A cohort study of childhood cancer incidence after postnatal diagnostic X-ray exposure
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Transcript of A cohort study of childhood cancer incidence after postnatal diagnostic X-ray exposure
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A cohort study of childhood cancer incidence after postnatal diagnostic X-ray exposure
IMBEI, DKKR Dr von Hauner‘sche Kinderhospital
Helmholz-München
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Institut für Biometrie, Epidemiologie und Medizinische Informatik
2RICC Study
Introduction
Good epidemiologic knowledge on Adults and children exposed to high doses of radiation
Atomic bomb victims Patients following radiation radiotherapy
Adults exposed to low doses of radiation NPW-workers, uranium mine workers, pilots… Radon in homes
Adverse effects among children exposed to low level radiation?
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3RICC Study 3
Introduction
Source: German Federal Office for Radiation Protection
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4RICC Study 4
Background
Source: German Federal Office for Radiation Protection, Yearly Report 2005
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Typical doses in paediatric radiology
Examination
Entrance surface dose (µGy)
Age
0 1 5 15
Abdomen AP
Chest PA/AP
Pelvis AP
Skull AP
Skull LAT
110
60
170
/
/
340
80
350
600
340
590
110
510
1250
580
2010
110
1300
/
/
Source: NRPB-W14, 2000
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Major studies of cancer risk following diagnostic radiation exposure in childhood and adolescence
Cohort/underlying condition Cancer site investigated
Breast Leukaemia All sites
Tuberculosis, USA
Tuberculosis, Canada
Scoliosis, USA
Diagnostic x-ray of broken bones, Canada
Diagnostic x-rays, China
Diagnostic x-rays, USA
Cardiac catheterisation, Israel
Cardiac catheterisation, Canada
X
X
X
X
X
X
X
X
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ERR of brain cancer by age at exposure among selected cohorts treated with radiotherapy
Dose ranges refer to doses to the brain. Source: Sadetzki & Mandelzweig, 2009
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Estimated lifetime risk from a single dose of radiation as a function of age at exposure (BEIR 2006)
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RICC: Radiation induced Cancer in Children:
A cohort study of childhood cancer incidence after postnatal diagnostic X-ray exposure
Objectives:To estimate precise radiation doseTo estimate cancer risk (in children)
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12RICC Study 12
Material
Data collected at Dr. von Hauner Children’s Hospital - Munich
National X-ray ordinance 1973 Protocol of all x-ray examinations since 1976 in
databanks (as from 1998 RIS system) 270.000 examinations until 2003
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13RICC Study 13
Available data
Patient history Name, Gender, Date of birth, Date of examination, Height, Weight,
Address
Examination data Projection radiography / Screening, Organ of interest, X-ray tube
type, Radiation entry, Focus-skin distance (implicit), X-ray tube voltage, Total filtration (implicit), Exposure time / Duration of screening, mAs-Product / Dose area product
Clinical data Indication, Radiological diagnosis
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14RICC Study 14
Base data
Examination databases MINDIUS I-III 1976 – 1991 Paper only 1992 - 1997 RIS / discharge letters 1998 - 2003
Additional databases
X-ray machine details Dosimeter details Exposure modeling
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16RICC Study 16
Cohort
Inclusion criteria At least one diagnostic procedure performed at Dr.
von Hauner’s Children’s Hospital Age at “examination” ≤ 14.5 years Main residence in Germany Time period 1976-2003
Cancer free at beginning (incl. first 6 months)
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17RICC Study 17
Follow-Up
Cancer: Linkage of pseudonymised data with the German
Childhood Cancer Registry Observation period: 1980-2006
Person Years: No individual follow-up ! Calculating PY with age-specific mortality rates Excluding children with “high” mortality risk
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18RICC Study 18
Methods: Patient groups
On the basis of clinical indications / diagnosis Patients with elevated mortality risk Syndromes with elevated cancer risk Pre-term babies
On the basis of exposure records Highly exposed (CT, contrast media, single dose > 5
mSv, cardiac patients)
RIS only patients (no specific diagnosis available!)
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19RICC Study 19
CategoriesGroup Disease ICD-10-Codes„elevated mortality risk“
Acute pericarditis I30Acute rheumatic fever I00-I02Aneurysms I71-I72, Q25.4Appendicitis K35-K36Bronchopulmonary dysplasia P27Chronic rheumatic heart diseases I05-I09Other coagulation defects D68Diverticular disease of intestine K57 K60 K62Endocarditis I38Inflammatory diseases of the central nervous system (Meningitis, Encephalitis)
G00-G09
Epiglottitis J05.1 J37Cardiac defect (complex defects, not isolated ASD or VSD) Q20-Q24HIV-disease B20-B24
„elevated cancer risk“
Agranulocytosis and neutropenia D70Chromosome anomalies, not classified elsewhere Q90-Q99Colitis ulcerosa K50-K51Immunodeficiencies D80-83Crohn’s disease K50
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20RICC Study 20
Methods: Dosimetry
Source: Michael Seidenbusch
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22RICC Study 22
Radiation Exposure
Organ dose was estimated
For risk analysis: effective dose (=whole body dose) Leukaemia: red bone marrow dose Dose: continuous and categorical variable
Latency period: ½ year
Imputation for (some) missing values
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23RICC Study
Statistical Analyses Plan (SAP)
„External comparison“ SIR (by sex):
All cancers, Leukaemia,lymphocytic leukaemia, acute myeloid leukaemia,
lymphoma, CNS-tumours, other tumours)
Dose categories
Internal comparison: RR (multivariate)
Sensitivity analysis Excluding specific subgroups
High exposed, elevated mortality risk No. of examinations: 1, 2, 3+ Cox Regression (time-dependent covariable)
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24RICC Study
Excurse: The German Childhood Cancer Registry (GCCR)
Begin of registration 1980
Population base (children below 15) 13.0 million
Number of reported cases (1980-2008) 43.014
Completeness of registration ca. 95 %
Number of cases annually 1,700-1,800
Since 1991 inclusion of former GDR
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25RICC Study
GCCR:
Society for Paediatric Oncology and Haematology (GPOH)
34 large treatment centres treat 75% of all children
Each year nearly 70 hospitals report cases since 1980 more than 130 reporting hospitals
25 GPOH-clinical trials
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29RICC Study 29
Power calculation for RICC
Cancer endpoint Expected Numbers
All cancers 104
Leukaemia 36
Lymphocytic 30
Acute myeloid 5
CNS-tumours 22
Lymphoma 15
All others 31
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30RICC Study 30
RICC: Year of first examination
0
1000
2000
3000
4000
5000
6000
1976 1981 1986 1991 1996 2001
Year of first X-ray examination
# S
ub
ject
s
UnknownGirlsBoys
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31RICC Study 31
Results: Cohort
n %All Patients 92957 100 Boys 50005 54 Girls 41432 45 unknown gender 1520 1Patients with elevated mortality risk 14174 15Syndromes with elevated cancer risk 398 0,4
Premature children 279 0,3
Highly exposed 3428 5
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32RICC Study 32
Results: Cohort
All % CasesAll Patients 92957 100 87 Boys 50005 54 52 Girls 41432 45 35 unknown gender 1520 1 0Patients with elevated mortality risk 14174 15 21Syndromes with elevated cancer risk 398 0,4 0
Premature children 279 0,3 0
Highly exposed 3428 5 4
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33RICC Study 33
Results – Cohort
Age at inclusion n %
0 20546 22
1 9096 10
2 6945 7
3 6202 7
4 6387 7
5-9 24891 27
10-14 18890 20
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34RICC Study 34
Results – Cohort
Number of examinations (per patient) All % 1 54605 59 2 17818 19 3 7515 8 4 4042 4 5 2341 3 6 1611 2 7 1128 1 8 737 1 9 561 1 10+ 2599 3
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36RICC Study 36
Results: incident cases
Gender
ICCC-3
Diagnosis Boys Girls
I-XII All cancers 52 35
ILeukaemias, myeloproliferative diseases and myelodysplastic diseases
19 14
Ia Lymphocytic leukaemia 15 9Ib Acute myeloid leukaemia 2 3Ic-Ie Other leukaemias 2 2II Lymphoma 11 2III CNS-tumours 7 3IV-XII Other tumours 15 16
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38RICC Study
38
Results: Cumulative exposure by status
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
0- 100- 200- 300- 400- 500- 600- 700- 800- 900- 1000+
Cumulative effective Dose (µSv)
% S
ub
ject
s
0%
10%
20%
30%
40%
50%
60%
0- 10- 20- 30- 40- 50- 60- 70- 80- 90-
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39RICC Study 39
Results – Exposure per examination, by age
(whiskers show 10% and 90% percentiles)
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40RICC Study
Results – Exposure per examination, by year
(whiskers show 10% and 90% percentiles)
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43RICC Study 43
Results: Cumulative exposure (µSv) ATTENTION: µSv
n / N Median
All patients 92957 7.0
Highly exposed 3428 24.0
RIS only 21319 3.0
MUNDUS 71638 10.0
elevated mortality risk 14174 84.0
elevated cancer risk 398 58.0
premature children 279 51.0
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44RICC Study 44
External Comparison
O E SIR 95%-CI
Gender
Boys 52 52.8 0.99 0.74-1.29
Girls 35 35.2 1.00 0.69-1.38
All cancers 87 88.0 0.99 0.79-1.22
Leukaemia 33 30.5 1.08 0.74-1.52
Lymphocytic leukaemia 24 24.5 0.98 0.63-1.45
Acute myeloid leukaemia 5 4.3 1.16 0.38-2.70
Lymphoma 13 13.4 0.97 0.52-1.66
CNS-tumours 10 19.3 0.52 0.25-0.95
Other tumours 31 24.8 1.25 0.85-1.77
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45RICC Study 45
Sensitivity Analysis
O E SIR 95%-CI
Elevated mortality risk
No 58 56.1 1.03 0.79-1.34
yes 21 16.4 1.28 0.79-1.96
Highly exposed
No 83 84.4 0.98 0.78-1.22
Yes 4 3.7 1.09 0.30-2.78
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47Nov. 2009 RICC Study 47
SIR-Analysis: Effective dose
Trend test: p = 0,320,1
1
10
<1(16)
1-(10)
5-(14)
10-(12)
25-(11)
50-(6)
100-(8)
250-(5)
500+(5)
Cumulative effective dose (µSv)(# cases; p(trend) = 0.32)
SIR
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49Nov. 2009 RICC Study 49
RR-Analysis
Eff. Dosis (µSv)
All cancersRR* 95%-KI
Total 0- 1.0010- 1.02 0.60-1.7450+ 1.01 0.60-1.71
elevated mortality risk excluded
0- 1.0010- 1.08 0.61-1.8950+ 1.04 0.55-1.96
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50RICC Study 50
RR-Analysis
Eff. Dosis (µSv)
Leukaemia + Lymphoma
RR* 95%-KI
Total 0- 1.0010- 1.00 0.48-2.0750+ 1.04 0.51-2.12
elevated mortality risk excluded
0- 1.0010- 1.13 0.53-2.4450+ 1.24 0.54-2.83
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51RICC Study 51
RR-Analysis
Eff. Dosis (µSv)
Solid Tumours
RR* 95%-CI
Total 0- 1.0010- 1.05 0.49-2.27
50+ 0.98 0.46-2.12
elevated mortality risk excluded
0- 1.00
10- 1.01 0.44-2.34
50+ 0.84 0.31-2.25
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52RICC Study 52
Summary
Cohort of 92957 children Observed 1980-2006; 7,8 years
726200 person years 87 cancer cases
No increased incidence No dose-effect relationship
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54RICC Study
Strengths
+ Unique patient collective
+ Large cohort
+ Prospective data acquisition
+ Good documentation
+ Excellent dosimetry
+ Cancer register with complete coverage,
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55RICC Study
Strengths and weaknesses
+ Unique patient collective
+ Large cohort
+ Prospective data acquisition
+ Good documentation
+ Good dosimetry
+ Cancer register with complete coverage, extensive inquiries
- Small numbers of cases
- Very low radiation doses
- Underestimation of exposure
- CT-exposures not yet quantified
- Confounding by indication
- No ascertainment of confounders
- No cancer after age 15
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56RICC Study 56
Perspective
Current cohort Further follow-up possible Nested case-control study on biological markers ??
Cohort of children with CT exposures CT risks only roughly assessable up to now Missing epidemiologic data Pilot study is ongoing
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Estimation Risk of CT Exposure
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Estimated number of CT scans performed annually in the US
Source: Brenner et al. 2007
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Special focus: CT scans in children
Increase in CT use in children
1989: ~ 4% of all CT scans
1993: ~ 6% of all CT scans
2000: ~ 8-11 of all scans
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Estimated Organ Doses from Typical Single CT Scans of the Head
Source: Brenner et al. 2007
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Estimated lifetime risk from a single dose of radiation as a function of age at exposure (BEIR 2006)
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Age-related effect of a single pediatric head CT scan on tumor occurrence and fatality
Age at exposure
years
Lifetime risk of radiation induced cancer per 10 000
exposed children
tumour fatality
1 220 70
2 150 60
5 120 50
10 80 33
15 50 20
20 40 15Adjustment of table 4: Stein et al. 2008
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65
CT-Cohort Study
Design:
Similar to RICC
Data sources: Radiological and Neuro-radiology departments of several clinics
(PACS and RIS) Estimated size: 47 000 children exposed between 1990 and
2003 in Germany Cohort planned: 5000 children Feasibility study is ongoing EU-consortium, BMBF funding
Problems: Data on indication, Confounding by indication Dosimetry Cancer after age 15!!
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66Nov. 2009 RICC Study 66IMBEI 12.08.2008
Acknowledgements
Mainz: IMBEI:
Gael Hammer Hajo Zeeb Doris Bardehle (!!) Susanne Seuchter
Data protection officer Irene Reinisch
GCCR Claudia Bremensdorfer Irene Jung Claudia Spix Thomas Ziegler
München: Michael Seidenbuch Karl Schneider Dieter Regulla
Monika-Maria Deml Sieglinde Eberle Toni Galitzendorfer Sabine Heyn Renate Ritzer Ina Schneider
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Institut für Biometrie, Epidemiologie und Medizinische Informatik
67RICC Study 67
Publications Hammer GP, Seidenbusch MC, Schneider K, Regulla DF, Zeeb H, Spix C,
Blettner M. A cohort study of childhood cancer incidence after postnatal diagnostic X-ray exposure. Radiat Res 2009; 171(4):504-512.
Seidenbusch MC, Regulla D, Schneider K., Zur Strahlenexposition von Kindern in der pädiatrischen Radiologie. Teile 1-6. Fortschr Röntgenstr 2008/2009 ; 180(5):410-422 ; 180(6):522-539 ; 180(12):1061-1081 ; 180(12):1082-1103 ; 181(5):454-471 ; 181(10):945-961.
Hammer GP, Seidenbusch MC, Schneider K, Regulla DF, Zeeb H, Spix C, Blettner M. Inzidenz von Kinderkrebs nach Röntgendiagnositik im Patientenkollektiv der Jahre 1976-2003 einer Universitätsklinik. Fortschr Röntgenstr 2010, 182: 404-414