The study is the largest ever done of breast cancer treatment, and the results are expected to spare up to 70,000 patients a year in the United States and many more elsewhere the ordeal and expense of these drugs.
Certain women 50 or younger did benefit from chemo; slightly fewer cases of cancer spreading far beyond the breast occurred among some of them given chemo, depending on their risk scores on the gene test.
According to first author Joseph Sparano of Montefiore Medical Center in NY, "any woman with early-stage breast cancer 75 or younger should have the test and discuss the results" with her doctor.
Seventeen percent of women with high risk scores were advised to have chemo and 16 percent with low risk now know they can skip the treatment.
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The treatment, which succeeded after all other conventional treatments had failed, marks the first successful application of T-cell immunotherapy for late-stage breast cancer. Despite seven types of chemotherapy and hormonal therapy, her disease was still growing. Until now, existing immunotherapy drugs have shown little or no effectiveness against some of the most common cancers, including malignancies of the breast, prostate and colon.
British experts said the study was "exciting" even though it involved just one patient.
"Patients really struggle having to make that decision, and now they don't have to". This showed that the chemotherapy had no influence in the outcome of the cancer.
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The women enrolled in the study were assigned to treatment groups based on their genetic testing score, to examine if chemo plus hormone therapy was beneficial when compared to what has become the standard treatment for this form of breast cancer - hormone therapy alone.
For years doctors were unsure how to treat women who fell in the middle range of the scoring system.
"It means that people who are estrogen positive and early stage, often don't have to" said Dr. Maryland Raymond, Medical Director at Good Samaritan's Medical Center Breast Cancer Center. The tumor is assigned a "recurrence score" from 0 to 100; the higher the score, the greater the chance the cancer will recur in distant organs and decrease survival.
Her cancer did not respond to any treatments including chemotherapy and hormone therapy, until this one time treatment with more personalized immunotherapy. The prospective TAILORx study was created to help to discover whether chemotherapy is beneficial for women with a mid-range recurrence score of 11 to 25, as well as to prospectively confirm that a low recurrence score of 0-10 is associated with a low rate of distant recurrence if patients receive endocrine therapy without adjuvant chemotherapy.
Dr. Otis Brawley, chief medical and scientific officer for the American Cancer Society said that he was "delighted" by the study and anxious about unnecessary cancer treatment and the side effects that come from chemotherapy.
The experiment led to "complete durable regression" of the cancer that had spread to Judy Perkins' liver, the team said, writing in the journal Nature Medicine. However, most breast cancer occurs in older women.
However, these are the results from a single patient and much larger trials will be needed to confirm the findings. But they tend to work best on cancers that are influenced by environmental factors and are driven by lots of mutated genes.