Editor's note: This popular story from the Daily Briefing's archives was republished on Oct. 11, 2018.
Tens of thousands of women with an early-stage diagnosis of the most common type of breast cancer can safely decide to not receive chemotherapy, according to study published Sunday in the New England Journal of Medicine, the Chicago Tribune reports.
The National Cancer Institute in 2006 began a large-scale clinical trial to evaluate whether women with hormone-receptor-positive, human epidermal growth factor receptor 2 (HER2)-negative, axillary node-negative breast cancer and moderate risk of cancer recurrence could safely forgo chemotherapy.
Researchers assessed the immediate risk of cancer recurrence among 10,273 patients using Genomic Health's gene test Oncotype DX, which examines breast cancer biopsy samples to assign a cancer recurrence score from 0 to 100. According to the New York Times, previous research showed patients with scores 10 and below do not need to receive chemotherapy, while patients with scores above 25 do need chemotherapy, but guidance was less clear for patients with intermediate scores.
Of the women with complete follow-up information, 6,711 had a midrange cancer recurrence score. These women were randomly assigned to receive either endocrine therapy alone or endocrine therapy plus chemotherapy, after undergoing surgery and radiation.
The researchers found women who received endocrine therapy and endocrine therapy plus chemotherapy had similar overall survival rates at nine years. In particular, the researchers found the overall survival rate among women who received endocrine therapy alone was 93.9%, while the rate among those who received endocrine therapy plus chemotherapy was 93.8%.
In addition, the researchers found the rate of invasive-disease-free survival among women who received endocrine therapy alone was 83.3%, while the rate among women who received endocrine therapy plus chemotherapy was 84.3%.
The researchers concluded that there were no significant differences between the treatments. They indicated, however, that the benefits of chemotherapy may vary depending on a woman's recurrence score and age. Specifically, they found "some benefit of chemotherapy … in women 50 years of age or younger with a recurrence score of 16 to 25."
Joseph Sparano, lead investigator of the study and associate director for clinical research at the Albert Einstein Cancer Center and Montefiore Health System in New York, said, "You can spare tens of thousands of women per year the need for chemotherapy in this setting with a high degree of confidence." Sparano said the study's findings are applicable to about 60,000 U.S. women a year.
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Ingrid Mayer, an author of the study from Vanderbilt University Medical Center, said, "We were probably overtreating a lot of these women." Mayer added, "We really didn't know what to do with women in the middle. Some seemed to benefit and some didn't. We were back to square zero, safe rather than sorry, giving chemo to a lot who didn't need it."
Larry Norton of Memorial Sloan Kettering Cancer Center said, "I think this is a very significant advance. I'll be able to look people in the eye and say, 'We analyzed your tumor, you have a really good prognosis, and you actually don't need chemotherapy.' That's a nice thing to be able to say to somebody." Norton added, "This has been one of the large unanswered questions in breast cancer management in recent times, what to do with patients with intermediate scores."
Otis Brawley, chief medical officer of the American Cancer Society, said, "I don't get optimistic about a lot of things, but I've been very optimistic about this." Brawley said the study's findings mean that patients and physicians can feel at ease with a decision to forgo chemotherapy and that tens of thousands of breast cancer patients annually will avoid the risks associated with chemotherapy, including congestive heart failure, hair loss, leukemia, nausea, and vomiting. Brawley said, "Chemotherapy is no Shangri-La. We're saving people these side effects" (Ortiz, Chicago Tribune/Sacramento Bee, 6/3; Grady, New York Times, 6/3; Loftus, Wall Street Journal, 6/3)
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