Validation of a breast cancer assay for radiotherapy omission: an individual participant data meta-analysis

J Natl Cancer Inst. 2025 Mar 1;117(3):486-495. doi: 10.1093/jnci/djae262.

Abstract

Background: There are currently no molecular tests to identify individual breast cancers where radiotherapy (RT) offers no benefit. Profile for the Omission of Local Adjuvant Radiotherapy (POLAR) is a 16-gene molecular signature developed to identify low-risk cancers where RT will not further reduce recurrence rates.

Methods: An individual participant data meta-analysis was performed in 623 patients of node-negative estrogen receptor-positive and HER2-negative early breast cancer enrolled in 3 RT randomized trials for whom primary tumor material was available for analysis. A Cox proportional hazards model on time to locoregional recurrence was used to test the interaction between POLAR score and RT.

Results: A total of 429 (69%) patients' tumors had a high POLAR score, and 194 (31%) had a low score. Patients with high POLAR score had, in the absence of RT, a 10-year cumulative incidence of locoregional recurrence (20%, 95% confidence interval [CI] = 15% to 26%, vs 5%, [CI] 2% to 11%) for those with a low score. Patients with a high POLAR score had a large benefit from RT (hazard ratio [HR] for RT vs no RT = 0.37, 95% CI = 0.23 to 0.60; P < .001). In contrast, there was no evidence of benefit from RT for patients with a low POLAR score (HR = 0.92, 95% CI = 0.42 to 2.02; P = .832). The test for interaction between RT and POLAR was statistically significant (P = .022).

Conclusions: POLAR is not only prognostic for locoregional recurrence but also predictive of benefit from RT in selected patients. Patients aged 50 years and older with estrogen receptor-positive and HER2-negative disease and a low POLAR score could consider omitting adjuvant RT. Further validation in contemporary clinical cohorts is required.

Publication types

  • Meta-Analysis
  • Validation Study

MeSH terms

  • Adult
  • Aged
  • Biomarkers, Tumor* / analysis
  • Biomarkers, Tumor* / genetics
  • Breast Neoplasms* / chemistry
  • Breast Neoplasms* / genetics
  • Breast Neoplasms* / pathology
  • Breast Neoplasms* / radiotherapy
  • Female
  • Gene Expression Profiling
  • Humans
  • Middle Aged
  • Neoplasm Recurrence, Local* / epidemiology
  • Neoplasm Recurrence, Local* / prevention & control
  • Proportional Hazards Models
  • Radiotherapy, Adjuvant
  • Randomized Controlled Trials as Topic
  • Receptor, ErbB-2 / analysis
  • Receptors, Estrogen / analysis

Substances

  • Receptors, Estrogen
  • Receptor, ErbB-2
  • Biomarkers, Tumor
  • ERBB2 protein, human