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AJCC Recognizes Role of Oncotype DX in Classifying Patients


American Joint Commission of Cancer (AJCC) Incorporates the Oncotype DX Breast Recurrence Score in Its Cancer Staging Manual; Recognizes Role of Oncotype DX in Classifying Patients

The AJCC has announced that the Oncotype DX Breast Recurrence Score® will be added to its latest criteria for staging breast cancer patients. This is the first and only molecular marker incorporated in the staging criteria, along with estrogen receptor (ER), progesterone receptor (PR) and HER2 status. This milestone decision marks the transition of cancer care and diagnosis to personalized medicine, recognizing the value of genomic testing to more precisely define prognosis and tailor treatment to the individual biology of each patient’s disease.

The inclusion of Oncotype DX in the Eighth Edition AJCC Cancer Staging Manual was the result of a rigorous, multi-disciplinary assessment of clinical prospective, level 1 evidence in more than 63,000 patients, including –

  • Prospective validation results published in the New England Journal of Medicine in 2015,
  • Clinical outcomes data from tens of thousands of patients obtained by the Surveillance, Epidemiology and End Results (SEER) Registry program of the National Cancer Institute (NCI), and
  • The first subset of results from the TAILORx (Trial Assigning Individualized Options for Treatment (RX)) study.

For a patient with a Oncotype DX Breast Recurrence Score of less than 11, a cancer previously classified as Stages IB-IIIA will be downstaged as Stage IA – meaning that these patients can safely avoid chemotherapy and its side effects. The new staging criteria will be implemented January 1, 2018, by the AJCC and its partners, the College of American Pathologists (CAP) and the National Comprehensive Cancer Network (NCCN)®


T1 G1 PR-
T1 G3 PR+
T2 G1 PR+
T2 G2 PR+

T1 G3 PR-
T2 G1 PR-
T2 G3 PR+

T2 G2 PR-

T2 G3 PR-
When Recurrence Score result <11, all of these patients are classified as Stage IA

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