Clinical experience of using Oncotype DX as an additional treatment decision tool in early breast cancer - a retrospective analysis from 5 Greek institutions

Eur J Surg Oncol. 2012 May;38(5):413-9. doi: 10.1016/j.ejso.2012.02.183. Epub 2012 Mar 17.


Aims: The objective of this retrospective study was to describe the results from five institutions' experience of using Oncotype DX(®) to identify patients who need chemotherapy despite the presence of primarily favorable characteristics.

Patients and methods: Oncotype DX was performed in 106 pre- and postmenopausal patients with estrogen receptor-positive, HER2-negative, early breast cancer with a combination of favorable prognostic factors or favorable prognostic factors with at least one unfavorable characteristic (tumor size >2 cm, tumor grading of II-III, Ki-67 ≥ 10%, presence of lymph node micrometastases) in which it was unclear whether hormonal therapy only or chemotherapy plus hormonal therapy was the optimal adjuvant treatment.

Results: Sixty-four (60.4%) women had Recurrence Score (RS) values <18, 29 (27.4%) intermediate RS values of 18-30, and 13 (12.3%) high RS values of ≥31. Tumor size, grading and presence of micrometastases were not associated with the RS. There was a significant association between Recurrence Score and the number of unfavorable characteristics as a categorical but not as a continuous variable. High Recurrence Scores were predictive of high Ki-67 but the converse was not true. Overall, 29 of 106 (27.4%) patients received chemotherapy because of an intermediate or a high Recurrence Score.

Conclusion: The Recurrence Score helped in treatment decision-making for estrogen receptor-positive, HER2-negative patients with favorable characteristics or an intermediate risk of recurrence due to the presence of at least one unfavorable factor. The results of the 21-gene assay increased the likelihood for patients with intermediate clinical and histopathological risk factors receiving chemotherapy.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Aged
  • Antineoplastic Agents, Hormonal / therapeutic use*
  • Antineoplastic Combined Chemotherapy Protocols / therapeutic use*
  • Biomarkers, Tumor / analysis*
  • Breast Neoplasms / chemistry
  • Breast Neoplasms / drug therapy*
  • Breast Neoplasms / pathology*
  • Chemotherapy, Adjuvant
  • Decision Making
  • Female
  • Gene Expression Profiling
  • Humans
  • Immunohistochemistry
  • Ki-67 Antigen / analysis
  • Lymphatic Metastasis
  • Medical Records
  • Middle Aged
  • Neoplasm Grading
  • Neoplasm Proteins / analysis*
  • Neoplasm Recurrence, Local / prevention & control*
  • Predictive Value of Tests
  • Receptor, ErbB-2 / analysis
  • Receptors, Estrogen / analysis
  • Retrospective Studies


  • Antineoplastic Agents, Hormonal
  • Biomarkers, Tumor
  • Ki-67 Antigen
  • Neoplasm Proteins
  • Receptors, Estrogen
  • ERBB2 protein, human
  • Receptor, ErbB-2