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> Latest update of the ASCO guidelines in early breast cancer

17/5/2022

The latest update of the ASCO guidelines in early breast cancer highlights the differential level of evidence and applicability of the Oncotype DX Breast Recurrence Score®, in both node-negative patients and in the majority of node-positive patients.
  • Oncotype DX® stands out from the rest of the multigenic tests in terms of its evidence quality and level of recommendation, both for patients with early HR+, HER2- lymph node-positive breast cancer, and for those patients with no lymph node involvement.
  • The new guidelines incorporate the results of the RxPONDER study, recently published in the prestigious The New England Journal of Medicine, and whose results have led to a change in clinical practice for HER+, HER2- and lymph node-positive patients.

MADISON, Wisconsin, April 28, 2022

Exact Sciences Corp. (NASDAQ: EXAS), a global leader in cancer diagnostics, today announced that recommended use of its Oncotype DX Breast Recurrence Score® test in early-stage breast cancer patients has been expanded by ASCO (American Society of Clinical Oncology) in its 2022 Biomarkers for Adjuvant Endocrine and Chemotherapy in Early-Stage Breast Cancer guideline update.

This new version of the ASCO guidelines positions the Oncotype DX Breast Recurrence Score® as the only platform capable of simultaneously combining the highest level of recommendation and the highest level of evidence, both for pre/postmenopausal patients with no lymph node involvement, and for patients with up to three positive lymph nodes, irrespective of the clinical risk that these patients present. 

"We are pleased that the updated ASCO guidelines recognize the strength of the data supporting Oncotype DX and expand the recommended use of the test based on findings from the RxPONDER study,” said Rick Baehner, M.D., Chief Medical Officer of Precision Oncology at Exact Sciences. “The Oncotype DX test has been used to guide the treatment decisions for more than one million women around the world, and the updated guidelines provide even greater clarity and confidence to physicians in individualizing the discussion of the risks and benefits of chemotherapy with their patients." 

“This new version of the ASCO guidelines does nothing more than reinforce Palex Medical's commitment to medical professionals and their patients. Our challenge as a leading company is to facilitate access to disruptive technologies that, at the same time, can provide proven therapeutic value," said Carlos Hagen, Medical Director of Oncology at Palex Medical SA.

The new ASCO guidelines conclusively incorporate results from the RxPONDER study, published in December 2021 in The New England Journal of Medicine. Approximately one-third of patients diagnosed with early-stage hormone receptor-positive (HR+) and HER2 negative (HER2-) breast cancer have tumors that have invaded their lymph nodes. The vast majority of these patients were treated with adjuvant chemotherapy, which can now be avoided in 85% of cases. Specifically, the RxPONDER study has shown that postmenopausal women with Oncotype DX Breast Recurrence Score® results of 0 to 25 did not show benefit from the addition of chemotherapy, while premenopausal women with results of 0 to 25 received a 2.4% benefit in terms of distant recurrence after five years.

The updated ASCO guidelines, along with NCCN7 guideline recommendations, position the Oncotype DX Breast Recurrence Score® as the diagnostic standard for guiding chemotherapy treatment decisions in patients with early HR+, HER2- breast cancer, regardless of their menopausal status, age and node status.

For more information: Biomarkers for Adjuvant Endocrine and Chemotherapy in Early-Stage Breast Cancer: ASCO Guideline Update | Journal of Clinical Oncology (ascopubs.org)


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