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Phase II study of cisplatin plus etoposide and bevacizumab for previously untreated, extensive-stage small-cell lung cancer: Eastern Cooperative Oncology Group Study E3501
Journal of Clinical Oncology, 10/15/09

Horn L et al. – The addition of bevacizumab to cisplatin and etoposide in patients with ED-SCLC results in improved PFS and OS relative to historical controls who received this chemotherapy regimen without bevacizumab. This regimen appears to be well tolerated and has minimal increase in toxicities compared with chemotherapy alone. Baseline VCAM levels predicted survival, but no other relationships among treatment, biomarkers, and outcome were identified.

Methods

Phase II trial
63 patients treated with bevacizumab 15 mg/kg plus cisplatin 60 mg/m2 and etoposide 120 mg/m2, followed by bevacizumab alone until death or disease progression occurred
Primary end point was proportion of patients alive at 6 mos without disease progression
Secondary end points included overall survival (OS), objective response rate, and toxicity
Correlative studies performed to explore relationship between baseline and changes in plasma vascular endothelial growth factor (VEGF), soluble cell adhesion molecules and basic fibroblast growth factor and outcome

Results

6-mo PFS 30.2%, median PFS was 4.7 mos, and OS was 10.9 mos
Response rate 63.5%
Most common adverse event neutropenia (57.8%)
Only 1 patient had grade 3 pulmonary hemorrhage
Patients who had high baseline VCAM had higher risk of progression or death compared with those with low baseline VCAM levels
No relationships between outcome and any other biomarkers