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St. Gallen International Breast Cancer Guidelines for the Third Time Distinguish Oncotype DX as the Only Multi-Gene Test Validated to Predict Chemotherapy Benefit

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Genomic Health (Nasdaq: GHDX) recently announced that the 14th St. Gallen International Breast Cancer Conference Expert Panel, for the third time, recognized the Oncotype DX® breast cancer test for its ability to provide not only prognostic but also predictive information regarding the likelihood of chemotherapy benefit for patients with early-stage, estrogen receptor-positive, invasive breast cancer. Oncotype DX was the only multi-gene test accepted with a strong majority of panellists supporting it as a predictive tool to guide chemotherapy treatment decision making. The new guidelines were recently published online in the Advance Access section of Annals of Oncology and will appear in a future print issue.

“Many newly diagnosed breast cancer patients face the difficult decision of whether or not to undergo chemotherapy,” said Dr Angelo Di Leo, member of the St. Gallen Expert Panel and Head of the Medical Oncology Unit at the Hospital of Prato, Istituto Toscano Tumori, Italy. “A tool like the Oncotype DX test can be helpful in identifying the group of patients with endocrine sensitive breast cancer who are likely to derive benefit from adjuvant chemotherapy.”

Standard clinical criteria commonly used for making chemotherapy treatment decisions prior to the availability of Oncotype DX often resulted in substantial overtreatment and unnecessary costs to the healthcare system. Research shows that less than 10 percent of patients with early-stage breast cancer actually benefit from chemotherapy and about one-third of treatment recommendations for early-stage breast cancer patients change after the use of the Oncotype DX test. It has been shown through more than 20 studies that testing with Oncotype DX saves costs across healthcare systems. Recently-presented results from Ireland4 showed that use of the Oncotype DX test in early-stage breast cancer reduced chemotherapy use by half, resulting in net cost savings of nearly €800,000, or approximately $900,000 U.S. dollars.

The clinical validation studies of Oncotype DX in early-stage breast cancer have shown that the Recurrence Score is prognostic and predicts the benefit of adding chemotherapy at diagnosis with long-term follow-up of 10 years. Additionally, the Panel this year expressed substantial (43.8 percent) support for the prognostic value of Oncotype DX beyond five years, as it relates to considering whether to extend hormonal treatment for an additional five years in some patients.

“We are pleased that the St. Gallen expert panel recognized once again the unmatched value of Oncotype DX in guiding important chemotherapy treatment decisions as well as the test’s benefit in better defining who is at greatest risk for late recurrences and may be considered for extended tamoxifen or aromatase inhibitor treatment,” said Phil Febbo, M.D., chief medical officer, Genomic Health. “Since our test became available in 2004, we have served more than half a million patients in over 80 countries, and our test continues to be recognized in international treatment guidelines, including NICE, St. Gallen ESMO®, and AGO in Germany.”

Source: PR Newswire