2019 ASCO Annual Meeting!
Session: Breast Cancer—Local/Regional/Adjuvant
Type: Oral Abstract Session
Time: Monday June 3, 9:45 AM to 12:45 PM
Location: Hall D2
Impact of clinical risk category on prognosis and prediction of chemotherapy benefit in early breast cancer (EBC) by age and the 21-gene recurrence score (RS) in TAILORx.
2019 ASCO Annual Meeting
J Clin Oncol 37, 2019 (suppl; abstr 503)
Author(s): Joseph A. Sparano, Robert James Gray, 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, Kathy S. Albain, George W. Sledge; Montefiore Medical Center, Albert Einstein College of Medicine, Albert Einstein Cancer Center, Bronx, NY; Dana-Farber Cancer Institute-ECOG-ACRIN Biostatistics Center, Boston, MA; National Cancer Institute, Rockville, MD; Aurora Cancer Care, Green Bay, WI; Department of Medical Oncology, University Hospital Galway, Galway, Ireland; Departamento de Medicina Oncologica, Oncosalud-AUNA, Lima, Peru; Cancer Ctr of Kansas, Wichita, KS; Fox Valley Hem Onc, 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; NSABP Foundation and Virginia Commonwealth University Massey Cancer Center, Richmond, VA; University of Maryland School of Medicine, Baltimore, MD; Loyola University Chicago Stritch School of Medicine, Cardinal Bernardin Cancer Center, Maywood, IL; Stanford University School of Medicine, Stanford, CA
Background: TAILORx established that endocrine therapy (ET) alone is non-inferior to adjuvant chemotherapy (CT) plus ET in EBC and a 21-gene RS of 11-25, with some benefit if ≤50 years (y) with RS 16-25 (PMID: 29860917). We evaluated whether clinical risk (tumor size & histologic grade) provides additional prognostic information to RS, a secondary trial objective. Methods: Clinical risk by was assessed by Adjuvant! (version 8.0) using MINDACT criteria (PMID 27557300), defined as low clinical risk (LCR - tumor ≤3 cm and low grade, <2 cm and intermediate grade, or ≤1 cm and high grade) or high clinical risk (HCR -not meeting LCR criteria). Results: Of 9427 women with RS and clinical risk information, 70% were LCR and 30% HCR, with comparable distribution by age ( ≤50 vs. >50). The RS was 26-100 in 9% of LCR and 27% of HCR patients, with similar distributions by age. Although LCR/HCR provided additional prognostic information in each RS category for iDFS, including RS 0-10 (9-year rates 86.7% vs. 75.7% LCR vs. HCR), 11-25 (85.4% vs. 78.9%), and 26-100 (82.0% vs. 70.4%), iDFS rates were similar irrespective of CT (no vs. yes) in the entire RS 11-25 cohort whether LCR (85.8% vs. 85.1%) or HCR (79.8% vs. 77.9%). DRFI rates were also similar irrespective of CT in the RS 11-25 cohort or > 50y group whether LCR (96.0% vs. 96.1% overall; 96.5% vs. 96.0% > 50y) or HCR (92.3% vs. 89.9% overall; 91.7% vs. 90.7% >50y). For women ≤50y, the absolute reduction in distant recurrence from CT with a RS of 16-20 (N=923) was -0.2% (standard error [SE]±2.1%) for LCR vs. 6.5%(SE±4.9%) for HCR (vs. 1.6%[SE±1.9%] overall), whereas for a RS 21-25 (N=492) it was 6.4% (SE±4.9%) for LCR vs. 8.6% (SE±6.2%) for HCR (vs. 6.5%[SE±3.7%] overall). Conclusions: Clinical risk stratification provides additional prognostic information to the 21-gene RS, but not prediction of CT benefit in the overall TAILORx population or those > 50y, and facilitates more refined estimates of absolute CT benefit for women ≤50y with a RS 16-25. (Funded by National Cancer Institute, Komen Foundation, Breast Cancer Research Foundation). Clinical trial information: NCT00310180.
1. Neoadjuvant trastuzumab (H), pertuzumab (P), and chemotherapy versus trastuzumab emtansine (T-DM1) and P in human epidermal growth factor receptor 2 (HER2)-positive breast cancer (BC): Final outcome results from the phase III KRISTINE study.