1. Surveillance Research Program
Feasibility Study for Collection of HER2 Data by SEER Registries in Seattle, Louisiana and Los Angeles
Marsha E. Reichman
June 18, 2009
Surveillance Research Program
NCI

2. Study Collaborators Seattle-Puget Sound Louisiana
Christopher I Li - Vivien W Chen
Steven Schwartz - Xiao-Cheng Wu
Mary Potts Los Angeles
Jennifer Hafterson - Dennis Deapen
Amanda I Phipps -Donna Morrell
NCI IMS
Marsha E Reichman - Jennifer Stevens
Linda C Harlan
Lynn G Ries
Sean Altekruse
Brenda Edwards

3. Study Rationale Clinical importance of HER2
Guide therapy – trastuzamab
Prognostic indicator
Marker of sensitivity to anthracycline-based chemotherapy
Laboratory methodology relatively stable
Two major testing modalities
IHC – immunohistochemistry
FISH – fluorescence in situ hybridization
Prevalence of testing
ASCO recommendations

4. Goals of Pilot Project
Ascertain whether HER2 data items can be reasonably easily collected with high levels of completeness
Determine the source of the HER2 data (path report, path report addendum, other)
Determine the minimum data fields desirable
Determine suggested coding for these fields

5. Study Design Three SEER registries
Los Angeles, Louisiana, Seattle-Puget Sound
Invasive, first primary breast cancer patients
Diagnosed July to December 2007
Divide facilities into tertiles by size
Run-in period
Main study
Recruitment goal 290/registry
120 from large facilities (at least 4)
120 from medium facilities (at least 4)
50 from small facilities (at least 5)

6. Data Collection
Data collected from medical record only; no attempt to contact physicians for information
Due to early reporting complete data abstraction had not been done for all records, so some data items (e.g. race) are not complete

7. Data Collection IHC Value IHC Interpretation FISH Value
FISH Interpretation
Interpretation when test type unknown
Type of FISH test
FISH positive cut point
For each data item collected source of data (path report, addenda to path report, lab report in chart, other electronic data, data not available)

8. Overall Results 541 observations 522 = 96.5% had a HER2 test reported
515 = 95.2% had a test result* available
*test value and/or interpretation (positive/negative)

9. Results by Registry 541 observations Overall known HER2 result = 95.2%
Los Angeles 49
Louisiana 221
Seattle 271
Overall known HER2 result = 95.2%
Los Angeles 89.8
Louisiana 95.5
Seattle 95.9

10. Percent with known HER2 results by age at diagnosis
Age at Diagnosis N % with Known HER2
< % % % %

11. Percent with known HER2 results by stage at diagnosis
Stage at Diagnosis N % w Known HER2
I %
II %
III %
IV %
Unknown %

12. Percent with known HER2 results by race
Race N % w Known HER2
White %
Black %
API %
Other/Unknown %

13. Percent with known HER2 results by facility size
Facility Size N % w Known HER2
Small %
Medium %
Large %

14. Results of HER2 Testing Results N % w Known HER2 Negative 411 79.8%
Equivocal %
Positive %

15. Type of HER2 Test Performed
Test Type N % w Known HER2
IHC %
FISH %
IHC and FISH %
Other %

16. Source of HER2 Data Data Source N % of Observations
Pathology Report %
Addenda to Path Report %
Lab Report in Chart %
Other Electronic Data %
Other %

17. Conclusions HER2 data can be collected by SEER registries
Collection should be possible from data sources in current use
Estimate of completeness obtainable from path report and addenda is 74%; if include lab report this estimate is 89%
Wider data collection necessary to refine this estimate

18. Current Plans
HER2 data is being collected by several SEER registries for diagnosis year 2009 on a voluntary basis
Intent is to make these data fields required for diagnosis year 2010

19. Current Plans – Data Fields
Collected data fields
IHC interpretation
FISH interpretation
“Other test” interpretation
Derived data fields
HER2 test performed
HER2 test result

20. Molecular Markers in Cancer Registries
What are determinants of when to consider collecting a molecular marker?
Clinical relevance
Assay stability
Available data source
What kind of initial studies should be done?
Limited geographic area
Sample appropriate cases

21. Molecular Markers in Cancer Registries
How should markers be identified?
Clinical trial results – too early?
Professional organization standards for care – too late?
RRSS or similar localized studies for set time periods?
Should there be an expert panel / advisory group to discuss / evaluate potential markers on a regular basis?