In light of LabRoots’ theme this month of precision medicine, the most recent news release from the National Cancer Institute is groundbreaking. Findings from a current clinical trial started in 2006, called TAILORx, indicate that a good portion of women with early hormone receptor (HR) positive, HER2-negative, axillary node negative breast cancer do not gain better cancer reduction rates with chemotherapy and hormone therapy combined compared to hormone therapy alone after surgical remove of tumor. In fact, according to trial results, 70% of women with this type of common early breast cancer showed no advantage from chemotherapy treatment.
Breast cancer is one of the most common cancers in women across the globe. In the United States, the American Cancer Society estimates that there will be over 266,000 new cases of breast cancer in 2018 alone. While death rates have dropped over the past few decades, death rates in women under 50 years of age have remained steady.
TAILORx is a long-term phase III clinical trial to examine whether hormone therapy alone is sufficient for treatment of this specific breast cancer type as compared to the chemotherapy/hormone therapy combination traditionally used. To identify appropriate trial candidates, the researchers used a 21 gene assessment test to assign patients into groups based on breast cancer biomarkers, staging of disease, and recurrence risk. This is a worldwide trial with groups and sites collaborating in the United States, Australia, Canada, Ireland, New Zealand, and Peru. In total, over 10,200 women having this common but specific HR-positive, HER2-negative, axillary node negative breast cancer across the world were able to participate.
One of the key outcomes of this study will be the ability of providers to personalize their treatment recommendations to patients in the intermediate recurrence risk category. Historically, oncologists have been able to guide therapeutic plans for women determined to be at high risk or low risk of cancer recurrence; the findings demonstrate that for most patients in this intermediate recurrence risk category, there is no benefit from receiving chemotherapy and hormone therapy. Chemotherapy is very challenging because of the multitude of side effects and in some cases, the whole person is debilitated during treatment. In terms of preserving quality of life and potential late-stage effects of chemotherapy including treatment related cancers later in life, having this new evidence will help significant numbers of patients in the short term and long term. These findings also affect healthcare financial responsibilities for both the patient and the complex system in general.
Sources: National Cancer Institute https://www.cancer.gov/news-events/press-releases/2018/tailorx-breast-cancer-chemotherapy?cid=eb_govdel, American Cancer Society https://www.cancer.org/cancer/breast-cancer.html, ClinicalTrials.Gov https://clinicaltrials.gov/ct2/show/NCT00310180?term=TAILORx&rank=2,