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

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

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

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

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)

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

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)

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)

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

Percent with known HER2 results by age at diagnosis Age at Diagnosis N % with Known HER2 < 50 172 96.5% 50-59 121 96.7% 60-69 122 94.3% 70+ 126 92.9%

Percent with known HER2 results by stage at diagnosis Stage at Diagnosis N % w Known HER2 I 220 93.2% II 143 97.2% III 56 98.2% IV 24 95.8% Unknown 98 94.9%

Percent with known HER2 results by race Race N % w Known HER2 White 360 94.4% Black 75 96.0% API 22 100.0% Other/Unknown 84 96.4%

Percent with known HER2 results by facility size Facility Size N % w Known HER2 Small 79 88.6% Medium 198 94.4% Large 264 97.7%

Results of HER2 Testing Results N % w Known HER2 Negative 411 79.8% Equivocal 13 2.5% Positive 91 17.7%

Type of HER2 Test Performed Test Type N % w Known HER2 IHC 262 50.9% FISH 61 11.8% IHC and FISH 182 35.3% Other 10 2.0%

Source of HER2 Data Data Source N % of Observations Pathology Report 176 34.2% Addenda to Path Report 222 43.1% Lab Report in Chart 82 15.9% Other Electronic Data 34 6.6% Other 1 0.2%

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

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

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

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

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?