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Phase II study of cisplatin plus etoposide and bevacizumab for previously untreated, extensive-stage small-cell lung cancer
Journal of Clinical Oncology, 10/29/09

Horn L et al. – Goal of this study was to investigate the efficacy and safety of bevacizumab plus cisplatin and etoposide in patients with extensive-stage disease, small-cell lung cancer.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 months without disease progression
Correlative studies performed to explore relationship between baseline and changes in plasma vascular endothelial growth factor (VEGF), soluble cell adhesion molecules (ie, vascular cell adhesion molecule [VCAM], intercellular cell adhesion molecule [ICAM], and E-selectin) and basic fibroblast growth factor and outcome

Results

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

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