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Breast Cancer Research and Treatment

, Volume 163, Issue 2, pp 303–310 | Cite as

Breast cancer-specific survival in patients with lymph node-positive hormone receptor-positive invasive breast cancer and Oncotype DX Recurrence Score results in the SEER database

  • Megan C. Roberts
  • Dave P. Miller
  • Steven Shak
  • Valentina I. Petkov
Epidemiology

Abstract

Purpose

The Oncotype DX® Breast Recurrence Score™ (RS) assay is validated to predict breast cancer (BC) recurrence and adjuvant chemotherapy benefit in select patients with lymph node-positive (LN+), hormone receptor-positive (HR+), HER2-negative BC. We assessed 5-year BC-specific survival (BCSS) in LN+ patients with RS results in SEER databases.

Methods

In this population-based study, BC cases in SEER registries (diagnosed 2004–2013) were linked to RS results from assays performed by Genomic Health (2004–2014). The primary analysis included only patients (diagnosed 2004–2012) with LN+ (including micrometastases), HR+ (per SEER), and HER2-negative (per RT-PCR) primary invasive BC (N = 6768). BCSS, assessed by RS category and number of positive lymph nodes, was calculated using the actuarial method.

Results

The proportion of patients with RS results and LN+ disease (N = 8782) increased over time between 2004 and 2013, and decreased with increasing lymph node involvement from micrometastases to ≥4 lymph nodes. Five-year BCSS outcomes for those with RS < 18 ranged from 98.9% (95% CI 97.4–99.6) for those with micrometastases to 92.8% (95% CI 73.4–98.2) for those with ≥4 lymph nodes. Similar patterns were found for patients with RS 18–30 and RS ≥ 31. RS group was strongly predictive of BCSS among patients with micrometastases or up to three positive lymph nodes (p < 0.001).

Conclusions

Overall, 5-year BCSS is excellent for patients with RS < 18 and micrometastases, one or two positive lymph nodes, and worsens with additionally involved lymph nodes. Further analyses should account for treatment variables, and longitudinal updates will be important to better characterize utilization of Oncotype DX testing and long-term survival outcomes.

Keywords

Breast cancer Disease-specific survival Lymph node-positive Oncotype DX Recurrence Score SEER 

Abbreviations

1LN

One positive lymph node

1–3LN

One to three positive lymph nodes

2LN

Two positive lymph nodes

2–3LN

Two to three positive lymph nodes

3LN

Three positive lymph nodes

≥4LN

Four or more positive lymph nodes

ANOVA

Analysis of variance

BC

Breast cancer

BCSS

Breast cancer-specific survival

CI

Confidence interval

ER

Estrogen receptor

HER2

Human epidermal growth factor receptor 2

HR+

Hormone receptor-positive (ER-positive, PR-positive, or both)

LN+

Lymph node-positive

N1mi

Micrometastases

PR

Progesterone receptor

RS

Recurrence Score®

RT-PCR

Reverse transcription-polymerase chain reaction

RxPONDER

Treatment (Rx) for positive node, endocrine-responsive breast cancer

SD

Standard deviation

SEER

Surveillance, epidemiology, and end results

SES

Socioeconomic status

Notes

Acknowledgements

We acknowledge Anna Lau for medical writing and editorial assistance. The ideas and opinions expressed herein are those of the author(s) and endorsement by any State, Department of Public Health, the National Cancer Institute, the Centers for Disease Control and Prevention, or their Contractors and Subcontractors is not intended nor should be inferred. The Surveillance, Epidemiology and End Results (SEER) Program is funded by the National Cancer Institute (NCI). Genomic Health performed the work to electronically submit the Recurrence Score results, but provided no funding for this study. We acknowledge the SEER registries for collecting the SEER data.

Compliance with ethical standards

Conflict of interest

Dr. Roberts and Dr. Petkov declare no conflicts of interest. Mr. Dave Miller and Dr. Stephen Shak are employed by and have stock ownership in Genomic Health Inc.

Supplementary material

10549_2017_4162_MOESM1_ESM.pdf (364 kb)
Supplementary material 1 (PDF 364 kb)

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Copyright information

© Springer Science+Business Media New York (outside the USA) 2017

Authors and Affiliations

  • Megan C. Roberts
    • 1
  • Dave P. Miller
    • 2
  • Steven Shak
    • 2
  • Valentina I. Petkov
    • 1
  1. 1.National Cancer InstituteBethesdaUSA
  2. 2.Genomic Health Inc.Redwood CityUSA

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