Phase I study of epidermal growth factor receptor (EGFR) inhibitor, erlotinib, and vascular endothelial growth factor monoclonal antibody, bevacizumab, in recurrent and/or metastatic squamous cell carcinoma of the head and neck (SCCHN)

摘要: 5539 Background: Studies of EGFR inhibitors in SCCHN have demonstrated reproducible activity. Preclinical studies implicated angiogenesis as a mechanism resistance to these agents. Furthermore, has been linked with tumor progression and worse outcome SCCHN. This phase I multi-institutional trial was undertaken assess the feasibility toxicity adding bevacizumab, an anti-VEGF monoclonal antibody erlotinib, tyrosine kinase inhibitor. Methods: Eligible patients were required performance status 2 or better, measurable disease, intact organ function, no more than one prior therapy for recurrent/metastatic VEGF based therapy. Escalating doses bevacizumab (5, 10, 15 mg/kg IV q3 weeks) administered fixed dose erlotinib (150 mg PO QD) consecutive patient cohorts establish II dose. Plasma serum TGF-alpha levels drawn therapy, after weeks, 8 weeks Result...