Phase II, Randomized Trial Comparing Bevacizumab Plus Fluorouracil (FU)/Leucovorin (LV) With FU/LV Alone in Patients With Metastatic Colorectal Cancer

作者: Fairooz Kabbinavar , Herbert I. Hurwitz , Louis Fehrenbacher , Neal J. Meropol , William F. Novotny

DOI: 10.1200/JCO.2003.10.066

关键词:

摘要: Purpose: This phase II trial investigated the safety and efficacy of two doses bevacizumab, a monoclonal antibody to vascular endothelial growth factor, plus fluorouracil (FU)/leucovorin (LV) versus FU/LV alone in patients with metastatic colorectal cancer. Patients Methods: One hundred four previously untreated measurable cancer were randomly assigned one following three treatment groups: 36 FU (500 mg/m2)/LV mg/m2) alone, 35 + low-dose bevacizumab (5 mg/kg every 2 weeks), 33 high-dose (10 weeks). was given weekly for first 6 weeks each 8-week cycle. Results: Compared control arm, (at both dose levels) resulted higher response rates (control 17%, 95% confidence interval [CI], 7% 34%; 40%, CI, 24% 58%; 24%, 12% 43%), longer median time disease progression 5....

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