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Hormone therapy (HT) and breast cancer

Hormone therapy (HT) and breast cancer. Øjvind Lidegaard. Gynaecological Clinic Rigshospitalet Copenhagen University. HT sale DK 2002. DDD/1,000 per day. www.dachre.dk. Danish Sex Hormone Register Study (DaHORS). HT sale DK 2004. DDD/1,000 per day. www.dachre.dk.

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Hormone therapy (HT) and breast cancer

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  1. Hormone therapy (HT)and breast cancer Øjvind Lidegaard Gynaecological Clinic Rigshospitalet Copenhagen University

  2. HT sale DK 2002. DDD/1,000 per day www.dachre.dk Danish Sex Hormone Register Study (DaHORS).

  3. HT sale DK 2004. DDD/1,000 per day www.dachre.dk Danish Sex Hormone Register Study (DaHORS).

  4. Breast cancer incidence rate by age Incidence per 100,000 Total: 4,000 per year Lifetime risk: 10% 20% 80% Health statistics, National Board of Health, DK 2003

  5. BC incidence rate in DK 1945-2000 Incidence per 100,000 age standardised Oksbjerg S. Ugeskr Læger 1997; 159: 7134-40. Li/07

  6. Family disposition and BC Collaborative group, Lancet 2001; 358: 1389-99

  7. Age at first birth and risk of BC Case-control study Norway 373 cases 1,150 controls Vatten LJ. Br J Cancer 2002, 86: 89-91

  8. Age at first birth Dk 1965-2008 Increase: 1 year/6 years Childless at 49 years 1995: 7.9% Childless at 49 years 2005: 12.7% Li/09 Danmarks Statistik Online: www.dst.dk

  9. Alcohol intake and risk of breast cancer 10%/drink 13%/drink 7.1%/drink drinks per day Longnecker. Canc Causes and Control 1994; 5: 73-82 Beral V et al. Lancet 2002; 87: 234-45. Tjønneland et al. Canc Causes Control 2003; 14: 277-84

  10. Can we explain the increase? Yes: • Increase in age at first birth 22→30 years • Higher birth weight • Less physical activity • Fewer children per woman • Increase in daily alcohol consumption • Dramatic increase in BMI These factors fully explain the increase Lidegaard & Kroman. Eur Clinics Obstet Gynaecol 2005; 1: 24-8

  11. Message 1 • Breast cancer is a multifactorial disease. • Risk factors are identified and quantified • We can explain the increase.

  12. HT and breast cancer (BC)Seven different axes • Hormone regimen (estrogen vs combined) • Cyclic combined vs continuous combined • Length of use • Estrogen dose • Progestogen type (NETA, MPA, levo) • Progestogen dose • Route of administration; oral, transdermal, vaginal, intrauterine,

  13. HT and breast cancer (BC)Seven different axes To discriminate between these seven different axes at the samt time, demands • Large-scale studies • Precise exposure history • High follow-up rate

  14. Danish sex Hormone Register StudyDaHoRS Hormone therapy and breast cancer Øjvind Lidegaard Ellen Løkkegaard Lisbeth Møller Carsten Agger Anne Helms Andreasen

  15. HT and breast cancer: Methods National Registry of Patients (NRP) BC diagnoses, Previous CaVD/canc. Pregnancies National Registry of Medicinal products (NRM): HT, OC, Medication against BP , DM, Hyperchol. 1995 2005 Statistics of Denmark Education, PIN-codes, address, vital status

  16. HT and breast cancer: Results • 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 Danish Sex Hormone Register Study (DaHoRS): www. dachre.dk

  17. BC risk: Length of systemic HTStratified by age and duration of use Corrected RR, 95% CI 51-54 55-59 60-64 65-69

  18. BC risk according to HT regimen Adjusted HR, 95% CI Estrogen Long cycCyc comCont comTibolone

  19. BC risk according to route Adjusted HR, 95% CI Oral EOralcombTDEstrogenTDcomb. DaHoRS/07

  20. The impact of progestagen doseLow = 0.5mg NETA or 2.5mg MPA. High = 1mg NETA or 5mg MPA Adjusted RR, 95% CI All continuous combined regimens 51-54 55-59 60-64 65-69 DaHoRS/07

  21. BC risk acc to progestagen type and estrogen dose. Cyclic combined regimen Adjusted HR, 95% CI DaHoRS/07

  22. Case-fatality rate 5 yrs after diagnosis Adjusted RR, 95% CI Women with BC: 12,831 Dead after diagnosis: 2,347 (18%) Five years follow-up: 1,269 DaHoRS/07

  23. Risk of BC and subsequent death within five years after diagnosis Adjusted RR, 95% CI Women with BC: 12,831 Dead after diagnosis: 2,347 (18%) Five years follow-up: 1,269 DaHoRS/07

  24. HT and BC: Randomised studiesRisk after 5.2 and 6.8 years MPA+EE WHI study: Cohort: 8,506 EE+MPA, 8,102 placebo. Follow up: 5.2 yrs. Endpoints: 166 exposed, 124 non-exposed HERS: 5,100 women with AMI randomised for EE+ MPA 2,5mg. Follow up 6.8 years. Endpoints: 49 exposed, 39 non-exposed women with BC Rossouw et al. JAMA 2002; 288: 321-33. Hulley et al. JAMA 2002; 288: 58-66

  25. WHI results EPT ET 50-59 • Coronary heart disease 1.3 0.9 0.6 • Stroke 1.4 1.4 1.1 • Venous thromboembolism 2.1* 1.3 1.2 • Breast cancer 1.3 0.8 0.7 • Endometrial cancer 0.8 hysterect. • Colorectal cancer 0.6 1.1 0.6 • Hip fracture 0.7 0.6 NA • Vertebral fracture 0.7 0.6 NA • All cause mortality 1.0 1.0 0.7 Rossouw et al. JAMA 2002; 288: 321-33.

  26. Million women study

  27. Metaanalysis on HT and death OR, 95% CI Aim: HT, deaths, age Meta-analysis on 30 RCT 26,708 participants Salpeter et al. J Gen Intern Med 2004; 19: 791-804

  28. 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 Danish Sex Hormone Register Study (DaHoRS): www. dachre.dk

  29. HT and breast cancer – new study Finnish Cancer Registry (cases) BC diagnoses: 9,956 Previous canc. National medical Reimbursement Registry. HT 1995 2007 Population reg of Finland 3 controls per case N = 29,868 Lyytinen et al. Int J Cancer 2010; 126: 483-9

  30. BC risk according to HT regimen Adjusted OR, 95% CI Adjusted for age, parity, age at first birth, district Estrogen Long cycCyc comCont comIUD+E2 Lyytinen et al. Int J Cancer 2010; 126: 483-9

  31. BC risk: Length of systemic HTStratified by age and duration of use Corrected RR, 95% CI 51-54 55-59 60-64 65-69

  32. BC risk according to HT regimen Adjusted HR, 95% CI Estrogen Long cycCyc comCont comTibolone DaHoRS/07

  33. Message 2 • HT for less than five years plays a little quantitative role for the risk of getting BC • Estrogen only confer less risk than combined regimens, and cyclic combined less risk than continuous combined therapy • Dose seems more important than length of use according to Danish data, opposite according to data from Finland • The risk of lethal breast cancer is not increased in users of hormones

  34. HT in US 2000-2004 Ravdin et al. N Engl J Med 2007; 356: 1670-4.

  35. US trend in BC 00-04, 50-69 yrs -11.8% -14.7% Ravdin et al. N Engl J Med 2007; 356: 1670-4.

  36. BC incidence in Norway 1996-2005 Incidence per 100,000 Cancer Registry, Norway

  37. BC incidence rate Norway 2002 and 2005 Incidence per 100,000 -5.1% Cancer Registry, Norway

  38. BC incidence rate Sweden 2002 and 2005 Incidence per 100,000 -4.7% Cancer Registry, Sweden

  39. Breast cancer: Etiologic fraction of HT Incidence per 100,000 Etiological fraction: All: 3% All >50 years: 4% Health Statistics, National Board of Health, Denmark Li/07

  40. Message 3 • Hormone IUD + systemic oestrogen is apparently not more safe than combined oral regimens • The overall risk of death is not increased in users of hormones

  41. Message 3 • Hormone IUD + systemic oestrogen is apparently not more safe than combined oral regimens • The overall risk of death is not increased in users of hormones Thank you. Presentation on www.Lidegaard.dk

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