TAILORX CLINICAL TRIAL RESULTS

TAILORx Clinical Trial Results – Chemotherapy Not Needed in Some Early Stage Breast Cancer Patients

The results of the TAILORx clinical trial show that some women with the most common type of breast cancer may no longer need to have chemotherapy to increase their chance of survival when guided by a diagnostic test.

The study found that for some women with hormone receptor (HR) positive, HER2 negative, axillary lymph node-negative breast cancer, treatment with chemotherapy and hormone therapy after surgery is no more beneficial than treatment with hormone therapy alone. A genetic test called Oncotype DX or 21-gene assay may identify up to 70% of women with early stage HR positive HER2 negative breast cancer, which has not spread to the lymph nodes, who can be spared chemotherapy and the side effects of this treatment, especially those who are older than 50 years of age.

The commercial test is widely used in the USA, to provide prognostic information about the risk of breast cancer recurrence within 10 years and to predict which patients are most likely to derive a meaningful benefit from chemotherapy. The test requires a sample of the breast cancer to be sent to and tested in a laboratory in the USA. Women with a low score (0–10) typically receive hormone therapy alone and those with a high score (26–100) receive hormone therapy and chemotherapy.

The findings suggest that chemotherapy may be spared in:

• Women older than 50 years with hormone receptor–positive, HER2-negative, node-negative breast cancer and a Recurrence Score of 0 to 25 (about 85% of women with breast cancer in this age group);
• Women 50 years or younger with hormone receptor–positive, HER2-negative, node-negative breast cancer and a Recurrence Score of 0 to 15 (about 40% of women with breast cancer in this age group).

TAILORx is the largest ever adjuvant breast cancer treatment trial, which aims to identify which patients can effectively use hormone therapy alone, avoiding the negative effects of chemotherapy. The results were announced at the American Society of Clinical Oncology Annual Meeting in Chicago and published in the New England Journal of Medicine.

The study involved 10,273 patients worldwide, including 25 women from Australia and New Zealand. The study was coordinated by the ECOG-ACRIN Cancer Research Group in the United States and was conducted in Australia and New Zealand by Breast Cancer Trials (BCT). The Chair of the BCT Scientific Advisory Committee is Associate Professor Prue Francis.

“The Oncotype DX test has been widely used in the USA for years to assist with chemotherapy decision-making, without prospective randomised clinical trial results from a large trial to clarify what to do for those with mid-range (ie. not low and not high) Recurrence Scores. Previously, for the women with mid-range Recurrence Score results, persisting uncertainty remained about the need for chemotherapy. Now these new results have significantly expanded the group of women who can be advised that chemotherapy is not likely to be helpful after results of their tumour testing,” said Associate Professor Francis.

Breast Cancer Trials (BCT) is the largest, independent oncology clinical trials research group in Australia and New Zealand and has conducted a national clinical trials research program for the treatment, prevention and cure of breast cancer for 40 years. The research program involves almost 800 members at 101 leading medical institutions in Australia and New Zealand. For more information about BCT and its research program visit www.breastcancertrials.org.au.

For media enquiries contact: Anna Fitzgerald, Communications Manager 0400 304 224 or anna.fitzgerald@bctrials.org.au

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