AVALUZ study: First line with bevacizumab in combination with paclitaxel (P) and gemcitabine (G) in patients with HER2-negative or recurrent mBC: OS analysis.

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e11535 Background: The combination of bevacizumab (B) with taxanes, capecitabine or anthracyclines has shown increased PFS in pts with mBC. The combination with G and P has been evaluated and has demonstrated high response rate and good toxicity profile. The aim of this study is to evaluate the efficacy and toxicity profile of the combination of B with G and P, providing the final result of PFS, update of OS and the toxicity experienced in all pts treated. Methods: A phase II multicenter, national, open-label study in pts diagnosed of recurrent or metastatic HER-2 negative BC, treated with first line B 10 mg/kg, P 150 mg/m2 and G 2000 mg/m2 day 1 and 15 c/28 d until progression disease, unacceptable toxicity or medical decision. This abstract evaluates efficacy by PFS as primary endpoint and as secondary endpoints: OS, response rate and toxicity profile (NCI CTC v3.0 criteria). Results: From January 2009 to December 2009, 82 evaluable pts were recruited in 23 sites. The characteristic of the all of pts included (90) are: median age 51.5 (26-81), ER + 68%, PR + 59%, triple negative pts 19%, previous chemotherapy (neoadj or adj) 64.4% and > 3 metastatic sites 21% of patients (19). The median cycles administered per pts was 7 (1-28) and the relative median dose intensity was 0.93 for B, 0.89 for P and 0.91 for G. Of the 76 pts with response assessment, the overall response rate obtained was 72% with a clinical benefit of 89.5% (80.3-95.34%). Of the 82 pts with a median follow up of 20.21m (0.23- 30.07), median PFS (50% events) for these pts was 11.51 m (9.01-17.6), the median duration of first response (MDR) was 12.4 m (7.6-15.2) and the median OS (42% events) was 27.4 m (21.9- NA). The one year OS % was 84.15 (74.27 – 90.47). Toxicity was generally manageable. Related AEs have been reported in 69/82 pts which were mostly mild or moderate. Safety analysis revealed 24 SAEs in 21 pts Conclusions: Bevacizumab in combination with paclitaxel and gemcitabine showed significant OS compared with the published data with paclitaxel and gemcitabine and high clinical benefit with manageable safety profile.

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