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New St. Gallen International Breast Cancer Guidelines Recommend Oncotype DX Breast Recurrence Score® Test to Guide Chemotherapy for Node-negative and Node-positive Early-stage Breast Cancer

New St. Gallen International Breast Cancer Guidelines Recommend Oncotype DX Breast Recurrence Score® Test to Guide Chemotherapy for Node-negative and Node-positive Early-stage Breast Cancer

- Guidelines include TAILORx-defined cutoff of 26 for determining chemotherapy benefit in node-negative disease, and recommend that more women with limited nodal involvement may avoid chemotherapy

- Oncotype DX® test recommended based on prospective landmark TAILORx and German PlanB studies, recognized as key scientific and clinical research innovations of the past two years

- Genomic testing strongly endorsed by vast majority of panelists

REDWOOD CITY, Calif., Aug. 21, 2019  Genomic Health today announced that, based on results from the prospective TAILORx1 and PlanB2 studies, the 16thSt. Gallen International Breast Cancer Conference Expert Panel has recommended the Oncotype DX Breast Recurrence Score® test to guide chemotherapy treatment use for patients with hormone-receptor positive, HER-2 negative early-stage breast cancer with and without lymph node involvement (up to three positive nodes).

In particular, the panelists recognized the value of the landmark TAILORx study results and noted that women with node-negative cancers and Recurrence Score® results ≤25 do not need chemotherapy.3 This group represents up to about 80% of patients who may be safely spared chemotherapy. The Breast Recurrence Score test also identifies those patients (with results of 26 to 100) who may receive a life-saving benefit from chemotherapy.

In the new guidelines, genomic testing with robust validation through prospective, randomized trials is preferred over clinical-pathological features "for basing the critical yes/no chemotherapy decision." 4 Results from a recently published subset analysis of the prospective, randomized TAILORx study5 showed that only the Breast Recurrence Score test is predictive of chemotherapy benefit; clinical and pathological features are only prognostic and do not provide predictive information.