Abstract
e11042 Background: Upon MBC progression with AI treatment; F, an estrogen receptor (ER) antagonist, is often used. Furthermore, vascular endothelial growth factor (VEGF) remains a potential target in MBC. S is a multi-kinase inhibitor of VEGF, Raf, platelet-derived growth factor receptor beta, Flt-3, and c-KIT. Prior studies of S show activity with chemotherapy and as a single agent. Combination therapy with an anti-estrogen and a VEGF inhibitor may be more effective than either agent alone. This pilot study combines F + S for HR+ MBC. Methods: Upon disease progression with an AI, 8 pts were treated with F. Concurrent S was administered starting day 1 until disease progression or unacceptable toxicity. Assessment of tumor status with computed tomography and/or bone scan was performed at baseline and every 2 cycles until disease progression. Results: Median age = 58; 75 % <65. ER and PR + = 6 pts; ER + and PR - = 2 pts. 6 pts were treated with adjuvant chemotherapy and endocrine therapy, with subsequent AI for MBC. 2 pts were metastatic at presentation and treated with prior AI. Median number of days on treatment = 220; median number of cycles = 7. 75% had grade 2/3 HFS; 50% required S dose modification. However, HFS and rash/desquamation were the only grade 3 toxicities (3 pts) with no additional grade 3/4 toxicities or dose modifications for other toxicities. Other grade 2 toxicities: neutropenia, myalgias, arthralgias, fatigue, pruritis. Only 1 pt discontinued the study at investigator’s decision for grade 3 HFS. There were no deaths on study. The remaining 7 pts continued F + S until disease progression with stable disease over a range of 2 to 22 cycles. Median time to progression was 7.3 months. Conclusions: Upon progression with an AI, treatment with F + S may provide advantage for some HR+ MBC pts beyond treatment with F alone. Future studies involving S in MBC should focus on identifying the population that will benefit the most in exchange for toxicities associated with S. [Table: see text]
Published Version
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