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Expanding the Staging Criteria for T1-2N0 Hormone-Receptor Positive Breast Cancer Patients Enrolled in TAILORx

  • Breast Oncology
  • Published:
Annals of Surgical Oncology Aims and scope Submit manuscript

Abstract

Background

The American Joint Committee on Cancer (AJCC) 8th edition pathologic prognostic staging (PPS) incorporates anatomic and biologic factors. The OncotypeDX Breast Recurrence Score (RS) was included based on the initial report of the TAILORx trial, with T1-2N0 hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2−) breast cancer patients who had a RS < 11 staged as PPS 1A. This study examined whether the RS criteria for PPS 1A can be further expanded using patients enrolled in the TAILORx trial.

Methods

The TAILORx trial enrolled 10,273 HR+HER2− T1-2N0 patients. Those with incomplete HR-status/grade and T3 disease were excluded for analysis. The recurrence-free interval (RFI) was compared between the patients who did and those who did not fall into the current PPS 1A category using the Kaplan-Meier method.

Results

The study enrolled 9535 patients for analysis. The RS was < 11 in 16.1%, 11–17 in 35.9%, 18–25 in 32.4%, and > 25 in 15.6% of the patients. The majority (91.2%) of the patients (including all the T1N0 patients regardless of RS) were PPS 1A, and 8.8% were not-PPS 1A. The median follow-up time was 95 months. The PPS 1A patients had an 8-year RFI of 94.2%, which was similar to that of the patients with a RS of 11–17 who were not-PPS 1A (91.7%; p = 0.07) and better than that of the patients with a RS ≥ 18 who were not-PPS 1A (85.4% for a RS of 18–25, 76.0% for a RS > 25; both p < 0.01). Similar RFI trends were seen in patients who received endocrine therapy or chemotherapy followed by endocrine therapy.

Conclusions

Patients with T1-2N0 HR+HER2− breast cancer and a RS < 18 have an RFI similar to that of patients staged as PPS 1A by the current AJCC staging system, regardless of treatment, suggesting that the criteria for PPS 1A can be expanded to include a RS < 18.

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Acknowledgment

The manuscript was prepared using data from Dataset NCT00310180-D1 from the NCTN/NCORP Data Archive of the National Cancer Institute’s (NCI’s) National Clinical Trials Network (NCTN). Data were originally collected from clinical trial NCT number 00310180 Program for the Assessment of Clinical Cancer Tests (PACCT-1): Trial Assigning Individualized Options for Treatment (TAILORx) Trial. All analyses and conclusions in this manuscript are the sole responsibility of the authors and do not necessarily reflect the opinions or views of the clinical trial investigators, the NCTN, the NCORP, or the NCI. The TAILORx clinical trial data are available by request through the NCTN data archive. Elizabeth A. Mittendorf receives support as the Rob and Karen Hale Distinguished Chair in Surgical Oncology. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.

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Authors and Affiliations

  1. Division of Breast Surgery, Department of Surgery, Brigham and Women’s Hospital, Boston, MA, USA

    Olga Kantor MD, MS, Tari A. King MD & Elizabeth A. Mittendorf MD, PhD

  2. Breast Oncology Program, Dana-Farber Brigham Cancer Center, Boston, MA, USA

    Olga Kantor MD, MS, Harold J. Burstein MD, PhD, Tari A. King MD, Eric P. Winer MD & Elizabeth A. Mittendorf MD, PhD

  3. Harvard Medical School, Boston, MA, USA

    Olga Kantor MD, MS, Harold J. Burstein MD, PhD, Tari A. King MD, Eric P. Winer MD & Elizabeth A. Mittendorf MD, PhD

  4. Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA, USA

    Harold J. Burstein MD, PhD & Eric P. Winer MD

  5. Exact Sciences Corporation, Redwood City, CA, USA

    Steven Shak MD & Christy A. Russell MD

  6. Department of Surgery, Cedars-Sinai Medical Center, Los Angeles, CA, USA

    Armando E. Giuliano MD

  7. Department of Breast Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA

    Gabriel N. Hortobagyi MD

  8. Yale Cancer Center, New Haven, CT, USA

    Eric P. Winer MD

  9. Cancer Therapy Evaluation Program, Division of Cancer Treatment and Diagnosis, National Cancer Institute, Bethesda, MD, USA

    Larissa A. Korde MD, MPH

  10. Montefiore Medical Center, Albert Einstein College of Medicine, Bronx, NY, USA

    Joseph A. Sparano MD

  11. Icahn School of Medicine at Mount Sinai, Tisch Cancer Institute, New York, NY, USA

    Joseph A. Sparano MD

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  1. Olga Kantor MD, MS
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  2. Harold J. Burstein MD, PhD
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  3. Tari A. King MD
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  6. Armando E. Giuliano MD
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  7. Gabriel N. Hortobagyi MD
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  11. Elizabeth A. Mittendorf MD, PhD
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Corresponding author

Correspondence to Elizabeth A. Mittendorf MD, PhD.

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Disclosure

Elizabeth A. Mittendorf reports compensated service on scientific advisory boards for AstraZeneca, Exact Sciences, Merck, and Roche/Genentech; uncompensated service on steering committees for Bristol Myers Squibb, Lilly, and Roche/Genentech; and institutional research support from Roche/Genentech (via SU2C grant) and Gilead. She reports the following nonfinancial interests and nonremunerated activities: Board of Directors for the American Society of Clinical Oncology and Scientific Advisor for Susan G. Komen for the Cure Foundation. Tari A. King reports speaker’s honoraria and compensated service on the scientific Advisory Board of Exact Sciences (formerly Genomic Health, Inc.) and compensated service for a Global Advisory Board of Besins Healthcare. Christy A. Russell and Steven Shak report employment by Exact Sciences (formerly Genomic Health, Inc.) and stock ownership of Exact Sciences. Eric P. Winer reports institutional research funding from Genentech/Roche; serving as a consultant for Athenex, Carrick Therapeutics, G1 Therapeutics, Genentech/Roche, Genomic Health, Gilead, GlaxoSmithKline, GSK, Jounce, Lilly, St. Lucia, Syros, and Zymeworks; a non-paid scientific advisory board membership at Leap Therapeutics; and serving as President-Elect of ASCO. The remaining authors have no conflicts of interest.

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Kantor, O., Burstein, H.J., King, T.A. et al. Expanding the Staging Criteria for T1-2N0 Hormone-Receptor Positive Breast Cancer Patients Enrolled in TAILORx. Ann Surg Oncol 29, 8016–8023 (2022). https://doi.org/10.1245/s10434-022-12225-5

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