Quantitative Determination of ER:
Adding Clarity to Your Patients’ ER Status
•
•
Accurate and reproducible methods for evaluating Estrogen Receptor status are essential for making the appropriate hormonal treatment decisions for breast cancer patients.
Our quantitative ER score determined by RT-PCR is another measure determining ER status, and provides further insight into an individual’s breast cancer biology and their magnitude of tamoxifen benefit.
Facilitating Identification of Patients Who Are ER-positive
An Oncotype DX® Recurrence Score® will automatically be generated if
the ER status is:
1) positive by IHC or
2) positive by RT-PCR. The patient’s insurance company will be billed in this case.
If the sample is ER-negative by both IHC and RT-PCR, Genomic Health will not provide the Oncotype DX Recurrence Score or
quantitative single gene results, but will provide a qualitative report
confirming the patient’s ER-negative status. The patient’s insurance company will not be billed in this case.
www.oncotypeDX.com
(866) ONCOTYPE • (866) 662-6897
Continuous Measurement & Wide Range of Expression
•Breast cancers show a broad range of hormone receptor expression, and RT-PCR is able to measure ER as a continuous variable and capture this wide range of gene expression.
Overall Range
of PR 1000-fold
Range of ER for
ER+ 200-fold
Continuous Measurement of ER and PR1
NSABP B-14 (n = 668)
12
ER-PR+
ER+PR+
ER-PR-
ER+PR-
PR Expression by RT-PCR
11
10
9
8
7
6
5
4
3
2
2
3
4
5
6
7
8
9
10
11
12
13
14
ER Expression by RT-PCR
Overall Range
of ER 3000-fold
•Delay to fixation, duration of fixation and choice of fixative may affect accurate hormone receptor assessment.
•Our RT-PCR employs a wide range of controls and calibrators including reference gene
normalization to reduce this impact and to enhance accuracy and reproducibility in quantitative
single gene assessment.
1
Data on file compiled from Paik, et al.
Data from ECOG & Kaiser Studies
•Studies have demonstrated a high degree of concordance between ER status determined through our quantitative RT-PCR and IHC:
• 9
3% concordance for ER status: E2197 (769 patient samples)2
• 9
6% concordance for ER status: Northern California Kaiser Permanente (607 patient samples)3
ER Measurement: IHC x RT-PCR2
8
ER
Central IHC Allred Score
7
6
IHC-,
RT-PCR+
Discordant
Cases
5
4
3
2
1
0
2
3
4
5
6
7
8
9
10
11
12
13
14
ER Expression by RT-PCR
•Although concordance was high, IHC ER-negative cases that were RT-PCR positive were more common than IHC ER-positive cases that were RT-PCR negative.
• In one study, 14% (central IHC) and 13% (local IHC) of samples classified as ER-negative by
IHC are ER-positive by central RT-PCR.2
J Clin Oncol. 2008;26(25). Badve SS, Baehner FL, Gray R, et al. Estrogen- and progesterone-receptor status in ECOG 2197: comparison of immunohistochemistry by local and central laboratories and quantitative reverse transcription polymerase chain reaction by central laboratory. J Clin Oncol.
2008;26(15):2473-2481.
2
Baehner FL, Maddala T, Alexander C, et al. A Kaiser Permanente population-based study of ER and PR expression by the standard method, immunohistochemistry (IHC), compared to a new method, quantitative reverse transcription polymerase chain reaction (RT-PCR). Presented at the ASCO Breast
Cancer Symposium. September 7-8, 2007; San Francisco, CA. Abstract #88.
3
Accurate, Precise and Reproducible
Now Accepting All Appropriate* Early Stage Breast Cancer Samples
Please designate your patient’s ER-negative status on the Requisition Form
in the Exception Criteria box in the Physician Signature area.
Analysis by IHC
(or Unknown)
Quantitative Analysis
by RT-PCR
Report Generation
ER-negative
ER-positive
ER-negative
by RT-PCR
ER-positive
by RT-PCR
ER-positive
by RT-PCR
ER-negative
by RT-PCR
YES
Y ES
Y ES
NO
Oncotype DX:
Recurrence
Score
Oncotype DX:
Recurrence
Score
Oncotype DX:
Recurrence
Score
FAILED
SPECIMEN:
No Recurrence
Score
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of 4
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c Health,
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(866-662
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Tel (866 otypeDX.com
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