Multi-istitutional study of the evaluation of eribulin (E) use in Sicily in metastatic breast cancer (MBC): A prospective registry (VESPRY trial).

2015 
e12565Background: Eribulin Mesylate is a non taxane microtubule dynamics inhibitor, approved for heavily-pretreated MBC patients (pts). Methods: This is a multicenter, prospective, single arm study for E-treatment of third line in pretreated MBC pts, conducted in 14 oncology centers in Sicily. All pts had received two previous chemotherapy regimens for MBC. Pts received E at 1.23 mg/m2 on days 1,8 every 3 weeks until progression. Primary Endpoints: overall response rate (ORR) according to the site of metastases and safety. Secondary objectives: Progression-free survival (PFS) and ORR according to different subtypes. PFS curve was estimated using the Kaplan-Meier method. Multivariable logistic regression model were used to evaluate the associations of each variables with tumor response. ORR was assessed according to RECIST 1.1 and safety with CTCAE v4.0. Results: 122 pts were enrolled and received at least 1 dose of E. Median age was 58 (range 29-79). All received previously anthracycline and taxane based-...
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