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Safety and effectiveness of bevacizumab-containing treatment for non-small-cell lung cancer : final results of the ARIES observational cohort study . INTRODUCTION Bevacizumab , a recombinant humanized monoclonal antibody against vascular endothelial growth factor , was approved by the US Food and Drug Administration for the treatment of advanced non-small-cell lung cancer ( NSCLC ) in combination with carboplatin and paclitaxel . ARIES ( Avastin Regimens : Investigation of Effectiveness and Safety ) , a prospective observational cohort study , evaluated outcomes in a large , community-based population of patients with first-line NSCLC . METHODS From 2006 to 2009 , ARIES enrolled patients with locally advanced or metastatic NSCLC who were eligible for bevacizumab , excluding those with predominantly squamous histology . Patients were required to provide informed consent and to have initiated bevacizumab with chemotherapy within 4 months before enrollment . There were no protocol-defined treatments or assessments . The dosing of bevacizumab and chemotherapy , and the choice of chemotherapy regimen , was at the discretion of the treating physician . RESULTS ARIES enrolled 1967 patients with first-line NSCLC . At study closure , median follow-up was 12.5 months ( range , 0.2-65.5 ) . Median age was 65 years ( range , 31-93 ) , and 252 patients ( 12.8 % ) identified as never smokers . Median progression-free survival was 6.6 months ( 95 % confidence interval , 6.3-6.9 ) , and median overall survival was 13.0 months ( 95 % confidence interval , 12.2-13.8 ) with first-line bevacizumab plus chemotherapy . Incidences of bevacizumab-associated adverse events ( 19.7 % overall ) were consistent with those in randomized controlled trials of bevacizumab in NSCLC . CONCLUSION Results from ARIES demonstrate similar outcomes to randomized controlled trials of bevacizumab when added to standard chemotherapy in a real-world patient population with advanced NSCLC .
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Intervention_Pharmacological
bevacizumab-containing
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Intervention_Pharmacological
Bevacizumab
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Intervention_Pharmacological
carboplatin
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Intervention_Pharmacological
paclitaxel
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Intervention_Pharmacological
bevacizumab
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Intervention_Pharmacological
bevacizumab
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Intervention_Physical
chemotherapy
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Intervention_Physical
bevacizumab and chemotherapy
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Intervention_Pharmacological
bevacizumab plus chemotherapy
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Intervention_Pharmacological
bevacizumab-associated
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Intervention_Pharmacological
bevacizumab
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Intervention_Pharmacological
bevacizumab
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Outcome_Other
Safety and effectiveness
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Outcome_Other
median follow-up
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Outcome_Mortality
Median progression-free survival
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Outcome_Mortality
median overall survival
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Outcome_Adverse-effects
Incidences of bevacizumab-associated adverse events
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Participant_Condition
patients with first-line NSCLC
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Participant_Condition
ARIES enrolled patients with locally advanced
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Participant_Condition
metastatic NSCLC who were eligible for bevacizumab
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Participant_Condition
excluding those with predominantly squamous histology
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Participant_Condition
provide informed consent
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Participant_Condition
have initiated bevacizumab with chemotherapy within 4 months before enrollment
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Participant_Sample-size
1967
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Participant_Condition
with first-line NSCLC
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Participant_Age
Median age was 65 years ( range , 31-93 )
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Participant_Sample-size
252
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Participant_Condition
real-world patient population with advanced NSCLC