Sister Study Breast Cancer Diagnosis Variables

1. Sister Study Breast Cancer Diagnosis Variables Data Release 3.1

2. Breast cancer diagnosis variables Data Sources • Medical Report (MR) • “Gold standard” for breast cancer (BC) diagnosis data • Abstracted from medical records and pathology reports • Multiple BC diagnoses per subject are available • Tumor-level data for: type (invasive/in situ), location (ducts/lobules), ER, PR, HER2-Neu, etc. • Breast Cancer Follow-Up (BCFU) self-report • Best quality of self-reports • Data collected only for one diagnosis in latest version of BCFU form • Subject-level data for: type (invasive/in situ), location (ducts/lobules), ER , PR, HER2-Neu, etc. • There are substantial differences in what was collected in v.1, v.2 and v.3 of the BCFU form. • Other self-report sources • Annual/biennial/triennial health update, calls to help desk • Only diagnosis date is collected. • Subjects can report a diagnosis as “breast cancer”, “DCIS”, or “LCIS” on health update forms, but quality of these distinctions is questionable in some cases. Sister Study Breast Cancer Diagnosis Variables

3. Breast cancer diagnosis variables Incoming data The multiple sources of diagnosis information are used discretely. That is, data is not merged from different sources except under special circumstances of using BCFU data to fill in missing MR data for • diagnosis date, • ER, PR and HER2-Neu. Once the earliest BC diagnosis is determined, the data is taken from the “best” form that coincides with that incidence, based on the hierarchy below: 1) Medical Reports (MR), 2) Breast Cancer Follow-Up (BCFU) self-report, 3) Other Health Update self-report forms, annual/biennial/triennial 4) Help desk reports. Sister Study Breast Cancer Diagnosis Variables

4. Breast cancer diagnosis variables Data used in data request transfers • The diagnosis data is updated with each production release of the Sister Study data (see page 1 of Data Release Schedule.pdf on the home page of this site). • The timing for inclusion of diagnosis data in each production release corresponds roughly to the cut-off dates, not the release dates, for each release (see pages 2 & 3 of Data Release Schedule.pdf). • Transition from breast cancer case to breast cancer event is described in the document Breast Cancer Event Definition and Assignment of Follow-up Time. Sister Study Breast Cancer Diagnosis Variables

5. Breast cancer diagnosis variables Subject-level variables These variables summarize first BC diagnosis using best available source. SS: Sister Study TS: Two Sister Study Sister Study Breast Cancer Diagnosis Variables

6. Breast cancer diagnosis variables Subject-level variables (cont’d) SS: Sister Study TS: Two Sister Study Note: Occasionally, ER, PR and HER2-Neu results are not from the data source mentioned in BC_DxDate_Source. Sister Study Breast Cancer Diagnosis Variables

7. Breast cancer diagnosis variables Subject-level variables (cont’d) SS: Sister Study TS: Two Sister Study Sister Study and BrCA Risk Estimates

8. Breast cancer diagnosis variables FU_DxBCType - indicates breast cancer type for diagnoses from MR or BCFU data (Data Release 3.1, Sister Study) Sister Study Breast Cancer Diagnosis Variables

9. Breast cancer diagnosis variables Subsetting diagnosis data Examples: • To keep medically validated events only, use FU_DxDate_Source=:’MR’ (in SAS). • To keep invasive BC only, use 12<=FU_DxBCType<20. Limitations: • FU_Dx… variables are populated with first reported BC. • There may be later diagnoses of the BC type that you are interested in. Example: • If you subset on invasive BC only, subjects with DCIS or LCIS for initial diagnosis who have a later diagnosis of invasive BC are not included • If you want to include the invasive BC cases that occur after DCIS or LCIS diagnosis, you will need to request custom derived variables Sister Study Breast Cancer Diagnosis Variables

10. Breast cancer diagnosis variables Revision of criteria for BC diagnosis starting 8/2012. • Original definition: Invasive BC or DCIS only. • Excludes LCIS and some MR and BCFU reports that contained insufficient information to determine if the BC was invasive or ductal. If there were multiple diagnoses, the first invasive or ductal BC diagnosis was used. • Revised definition: Expanded to include LCIS and instances where there was insufficient information to determine if the BC was invasive or ductal. • Any report of breast cancer from MR, BCFU or other self-report sources is considered to be breast cancer. Sister Study Breast Cancer Diagnosis Variables