"This is a major finding," said Dr. Larry Norton, a breast cancer
expert at Memorial Sloan Kettering Cancer Center in New York, who
helped organize the government-funded study more than a decade ago.
"It means that maybe 100,000 women in the United States alone do not
require chemotherapy," Norton said.
The research, presented at the American Society of Clinical Oncology
(ASCO) meeting in Chicago, studied how to treat women with
early-stage breast cancer that responds to hormone therapy.
Women were deemed to have a medium level risk of the cancer coming
back based on a 21-gene panel known as Oncotype DX from Genomic
Health <GHDX.O>. The test predicts the likelihood of cancer
recurrence within 10 years. Those who score low on the test - from
zero to 10 - are already told to skip chemotherapy after their
tumors are removed and they receive hormone therapy. Those who score
high - 26 to 100 - receive both hormone therapy and chemotherapy.
The study, dubbed TAILORx, was also published in the New England
Journal of Medicine. It involved more than 10,000 women with breast
cancer that had not spread to nearby lymph nodes and whose tumors
respond to hormone therapy and test negative for the HER2 gene.
Of those, 6,711 scored in the intermediate range of 11-25, and were
randomly assigned hormone therapy alone or hormone therapy plus
chemotherapy.
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The study found that all women over 50 with this type of breast
cancer could skip chemotherapy, a group that represented 85 percent
of the study's population. In addition, women 50 and younger who
scored between zero and 15 could be spared chemotherapy and its
toxic side effects.
However, chemotherapy did offer some benefit to women aged 50 and
younger who had a cancer recurrence score of 16-25, researchers
found.
Dr. Steven Shak, chief scientific officer at Genomic Health, said
about four in 10 women in the United States with early stage breast
cancers are not tested for recurrence risk. He expects the study's
results will change that practice.
"This is going to provide the highest level of evidence now for our
test being indispensable in clinical practice," Shak said.
The company currently provides tests to more than 900,000 patients
in more than 90 countries, Shak said. In the United States, the test
costs $4,000 and is covered by Medicare and all major private
insurers.
For more ASCO coverage, see: https://www.reuters.com/conquering-cancer
(Reporting by Julie Steenhuysen; Editing by Bill Berkrot)
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