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Related Concept Videos

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Related Experiment Video

Updated: Jun 19, 2025

Establishing a Competing Risk Regression Nomogram Model for Survival Data
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Clinical and Genomic Risk for Late Breast Cancer Recurrence and Survival.

Joseph A Sparano1, Michael Crager2, Robert J Gray3

  • 1Icahn School of Medicine at Mount Sinai, Tisch Cancer Institute, New York.

NEJM Evidence
|July 23, 2024
PubMed
Summary
This summary is machine-generated.

The 21-gene recurrence score (RS) assay improves distant recurrence risk prediction in early breast cancer when combined with clinicopathologic factors. This integrated model offers better prognostic information than RS or factors alone for late recurrence.

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Area of Science:

  • Oncology
  • Genomics
  • Biostatistics

Background:

  • The 21-gene recurrence score (RS) assay (Oncotype DX) is crucial for guiding adjuvant chemotherapy in early-stage, hormone receptor-positive, HER2-negative breast cancer.
  • The prognostic value of RS for late distant recurrence, beyond established clinicopathologic factors, remains under investigation.

Purpose of the Study:

  • To evaluate the added prognostic value of the 21-gene RS to clinicopathologic factors for predicting distant recurrence in early breast cancer.
  • To develop and validate a combined prognostic model (RSClin) for improved risk stratification.

Main Methods:

  • A meta-analysis of 10,004 patients from three trials was updated with extended follow-up data.
  • The RS was integrated with histologic grade, tumor size, and age to create the RSClin tool.
  • External validation was performed in an independent cohort of 1098 patients.

Main Results:

  • The RSClin model significantly improved prognostic information compared to clinicopathologic factors alone (ΔLR χ², 86.2; P<0.001) and RS alone (ΔLR χ², 131.0; P<0.001).
  • The model demonstrated prognostic capability for distant recurrence up to 10 years post-diagnosis in an independent cohort.
  • RSClin accurately approximated observed distant recurrence risks at 10 years (Lin concordance, 0.87) and between 5-10 years (Lin concordance, 0.92).

Conclusions:

  • The 21-gene RS is a significant prognostic marker for distant recurrence and survival in early breast cancer.
  • Integrating the 21-gene RS with clinicopathologic factors enhances distant recurrence risk estimation and stratifies late recurrence risk effectively.