title: Ramucirumab With Eribulin Versus Eribulin in Locally Recurrent or Metastatic Breast Cancer Previously Treated With Anthracycline and Taxane Therapy: A Multicenter, Randomized, Phase II Study.
abstract: Use 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.
  
  
  
  In 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/m2intravenously 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.
  
  
  
  One 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.
  
  
  
  Ramucirumab combined with eribulin did not significantly improve PFS in advanced MBC.
authors: Sarah Cannon Research Institute, Tennessee Oncology PLLC, Nashville, TN. Electronic address: dyardley@tnonc.com.
authors: Denise A
authors: DA
authors: Yardley
authors: Florida Cancer Specialists and Research Institute, Fort Myers, FL.
authors: James
authors: J
authors: Reeves
authors: University of North Carolina Lineberger Comprehensive Cancer Center, Chapel Hill, NC.
authors: E Claire
authors: EC
authors: Dees
authors: Baylor Charles A. Sammons Cancer Center, US Oncology Research, Dallas, TX.
authors: Cynthia
authors: C
authors: Osborne
authors: Rocky Mountain Cancer Centers, US Oncology Research, Denver, CO.
authors: Devchand
authors: D
authors: Paul
authors: Division of Oncology, Department of Medicine, Washington University School of Medicine, St Louis, MO.
authors: Foluso
authors: F
authors: Ademuyiwa
authors: Department of Breast Oncology, H. Lee Moffitt Cancer Center and Research Institute, Tampa, FL.
authors: Hatem
authors: H
authors: Soliman
authors: Baptist Cancer Institute, Jacksonville, FL.
authors: Troy
authors: T
authors: Guthrie
authors: Northwest Cancer Specialists, PC, US Oncology Research, Portland, OR.
authors: Jay
authors: J
authors: Andersen
authors: Texas Oncology-Bedford, US Oncology Research, Bedford, TX.
authors: Lea
authors: L
authors: Krekow
authors: Medical Oncologist, Alamance Regional Medical Center, Burlington, NC.
authors: Janak
authors: J
authors: Choksi
authors: Tennessee Oncology, Chattanooga, TN.
authors: Brooke
authors: B
authors: Daniel
authors: Virginia Oncology Associates, US Oncology Research, Norfolk, VA.
authors: Michael
authors: M
authors: Danso
authors: Virginia Cancer Specialists, PC, US Oncology Research, Fairfax, VA.
authors: Anne
authors: A
authors: Favret
authors: Texas Oncology-Fort Worth, US Oncology Research, Fort Worth, TX.
authors: Sanjay
authors: S
authors: Oommen
authors: Division of Hematology/Oncology, Department of Medicine, University of Pittsburgh School of Medicine, Magee-Women's Hospital of University of Pittsburgh Medical Center, Pittsburgh, PA.
authors: Adam
authors: A
authors: Brufsky
authors: Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN.
authors: Jane L
authors: JL
authors: Bromund
authors: Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN.
authors: Yong
authors: Y
authors: Lin
authors: Eli Lilly and Company, Bridgewater, NJ.
authors: Ayman B
authors: AB
authors: Ibrahim
authors: Oncology and Hematology Associates of Southwest Virginia, US Oncology Research, Salem, VA.
authors: Paul D
authors: PD
authors: Richards
mesh_terms: D061605:Administration, Intravenous; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D020533:Angiogenesis Inhibitors / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D018943:Anthracyclines / Q000627:therapeutic use; D000911:Antibodies, Monoclonal / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D061067:Antibodies, Monoclonal, Humanized; D000970:Antineoplastic Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000401:mortality* / Q000473:pathology; D018572:Disease-Free Survival; D004334:Drug Administration Schedule; D005260:Female; D005663:Furans / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D006801:Humans; D007659:Ketones / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000188:drug therapy* / Q000473:pathology; D016019:Survival Analysis; D043823:Taxoids / Q000627:therapeutic use; D016896:Treatment Outcome; D040301:Vascular Endothelial Growth Factor Receptor-2 / Q000037:antagonists & inhibitors; D000096662:Ramucirumab; D000095662:Polyether Polyketides
chemical_list: D020533:Angiogenesis Inhibitors; D018943:Anthracyclines; D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D000970:Antineoplastic Agents; D005663:Furans; D007659:Ketones; D043823:Taxoids; D040301:Vascular Endothelial Growth Factor Receptor-2; D000096662:Ramucirumab; C000588866:KDR protein, human; C490954:eribulin; D000095662:Polyether Polyketides
keywords: Antiangiogenic therapy; Brain metastasis; Targeted agents; Triple-negative status; VEGFR-2