Many Patients with Early-Stage Breast Cancer May Not Need Chemotherapy – The TAILORx Study

A study seeking the answer to this important question was presented at the ASCO 2018 Congress on its 3rd day.

Breast cancer is the most common cancer type in women. Patients whose hormone receptor status is positive, whose HER2 test is negative and whose cancer has not metastasized to the underarm lymph nodes account for 50% of all breast cancer patients.

Publications from the 1990 period recommended preventive chemotherapy for all patients operated on for early-stage breast cancer. As breast cancer biology became better understood and genetic analyses were performed, it emerged that some patients with hormone receptor-positive, HER2 receptor-negative early-stage breast cancer would not benefit from chemotherapy. One test contributing to these evaluations and determining recurrence risk is the Oncotype Dx gene analysis score.

The Oncotype Dx test guides the decision to give chemotherapy in hormone receptor-positive, HER2-negative breast cancer that has not metastasized to the underarm lymph nodes

This scoring test evaluates 16 cancer-specific genes together with 5 reference genes in tumor tissue, revealing the likelihood of breast cancer recurrence. A low-risk result means chemotherapy is not needed; a high-risk result means giving chemotherapy will benefit the patient. Intermediate-risk patients’ chemotherapy decisions used to be made by the physician based on clinical findings. The TAILORx study, evaluating intermediate-risk patients, provided an answer to this question.

Among 6711 intermediate-risk patients, some received hormone-suppressing treatment alone, while the other group received preventive chemotherapy followed by hormone-suppressing treatment. Patients were followed for an average of 7.5 years. In those over 50 with hormone receptor-positive, HER2 receptor-negative disease and an Oncotype Dx recurrence score of 0-25, and those under 50 with an Oncotype Dx score of 0-15, preventive chemotherapy provided no additional benefit; hormonal therapy alone was shown to be sufficient.

Among patients with early-stage, hormone receptor-positive, HER2-negative breast cancer without underarm lymph node metastases, the study showed that 70% could be followed with hormone-suppressing treatment alone, without chemotherapy. A question for the future is whether some patients with early-stage disease that has metastasized to the underarm lymph nodes might also benefit from hormonal therapy alone after assessment using Oncotype Dx. Ongoing clinical trials will answer this question in the coming years. We will keep following the results for you as they are announced.

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