Phase II Study of Cisplatin Plus Etoposide and Bevacizumab for Previously Untreated, Extensive-Stage Small-Cell Lung Cancer: Eastern Cooperative Oncology Group Study E3501

• DOI: 10.1200/jco.2009.23.7545
• Publication Date: 2009-10-14T07:09:08Z
• Authors: Leora Horn; Suzanne E. Dahlberg; Alan B. Sandler; Afshin Dowlati; Dennis F. Moore; John R. Murren; Joan H. Schiller
• Keywords: Clinical Oncology

Purpose To investigate the efficacy and safety of bevacizumab plus cisplatin etoposide in patients with extensive-stage disease, small-cell lung cancer (ED-SCLC). Patients Methods In this phase II trial, 63 were treated 15 mg/kg 60 mg/m 2 120 , which was followed by alone until death or disease progression occurred. The primary end point proportion alive at 6 months without (ie, progression-free survival [PFS]). Secondary points included overall (OS), objective response rate, toxicity. Correlative studies performed to explore relationship between baseline changes plasma vascular endothelial growth factor (VEGF), soluble cell adhesion molecules molecule [VCAM], intercellular [ICAM], E-selectin) basic fibroblast outcome. Results 6-month PFS 30.2%, median 4.7 months, OS 10.9 months. rate 63.5%. most common adverse event neutropenia (57.8%). Only one patient had grade 3 pulmonary hemorrhage. who high VCAM a higher risk compared those low levels. No relationships outcome any other biomarkers seen. Conclusion addition ED-SCLC results improved relative historical controls received chemotherapy regimen bevacizumab. This appears be well tolerated has minimal increase toxicities alone. Baseline levels predicted survival, but no among treatment, biomarkers, identified.