1. United States Cancer Registries FDA Meeting of Pediatric Subcommittee of the Anti-Infective Drugs Advisory Committee October 30, 2003 Phyllis A. Wingo, PhD, MS

2. Outline of Presentation u Cancer registry programs in the United States u Data available u Data quality issues u United States Cancer Statistics (USCS), including childhood cancers u Follow-up u Summary

3. Cancer Registry Programs in the United States

4. History of Cancer Registration in the United States u 1930's -First hospital based registries u 1941 - Connecticut Cancer Registry u 1971 - SEER Program u 1987 - NAACCR u 1990 - National Cancer Data Base u 1992 - National Program of Cancer Registries u 2000 -CDC and NCI Memorandum of Understanding u 2002 - United States Cancer Statistics

5. Surveillance Epidemiology and End Results (SEER) Program u NCI u 1973+ u 9 States and 6 metropolitan areas u 26% population coverage AK HI SEER SEER/NPCR (2000+)

6. National Program of Cancer Registries (NPCR) u CDC u 1995+ u 45 states, 3 territories, District of Columbia u 96% population coverage NPCR NPCR/SEER AK HI

7. Cancer Registries Amendment Act (PL 102-515) u Passed by Congress October 1992 u Authorized establishment of National Program of Cancer Registries (NPCR) u Set requirements for funded central registries

8. Requirements of Cancer Registries Amendment Act u Statewide, population-based registry u Statewide legislation/regulations u Compliance with standards l Completeness l Timeliness l Quality u Uniform data elements, uniform format u Statewide annual report

9. Legislation and Regulations u Authorizing legislation supports existence of central registries u State regulations: - Comprehensive reporting - Access to records - Reporting of uniform data - Protection of confidentiality - Access to data by researchers - Authorization to conduct research - Protection from liability

10. Data available in population-based registries in the United States

11. Reportable Cancer Case Defined as "each form of invasive cancer with the exception of basal cell and squamous cell carcinoma of the skin and each form of in situ cancer except for carcinoma in situ of the cervix uteri"

12. Data Items Demographic Information, including at a minimum: l Name l Address at diagnosis l Census tract l Race and Spanish/Hispanic origin l Sex l Birth date l Social security number

13. Data Items (Continued) Clinical Information, including at a minimum: l Date of diagnosis l Date of admission/first contact l Source of information l Date and type of first course of definitive treatment (surgery) l Date of death l Underlying cause of death

14. Data Items (Continued) Pathologic Information, including at a minimum: l Primary site l Morphology Type, behavior, and grade l Sequence number l Laterality l Diagnostic confirmation

15. Data Quality Issues

16. NPCR Standards for Completeness Standard processes for measuring completeness: u Case sharing with all bordering states u Case reporting from all facilities providing cancer screening, diagnosis, and treatment u Case finding audits u Death clearance and follow-back u Duplicate records protocol

17. NPCR Standards for Timeliness Standard data items for measuring timeliness: u Dates case report l sent to central registry l received by central registry l loaded into central registry database u Date tumor record available in central registry

18. NPCR Standards for Completeness and Timeliness u Within 24 months, l <3% death certificate only cases l ≤0.1% of records are duplicates u 90% of unduplicated, expected, malignant cases within 12 months u 95% of unduplicated, expected, malignant cases within 24 months

19. NPCR Standard for Quality u Within 12 months of the close of the dx year, 97% of the cases pass an NPCR prescribed set of standard data edits. u Within 24 months of the close of the dx year, 99% of the cases pass an NPCR prescribed set of standard data edits.

20. North American Association of Central Cancer Registries (NAACCR) u Uniform data standards for cancer registration u Education and training u Certification u Data publication u Data use

21. 19971998 *North American Association of Central Cancer Registries 2000 2002 NAACCR*-Certified State Cancer Registries by Year of Data Submission DC

22. United States Cancer Statistics, 2000 Incidence

23. Joint Publication of National, Regional, and State Cancer Incidence Data United States Cancer Statistics (USCS) u 2000 incidence data u Crude and age- adjusted rates per 100,000 u 95% CI u 84% population coverage

24. USCS – Eligibility Criteria u High quality data l > 90% completeness of case ascertainment l < 5% death certificate-only cases l > 97% records pass EDITS l < 3% records missing information on race l < 2% records missing information on sex and age u 41 statewide and 6 metropolitan area cancer registries met criteria

25. Registry Programs Meeting Quality Criteria 2000 PUERTO RICO AK HAWAII CA ID WA MT WY UT CO AZ NM TX OK KS NE SD ND MN WI IA IL OH IN KY WV VA NC GA FL AL MS MO AR LA NV MI PN NJ NY MA VT NH ME TN SC MD DE CT RI DC OR Atlanta Detroit San Francisco/ Oakland Los Angeles Seattle/ Puget Sound San Jose/ Monterey REPUBLIC of Palau 7 VIRGIN ISLANDS

26. USCS - Content u Section 1: National cancer incidence data by site,sex and race l 84% coverage US population u 84% White u 81% Black u 91% Asian / Pacific Islander l > 1 million new cases l > 10,000 new cases among children 0- 19 years old u Section 2 u Section 3

27. Invasive Cancer Incidence Rates for the 15 Primary Sites with the Highest Age-Adjusted Incidence Rates, United States, 2000 Liver & IBD Brain & ONS Larynx Esophagus Stomach Pancreas Leukemias Oral Cavity & Pharynx Kidney & Renal Pelvis Melanomas of the Skin Non-Hodgkin Lymphoma Urinary Bladder Colon & Rectum Lung & Bronchus Prostate 050100150200250300 7.4 7.7 7.8 8.5 10.5 12.1 14.5 15.7 16.4 19.4 21.6 37.8 65.0 87.9 160.4 Males, All Races Rate per 100,000

28. Invasive Cancer Incidence Rates for the 15 Primary Sites with the Highest Age-Adjusted Incidence Rates, United States, 2000 Brain & ONS Oral Cavity & Pharynx Kidney & Renal Pelvis Leukemias Cervix Uteri Pancreas Urinary Bladder Thyroid Melanomas of the Skin Non-Hodgkin Lymphoma Ovary Corpus & Uterus, NOS Colon & Rectum Lung & Bronchus Breast 050100150200250300 5.5 6.0 8.4 8.7 9.2 9.5 9.8 10.7 12.4 15.4 15.8 23.5 47.0 52.5 128.9 Females, All Races Rate per 100,000

29. Lymphoma Incidence Rates by Sex, United States, 2000 MalesFemales RateCountRateCount Lymphoma2223,0921426,052 Hodgkin1912 Non-Hodgkin 3 1 Age-adjusted rates (2000) per 100,000

30. Invasive Skin Cancer Incidence Rates by Sex, United States, 2000 MalesFemales RateCountRateCount Skin*2526,0521823,162 Melanoma of skin 3 2 Non-epi skin2215 Age-adjusted rates (2000) per 100,000 *Excluding basal and squamous cell skin cancer

31. Invasive Cancer Incidence Rates for Childhood Cancers, by Sex, Ages 0-19, 2000 MalesFemales ICCC categoryRateCountRateCount All sites combined1665,6741474,782 I Leukemia 42 36 II Lymphoma 28 20 III CNS 30 25 IV Sympath nerv sys 8 7 V Retinoblastoma 3 2 VI Renal tumors 6 7 Age-adjusted rates (2000) per 1,000,000

32. MalesFemales ICCC category VII Hepatic tumors 2 2 VIII Malignant bone 9 8 IX Soft-tissue sarcoma 13 10 X Germ-cell tropho 13 10 XI Carcinomas 11 19 XII Other 1 1 Not classified ^ 1 Age-adjusted rates (2000) per 1,000,000 Invasive Cancer Incidence Rates for Childhood Cancers, by Sex, Ages 0-19, 2000

33. USCS - Content u Section 1: National cancer incidence data by site, sex and race u Section 2: Cancer incidence data by states, census division, sex and race l Regions > 80% population coverage u Pacific 100%, u Mt. 100% u W.N. Central 96% u E.N. Central 100% u Mid. Atlantic 100% u New England 91% u South 57% u Section 3

35. USCS - Content u Section 1: National cancer incidence data by site, sex and race u Section 2: Cancer incidence data by states, census division, sex and race for the leading 20 sites males, 29 sites females u Section 3: State-specific cancer incidence rates ranked within sex and race for the leading 15 sites

36. Follow-up in Population-Based Registries in the United States

37. Follow-up to Determine Vital Status To confirm deaths among cancer patients, all NPCR and SEER registries link with: u State death certificates files u Social security files u National Death Index (NDI)

38. Follow-up to Determine Vital Status To confirm alive status among cancer patients, all SEER (9 states) and selected NPCR registries (very few) link with: u Social security files u Hospital discharge data u Medicare (CMS) u Voter registration u Motor vehicle registration u Other

39. Summary u Population-based cancer registries in all 50 states and the District of Columbia. u CTQ varies across states u Follow-up good for death status, limited for alive status

40. Summary u Strong nationwide cancer registry infrastructure in place u Data available at national, regional, state and local levels for: l Monitoring burden of disease l Planning comprehensive cancer control programs l Conducting special research studies

41. www.cdc.gov/cancer/npcr

42. Future Plans u Expand population-based coverage u Include other racial and ethnic groups u Estimated of case counts at the national and regional levels u Trend data u Pediatric cancers u Mortality data

43. Frequency Distribution Ages 0-19, 2000 ICCC category NPCR N=9,882 SEER N=1,82 3 I Leukemia25%27% II Lymphoma1514 III CNS1817 IV Sympathetic nervous system 5 5 V Retinoblastoma 2 2 VI Renal tumors 4 4 VII Hepatic tumors 1 1 VIII Malignant bone tumors 5 5

44. Frequency Distribution, continued Ages 0-19, 2000 ICCC category NPCR N=9,882 SEER N=1,823 IX Soft-tissue sarcoma 8 % 9 % X Germ-cell trophoblastic 7 7 XI Carcinomas 9 9 XII Other 0 0 Not classified 0 0 Total100

45. Lymphoma and Reticuloendothelial Neopl, 2000 Age-Specific and Age-Adjusted Incidence Rates Rates are per 1,000,000 and are age-adjusted to the 2000 US standard population

46. Acute Lymphocytic Leukemia, 2000 Age-Specific and Age-Adjusted Incidence Rates 0-04 Rates are per 1,000,000 and are age-adjusted to the 2000 US standard population