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Women with ER+/HER-/node- breast cancer and intermediate Oncotype score do not benefit from chemo (TAILORx)
Clinical Question
For women with breast cancer and an intermediate genetic risk score, does chemotherapy improve outcomes?
Bottom line
For women with hormone receptor–positive, human epidermal growth factor receptor 2 (HER2)–negative, axillary node–negative breast cancer and an Oncotype DX score of between 11 and 25, chemotherapy offers no benefit. There may be some benefit for the subgroup of women 50 years and younger with a score between 16 and 25, though this result was based on post-hoc analysis. 1b
Reference
Study design: Randomized controlled trial (double-blinded)
Funding: Industry + govt
Setting: Outpatient (specialty)
Synopsis
This study identified women with hormone receptor–positive, HER-2–negative, axillary node–negative breast cancer. All women underwent the Oncotype DX test, which evaluates 21 genes and determines the likelihood of benefit from chemotherapy. Women with a score of 10 or lower do not benefit from chemotherapy, while women with a score of either 26 or higher are more likely to benefit. However, many women fall into the intermediate range of 11 to 25. This study enrolled these women and randomized them to receive either endocrine therapy alone or endocrine therapy plus chemotherapy ("chemoendocrine therapy"). A total of 10,273 women were identified. Those with a score of 10 or lower were assigned to endocrine therapy, those with a score of 26 or higher were assigned to chemoendocrine therapy. The 6907 women with a score between 11 and 25 were randomized receive either endocrine or chemoendocrine therapy. Their median age was 55 years, 36% were premenopausal, and almost all were both estrogen receptor–positive and progesterone receptor–positive. Treatment consisted of mastectomy for 28% of the women and breast-conserving surgery for 72%. A total of 95% in the endocrine therapy group and 82% in the chemoendocrine therapy group received the assigned treatment. There was no difference overall in freedom from disease recurrence at a distant site, or at a distant or locoregional site, or in overall survival. There was a benefit regarding invasive disease-free survival for women 50 years and younger with an Oncotype DX score between 16 and 20 (94.7% vs 92.0%) and those with score between 21 and 25 (92.1% vs 86.3%), but these were post-hoc exploratory analyses.
Reviewer
Mark H. Ebell, MD, MS
Professor
University of Georgia
Athens, GA
Comments
good poem
Was the diagnostic profile obtained for each patient the standard data set used routinely. How securely is the individuals database stored and have the capabilities of later retrieval been demonstrated
I have encouraged my own patients to keep their own hard copy of all significant medical data because of the poor long term accessibility of our database in Nova Scotia
Although is not relevant to my neurosurgery consultation practice , But there are patient with different other condition, this information increase your confidence, but you have to be careful not become engaged in discussion her condition and treatment but to get information you need to know for patient investigation and treatment.
This information will reduce the stress on patients when presented with treatment options and importantly health care resources will be available for treatment of patients where the evidence supports chemotherapy interventions. The large direct and indirect costs both from a financial perspective on the health care system and the personal emotional and financial costs to patients receiving treatments that do not benefit and potentially harm. This is an important study from many lenses.
Although not relevant directly for an adult rheumatology practice decision tree, important to know for me as a collaborator, perhaps able to influence Rx decisions in a common co-existent disorder
These suffering patients and their families typically want everything done, given the information they have aquired when they come to visit. This study helps us to bolster those for whom ‘less is better’ as compared to the harms some are guaranteed through chemotherapy.
Excellent