BCNA News 04 Jun 2018
New research findings confirm the benefit of the Oncotype DX tumour profiling test
Results from the TAILORx clinical trial presented at the 2018 American Society of Clinical Oncology (ASCO) meeting on Monday 3 June suggest that women diagnosed with hormone receptor positive, HER2-negative, node-negative early breast cancer may be able to avoid chemotherapy if they undergo the Oncotype DX test and receive a mid-range recurrence score.
The Oncotype DX test is a tumour profiling test that analyses 21 genes within a sample of tumour. The benefit of the test, and other similar tumour profiling tests, is that it can help predict the risk that a woman’s breast cancer may recur and the likely benefit chemotherapy may have in reducing that risk. The benefit of tumour profiling for women who receive a low or high recurrence score via the Oncotype DX test has already been well documented. Typically women with a score of 0-10 (low) are recommended hormone therapy only; whereas women who receive a score of 26-100 (high) are typically recommended the addition of chemotherapy to hormone therapy.
Until today’s findings it has been unclear if chemotherapy might also benefit women who receive a mid-range score (i.e. 11 to 25). The Phase III TAILORx clinical trial enrolled 10,273 women with hormone receptor positive, HER2-negative, axillary node-negative early breast cancer. Of these women, 6,711 received a mid-range score via the Oncotype DX test and were randomly assigned to receive either hormone therapy alone or hormone therapy and chemotherapy. The study explored whether adding chemotherapy would benefit women with the mid-range score by reducing the likelihood of a cancer recurrence compared with hormone therapy alone.
At nine years of follow-up, the researchers found that the rate of disease free survival was similar for women in both groups (83.3% for women who received hormone therapy only compared with 84.3% for women who received both hormone therapy and chemotherapy).
The researchers also found very little difference in the rate of overall survival between the two groups. For women who received hormone therapy only, the overall survival rate was 93.9% compared with an overall survival rate of 93.8% for women who received hormone therapy and chemotherapy.
The researchers also explored the impact of women’s age on these results. They found that women aged 50 years or younger may still benefit from chemotherapy if they receive a mid-range Oncotype DX score of 16 to 25.
“The results from the TAILORx trial indicate that women diagnosed with hormone receptor positive, HER2-negative, node negative early breast cancer who receive a mid-range score via the Oncotype DX test may be able to avoid chemotherapy, especially women over 50 years,” said Australian medical oncologist and BCNA Board member Professor Dorothy Keefe. “Results of the TAILORx trial will help transform clinical decision making for this group of patients. The next step is to advocate for this test to be available here.”
In Australia, there is currently no Medicare rebate for tumour profiling tests for breast cancer including the Oncotype DX test. Australian women who wish to access chemotherapy predictive tests such as Oncotype DX currently pay up to $5,000. BCNA has been advocating for the Oncotype DX test to be added to the Medicare Benefits Schedule (MBS) for a number of years to ensure that all women who may benefit from the diagnostic tool are able to affordably access it.
“Now we have this new evidence we will step up our efforts for the Oncotype DX test to be fast tracked through the Medicare approval process,” said BCNA CEO Kirsten Pilatti.
If you have been diagnosed with breast cancer and are interested in finding out more about how these results may benefit you, you may like to talk to your medical oncologist.
- Listen to TAILORx explained from an Australian oncologist’s perspective.
- Read an article in The ASCO Post ‘2018 ASCO: TAILORx: Most Women With Early-Stage Breast Cancer Can Forgo Chemotherapy When Guided by a Diagnostic Test’
- Read an article in the New England Journal of Medicine, ‘Adjuvant Chemotherapy Guided by a 21-Gene Expression Assay in Breast Cancer’
- Read BCNA’s News item No Medicare rebate for Oncotype DX test
- Read BCNA’s submission to the Medical Services Advisory Committee in support of an application for a Medicare rebate for the Oncotype DX test.