2018 ASCO Annual Meeting!
Session: Plenary Session Including the Science of Oncology Award and Lecture
Type: Plenary Session
Time: Sunday June 3, 1:00 PM to 4:00 PM
Location: Hall B1
TAILORx: Phase III trial of chemoendocrine therapy versus endocrine therapy alone in hormone receptor-positive, HER2-negative, node-negative breast cancer and an intermediate prognosis 21-gene recurrence score.
2018 ASCO Annual Meeting
J Clin Oncol 36, 2018 (suppl; abstr LBA1)
Author(s): Joseph A. Sparano, Robert James Gray, William C. Wood, Della F. Makower, Tracy G. Lively, Thomas James Saphner, Maccon M. Keane, Henry Leonidas Gomez, Pavan S. Reddy, Timothy F Goggins, Ingrid A. Mayer, Deborah Toppmeyer, Adam Brufsky, Matthew P. Goetz, Daniel F. Hayes, Elizabeth Claire Dees, Kathleen I. Pritchard, Charles E. Geyer, John A. Olson, George W. Sledge; Montefiore Medical Center, Bronx, NY; Dana-Farber Cancer Institute, Boston, MA; Winship Cancer Institute, Atlanta, GA; Montefiore Medical Center, Mamaroneck, NY; National Cancer Institute, Rockville, MD; Aurora Cancer Care, Green Bay, WI; West of Ireland Cancer Center, Galway, Ireland; Departamento de Medicina Oncologica, Oncosalud-AUNA, Lima, Peru; Cancer Ctr of Kansas, Wichita, KS; Fox Valley Hematology and Oncology, Appleton, WI; Vanderbilt-Ingram Cancer Center, Nashville, TN; Rutgers Cancer Institute of New Jersey, New Brunswick, NJ; University of Pittsburgh Medical Center, Division of Hematology Oncology, Pittsburgh, PA; Mayo Clinic, Rochester, MN; University of Michigan Comprehensive Cancer Center, Ann Arbor, MI; The University of North Carolina at Chapel Hill, Chapel Hill, NC; Sunnybrook Odette Cancer Centre, Toronto, ON, Canada; Virginia Commonwealth University Massey Cancer Center, Richmond, VA; University of Maryland School of Medicine, Baltimore, MD; Stanford University School of Medicine, Stanford, CA
Background: In hormone receptor (HR)-positive, HER2-negative, axillary node (AN)-negative breast cancer, the 21-gene expression assay (Oncotype DX Recurrence Score [RS]) is prognostic for distant recurrence, prognostic for low recurrence with endocrine therapy alone if low (0-10), and predictive of chemotherapy benefit if high (26 or higher). We performed a prospective, randomized trial of endocrine therapy (ET) versus chemoendocrine therapy (CET) in women with a mid-range RS of 11-25. Methods: Eligibility criteria included women 18-75 years of age with HR-positive, HER2-negative, axillary node (AN)-negative breast cancer and tumors 1.1-5.0 cm in size (or 0.6-1.0 cm and int/high grade) and agreed to have chemotherapy assigned or randomized based on the RS. Women with a mid-range RS (11-25) were randomized to receive ET or CET. The primary endpoint was invasive disease-free survival (iDFS), and the trial was designed to show non-inferiority for ET alone by not rejecting equality (hazard ratio [HR] margin up to 1.322 for omission of chemotherapy, 1-sided type I error rate 10%, type II error rate 5%). The target sample size was adjusted to compensate for non-adherence to randomized treatment, and the protocol-specified final analysis was triggered after 835 iDFS events. Results: Of the 10,253 eligible women enrolled between 4/7/06-10/6/10, 6711 (65.5%) had a RS of 11-25 and adequate information. There were 836 iDFS events at final analysis with a median followup of 90 months. ET was non-inferior to CET for iDFS (HR 1.08, 95% confidence intervals [CI] 0.94, 1.24, p=0.26) in the intention-to-treat (ITT) population. ET was also non-inferior for distant recurrence-free interval (DRFI; HR 1.03, p=0.80), recurrence-free interval (RFI; HR 1.12, p=0.28), and overall survival (OS; HR 0.97, p=0.80). Nine year rates were similar for iDFS (83.3% vs. 84.3%), DRFI (94.5% vs. 95.0%), RFI (92.2% vs. 92.9%), and OS (93.9% vs. 93.8%). Recurrence accounted for 338 (41.6%) the first iDFS event, of which 199 (23.8%) were distant recurrences. Treatment interaction tests were significant for age (iDFS p=0.03; RFI p= 0.02), but not menopause, tumor size, grade, or RS (continuous or RS 11-15, 16-20, 21-25). Conclusions: In women with HR-positive, HER2-negative, AN-negative breast cancer and a RS of 11-25, adjuvant ET was not inferior to CET in the ITT analysis. (Funded by NCI, BCRF, and Komen Foundation.) Clinical trial information: NCT00310180