32736
document
Phase II study of efficacy and safety of bevacizumab in combination with chemotherapy or erlotinib compared with chemotherapy alone for treatment of recurrent or refractory non small-cell lung cancer . PURPOSE Bevacizumab , a humanized anti-vascular endothelial growth factor monoclonal antibody , and erlotinib , a reversible , orally available epidermal growth factor receptor tyrosine kinase inhibitor , have demonstrated evidence of a survival benefit in the treatment of non-small-cell lung cancer ( NSCLC ) . A single-arm phase I and II study of bevacizumab plus erlotinib demonstrated encouraging efficacy , with a favorable safety profile . PATIENTS AND METHODS A multicenter , randomized phase II trial evaluated the safety of combining bevacizumab with either chemotherapy ( docetaxel or pemetrexed ) or erlotinib and preliminarily assessed these combinations versus chemotherapy alone , as measured by progression-free survival ( PFS ) . All patients had histologically confirmed nonsquamous NSCLC that had progressed during or after one platinum-based regimen . RESULTS One hundred twenty patients were randomly assigned and treated . No unexpected adverse events were noted . Fewer patients ( 13 % ) in the bevacizumab-erlotinib arm discontinued treatment as a result of adverse events than in the chemotherapy alone ( 24 % ) or bevacizumab-chemotherapy ( 28 % ) arms . The incidence of grade 5 hemorrhage in patients receiving bevacizumab was 5.1 % . Although not statistically significant , relative to chemotherapy alone , the risk of disease progression or death was 0.66 ( 95 % CI , 0.38 to 1.16 ) among patients treated with bevacizumab-chemotherapy and 0.72 ( 95 % CI , 0.42 to 1.23 ) among patients treated with bevacizumab-erlotinib . One-year survival rate was 57.4 % for bevacizumab-erlotinib and 53.8 % for bevacizumab-chemotherapy compared with 33.1 % for chemotherapy alone . CONCLUSION Results for PFS and overall survival favor combination of bevacizumab with either chemotherapy or erlotinib over chemotherapy alone in the second-line setting . No unexpected safety signals were noted . The rate of fatal pulmonary hemorrhage was consistent with previous bevacizumab trials . The toxicity profile of the bevacizumab-erlotinib combination is favorable compared with either chemotherapy-containing group .
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Intervention_Pharmacological
bevacizumab in combination with chemotherapy
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Intervention_Pharmacological
erlotinib
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Intervention_Control
chemotherapy alone
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Intervention_Pharmacological
Bevacizumab
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Intervention_Pharmacological
erlotinib
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Intervention_Pharmacological
bevacizumab
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Intervention_Pharmacological
erlotinib
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Intervention_Pharmacological
bevacizumab
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Intervention_Pharmacological
chemotherapy ( docetaxel or pemetrexed
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Intervention_Pharmacological
erlotinib
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Intervention_Control
chemotherapy
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Intervention_Pharmacological
bevacizumab-erlotinib
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Intervention_Control
chemotherapy
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Intervention_Pharmacological
bevacizumab-chemotherapy
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Intervention_Pharmacological
bevacizumab
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Intervention_Pharmacological
bevacizumab-chemotherapy
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Intervention_Pharmacological
bevacizumab-erlotinib .
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Intervention_Pharmacological
bevacizumab-erlotinib
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Intervention_Pharmacological
bevacizumab-chemotherapy
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Intervention_Control
chemotherapy
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Intervention_Pharmacological
bevacizumab
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Intervention_Pharmacological
chemotherapy
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Intervention_Control
chemotherapy
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Intervention_Pharmacological
bevacizumab
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Intervention_Pharmacological
bevacizumab-erlotinib combination
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Intervention_Control
chemotherapy-containing
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Outcome_Other
efficacy
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Outcome_Other
safety
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Outcome_Mortality
progression-free survival ( PFS )
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Outcome_Adverse-effects
adverse events
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Outcome_Adverse-effects
result of
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Outcome_Physical
adverse events
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Outcome_Physical
grade 5 hemorrhage
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Outcome_Physical
risk of disease progression or
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Outcome_Mortality
death
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Outcome_Mortality
One-year survival rate
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Outcome_Mortality
PFS
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Outcome_Mortality
overall survival
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Outcome_Physical
safety signals
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Outcome_Mortality
fatal pulmonary hemorrhage
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Outcome_Physical
toxicity
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Participant_Condition
recurrent or refractory non small-cell lung cancer
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Participant_Condition
histologically confirmed nonsquamous NSCLC
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Participant_Sample-size
One hundred twenty patients