We outline the initial results from the TAILORx clinical trial. This large study utilized the Oncotype DX genomic genomic assay. Its results show that more women can avoid chemotherapy for their breast cancer in the future.


Questions for your Breast Surgeon and Medical Oncologist:

  • Do I qualify for a Oncotype DX genomic assay?
  • What is an “Intermediate” Recurrence Score?
  • Tell me about the TAILORx Clinical Trial results?
  • Can I avoid chemotherapy for my early stage breast cancer?

Why is the TAILORx Breast Cancer Trial a big deal?

This cutting edge information now allows us to offer chemotherapy to only those women who will need it. The TAILORx trial has proven that even more women can now avoid chemotherapy when the genomic test (Oncotype DX) is a part of their treatment decision. This is a leap forward in “Personalized Medicine.” Using sophisticated breast cancer genomic tests to make sure women get chemotherapy, only if they need it. As a result, thousands of women with breast cancer will now be spared the toxicity and side effects of chemotherapy due to the TAILORx clinical trial.


Why do many women get unnecessary chemotherapy for their breast cancer?

Fifteen years ago, we would offer chemo to nearly all patients with breast cancer. Back then, we were unable to determine which cancers were at a “low risk” for coming back and would not have benefited from chemotherapy. So we gave it to everyone. We can now do a “genomic” analysis of a woman’s actual breast cancer tissue. These sophisticated tests look deeper into the cancer cells and can let us determine more precisely if a woman will or will not need chemotherapy. The TAILORx trial tells us there are many more women who can now avoid chemotherapy, that would have unnecessarily had to endure it.


What do the early TAILORx results tell us?

Until now, women who qualified for a genomic assay (Oncotype DX) of their cancer tissue, often had a result that was “Intermediate” or inconclusive. This meant the test did not point convincingly towards or against the need for chemotherapy. The TAILORx trial concluded that most patients in this intermediate group do not benefit from chemotherapy for their early stage breast cancer. It is a major advance for patients and will save thousands from undergoing chemotherapy.


What is a genomic assay?

These sophisticated tests are performed on a small sample of cancer tissue in appropriate patients with early stage breast cancer. Genomic tests are usually ordered after surgery when the pathology report is finalized. It measures unique aspects of the tumor to determine if a patient will benefit from chemotherapy in addition to hormonal therapy. Such “genomic assays” developed over the last decade are a dramatic advance in breast cancer care. The Oncotype DX assay (here) by Genomic Health Inc. is the most utilized genomic assay of those available in the United States.

While their names sound similar, breast cancer genomic testing and genetic testing are very different. Genetic testing determines if you inherited a broken gene that may cause you to develop certain types of cancers in your lifetime. Genomic testing is a deeper look into the genetic changes of your individual cancer cells to determine the best cancer therapy. View our video lesson on “BRCA Genetic Testing” (here) to learn more about genetic testing for breast cancer.


Who should consider a genomic test?

Patients who have small “Estrogen receptor positive” (ER+) and “HER2 receptor negative” (HER2-) tumors and no evidence of cancer in their lymph nodes may benefit from an Oncotype DX assay. The purpose of this test is to better identify people who do and do not benefit from chemotherapy. The decision to undergo chemotherapy is a complicated one. Your medical oncologist will examine multiple factors to help determine if you will benefit from chemotherapy. The NCCN Guidelines, listed in the website links below, outline in much greater detail recommendations for the use of genomic tests. An Oncotype DX test can be instrumental in this decision for many patients.


You may qualify for an Oncotype DX test if…

• You have early stage cancer (Stage I or II)

• Your tumor is Estrogen receptor positive (ER+)

• Your tumor is Her2 receptor negative (HER2-)

• No cancer was found in your lymph nodes

• You are willing to consider having chemotherapy

• You are healthy enough to undergo chemotherapy


How is chemotherapy tailored to patients?

Genomic breast cancer tests are a leap forward in our ability to “look inside” breast cancer cells. Sophisticated breast cancer care is based upon the principle of providing maximal benefit from the least toxic therapy. Newly diagnosed breast cancer patients deserve the best information available to decide whether they need chemotherapy. Take our video lesson on “Will I Need Chemotherapy?“ (here) to understand the general concepts. Genomics is a promising and rapidly developing field.


Take Home Message:

Make sure to ask both your breast surgeon and medical oncologist if a genomic assay might play a role in your treatment decisions. For appropriate patients, these tests should be considered only one piece of the many “pieces of the puzzle” in deciding treatment decisions about chemotherapy and hormonal therapy.


Patient-Friendly References:

This page (here) contains resources and educational material from the organization that designed the TAILORx clinical trial. The ECOG-ACRIN Cancer Research Group is an organization that designs and conducts biomarker-driven cancer research involving adults who have or are at risk of developing cancer. It is dedicated to reducing the burden of cancer and to improve the quality of life and survival in patients with cancer.


The above YouTube video also linked (here) is an excellent outline of the TAILORx trial and Oncotype DX genomic assay. It was released one week before the clinical trial results were available. Genomic Health Inc. is a leading personalized medicine company.


This early summary (here) of the TAILORx results were published by the ASCO online magazine. The American Society of Clinical Oncology is the largest professional oncology society in the world.


More Detailed References:

  • www.nejm.org
    The formal TAILORx trial results are published (here) in the New England Journal of Medicine.



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