin: an active regimen for first-line metastatic colorectal cancer.
- Source :
-
Journal of clinical oncology : official journal of the American Society of Clinical Oncology [J Clin Oncol] 2005 May 20; Vol. 23 (15), pp. 3502-8. - Publication Year :
- 2005
-
Abstract
- Purpose: In a phase III trial, combining bevacizumab (BV)--a recombinant, humanized, monoclonal antibody targeting vascular endothelial growth factor--with irinotecan, bolus fluorouracil (FU), and leucovorin (LV; IFL) increased survival compared with IFL alone in first-line treatment of patients with metastatic colorectal cancer (CRC). Results for the parent study of IFL/BV versus IFL/placebo are reported elsewhere. Here, we describe efficacy and safety results for the third patient cohort in this trial, who received BV combined with FU/LV, and compare them with results for concurrently enrolled patients who received IFL.<br />Methods: Patients (N = 923) were randomly assigned to receive IFL/placebo (control), IFL/BV, or FU/LV/BV. Bevacizumab (Avastin; Genentech Inc, South San Francisco, CA) 5 mg/kg was administered intravenously every 2 weeks. Before an interim analysis confirmed acceptable safety for IFL/BV, 313 patients were concurrently randomly assigned to these three arms; after this analysis, the FU/LV/BV arm was discontinued.<br />Results: Median overall survivals were 18.3 and 15.1 months with FU/LV/BV (n = 110) and IFL/placebo (n = 100), respectively. Median progression-free survivals were 8.8 and 6.8 months, respectively. Overall response rates were 40.0% and 37.0%, and median response durations were 8.5 and 7.2 months, respectively. Adverse events consistent with those expected from FU/leucovorin- or IFL-based regimens were seen, as were modest increases in hypertension and bleeding in the bevacizumab arm, which were generally easily managed.<br />Conclusion: The FU/LV/BV regimen seems as effective as IFL and has an acceptable safety profile. FU/LV/BV is an active alternative treatment regimen for patients with previously untreated metastatic CRC.
- Subjects :
- Adult
Aged
Antibodies, Monoclonal administration & dosage
Antibodies, Monoclonal adverse effects
Antibodies, Monoclonal, Humanized
Antineoplastic Combined Chemotherapy Protocols adverse effects
Bevacizumab
Colorectal Neoplasms mortality
Dose-Response Relationship, Drug
Drug Administration Schedule
Female
Fluorouracil administration & dosage
Fluorouracil adverse effects
Humans
Leucovorin administration & dosage
Leucovorin adverse effects
Male
Maximum Tolerated Dose
Middle Aged
Neoplasm Metastasis
Neoplasm Staging
Probability
Prognosis
Risk Assessment
Survival Analysis
Treatment Outcome
Antineoplastic Combined Chemotherapy Protocols administration & dosage
Colorectal Neoplasms drug therapy
Colorectal Neoplasms pathology
Neoplasm Invasiveness pathology
Subjects
Details
- Language :
- English
- ISSN :
- 0732-183X
- Volume :
- 23
- Issue :
- 15
- Database :
- MEDLINE
- Journal :
- Journal of clinical oncology : official journal of the American Society of Clinical Oncology
- Publication Type :
- Academic Journal
- Accession number :
- 15908660
- Full Text :
- https://doi.org/10.1200/JCO.2005.10.017