By now you may have heard the great news from a ground-breaking clinical trial which found that many women with early-stage breast cancer don’t need chemotherapy as part of their cancer treatment.
The finding, announced at a meeting of the American Society of Clinical Oncology, will change the way cancer specialists treat women with early breast cancer. The Prisma Health Cancer Institute was one of the trial sites in the multi-site research project sponsored by the National Cancer Institute. Nearly 40 women took part in the local trial under the direction of Prisma Health’ Jeffrey Giguere, MD.
The study found that women with the most common type of breast cancer who have a mid-range score on a 21-tumor gene expression assay don’t require chemotherapy after surgery. Instead, the study indicated that these women do just as well post-surgery with only hormone therapy.
The findings are only applicable to women with hormone receptor-positive, HER2-negative, axillary node-negative, early-stage breast cancer, which is the most common type of breast cancer.
The study results expected to have an immediate impact on clinical practice, sparing thousands of women the side effects of chemotherapy. While chemotherapy can kill cancer cells, it can also damage healthy cells as well, resulting in debilitating side effects for some women, including nausea, hair loss, peripheral neuropathy, cognitive effects frequently referred to “chemo brain” and potentially longer-term side effects.
Thanks to a personalized medicine approach called the 21-gene recurrence score (RS) assay, we already knew that women with a low score for recurrence (as demonstrated through the test done on the tumor tissue) didn’t need chemotherapy. What we didn’t know, however, was the best approach for women with mid-range scores. We now know with certainty that many of these women can also avoid chemotherapy without harm.
Under the TAILORx study, clinical trials compared the outcomes of using only endocrine therapy versus a combination of both chemotherapy and endocrine therapy.
Among the women with recurrence scores between 11 and 25, those who received endocrine therapy alone did as well as those who received chemotherapy and endocrine. The big conclusion is that this intermediate recurrence score group, like the low recurrence score group, can be treated for their breast cancer with surgery, maybe radiation therapy, and endocrine therapy (like tamoxifen or anastrazole), but not chemotherapy. This is great news!
With the recurrence score tumor test, cancer specialists are able to “tailor” the treatment to better fit the needs of the patient. Those whose tumor recurrence score is low or intermediate, which is about 71% of women with estrogen receptor positive, Her 2 negative, early breast cancer, can avoid adjuvant chemotherapy, while the other 31%, whose tumor recurrence scores were high, can receiving chemotherapy knowing that there is a definite statistical benefit.
In the 21st century, cancer therapy is increasingly determined by tumor characteristics that identify which patients will benefit from a certain therapy and which will not. The results of the TAILORx study continue the trend toward precision medicine in oncology. This study took 12 years to complete. It could not have been done with the 10,000 women and their cancer treatment teams who agreed to participate in the study.
I thank all who participated, including those from the Upstate. This news is one more definitely positive step toward better controlling cancer in the 21st century.
Mark O’Rourke, MD, is the medical director over the Center for Integrative Oncology and Survivorship, which is part of the Prisma Health Cancer Institute. For more information about the study, click here.