Clinical and Genomic Risk to Guide the Use of Adjuvant Therapy for Breast Cancer

Joseph A Sparano ¹, Robert J Gray ¹, Peter M Ravdin ¹, Della F Makower ¹, Kathleen I Pritchard ¹, Kathy S Albain ¹, Daniel F Hayes ¹, Charles E Geyer ¹, Elizabeth C Dees ¹, Matthew P Goetz ¹, John A Olson ¹, Tracy Lively ¹, Sunil S Badve ¹, Thomas J Saphner ¹, Lynne I Wagner ¹, Timothy J Whelan ¹, Matthew J Ellis ¹, Soonmyung Paik ¹, William C Wood ¹, Maccon M Keane ¹, Henry L Gomez Moreno ¹, Pavan S Reddy ¹, Timothy F Goggins ¹, Ingrid A Mayer ¹, Adam M Brufsky ¹, Deborah L Toppmeyer ¹, Virginia G Kaklamani ¹, Jeffrey L Berenberg ¹, Jeffrey Abrams ¹, George W Sledge ¹

Affiliations

¹ From Montefiore Medical Center, Albert Einstein College of Medicine, Bronx, NY (J.A.S., D.F.M.); Dana-Farber Cancer Institute, Boston (R.J.G.); University of Texas, San Antonio (P.M.R.); Sunnybrook Research Institute, Toronto (K.I.P.), and McMaster University, Hamilton, ON (T.J.W.) - both in Canada; Loyola University Medical Center, Maywood (K.S.A.), and Northwestern University, Chicago (L.I.W., V.G.K.) - both in Illinois; University of Michigan, Ann Arbor (D.F.H.); Virginia Commonwealth University School of Medicine and the Massey Cancer Center, Richmond (C.E.G.); University of North Carolina, Chapel Hill (E.C.D.), and Duke University Medical Center, Durham (J.A.O., J.A.) - both in North Carolina; Mayo Clinic, Jacksonville, FL (M.P.G.); National Institutes of Health, National Cancer Institute, Bethesda, MD (T.L.); Indiana University School of Medicine (S.S.B.) and Indiana University Hospital (G.W.S.), Indianapolis; Vince Lombardi Cancer Clinic, Two Rivers (T.J.S.), and Fox Valley Hematology and Oncology, Appleton (T.F.G.) - both in Wisconsin; Washington University, St. Louis (M.J.E.); the National Surgical Adjuvant Breast and Bowel Project Pathology Office (S.P.) and the University of Pittsburgh (A.M.B.), Pittsburgh; Emory University, Atlanta (W.C.W.); Cancer Trials Ireland, Dublin (M.M.K.); Instituto Nacional de Enfermedades Neoplasicas, Lima, Peru (H.L.G.M.); Cancer Center of Kansas, Wichita (P.S.R.); Vanderbilt University, Nashville (I.A.M.); Rutgers Cancer Institute of New Jersey, New Brunswick (D.L.T.); and the University of Hawaii Cancer Center, Honolulu (J.L.B.).

PMID: 31157962
28 References
45 citations

Abstract

Background: The use of adjuvant chemotherapy in patients with breast cancer may be guided by clinicopathological factors and a score based on a 21-gene assay to determine the risk of recurrence. Whether the level of clinical risk of breast cancer recurrence adds prognostic information to the recurrence score is not known.

Methods: We performed a prospective trial involving 9427 women with hormone-receptor-positive, human epidermal growth factor receptor 2-negative, axillary node-negative breast cancer, in whom an assay of 21 genes had been performed, and we classified the clinical risk of recurrence of breast cancer as low or high on the basis of the tumor size and histologic grade. The effect of clinical risk was evaluated by calculating hazard ratios for distant recurrence with the use of Cox proportional-hazards models. The initial endocrine therapy was tamoxifen alone in the majority of the premenopausal women who were 50 years of age or younger.

Results: The level of clinical risk was prognostic of distant recurrence in women with an intermediate 21-gene recurrence score of 11 to 25 (on a scale of 0 to 100, with higher scores indicating a worse prognosis or a greater potential benefit from chemotherapy) who were randomly assigned to endocrine therapy (hazard ratio for the comparison of high vs. low clinical risk, 2.73; 95% confidence interval [CI], 1.93 to 3.87) or to chemotherapy plus endocrine (chemoendocrine) therapy (hazard ratio, 2.41; 95% CI, 1.66 to 3.48) and in women with a high recurrence score (a score of 26 to 100), all of whom were assigned to chemoendocrine therapy (hazard ratio, 3.17; 95% CI, 1.94 to 5.19). Among women who were 50 years of age or younger who had received endocrine therapy alone, the estimated (±SE) rate of distant recurrence at 9 years was less than 5% (≤1.8±0.9%) with a low recurrence score (a score of 0 to 10), irrespective of clinical risk, and 4.7±1.0% with an intermediate recurrence score and low clinical risk. In this age group, the estimated distant recurrence at 9 years exceeded 10% among women with a high clinical risk and an intermediate recurrence score who received endocrine therapy alone (12.3±2.4%) and among those with a high recurrence score who received chemoendocrine therapy (15.2±3.3%).

Conclusions: Clinical-risk stratification provided prognostic information that, when added to the 21-gene recurrence score, could be used to identify premenopausal women who could benefit from more effective therapy. (Funded by the National Cancer Institute and others; ClinicalTrials.gov number, NCT00310180.).

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