21 – Gene Recurrence Score

TailoRx trial demonstrated about 70% of patients with hormone receptor-positive, human epidermal growth factor receptor 2 (HER2)-negative, axillary node-negative early-stage breast cancer, who received intermediate score on the Oncotype DX test, could be spared chemotherapy.

Trial Assigning IndividuaLized Options for TReatment (TAILORx), which involved more than 10,000 patients and tested the 21-tumor gene expression assay (Oncotype Dx, Genomic Health).

The trial enrolled women age 18-75 years with HR-positive, HER 2 negative breast cancer measuring 1-5 cm with unfavorable histologic features, without involvement of axillary lymph nodes.

The largest adjuvant breast cancer trial ever performed.

The TAILORx trial enrolled 10,273 women with hormone-sensitive, HER2-negative, axillary node-negative breast cancer.

The trial found no difference in the disease-free survival whether these women were treated with endocrine therapy alone or with the combination of endocrine therapy with chemotherapy.

The trial found about half of all breast cancers are hormone receptor positive, HER2 negative, and axillary node negative but up to 30% of patients have recurrences by 10 years,

This population can be spared an estimated 70% of patients and limit chemotherapy to the 30% who may benefit from it.

Adjuvant chemotherapy in the above patients reduced the risk for relapse, but the absolute benefit was only 3% to 5%,suggesting many women are being overtreated, because endocrine therapy would be adequate,

TAILORx trial showed that with equivalent treatments in women with hormone positive, HER2 neg, breast cancer, black women has significantly higher breast cancer recurrence and increased overall mortality compared to white women.

Black women in the US are more likely to have a high risk recurrence score and to die of axillary node-negative breast cancer compared with white women with comparable recurrence scores (Hoskins)
The study showed that postmenopausal women older than 50 years with recurrent score of 25 or less, including those with noden negative disease and up to three nodes involved, there was no benefit to chemotherapy.
For women age less than 50 years with node negative Disease a Recurrent score 15 or less, no chemotherapy benefit was observed.
For pre-menopausal women with node negative disease and a recurrent score of 16-25, there was a benefit from chemotherapy added to endocrine therapy.
For all premenopausal patients with up to three involved lymph nodes and a recurrence score of 25 or less chemotherapy adds  benefit to endocrine therapy.
Among pre-menopausal women with 1to 3 positive lymph nodes and a recurrent score of 25 or lower, those who receive chemo endocrine therapy have longer does invasive disease free survival and distance relapse free survival then those who receive endocrine only therapy, whereas postmenopausal women with similar characteristics do not benefit from adjuvant chemotherapy

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