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document
Bevacizumab plus irinotecan , fluorouracil , and leucovorin for metastatic colorectal cancer . 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 . 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 . 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 0.66 ( 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 .
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Intervention_Pharmacological
Bevacizumab plus irinotecan , fluorouracil , and leucovorin
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Intervention_Pharmacological
Bevacizumab
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Intervention_Pharmacological
irinotecan , bolus fluorouracil , and leucovorin ( IFL ) plus bevacizumab
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Intervention_Control
IFL plus placebo .
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Intervention_Pharmacological
IFL plus bevacizumab
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Intervention_Control
IFL plus placebo
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Intervention_Pharmacological
IFL plus bevacizumab
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Intervention_Control
IFL plus placebo
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Intervention_Pharmacological
IFL plus bevacizumab
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Intervention_Control
IFL plus placebo
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Intervention_Pharmacological
IFL plus bevacizumab
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Intervention_Control
IFL plus placebo
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Intervention_Pharmacological
bevacizumab
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Intervention_Pharmacological
fluorouracil-based combination chemotherapy
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Outcome_Mortality
overall survival
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Outcome_Mortality
progression-free survival
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Outcome_Physical
the response rate
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Outcome_Physical
the duration of the response
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Outcome_Other
safety
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Outcome_Physical
quality of life
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Outcome_Mortality
median duration of survival
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Outcome_Mortality
median duration of progression-free survival
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Outcome_Physical
median duration of the response
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Outcome_Physical
Grade 3 hypertension
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Outcome_Mortality
survival
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Participant_Condition
metastatic colorectal cancer
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Participant_Condition
metastatic colorectal cancer
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Participant_Sample-size
813
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Participant_Condition
untreated metastatic colorectal cancer
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Participant_Condition
metastatic colorectal cancer .