The TAILORx results provide definitive answers

"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.

Read the article on NEJM.org

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.

See the new analysis on NEJM from ASCO 2019

Participating cancer research groups included the Alliance for Clinical Trials in Oncology, NCIC-Clinical Trials Group, NRG Oncology, and SWOG.

In early stage ER+, HER2-, N0 breast cancer, who benefits from chemotherapy?

25% of patients with a low Recurrence Score (RS) result (0–25) had high clinical risk* and would have been overtreated without the RS result

*High clinical risk: Grade 1, > 3 cm; Grade 2, > 2 cm; Grade 3, > 1 cm.
43% of patients with a high Recurrence Score (RS) result (26–100) had low clinical risk** and would have been undertreated without the RS result

**Low clinical risk: Grade 1, ≤ 3 cm; Grade 2, ≤ 2 cm; Grade 3, ≤ 1 cm.

No more “Intermediate” Recurrence Score results

  • No statistically significant difference in invasive disease-free survival was found among patients with Recurrence Score (RS) results 11–25, proving that they do not benefit from chemotherapy2
  • TAILORx expanded on previous data, confirming excellent outcomes at 9 years for patients with RS results 0–25 treated with endocrine therapy alone1,2
  • For RS results 26–100, there was a significantly higher event rate despite treatment with adjuvant chemotherapy2

*Driven largely by the higher likelihood of having an event in the cohort with an RS 26–100.

Clarity on which patients can be spared chemotherapy

  • No statistically significant difference between treatment groups for freedom from distant recurrence at 9 years2
  • TAILORx showed that patients with Recurrence Score results 11–25 can be spared chemotherapy2

Subset analysis in patients aged 50 or younger

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

View Subset Analysis
View Subset Analysis

Backed by clinical data

The landmark TAILORx trial is not the only large, randomized clinical trial supporting the use of the Breast Recurrence Score® report.


View more evidence

 

 

TAILORx: Transforming the Treatment of Breast Cancer

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.

REFERENCES

1. Sparano et al. N Engl J Med. 2015.
2. Sparano et al. N Engl J Med. 2018.
3. Sparano et al. ASCO 2018.
4. Paik et al. J Clin Oncol. 2006.
5. Data on file, Genomic Health Inc.

 

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