Abstract
LBA4 Background: The results of a randomized phase II trial of PC +/- bevacizumab (A) suggested improved activity for the combination of PCA when compared to PC alone (Johnson DH, et al JCO 2004). Grade 5 hemoptysis was seen in the PCA arms & multivariate analysis suggested squamous cell histology to be a significant risk factor. Methods: The primary endpoint of this randomized trial was to compare the effects of the addition of A to PC on overall survival in patients (pts) with previously untreated non-squamous NSCLC. Secondary endpoints included response rate, time to progression, and tolerability. Correlative studies consisted of pre & post-treatment circulating VEGF, VCAM, E-selectin & bFGF as prognostic & predictive markers. Other eligibility criteria included ECOG PS 0 or 1, & adequate hematologic, renal, & hepatic function. Pts with brain metastases were excluded. Pts were randomized to receive P 200 mg/m2 + C AUC=6 on day 1 every 3 wks or PC + A 15mg/kg day 1 (PCA) every 3 weeks. Pts on PCA contin...
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