Denise A Yardley1, James Reeves2, E Claire Dees3, Cynthia Osborne4, Devchand Paul5, Foluso Ademuyiwa6, Hatem Soliman7, Troy Guthrie8, Jay Andersen9, Lea Krekow10, Janak Choksi11, Brooke Daniel12, Michael Danso13, Anne Favret14, Sanjay Oommen15, Adam Brufsky16, Jane L Bromund17, Yong Lin17, Ayman B Ibrahim18, Paul D Richards19. 1. Sarah Cannon Research Institute, Tennessee Oncology PLLC, Nashville, TN. Electronic address: dyardley@tnonc.com. 2. Florida Cancer Specialists and Research Institute, Fort Myers, FL. 3. University of North Carolina Lineberger Comprehensive Cancer Center, Chapel Hill, NC. 4. Baylor Charles A. Sammons Cancer Center, US Oncology Research, Dallas, TX. 5. Rocky Mountain Cancer Centers, US Oncology Research, Denver, CO. 6. Division of Oncology, Department of Medicine, Washington University School of Medicine, St Louis, MO. 7. Department of Breast Oncology, H. Lee Moffitt Cancer Center and Research Institute, Tampa, FL. 8. Baptist Cancer Institute, Jacksonville, FL. 9. Northwest Cancer Specialists, PC, US Oncology Research, Portland, OR. 10. Texas Oncology-Bedford, US Oncology Research, Bedford, TX. 11. Medical Oncologist, Alamance Regional Medical Center, Burlington, NC. 12. Tennessee Oncology, Chattanooga, TN. 13. Virginia Oncology Associates, US Oncology Research, Norfolk, VA. 14. Virginia Cancer Specialists, PC, US Oncology Research, Fairfax, VA. 15. Texas Oncology-Fort Worth, US Oncology Research, Fort Worth, TX. 16. 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. 17. Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN. 18. Eli Lilly and Company, Bridgewater, NJ. 19. Oncology and Hematology Associates of Southwest Virginia, US Oncology Research, Salem, VA.
Abstract
BACKGROUND: 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. PATIENTS AND METHODS: 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 receivedramucirumab 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. RESULTS: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. CONCLUSION:Ramucirumab combined with eribulin did not significantly improve PFS in advanced MBC.
RCT Entities:
BACKGROUND: 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. PATIENTS AND METHODS: 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/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. RESULTS: 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. CONCLUSION:Ramucirumab combined with eribulin did not significantly improve PFS in advanced MBC.
Authors: Neal Shah; Afroz S Mohammad; Pushkar Saralkar; Samuel A Sprowls; Schuyler D Vickers; Devin John; Rachel M Tallman; Brandon P Lucke-Wold; Katherine E Jarrell; Mark Pinti; Richard L Nolan; Paul R Lockman Journal: Pharmacol Res Date: 2018-03-28 Impact factor: 7.658
Authors: Li Danni; Zhang Lingyun; Wang Jian; Yan Hongfei; Xu Lu; Yang Peng; Qu Xiujuan; Liu Yunpeng; Teng Yuee Journal: Cancer Biol Ther Date: 2020-04-01 Impact factor: 4.742