Patient selection: lung cancer
Selection criteria - all of the following:
(1) adenocarcinoma
(2) newly diagnosed Stage IIIB or IV OR recurrent disease with no previous chemotherapy
(3) ECOG performance status 0 or 1
(4) absence of brain metastases
(5) absence of hemoptysis (defined as >= 0.5 teaspoon per event)
(6) absence of anticoagulation, antiplatelet drug therapy, or coagulation disorder
(7) adequate cardiovascular, hepatic and hematopoeitic function
(8) adequate renal function with 24 hour urinary protein excretion <= 500 mg
(9) absence of medically uncontrolled hypertension
(10) not pregnant or lactating
(11) no radiation within the 3 weeks prior to enrollment
(12) no major surgery within the 4 weeks prior to enrollment
Clinically significant hemorrhage is a complication associated with bevacizumab therapy. A patient with hemoptysis is at increased risk for fatal pulmonary hemorrhage. A patient with brain metastases may be at risk for intracranial hemorrhage.
Bevacizumab is not used in patients with squamous cell carcinoma because of an increased risk for pulmonary hemorrhage.
Patients who met the selection criteria and were treated with paclitaxel-carboplatin with bevacizumab:
(1) had a better overall survival (12.3 vs 10.3 months) and response rate (35% vs 15%) when compared to the group with chemotherapy alone
(2) had an increased risk for treatment-related death (3.5%)
