New TAILORx Data: Clinical Outcomes in Patients with High Recurrence Score® Results

Results from a new analysis of the Trial Assigning IndividuaLised Options for Treatment (Rx), or TAILORx, which reinforce the unique value of the Oncotype DX Breast Recurrence Score^® test to guide the use of adjuvant chemotherapy for women with hormone receptor-positive (HR+), HER2-negative, early-stage breast cancer and identify those patients who derive a significant benefit from treatment. The findings, published in JAMA Oncology and presented at the ESMO 2019 Congress, are consistent with results from the B20 trial and show that, in patients with high Recurrence Score results (26-100) treated with endocrine therapy plus chemotherapy, outcomes were better compared to what would be expected with endocrine therapy alone. The analysis also provides details on the outcomes of different chemotherapy regimens for the minority of patients who benefit from chemotherapy.

“We’re pleased to see that the landmark TAILORx trial continues to receive global recognition, as evidenced by this fourth peer-reviewed publication,” said Steven Shak, M.D., chief scientific officer, Genomic Health. “TAILORx established that the Oncotype DX test definitively identifies the vast majority of women with early-stage breast cancer who receive no benefit from chemotherapy and the important minority for whom chemotherapy can be life-saving. The additional insight from this new analysis is consistent with, and further supports, the conclusion that the Recurrence Score predicts which patients benefit from chemotherapy and which patients do not, giving them the standard of care they deserve.”

The objective of this secondary analysis of TAILORx, the largest ever breast cancer treatment trial, sponsored by the National Cancer Institute (NCI) and led by the ECOG-ACRIN Cancer Research Group, was to evaluate clinical outcomes for patients with a high Recurrence Score result assigned to receive adjuvant chemotherapy plus endocrine therapy. In this group of 1,389 women, treated largely with standard of care taxane and/or anthracycline-containing adjuvant chemotherapy regimens, the estimated proportion free from distant recurrence at five years was about 93%, an outcome much better than expected with endocrine therapy alone in this population.

“Last year, TAILORx established the highest level of evidence and unprecedented precision supporting the use of the Oncotype DX Breast Recurrence Score test to guide adjuvant chemotherapy treatment for women with early-stage breast cancer,” said lead author Joseph A. Sparano, M.D., associate director for clinical research at the Albert Einstein Cancer Center and Montefiore Health System in New York, and vice chair of the ECOG-ACRIN Cancer Research Group. “This new analysis provides the largest dataset on outcomes in patients with high Recurrence Score results, and confirms the importance of using the test to identify the patients who will receive a significant benefit from adding adjuvant chemotherapy.”

The groundbreaking TAILORx results, presented during the Plenary Session at the 2018 ASCO Annual Meeting and simultaneously published in The New England Journal of Medicine, have elevated the Oncotype DX test to a new standard of care with increasing, and more consistent, use of the test by physicians worldwide for all medically eligible patients. The study is also having an important impact on global reimbursement of the test, most recently in Germany and Italy. Following the German Institute for Quality and Efficiency in Health Care’s (IQWiG’s) positive assessment of the TAILORx results, the German Federal Joint Committee (G-BA) issued an exclusive nationwide reimbursement decision for the Oncotype DX test. In Italy, the Lombardy Regional Authority adopted a resolution to include the test in the Regional Health Service Fees List, thereby making it available as of September 1, 2019, to eligible patients living in the region.

Over the last several months, results of the TAILORx study have also influenced positive treatment guideline updates distinguishing the Oncotype DX Breast Recurrence Score test from prognostic-only tests based on clinical evidence and the critical importance of predicting chemotherapy benefit. The updates include:

1) The recent update to ASCO guidelines, which increased the proportion of women who can be effectively treated without chemotherapy based on the Recurrence Score results, highlighting the importance of testing all medically eligible early-stage breast cancer patients.
2) The National Comprehensive Cancer Network (NCCN), which updated its guidelines in 2018 to categorise the Breast Recurrence Score test as the only “preferred” test for chemotherapy treatment decision-making for patients with node-negative, early-stage breast cancer. NCCN also classified the Breast Recurrence Score test as the only test that is predictive of chemotherapy benefit.
3) The new St. Gallen International Breast Cancer Guidelines, which recommend the Oncotype DX 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).
4) The updated ESMO guidelines for early-stage breast cancer, which elevated the Oncotype DX test to highest 1A level of evidence and refer to TAILORx and PlanB results, which identify groups of patients – both in the node-negative and node-positive setting – for whom chemotherapy can be safely spared.