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• W2600232787 abstract "1027 Background: E2100, an open-label, randomized, phase III trial, demonstrated a significant improvement in progression free survival and overall response rate with paclitaxel plus bevacizumab compared with paclitaxel alone as initial chemotherapy for patients with HER2-negative metastatic breast cancer. Genentech completed additional clinical trials and submitted these data to the FDA. On 18 Nov, 2011, the FDA Commissioner revoked the agency’s approval of bevacizumab for the breast cancer indication because of the lack of evidence of an improvement in overall survival or a clinical benefit to patients sufficient to outweigh the risks. However, the Commissioner “encouraged Genentech to consider additional studies to identify if there are select subgroups of women who might benefit from this drug”. Hu et al. (BMC Medicine 2009) published a compact 13 gene VEGF-signature associated with distant metastases and poor outcomes. Supervised analyses comparing patients with distant metastases versus primary tumors or regional metastases showed that the distant metastases were distinct and distinguished by the lack of expression of fibroblast/mesenchymal genes, and by the high expression of a 13 gene profile that included VEGF, ANGPTL4, ADM and the monocarboxylic acid transporter SLC16A3. Methods: We have investigated the VEGF signature in silico on Illumina DASL analysis of 122 FFPE samples remaining from E2100. Results: PFS benefit is seen for pacli + bev vs pacli in both treatment arms with the low VEGF signature (HR 0.45 95% CI .27-.77 p .009 n 67) and with the high VEGF signature (HR 0.57 95% CI .32-1.0 p .015 n 55). However, OS benefit is only seen for pacli + bev vs pacli in the high VEGF group (HR 0.56 95% CI .30-1.05 p .02 n 52) and not in patients with the low VEGF signature (HR 1.12 95% CI .66-1.90 p .81 n 67). Conclusions: Hence, this signature, which suggests that the response to hypoxia includes the ability to promote new blood and lymphatic vessel formation, shows great potential as a predictive biomarker of those patients to whom bevacizumab would convey an OS advantage benefit. We note with great caution that this exploratory analysis of trial subset is underpowered, hence, this compact VEGF signature is being pursued in other bevacizumab trial sets." @default.
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• W2600232787 date "2012-05-20" @default.
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• W2600232787 title "Association of a compact 13-gene VEGF signature with OS in E2100." @default.
• W2600232787 doi "https://doi.org/10.1200/jco.2012.30.15_suppl.1027" @default.
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