Post on 29-Jan-2016
transcript
Use of Oncotype Dx® Testing
Breast SSG meeting 10th July 2015
Dr Rebecca Bowen
Prognostic and predictive markers used in breast cancer management
Prognostic (recurrence risk)Axillary node statusHistologic type/gradeTumour sizePatient ageLymphatic/Vascular invasionER/PR statusHER2 statusNPI/ Adjuvant Online/ NHS PredictGenomic assays: Endopredict
Prosigna uPA PAI1 Oncotype DX®
Predictive (treatment benefit)ER/PR statusHER2 neu statusOncotype DX® test
Predict treatment benefit
Estimate the risk of disease recurrence
Summary
• 2004 Paik et al NEJM publication on validation of Recurrence Score
• April 2010: first conversation with NICE
• Two UK decision impact studies set up
• Private health insurance companies start to reimburse
• May 2011: NICE diagnostics assessment commenced
• September 2013: NICE recommendation (DG10)
• April 2015: NHS patients can access!
The Oncotype DX® AssayThe only multi-gene assay incorporated into all major
guidelines to predict adjuvant chemotherapy benefit in ER+, HER2-
EBCQuantifies risk of recurrence as a continuous variable
and predicts responsiveness to both tamoxifen and chemotherapyNCCN Guidelines®1
>0.5cm, node negative, N1mi
Predicts the risk of recurrence and may be used to identify patients likely to benefit from tamoxifen or chemotherapy
ASCO® Guidelines2
Node negative
Provides additional prognostic and/or predictive information to complement pathology assessment and to predict response to
adjuvant chemotherapy
ESMO3
Node negative
Provides not only prognostic but also predictive information regarding the utility of cytotoxic therapy in addition to endocrine
therapy
St Gallen Consensus4
Node negative, node positive
Recommended as an option for guidance of chemotherapy decisions in patients at intermediate risk* of distant recurrence
NICE5
Node negative
1.NCCN Practice Guidelines in Oncology. V.2.2015.2.Harris L, et al. J Clin Oncol. 2007.3.Senkus E Ann Oncol 2013.4.Goldhirsch A, et al. Ann Oncol. 2013.
5. NICE Diagnostics Guidance DG10 2013. by other decision making tools or protocols
ASCO is a trademark of the American Society of Clinical Oncology. NCCN and NCCN Guidelines are trademarks of the National Comprehensive Cancer Network.
The guidelines do not endorse products or therapies.*Intermediate risk of distant recurrence is defined as NPI score ≥3.4 or at intermediate risk
The Oncotype DX® assay processGenomic Health has processed >500,000 tests from >70 countries; >3,800 tests from the UK
Resultsgeneration
Billing2-3 weeks
Report delivery
Secure online
portal
Extraction
Quantitation
gDNAdetection
Reverse transcription
QPCR
Order entry
Online
Specimen retrieval
Specimenaccessioning
RequestFedEx
Materials return
Order entry Shipping
Pathology
Analytical laboratory
Reportfulfilmen
t
Material return
Pathology review
Histopath
7-10 days
Triple-neg
Node-negative or with
*1 to 3 positive nodes
Newly diagnosed early stage invasive breast cancer
Newly diagnosed early stage invasive breast cancer
Metastatic or locally advanced breast cancer with 4+ positive nodes
HER2-posER-pos,
HER2-neg
The patient is assessed as being at intermediate risk; the decision to prescribe
chemotherapy remains unclear, so that information on the biological features of the cancer provided by the Oncotype DX® assay is likely to help in a predicting the course of
the disease
*Use of the Oncotype DX®
breast cancer assay in the N+ setting validated for post-menopausal patients
Accessed 14 Jan 2014 HER2: Human Epidermal Growth Factor Receptor 2NICE guidance DG10. http://guidance.NICE.org.UK/DG10 ER: Oestrogen receptor
Clinical indication NICE guidance
Node-negative, ER-positive, HER2-negative
Which patients may benefit from the Oncotype DX® Test?
Recurrence Score® results and patient discussion prior to the Oncotype DX® test
Eligible: Intermediate riskNPI >3.4 ≤ 5.4
Low Benefit of CT on Adjuvant! or ≥3% on PREDICT
• RS <18: Chemotherapy not recommended. Endocrine alone
• RS 18-30: Treatment recommendation discussed prior to testing based on individual score
• RS >30: Chemotherapy recommended
Eligible Patient Summary
• All node negative, ER positive, HER2 negative:
– Grade 1: > 70mm– Grade 2: > 20mm– Grade 3: Any size
Change in Recommendations – Choice Study
• Oncologists recommendation changed in 55 (42%) patients
• 43 chemotherapy to no chemotherapy• 12 no chemotherapy to chemotherapy
• Oncologists recommended chemotherapy in 51% patients pre Oncotype DX and 28% post Oncotype DX
• Changes in recommendation were consistent with the Recurrence Score