Effective August 2, 2022, mdxhealth has acquired the Oncotype DX Genomic Prostate Score (GPS) test from Exact Sciences. Additionally, Genomic Health Inc, part of Exact Sciences, will continue to perform the GPS test during the transition. Further communications explaining transition plans will be provided in the coming months. For more details, please review the press release.
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TAILORx

Celebrating TAILORx and all who made it possible

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

As presented at ESMO 2019, a new, secondary analysis of TAILORx, highlighted clinical outcomes in patients with a Recurrence Score result of 26‐100. This new analysis reinforces the definitive results of TAILORx, that only the Oncotype DX Breast Recurrence Score test identifies patients who will and will not benefit from chemotherapy.

See the new analysis on JAMA Oncology

 

Image TAILORx map

Participating cancer research groups included the Alliance for Clinical Trials in OncologyNCIC-Clinical Trials GroupNRG Oncology, and SWOG.

 

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

TAILORx No Chemo Benefit

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.

TAILORx Substantial Benefit RS 26-100

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

Graph TAILORx Probability1

*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

Graph TAILORx Probability2

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


  • Benefits for most patients (age >50)

  • May differ for younger patients (age ≤50)

TAILORx Benefit
TAILORx Benefit

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
Oncotype DX Breast Recurrence Score

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.

 

 

Graphic TAILORx NEJM 2018

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 theECOG-ACRIN Cancer Research Group.