Clinical Outcomes by Chemotherapy Regimen in Patients with RS 26-100 in TAILORx

Date

30 Sep 2019

Session

Proffered Paper - Breast cancer, early stage

Presenters

Joseph Sparano

Citation

Annals of Oncology (2019) 30 (suppl_5): v851-v934. 10.1093/annonc/mdz394

Authors

J. Sparano1, R.J. Gray2, D. Makower3, K. Albain4, T.J. Saphner5, S. Badve6, L. Wagner7, C. Mihalcioiu8, C. Desbiens9, D.F. Hayes10, E.C. Dees11, C. Geyer12, J. Olson13, W.C. Wood14, T. Lively15, S. Paik16, M. Ellis17, J.S. Abrams18, G. Sledge19

Author affiliations

  • 1 Oncology, Montefiore Medical Center, Albert Einstein College of Medicine, 10461 - Bronx/US
  • 2 Biostatistics, Dana Farber Cancer Instiute, Boston/US
  • 3 Oncology, Montefiore Medical Center, 10461 - Bronx/US
  • 4 Oncology, Loyola University Medical Center, 60153 - Maywood/US
  • 5 Oncology, Aurora Cancer Center, 52241 - Two Rivers/US
  • 6 Pathology, Indiana University Medical Center, 46202 - Indanapolis/US
  • 7 Psychology, Wake Forest University Health Science Center, 27109 - Winston Salem/US
  • 8 Oncology, McGill University Health Centre - Glen Site, H4A 3J1 - Montreal/CA
  • 9 Oncology, University Laval, 514-934-1934 - Quevec/CA
  • 10 Oncology, University of Michigan, 48109 - Ann Arbor/US
  • 11 Hematology And Oncology, UNC Lineberger Comprehensive Cancer Center, 27715 - Chapel Hill/US
  • 12 Oncology, Massey Cancer Center - McGlothlin Medical Education Ctr., 23298 - Richmond/US
  • 13 Surgery, University of Maryland, 21201 - Baltimore/US
  • 14 Surgery, Emory University, Atlanta/US
  • 15 Biostatistics, National Cancer Instituter, Bethesda/US
  • 16 Pathology, Yonsei University College of Medicine, seoul/KP
  • 17 Oncology, Baylor College of Medicine, 77030 - Houston/US
  • 18 Oncology, National Cancer Institute, Bethesda/US
  • 19 Medicine - Med/oncology, Stanford University, 94305 - Stanford/US
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Resources

Background

The recurrence score (RS) based on the 21-gene breast cancer assay predicts chemotherapy benefit if it is high and a low risk of recurrence in the absence of chemotherapy if it is low. There is little information from prospective clinical trials, however, regarding outcomes for patients with a high RS treated with chemotherapy regimens including taxanes and/or anthracyclines.

Methods

Women with hormone-receptor-positive, HER2-negative, axillary-node-negative breast cancer and a high RS of 26-100 were assigned to receive endocrine therapy plus a chemotherapy regimen selected by the treating physician.

Results

Among the 9719 eligible women, 1389 (14%) had a RS of 26-100.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-FU in 52 (4%), other regimens in 81 (6%), and no chemotherapy in 89 (6%). The estimated rates of freedom from recurrence of breast cancer at a distant site were 93.0% (standard error [SE]+0.8%) at 5 years and 86.8% (SE + 1.7%) at 9 years. In contrast, the projected rates of freedom from distant recurrence in this population if treated with endocrine therapy alone was estimated to be 78.8% (SE ± 14.0%) at 5 years and 65.4% (SE ± 10.4%) at 9 years when estimating outcomes based on the treatment effect of chemotherapy noted in the HER2-negative cohort of the B20 trial. Five-year rates of freedom from distant recurrence ranged from 92.3% to 95.5% for all chemotherapy regimens with the exception of CMF (88.5%).

Conclusions

The estimated rate of freedom from distant recurrence in women with a RS of 26-100 treated with a variety of adjuvant taxane and/or anthracycline-containing 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.

Clinical trial identification

NCT00310180.

Editorial acknowledgement

Legal entity responsible for the study

ECOG-ACRIN Cancer Research Group.

Funding

USA National Cancer Institute, Genomic Health.

Disclosure

All authors have declared no conflicts of interest.

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