Journal Article
. 2019 Oct;6(3).
doi: 10.1001/jamaoncol.2019.4794.

Clinical Outcomes in Early Breast Cancer With a High 21-Gene Recurrence Score of 26 to 100 Assigned to Adjuvant Chemotherapy Plus Endocrine Therapy: A Secondary Analysis of the TAILORx Randomized Clinical Trial

Joseph A Sparano 1 Robert J Gray 2 Della F Makower 1 Kathy S Albain 3 Thomas J Saphner 4 Sunil S Badve 5 Lynne I Wagner 6 Virginia G Kaklamani 6 Maccon M Keane 7 Henry L Gomez 8 Pavan S Reddy 9 Timothy F Goggins 10 Ingrid A Mayer 11 Deborah L Toppmeyer 12 Adam M Brufsky 13 Matthew P Goetz 14 Jeffrey L Berenberg 15 Catalin Mahalcioiu 16 Christine Desbiens 17 Daniel F Hayes 18 Elizabeth C Dees 19 Charles E Geyer 20 John A Olson 21 William C Wood 22 Tracy Lively 23 Soonmyung Paik 24 Matthew J Ellis 25 Jeffrey Abrams 23 George W Sledge 26 
  • PMID: 31566680
  •     13 citations


Importance: A high 21-gene recurrence score (RS) by breast cancer assay is prognostic for distant recurrence of early breast cancer after local therapy and endocrine therapy alone, and for chemotherapy benefit.

Objective: To describe clinical outcomes for women with a high RS who received adjuvant chemotherapy plus endocrine therapy in the TAILORx trial, a population expected to have a high distant recurrence rate with endocrine therapy alone.

Design, Setting, And Participants: In this secondary analysis of data from a multicenter randomized clinical trial, 1389 women with hormone receptor-positive, ERBB2-negative, axillary node-negative breast cancer, and a high RS of 26 to 100 were prospectively assigned to receive adjuvant chemotherapy in addition to endocrine therapy. The analysis was conducted on May 12, 2019.

Interventions: The adjuvant chemotherapy regimen was selected by the treating physician.

Main Outcomes And Measures: Freedom from recurrence of breast cancer at a distant site, and freedom from recurrence, second primary cancer, and death (also known as invasive disease-free survival [IDFS]).

Results: Among the 9719 eligible women, with a mean age of 56 years (range 23-75 years), 1389 (14%) had a recurrence score of 26 to 100, of whom 598 (42%) had an RS of 26 to 30 and 791 (58%) had an RS of 31 to 100. The most common chemotherapy regimens included docetaxel/cyclophosphamide in 589 (42%), an anthracycline without a taxane in 334 (24%), an anthracycline and taxane in 244 (18%), cyclophosphamide/methotrexate/5-fluorouracil in 52 (4%), other regimens in 81 (6%), and no chemotherapy in 89 (6%). At 5 years, the estimated rate of freedom from recurrence of breast cancer at a distant site was 93.0% (standard error [SE], 0.8%), freedom of recurrence of breast cancer at a distant and/or local regional site 91.0% (SE, 0.8%), IDFS 87.6% (SE, 1.0%), and overall survival 95.9% (SE, 0.6%).

Conclusions And Relevance: The estimated rate of freedom from recurrence of breast cancer at a distant site in women with an RS of 26 to 100 treated largely with taxane and/or anthracycline-containing adjuvant chemotherapy regimens plus endocrine therapy in the prospective TAILORx trial was 93% at 5 years, an outcome better than expected with endocrine therapy alone in this population.

Trial Registration: identifier: NCT00310180.

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