Results of the updated analysis were consistent with the primary analysis, which was conducted when ~50% of events (deaths) had been observed. HALAVEN demonstrated a median OS of 13.1 months (95% CI: 11.8, 14.3) vs 10.6 months with the TPC arm (95% CI: 9.3, 12.5), hazard ratio (HR)=0.81 (95% CI: 0.66, 0.99) (P=0.041)1,4
Reduction in risk of death—patients in the HALAVEN arm had a 19% reduction in risk of death vs real-world treatment options (defined as TPC)1,4-6
References: 1. Cortes J, O'Shaughnessy J, Loesch D, et al; EMBRACE (Eisai Metastatic Breast Cancer Study Assessing Physician's Choice Versus E7389) investigators. Eribulin monotherapy versus treatment of physician's choice in patients with metastatic breast cancer (EMBRACE): a phase 3 open-label randomised study. Lancet. 2011;377(9769):914-923. 2. Saad ED, Katz A, Buyse M. Overall survival and post-progression survival in advanced breast cancer: a review of recent randomized clinical trials. J Clin Oncol. 2010;28(11):1958-1962. 3. Sparano JA, Vrdoljak E, Rixe O, et al. Randomized phase III trial of ixabepilone plus capecitabine versus capecitabine in patients with metastatic breast cancer previously treated with an anthracycline and a taxane.J Clin Oncol. 2010;28(20):3256-3263. 4. HALAVEN [package insert]. Nutley, NJ: Eisai Inc. 5. NCI dictionary of cancer terms. National Cancer Institute Web site. http://www.cancer.gov/publications/dictionaries/cancer-terms?CdrlD=618612. Accessed May 4, 2018. 6. Barraclough H, Simms L, Govindan R. Biostatistics primer: what a clinician ought to know: hazard ratios. J Thorac Oncol. 2011;6(6):978-982. 7. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines© ) for Breast Cancer V1.2018. © National Comprehensive Cancer Network, Inc. 2018. All rights reserved. Accessed April 19, 2018. To view the most recent and complete version of the guideline, go online to NCCN.org. NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way.