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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
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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 SoundLouisiana • 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 • 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 DiagnosisN% 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 DiagnosisN% 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 RaceN% 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 SizeN% w Known HER2 Small 79 88.6% Medium 198 94.4% Large 264 97.7%
Results of HER2 Testing ResultsN% w Known HER2 Negative 411 79.8% Equivocal 13 2.5% Positive 91 17.7%
Type of HER2 Test Performed Test TypeN% 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 SourceN% 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?