Epidemiology of SV40-Associated Tumors

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1 Epidemiology of SV40-Associated Tumors Susan G. Fisher, Ph.D. Chief, Division of Epidemiology Community & Preventive Medicine University of Rochester

2 Background Mass polio immunization program in U.S. (Salk, 1955) SV40 identified in vaccine cultures (Sweet, 1960) Development of sarcomatous tumors in 71% of hamsters injected with SV40 (Eddy, 1961)

3 Background (cont ) No consistent epidemiologic data to suggest long-term effects of SV4- exposure; - cancer mortality (Fraumeni) - cancer incidence (Innis, Mortimer, Geissler, Olin) - tumor specific incidence (Strickler) Numerous reports of the presence of SV40 in human tumors (ependymoma, osteogenic sarcoma, mesothelioma).

4 Study Objective: - to investigate the potential association between exposure to contaminated polio vaccine and increased cancer risk.

5 Analytic Approach descriptive population analysis of age, time, and sex-adjusted cancer incidence rates by year birth cohort analysis comparing SV40-exposed ( ) and unexposed ( ) groups

6 Data Source: NCI SEER cancer incidence database (1997) - population-based, tumor-specific data from 12% of US population; - all invasive cancers,

7 Study Outcomes: newly diagnosed invasive cancers; ependymomas (ICDO ); other brain cancers (ICDO recode 31010); osteogenic sarcomas (ICDO ); other bone and joint tumors (ICDO recode 23000); mesothelioma (ICDO ).

8 Cancer Incidence, SEER,

9 Incidence of Ependymoma & Other Brain Tumors, SEER,

10 Incidence of Osteosarcoma & Other Bone Malignancies, SEER,

11 Incidence of Mesothelioma, SEER,

12

13 Table I. Average annual cancer incidence rates by tumor type for birth cohorts, age Birth cohorts Exposed ( ) n = 2,013,344 Number of Cases Incidence Rate Unexposed ( ) N = 2,111,190 Number of Cases Incidence Rate Percent increase in incidence, exposed vs. exposed Adjusted 1 increase in incidence, exposed vs. unexposed All Cancer % 2.3% Ependymoma & Choroid Plexux % 37% Other Brain % 5% Osteogenic Sarcoma % 26% Other Bone % 34% Mesothelioma % 220% 1 Adjusted increase in incidence was calculated using O-E/E where O equals the observed rated in the exposed cohort and E equals the expected rate in the unexposed group. The expected rate was calculated as 13% less than the rate in the unexposed group to adjust for the 13% lower age-adjusted cancer rate and cancer incidence in year olds in 1979 as compared to 1987.

14 Summary of Study Results age-adjusted rates for all cancers and tumor-specific types have increased since improved diagnosis/screening - improved reporting - changing profile of cancer incidence increased occurrence of ependymoma, osteosarcoma, and other bone tumors in exposed birth cohort; - risk estimates are imprecise - differences are not statistically significant - attributable risk due to SV40 remains small

15 Limitations of SV40-related Epidemiologic Research Use of mortality data may be biased by changes in treatment efficacy; SEER is most consistent, high quality database available; fails to capture childhood tumors of those potentially exposed; Strong correlation of each specific tumor with age complicates birth cohort analyses;

16 Limitations (cont. ) Potential transmission of SV40 (person-toperson, perinatal) from vaccinees negates availability of a truly unexposed cohort. Poor documentation of contaminated vaccine lots and vaccine distribution; Rarity of tumors of interest magnifies rates of change over time and decreases study power; Overall increase in cancer incidence complicates the interpretation of changing rates in rare tumors.

17 Implications for Future Research Our study provides preliminary epidemiologic evidence to support further investigations of SV40 and cancer risk; Increased attention in molecular studies to tumor histology, patient characteristics and disease course; Integrated multi-disciplinary approach to investigations.

18 New Development!.Potential Role of SV40 in NHL

19 Estimated New Cancer Cases*: 10 Leading Sites by Gender, US, 2000 Prostate 29% Lung & bronchus 14% Colon & rectum 10% Urinary bladder 6% Non-Hodgkin s 5% lymphoma Melanoma of skin 4% Oral cavity & pharynx 3% Kidney & renal pelvis 3% Leukemia 3% Pancreas 2% All other sites 19% 30% Breast 12% Lung & bronchus 11% Colon & rectum 6% Uterine corpus 4% Non-Hodgkin s lymphoma 4% Ovary 3% Melanoma of skin 2% Urinary bladder 2% Pancreas 2% Thyroid 22% All other sites

20 Epidemiology of NHL 14 cases per 100,000 persons - 56,200 cases in ,000 deaths each year Most common among whites Fifth most common cancer More often occurs in males 82% increase in disease incidence in 25 years

21 Lymphomas with Known Infectious Etiology LYMPHOMA AGENT Burkitt s Lymphoma Epstein Barr Virus Hodgkin s Disease HIV III Japanese T-cell Leukemia/Lymphoma HHV8 Body Cavity Lymphoma Immunocytoma Hepatitis C MALT-associated Helicobacter pylori Mediterranean Lymphoma Intestinal pathogen

22 Studies of SV40 & NHL Carbone & R. Fisher (1999) - 3+/29 NHL, 6+/25 PTLD, 2+/5 AIDSrelated NHL - SV40 regulatory region not identified - concluded SV40 prevalence was low Miller (2001) - 8+/58 NHL, 7+/21 AIDS-related lymphomas - no virus detected with Southern blot - no apparent direct role of SV40 in lymphoma

23 Studies of SV40 & NHL (cont.) Butel (2002) - 64+/154 NHL - similar rates in HIV+ and HIV- samples - concluded SV40 significantly associated with NHL Gazdar (2002) - 29+/68 NHL - approx. 5% of other pediatric & adult tumors positive for sequences at low frequency - concluded SV40 may be cofactor in NHL

24 Summary Molecular studies are likely to define the etiologic mechanisms of SV40 in cancer Well-designed epidemiologic studies are needed to delineate the potential public health impact of SV40.

25 Age of Persons from Birth Cohorts (Strickler et. al.) Unexposed Year of Birth '73 '74 '75 '76 '77 '78 '79 '87 '88 '89 90 '91 92 ' Cohort Born Age in 73 Age in 93 Exposed as Children Exposed as Infants

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