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Clinical Evidence for Node-Negative Patients

Only the Oncotype DX Breast Recurrence Score® test predicts the likelihood of chemotherapy benefit for premenopausal and postmenopausal, node-negative patients.1

TAILORx Trial (Predictive) | NSABP B-20 Study (Predictive)

TAILORx: the largest randomized adjuvant breast cancer trial

The Trial Assigning IndividuaLized Options for Treatment (Rx) (TAILORx) reports 9-year outcomes for 10,273 patients with early breast cancer. Over 1,000 trial sites in 6 countries participated.

The trial objective was to determine if the Oncotype DX® test predicts recurrence and guides treatment decisions.

“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.1-5

Key findings from the study, independently led by ECOG-ACRIN Cancer Research Group with sponsorship from the National Cancer Institute, indicate that patients with a low Recurrence Score® (RS) can safely forgo chemotherapy without compromising survival rates.

Graphic TAILORx Trial Design

Who benefits from chemotherapy in early-stage ER+, HER2-, N0 breast cancer?

Image No Chemo Benefit (Recurrence Score 0-25)


of patients with a low Recurrence Score result (0-25) had high clinical risk* and may have been overtreated without the Recurrence Score result

*High clinical risk: Grade 1, >3cm; Grade 2, >2cm; Grade 3, >1cm.
Assuming that adjuvant chemotherapy would have been recommended because of the high clinical risk

Image Substantial Chemo Benefit (Recurrence Score 26-100)


43%
of patients with a high Recurrence Score result (26-100) had low clinical risk and may have been undertreated without the Recurrence Score result §

Low clinical risk: Grade 1, ≤3cm; Grade 2, ≤2cm; Grade 3, ≤1cm.
§Assuming that adjuvant chemotherapy would not have been recommended because of the low clinical risk

In an exploratory analysis, TAILORx also showed a chemotherapy benefit for those aged 50 years or younger with Recurrence Score results of 16–25. This subgroup represents about 8% of patients.6

TAILORx eliminates “intermediate” Recurrence Score results (11-25) previously defined by the National Surgical Adjuvant Breast and Bowel Project (NSABP) B-20 study

Invasive disease-free survival
  • No statistically significant difference in invasive disease-free survival was found among patients with Recurrence Score results 11–25, proving that they do not benefit from chemotherapy5
  • TAILORx expanded on previous data, confirming excellent outcomes at 9 years for patients with Recurrence Score results 0–25 treated with endocrine therapy alone4,5
  • For Recurrence Score results 26–100, there was a significantly higher event rate despite treatment with adjuvant chemotherapy5
Freedom from distant recurrence
  • No statistically significant difference between treatment groups for freedom from distant recurrence at 9 years5
  • TAILORx showed that patients with Recurrence Score results 11–25 can be spared chemotherapy5

*Driven largely by the higher likelihood of having an event in the cohort with a Recurrence Score result 26–100.

Graph Low Recurrence

RS=Recurrence Score

TAILORx: Transforming the treatment of breast cancer

This 21-gene test is categorized by the NCCN Clinical Practice Guidelines In Oncology (NCCN Guidelines®) as “preferred” among gene expression assays for prognosis and prediction of chemotherapy benefits7,8

  • Recommend to “strongly consider” for N0 patients with tumors >0.5 cm who are candidates for chemotherapy


The only test recognized by major guidelines for its high quality of evidence and robust strength of recommendation8-13

  • Strongly recommended for most N0 women with ER+, HER2- early-stage breast cancer who are candidates for chemotherapy
  • The only recommended assay that provides prognostic and therapy-predictive information

NSABP B-20 study

The NSABP B-20 study was performed on a cohort of 651 patients with ER+, node-negative breast cancer from the NSABP B-20 trial. The objective of this study was to determine whether the Recurrence Score result predicted the likelihood of chemotherapy benefit.1

Key findings from the study indicate:
  • Low Recurrence Score result predicted little to no benefit from chemotherapy1
  • High Recurrence Score result predicted large benefit from chemotherapy1

TAM=tamoxifen.

Low Recurrence Score® Result (<18)

Graph Intermediate Recurrence Score® Result (18-30)

High Recurrence Score® Result(≥)

CLINICAL UTILITY IN NODE-POSITIVE PATIENTS

 

The TAILORx trial was conducted independently by the Eastern Cooperative Oncology Group - American College of Radiology and Imaging Network (ECOG-ACRIN) Cancer Research Group.

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