Entry Detail
| General information | |
| Database: | DB00019 |
| Objective: | Colorectal cancer is the second leading cause of cancer mortality in the United States. Antiangiogenic therapy with bevacizumab combined with chemotherapy improves survival in previously untreated metastatic colorectal cancer. This study was conducted to determine the effect of bevacizumab (at 10 mg/kg) on survival duration for oxaliplatinbased chemotherapy in patients with previously treated metastatic colorectal cancer. |
| Authors: | Giantonio BJ, et al |
| Title: | Bevacizumab in combination with oxaliplatin, fluorouracil, and leucovorin (FOLFOX4) for previously treated metastatic colorectal cancer: results from the Eastern Cooperative Oncology Group Study E3200. |
| Journal: | J Clin Oncol. |
| Year: | 2007 |
| PMID: | 17442997 |
| Trial Design | |
| Clinical Trial Id: | NA |
| Agent: | bevacizumab |
| Target: | Vascular endothelial growth factor Epidermal growth factor receptor |
| Cancer Type: | colorectal cancer |
| Cancer Subtype: | advanced colorectal cancer |
| Therapy Type: | com |
| Therapeutic Combination Type: | 2 |
| Therapeutic Combination Content: | oxaliplatinbased chemotherapy+bevacizumab |
| Study Type: | a multiinstitutional, cooperative group, openlabel, randomizedphase III study |
| Key Patients Feature: | metastatic colorectal cancer patients previously treated with a fluoropyrimidine and irinotecan |
| Biomarker: | NA |
| Biomark Analysis: | NA |
| Control Group Info: | oxaliplatin, fluorouracil, and leucovorin (FOLFOX4) with bevacizumab vs. FOLFOX4 without bevacizumab vs. bevacizumab alone |
| Treatment Info: | patients were randomly assigned to one of three treatment groups: oxaliplatin, fluorouracil, and leucovorin (FOLFOX4) with bevacizumab; FOLFOX4 without bevacizumab; or bevacizumab alone. |
| Primary End Point: | overall survival, with additional determinations of progression free survival, response, and toxicity. |
| Secondary End Point: | NA |
| Patients Number: | 829 |
| Trial Results | |
| DLT_MTD: | NA |
| Objective Response Rate: | NA |
| Disease Control Rate: | NA |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | The median progression free survival for the group treated with FOLFOX4 in combination with bevacizumab was 7.3 months, compared with 4.7 months for the group treated with FOLFOX4 alone (corresponding hazard ratio for progression = 0.61; P < .0001), and 2.7 months for those treated with bevacizumab alone. |
| Median OS A vs. C: | The median duration of survival for the group treated with FOLFOX4 and bevacizumab was 12.9 months compared with 10.8 months for the group treated with FOLFOX4 alone (corresponding hazard ratio for death = 0.75; P = .0011), and 10.2 months for those treated with bevacizumab alone.The corresponding overall response rates were 22.7%, 8.6%, and 3.3%, respectively (P < .0001 for FOLFOX4 with bevacizumab v FOLFOX4 comparison). |
| Adverse Event(agent arm): | Bevacizumab was associated with hypertension, bleeding, and vomiting. |
| Conclusions: | The addition of bevacizumab to oxaliplatin, fluorouracil, and leucovorin improves survival duration for patients with previously treated metastatic colorectal. |