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"Adjuvant chemotherapy may now be guided with an unprecedented level of evidence and precision" said lead author Joseph A. Sparano, MD. "The 21-gene assay ... [can] identify the 70% of women with no chemotherapy benefit, and the others where chemotherapy may be life-saving." Know with confidence who will benefit from chemotherapy and who will not.1-4
The largest randomized adjuvant breast cancer trial ever conducted, the Trial Assigning IndividuaLized Options for Treatment (Rx) (TAILORx) was independently led by ECOG-ACRIN Cancer Research Group with sponsorship from the National Cancer Institute.
As presented at ASCO 2019, a new analysis of TAILORx confirms the original, definitive conclusions reported previously with additional detail on clinical risk, focusing on patients with early-stage breast cancer who are age 50 years or younger.
The publication describes clinical outcomes for women with a high Recurrence Score (RS) result 26-100, who received adjuvant chemotherapy (CT) plus endocrine therapy (ET) in the TAILORx trial, a population expected to have a high distant recurrence rate with endocrine therapy alone. In this secondary analysis, among 1389 women with early breast cancer and a high RS result of 26-100, who received adjuvant CT, the estimated proportion free from distant recurrence at 5 years was 93%. These patients with RS results 26-100 had consistently better outcomes with CT+ET than what would be expected with ET alone.
Participating cancer research groups included the Alliance for Clinical Trials in Oncology, NCIC-Clinical Trials Group, NRG Oncology, and SWOG.
*Driven largely by the higher likelihood of having an event in the cohort with an RS 26–100.
In an exploratory analysis, TAILORx showed a chemotherapy benefit for early breast cancer patients aged 50 or younger with RS scores of 16–25. This subgroup represents about 8% of patients.5
For the great majority of early-stage (HR+, HER2-, N0) breast cancer patients aged 50+, the TAILORx trial results predict no statistically significant benefit from chemotherapy.
For patients with RS results from 26–100, there is a substantial benefit from chemotherapy.4
As with older patients, for those up to age 50 with a Recurrence Score result of 0–15, TAILORx predicts no benefit in adding chemotherapy to endocrine therapy.1
In these younger patients, an exploratory analysis of TAILORx predicts a small (~1.6%) chemotherapy benefit for patients with RS results from 16–20, and a modest (~6.5%) chemotherapy benefit for patients with RS results from 21–25.
Together, these two subgroups comprise about 8% of patients.5
As with patients over age 50, younger patients with RS results from 26–100 receive a substantial benefit from chemotherapy.4
The landmark TAILORx trial is not the only large, randomized clinical trial supporting the use of the Breast Recurrence Score® report.
The TAILORx trial reports 9-year outcomes for >10,000 women with early breast cancer. Over 1,000 trial sites in 6 countries participated.
ASCO = American Society of Clinical Oncology
ECOG-ACRIN = Eastern Cooperative Oncology Group - American College of Radiology and Imaging Network
NIH = National Institutes of Health
NRG = Non-profit Research Group
RS = Recurrence Score
SWOG = Southwest Oncology Group
TAILORx = A Clinical Trial Assigning IndividuaLized Options for Treatment (Rx)
The TAILORx trial was conducted independently by the ECOG-ACRIN Cancer Research Group.
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