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DaHoRS: Principal study design. . AimAssess the influence of OC and HT onThe risk of cardiovascular diseases and cancerMaterial and methodsA National cohort of 1.8 million women 15-69 years old January 1, 1995Followed from January 1995 through 2002Exposures and outcomes from national registersDetails on www.dachre.dk.
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1. Danish sex Hormone Register StudyDaHoRS
Hormone therapy and breast cancer
Řjvind Lidegaard1, Ellen Lřkkegaard2,
Anne Helms Andreasen3, Lisbeth Mřller3
Carsten Agger3, Torben Jřrgensen3
1) Rigshospitalet, Gynaecologic Clinic, 4232
2) Dept. Obstetrics & Gynaecology, Hilleroed Hospital, DK.
3) Research Centre for Prevention and Health, Glostrup, DK
2. DaHoRS: Principal study design Aim
Assess the influence of OC and HT on
The risk of cardiovascular diseases and cancer
Material and methods
A National cohort of 1.8 million women
15-69 years old January 1, 1995
Followed from January 1995 through 2002
Exposures and outcomes from national registers
Details on www.dachre.dk
3. Data retrieval: Registers involved National Register of Medicinal Product Statistics (NRM) assessing daily exposure of OCs and HT and medicine for diabetes, hypertension, and hyperlipidaemia
National Register of Patients (NRP)
assessing clinical outcomes, hysterectomy, oophorectomy
Central Person Register (CPR)
assessing education, job-status, address
4. Clinical outcomes Cancers included, total: 36,552
Breast, endometrium, ovaries, cervix, colon, rectum, lymphoma, leukaemia
Cardiovascular end points, total: 63,483
Acute myocardial infarction (AMI)
Ischaemic heart disease
Thrombotic stroke
Haemorrhagic stroke
Venous thromboembolism
5. Clinical outcomes Cancers included, total: 36,552
Breast, endometrium, ovaries, cervix, colon, rectum, lymphoma, leukaemia
Cardiovascular end points, total: 63,483
Acute myocardial infarction (AMI)
Ischaemic heart disease
Thrombotic stroke
Haemorrhagic stroke
Venous thromboembolism
6. Hormone therapy and breast cancer Cohort: Included women 50-69: 785,397
Exposed women (current+prev): 234,955
Control women (never users): 550,442
Women currently on HT with BC: 3,010 2.5
Women previously on HT w BC: 1,957 1.7
Women never on HT with BC: 7,864 1.4
Included with BC: 12,831
7. BC risk: Influence of age, current use
8. BC risk: Length of systemic HTStratified by age and duration of use (years)
9. BC risk according to HT regimen
10. BC risk according to route
11. The impact of progestagen doseLow = 0.5mg NETA or 2.5mg MPA. High = 1mg NETA or 5mg MPA
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14. Death after BC accord to HT Group Wom yrs Dead deaths/100wy
51-54 yrs 4,098 143 3.5
55-59 yrs 7,635 382 5.0
60-64 yrs 7,301 450 6.2
65-69 yrs 7,658 545 7.1
70-74 yrs 3,164 237 7.5
Never 29,856 1,757 5.9
Previous 5,876 263 4.5
Current 11,212 327 2.9
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18. The reduced case-fatality rate and low risk of lethal BC may be due to Earlier detection of BC in hormone users
Less pathological histology
More receptor positive tumors
Withdrawal of hormones after detection
More intensive screening of women on hormones with detection of tumours which would never have manifested as clinical BC
19. HT-BC: Conclusion HT in women 50-54 years old have little excess BC risk
Estrogen only for any length in women below 65 years implies only little risk of BC
Combined HT increases the risk of BC after >4 years therapy or age >55 years old
Cyclic comb therapy confers roughly the same risk as cont comb HT up to 4 years of hormone use.
>4 years cont comb therapy confers a higher risk of BC than >4 yrs cyclic comb. therapy
20. HT-BC: Conclusion Consistent association to duration of use.
Consistent association to estrogen dose.
Consistent association to progestagen dose.
Older women higher relative risk on cont combined regimen than younger postmenopausal women.
Risk disappears 6 months after last use
Case-fatality rate ratio 0.5 in current users
Risk of lethal breast cancer not increased
21. HT-BC: Clinical implications Low-dose products
Less concern of estrogen only therapy
Less concern about HT in women during their first five years after menopause.
Advise for low-progestagen dose regimens
- especially if long term use.
No concern about local estrogen
Probably no increased risk of lethal BC