Entry Detail
| General information | |
| Database: | DB00010 |
| Objective: | Bevacizumab, a monoclonal antibody against vascular endothelial growth factor, has shown promising preclinical and clinical activity against metastatic colorectal cancer, particularly in combination with chemotherapy. |
| Authors: | Hurwitz H, et al |
| Title: | Bevacizumab plus irinotecan, fluorouracil, and leucovorin for metastatic colorectal cancer. |
| Journal: | N Engl J Med |
| Year: | 2004 |
| PMID: | 15175435 |
| 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 carcinoma, with bidimensionally measurable disease. |
| Therapy Type: | com |
| Therapeutic Combination Type: | 2 |
| Therapeutic Combination Content: | irinotecan, bolus fluorouracil+leucovorin (IFL)+bevacizumab |
| Study Type: | a phase III trial |
| Key Patients Feature: | patients with previously untreated metastatic colorectal cancer |
| Biomarker: | NA |
| Biomark Analysis: | NA |
| Control Group Info: | IFL plus placebo |
| Treatment Info: | randomly assigned 402 to receive irinotecan, bolus fluorouracil, and leucovorin (IFL) plus bevacizumab (5 mg per kilogram of body weight every two weeks) and 411 to receive IFL plus placebo. |
| Primary End Point: | overall survival. |
| Secondary End Point: | progression free survival, the response rate, the duration of the response, safety, and the quality of life. |
| Patients Number: | 813 |
| Trial Results | |
| DLT_MTD: | NA |
| Objective Response Rate: | the corresponding rates of response were 44.8 percent and 34.8 percent (P=0.004). |
| Disease Control Rate: | NA |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | 10.6 months in the group given IFL plus bevacizumab, as compared with 6.2 months in the group given IFL plus placebo (hazard ratio for disease progression, 0.54; P<0.001); |
| Median OS A vs. C: | 20.3 ms in the group given IFL plus bevacizumab, as compared with 15.6 ms in the group given IFL plus placebo, corresponding to a hazard ratio for death of 0.66 (P<0.001). |
| Adverse Event(agent arm): | Grade 3 hypertension was more common during treatment with IFL plus bevacizumab than with IFL plus placebo (11.0 percent vs. 2.3 percent) but was easily managed |
| Conclusions: | The addition of bevacizumab to fluorouracilbased combination chemotherapy results in statistically significant and clinically meaningful improvement in survival among patients with metastatic colorectal cancer. |