The National Breast Cancer Coalition has always taken the position that a large percentage of toxic treatment for breast cancer is unnecessary. Women are often over treated, resulting in significant harm and questionable benefit.
What was NBCC’s Role in the TAILORx Trial?
In 2005, NBCC began working with the National Cancer Institute on a clinical trial, TAILORx, which would help determine if certain women with ER positive, node negative, early breast cancer (approximately 50% of women diagnosed with breast cancer) required chemotherapy or if they would do as well on hormonal therapy, such as tamoxifen, alone. Carolina Hinestrosa, then NBCC’s Vice President, was one of two advocate members of the steering committee for TAILORx and NBCC Project LEAD graduates gave input into the clinical trial protocol design. We nominated one of them, Musa Mayer, as a member of the Data Safety Monitoring Board, the first time a non-scientist was accepted in that role. NBCC developed an extensive outreach plan, to spread the word about the trial and to help women decide whether to enroll.
Many in the research and clinical community believed women would not agree to enroll in the trial and take the chance they would only receive tamoxifen or an aromatase inhibitor, and not chemotherapy. We knew women were smarter, stronger and more interested in getting answers than that. And we were right. More than 10,000 women enrolled in the trial.
Women were eligible for the trial if they were recently diagnosed with estrogen and progesterone receptor positive and Her2 negative breast cancer that had not spread to their lymph nodes. Trial participants were grouped depending upon where they fell in a range determined by a genomic test, Oncotype DX. Oncotype is a 21 gene panel that weighs proliferation and the expression of those genes in any one person’s breast cancer tumor. Depending on the weight given among the genes and other risk factors, reported by numerical ranges, a woman’s breast cancer can fall into three categories: low, intermediate or high risk of recurrence. The results recently reported for the TAILORx trial were those of women who fell into the “intermediate risk” range, identified by a score between 11 and 25. That was about 69% of the women in the trial. These women were randomized to receive hormonal therapy alone or hormonal therapy plus chemotherapy.
After nine years average follow up, the results showed that adding chemotherapy to hormonal and radiation therapy made no difference in outcome for most of the women. There was a benefit of chemotherapy in women 50 years of age or younger, with a recurrence score of 16 to 25, but no difference in overall survival.
What does all that mean for women?
The evidence for benefit of chemotherapy in this breast cancer group has never been strong. The TAILORx results give another level of evidence that the medical oncology community and many women may need to forgo toxic therapy. This is good news because it can spare tens of thousands of women unnecessary treatment that has significant and often life altering side effects.
While this is good news, the results do not mean that these women will be spared any treatment because they are “cured” without it. They still need surgery and hormonal therapy and, in most instances, radiation therapy. The same number of women will still die of breast cancer and the results will not bring us closer to ending breast cancer.
Visit www.stopbreastcancer.org to learn more.