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Clinical Trial
. 2004 Jun 3;350(23):2335-42.
doi: 10.1056/NEJMoa032691.

Bevacizumab plus irinotecan, fluorouracil, and leucovorin for metastatic colorectal cancer

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Free article
Clinical Trial

Bevacizumab plus irinotecan, fluorouracil, and leucovorin for metastatic colorectal cancer

Herbert Hurwitz et al. N Engl J Med. .
Free article

Abstract (V体育平台登录)

Background: 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. VSports手机版.

Methods: Of 813 patients with previously untreated metastatic colorectal cancer, we 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 V体育安卓版. The primary end point was overall survival. Secondary end points were progression-free survival, the response rate, the duration of the response, safety, and the quality of life. .

Results: The median duration of survival was 20. 3 months in the group given IFL plus bevacizumab, as compared with 15. 6 months in the group given IFL plus placebo, corresponding to a hazard ratio for death of 0 V体育ios版. 66 (P<0. 001). The median duration of progression-free survival was 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); the corresponding rates of response were 44. 8 percent and 34. 8 percent (P=0. 004). The median duration of the response was 10. 4 months in the group given IFL plus bevacizumab, as compared with 7. 1 months in the group given IFL plus placebo (hazard ratio for progression, 0. 62; P=0. 001). 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 fluorouracil-based combination chemotherapy results in statistically significant and clinically meaningful improvement in survival among patients with metastatic colorectal cancer. VSports最新版本.

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