A majority of women with early-stage breast cancer will not require to undergo chemotherapy says the results of very important clinical trial presented Sunday, June 3, 2018, at the American Society of Clinical Oncology (ASCO) annual clinical meeting in Chicago, Illinois and is also being published simultaneously in the New England Journal of Medicine.
This federally funded phase III randomized clinical trial is a game changer for most women diagnosed with early-stage breast cancer who are hormone receptor-positive, HER2-negative, axillary node-negative and who received a mid-range score on the Oncotype DX gene test.
"Half of all breast cancers are hormone receptor-positive, HER2-negative, and axillary node-negative," noted study author Dr. Joseph Sparano, MD, Associate Director for Clinical Research at the Albert Einstein Cancer Center and Montefiore Health System in New York, and Vice-Chair of the ECOG-ACRIN Cancer Research Group.
"Our study shows that chemotherapy may be avoided in about 70 percent of these women when its use is guided by the test, thus limiting chemotherapy to the 30 percent who we can predict will benefit from it," Sparano said in a news release from the American Society of Clinical Oncology (ASCO).
The Oncotype DX test looks at 21 separate genes in breast tumor cells samples and quantifies the individual risk of recurrence and likelihood of benefits from post-surgical chemotherapy. The test results give patients a "score" based on a continuous scale from 0-100.
Onco-surgeons are using this score since long to guide them about decisions on post-surgical chemotherapy. A woman with a low score (1-10) will only receive hormonal therapy while if she scores high (26-100), she receives additional chemotherapy also to prevent recurrence.
It was not clear how to proceed with treatment decisions for women who received the scores in mid-range 11-25. “The trial was designed to address this question, and provides a very definitive answer,” added Sparano.
The Trial Assigning IndividuaLized Options for TReatment (TAILORx) (ClinicalTrials.gov: NCT00310180) recruited 10,273 women 18-75 years of age diagnosed with hormone receptor-positive, HER2-negative, axillary node-negative breast cancer.
Of those, 6,711 had a mid-range Oncotype DX test score of 11-25 and were randomly assigned to receive hormone therapy alone or hormone therapy and chemotherapy.
After a median follow-up of 7.5 years, it was seen that the rates of overall survival, disease-free survival, or cancer spread beyond the breast was comparable for both the groups.
Adding chemotherapy only benefited a small subgroup of women who scored between 16-25 on the Oncotype DX test and were younger than 50 years.
Based on the results, the researchers concluded:
Chemotherapy can be safely omitted in women with this type of breast cancer who have an Oncotype score under 26 and are older than 50 years (85 % of women with breast cancer in this age group).
Chemotherapy can also be omitted in women who are younger than 50 and have an Oncotype score less than 16 (about 40% of women with breast cancer in this age group).
This study received funding primarily from the National Cancer Institute, part of the National Institutes of Health. Additional support was provided by the Breast Cancer Research Foundation, Komen Foundation, and the U.S. Postal Service Breast Cancer Stamp. The ECOG-ACRIN Cancer Research Group designed and conducted the study.
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