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

JAMA Oncol. 2020 Mar 1;6(3):367-374. doi: 10.1001/jamaoncol.2019.4794.

Abstract

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: ClinicalTrials.gov identifier: NCT00310180.

Publication types

  • Randomized Controlled Trial

MeSH terms

  • Adult
  • Aged
  • Anthracyclines / therapeutic use
  • Antineoplastic Agents / therapeutic use*
  • Breast Neoplasms / drug therapy*
  • Breast Neoplasms / genetics*
  • Bridged-Ring Compounds / therapeutic use
  • Chemotherapy, Adjuvant*
  • Cyclophosphamide / therapeutic use
  • Docetaxel / therapeutic use
  • Female
  • Fluorouracil / therapeutic use
  • Humans
  • Methotrexate / therapeutic use
  • Middle Aged
  • Neoplasm Recurrence, Local / genetics*
  • Taxoids / therapeutic use
  • Treatment Outcome
  • Young Adult

Substances

  • Anthracyclines
  • Antineoplastic Agents
  • Bridged-Ring Compounds
  • Taxoids
  • Docetaxel
  • taxane
  • Cyclophosphamide
  • Fluorouracil
  • Methotrexate

Associated data

  • ClinicalTrials.gov/NCT00310180