What My Patients Are Asking: What Do the TAILORx Trial Results Mean For Me?

By on October 30th, 2015 Categories: Research News

First results from the TAILORx trial (Trial Assigning IndividuaLized Options for Treatment) were published on Sept. 28, 2105 by the New England Journal of Medicine.

This powerful study showed that women eligible for the Oncotype DX test and who have an Oncotype DX Recurrence Score between 0 and 10 can safely skip chemotherapy.

The Oncotype DX test is a genomic test that analyzes the activity of a group of 21 genes from a breast cancer tissue sample that can affect how a cancer is likely to behave and respond to treatment.

Doctors use the Oncotype DX test to help figure out a woman’s risk of early-stage, estrogen-receptor-positive, HER2-negative breast cancer coming back (recurrence), as well as how likely she is to benefit from chemotherapy after breast cancer surgery.

Most early-stage, estrogen-receptor-positive, HER2-negative breast cancers that haven’t spread to the lymph nodes are considered to be at low risk for recurrence. After surgery, hormonal therapies such as an aromatase inhibitor or tamoxifen are prescribed to reduce the risk that the cancer will come back in the future. Whether chemotherapy is necessary has been an area of uncertainty for patients and their doctors. The Oncotype DX test was designed to offer more information to help women and their doctors make decisions about chemotherapy.

The Oncotype DX test assigns a Recurrence Score — a number between 0 and 100 — to the early-stage breast cancer. Doctors use the following ranges to interpret your results for early-stage invasive cancer:

  • Recurrence Score lower than 18: The cancer has a low risk of recurrence.  There is no benefit to having chemo.
  • Recurrence Score 18 up to and including 30: The cancer has an intermediate risk of recurrence. It’s unclear whether the benefits of chemotherapy outweigh the risks of side effects.
  • Recurrence Score 31 or greater: The cancer has a high risk of recurrence, and the benefits of chemotherapy are likely to be greater than the risks of side effects.

The TAILORx study included more than 10,000 women diagnosed with early-stage, hormone-receptor-positive, HER2-negative breast cancer that hadn’t spread to the lymph nodes. The researchers performed Oncotype DX texts on tissue samples from all the cancers and all the women were then assigned an Oncotype DX Recurrence Score:

  • women with a Recurrence Score of 0 to 10 received hormonal therapy alone (meaning they didn’t get chemotherapy) — 1,626 women were in this group (15.9% of the women in the study)
  • women with a Recurrence Score of 11 to 25 were randomly assigned to receive either chemotherapy plus hormonal therapy OR hormonal therapy alone — 6,897 women (67.3% of the women in the study)
  • women with a Recurrence Score of 26 or higher were assigned to receive chemotherapy plus hormonal therapy — 1,730 women were in this group (16.9% of the women in the study)

You’ll notice that the researchers changed the ranges of Recurrence Scores for low, intermediate, and high risk. Doctors usually consider a woman with a Recurrence Score of 0 to 17 at low risk for recurrence. But in the TAILORx trial, the researchers limited the low-risk category to women with scores of 10 and lower.

This was because the researchers wanted to make sure that they would not miss anyone who might benefit from chemotherapy.

After 5 years, less than 2% of the women with Recurrence Scores between 0 and 10 had a recurrence. Overall survival — how many women were alive with or without the cancer coming back — was 98%. These results provide the highest level of evidence that an Oncotype DX Recurrence Score of 0 to 10 means those women can safely avoid chemotherapy.

While these results are very exciting, many women are asking about the intermediate risk group in this study — women with Recurrence Scores of 11 to 25. What do the results suggest? Can these women skip chemo, too?

Unfortunately, this information isn’t available yet and wasn’t included in the Sept. 28 paper.

Dr. Steve Shak, chief scientific officer of Genomic Health, the company that makes the Oncotype DX test, said in an online interview that this is because there haven’t been enough recurrences or other events in this group of women to make a decision about the benefits of chemotherapy.

While the low number of recurrences in the intermediate risk group may sound promising, I’m telling my patients that the study is not finished yet and I will still use the standard values to determine risk. The women with intermediate risk scores are still being followed, so much could change before the next analysis is published.

Until the next TAILORx analysis is published, I plan to continue to consider a number of factors in addition to the Oncotype DX test results for my patients when making decisions about chemotherapy, including:

  • age
  • the size and stage of the cancer
  • hormone receptor protein levels and HER-2 status
  • the grade of the cancer
  • any other health conditions the patient has
  • the patient’s personal preferences

Have you talked to your doctor about the TAILORx study?

Brian S. Wojciechowski, M.D. joined the Breastcancer.org team as medical adviser in July 2012. He specializes in the care of patients with cancer and practices medical oncology in Delaware County, Pennsylvania at Riddle, Taylor, and Crozer Hospitals. A proud native of South Philadelphia, he trained at Temple University School of Medicine and Lankenau Medical Center. His research has been presented at the San Antonio Breast Cancer Symposium, the world's largest scientific meeting on breast cancer. Dr. Wojciechowski is a sought-after speaker on the topics of medical ethics and the biology of cancer. Beyond medicine, he is devoted to his faith, his family, and his guitar. He sees cancer as a scientifically complex disease with unique psychological, social, and spiritual dimensions, a perspective he takes into relationships with patients.

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