The DCISionRT test is not proven to predict radiation therapy (RT) benefit

What is the DCISionRT test?

DCISionRT is a biological risk signature that uses 2 algorithms to report the risk of progression to invasive breast cancer and any type of recurrence (DCIS or invasive).1

What is prediction of RT benefit?

A test is predictive of RT benefit if it distinguishes patients who are likely to benefit from radiation therapy from those who are not.2

When assessing the DCISionRT claim to determine radiation benefit, consider:

Have they demonstrated prediction in a randomized clinical trial (RCT)?
NO
P value for interaction of test result and RT benefit in RCT not presented3 or published
Do they have published validation studies?
NO
Only publication reports an exploratory analysis of RT prediction in an observational, nonrandomized cohort4
Do they have published clinical utility data?
NO
Have they followed established practices for development and validation of molecular assays?5
NO

The DCISionRT test has yet to prove its ability to predict RT benefit in DCIS patients

The Oncotype DX Breast DCIS Score test: Confirmed by validation studies, refined by meta-analysis6-8

The ONLY DCIS test backed by published validation studies confirming prediction of 10-year risk of local recurrence and invasive recurrence

Significantly associated with 10-year risk of any local recurrence (P = 0.002) and invasive local recurrence (P = 0.03)6

Validated

Validated in 2 studies to more accurately risk-stratify patients treated with breast-conserving surgery (BCS)6,7

ECOG E5194 prospective study (N = 327)

Associated with any local recurrence (DCIS or invasive) or invasive local recurrence

Ontario DCIS population-based study (N = 571)

Associated with any local recurrence, DCIS local recurrence, or invasive local recurrence following BCS alone

Refined

Refined risk estimates in a meta-analysis8

Adjusting for the effects of age and tumor size (N = 773)

Allows for a more precise estimate of the 10-year local recurrence risk

Proven: The Breast DCIS Score test establishes a baseline of 10-year recurrence risk for more informed decision-making9


 
REFERENCES
  1. PreludeDX website. https://preludedx.com/physicians. Accessed December 18, 2018.
  2. Ballman. J Clin Oncol. 2015.
  3. Wärnberg et al. SABCS 2017.
  4. Bremer et al. Clin Cancer Res. 2018.
  5. Hayes. Mol Oncol. 2015.
  6. Rakovitch et al. Breast Cancer Res Treat. 2015.
  7. Solin et al. J Natl Cancer Inst. 2013.
  8. Rakovitch et al. Breast Cancer Res Treat. 2018.
  9. Alvarado et al. J Surg Oncol. 2015.
 
† DCISionRT is a registered trademark of the Prelude Corporation. Please refer to this manufacturer directly for more information.

The ONLY DCIS test confirming prediction of 10-year risk of local and invasive recurrence.

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Clinical Validationa

A confirmatory validation study of Oncotype DX for DCIS.

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