Abstract
Abstract Purpose VEGF driven angiogenesis plays a key role in tumor growth. We determined clinical efficacy of bevacizumab monotherapy in unselected patients with metastatic melanoma. Patients and methods Thirty-five patients with metastatic melanoma in progression were enrolled in this phase II, single arm clinical trial. Each patient received bevacizumab monotherapy 10 mg/kg q14 d until intolerable toxicity or disease progression occurred. Clinical efficacy was evaluated by measuring objective response (OR), disease control (DC), and survival. We also evaluated potential predictive value of clinical parameters and BRAF/NRAS mutational status. Results We observed one complete (CR, 3%) and 5 partial (PR, 14%) responses. In addition, 5 patients experienced stable disease > 6 months (SD, 14%), while 24 patients had progressive disease (PD, 69%), corresponding to a total disease control (DC) at 6 months in 11 out of 35 patients (31 %). Median progression free survival (PFS) was 2.14 months and median overall survival (OS) was 9 months (1.12-49). Seven of the 11 patients experiencing DC developed early hypertension (< 2 months) after commencing bevacizumab compared to 3/24 of patients with PD (P= 0.001), and hypertension was associated with improved progression free survival (P= 0.005) and overall survival (P= 0.013). No correlation between BRAF and NRAS mutation status and response was recorded. Conclusion Bevacizumab monotherapy demonstrated promising clinical efficacy in patients with metastatic melanoma with disease control in 31% of the patients. The activity of the drug seemed particularly pronounced in patients developing by hypertension early during. Citation Format: {Authors}. {Abstract title} [abstract]. In: Proceedings of the 103rd Annual Meeting of the American Association for Cancer Research; 2012 Mar 31-Apr 4; Chicago, IL. Philadelphia (PA): AACR; Cancer Res 2012;72(8 Suppl):Abstract nr 3704. doi:1538-7445.AM2012-3704
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