• Denise A Yardley, James Reeves, E Claire Dees, Cynthia Osborne, Devchand Paul, Foluso Ademuyiwa, Hatem Soliman, Troy Guthrie, Jay Andersen, Lea Krekow, Janak Choksi, Brooke Daniel, Michael Danso, Anne Favret, Sanjay Oommen, Adam Brufsky, Jane L Bromund, Yong Lin, Ayman B Ibrahim, and Paul D Richards.
• Sarah Cannon Research Institute, Tennessee Oncology PLLC, Nashville, TN. Electronic address: dyardley@tnonc.com.
• Clin. Breast Cancer. 2016 Dec 1; 16 (6): 471-479.e1.

BackgroundUse of antiangiogenic agents in treatment of metastatic breast cancer (MBC) remains controversial. We evaluated the efficacy and safety of ramucirumab and eribulin versus eribulin alone as third- to fifth-line therapy in women with advanced breast cancer.Patients And MethodsIn this randomized (1:1), open-label, phase II study, US women aged 18 years or older with 2 to 4 previous chemotherapy regimens for locally recurrent or MBC, previous anthracycline and taxane treatment, and Eastern Cooperative Oncology Group performance status of 0 or 1 received ramucirumab with eribulin or eribulin alone in 21-day cycles (eribulin 1.4 mg/m2 intravenously on days 1 and 8; ramucirumab 10 mg/kg intravenously on day 1). Randomization was stratified according to previous antiangiogenic therapy and triple-negative status. The primary end point was progression-free survival (PFS) in the intention to treat population.ResultsOne hundred forty-one women were randomized to ramucirumab with eribulin (n = 71) or eribulin alone (n = 70). Median PFS for ramucirumab with eribulin was 4.4 months (95% confidence interval [CI], 3.1-6.7) compared with 4.1 months (95% CI, 3.2-5.6) for eribulin (hazard ratio [HR], 0.83; 95% CI, 0.56-1.23; P = .35). Median overall survival in patients who received ramucirumab with eribulin was 13.5 months (95% CI, 10.4-17.9) compared with 11.5 months (95% CI, 9.0-17.3) in patients who received eribulin alone (HR, 0.91; 95% CI, 0.59-1.41; P = .68); objective response rate was 21% (13 of 62 patients) for the combination and 28% (17 of 60 patients) for eribulin alone. No unexpected toxicity was identified for the combination.ConclusionRamucirumab combined with eribulin did not significantly improve PFS in advanced MBC.Copyright © 2016 The Author(s). Published by Elsevier Inc. All rights reserved.

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