Population Based Cervical Cancer Screening Programme in Turkey

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M. Faruk Kose - Population Based Cervical Cancer Screening Programme in Turkey

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Population Based Cervical Cancer Screening Programme in Turkey

  1. 1. POPULATION BASED CERVICAL CANCER SCREENING PROGRAMME IN TURKEYWorking Meeting on Comprehensive Cervical Cancer Prevention and Control in UNFPA, EECARO and ASRO Countries M. Faruk Kose, MD MoH Etlik Zubeyde Hanim Women’s Health Teaching&Research Hospital, Ankara Department of Gynecologic Oncology
  2. 2. Cancer Incidence and Mortality in Turkey (All Women) Incidence Mortality 9th 12thIARC, Globocan 2008
  3. 3. Estimated Cancer Incidence (15-44 Year-old Women) Breast 3105 Thyroid 684 Ovary 486 Brain, CNS 437 Leukaemia 407 Colorectum 362 Cervix uteri Non-Hodgkin lymphoma 345 340 7th Stomach 323 Corpus uteri 221 0 500 1000 1500 2000 2500 3000 3500IARC, Globocan 2008
  4. 4. Estimated Cervical Cancer Incidence and Mortality in Turkey Estimated number of cases: 1.443/3.7%IARC, Globocan 2008 Estimated number of deaths: 556/2.3%
  5. 5. Globocan 2002 vs. 20082500 Cervix Ovary Corpus uteri2000 1937 1804 16281500 1364 1443 1391 1247 10011000 726 556 581 519 500 0 Globocan Globocan Globocan Globocan Globocan Globocan 2002 2008 2002 2008 2002 2008 incidence mortality
  6. 6. Women Cancers in Turkey MoH 1996 MoH 2002 MoH 2005 Number of Number of Number of patients patients patientsBreast 3.755 Breast 5.271 Breast 12.414Stomach 1.083 Skin 1.302 Skin 6.230Ovary 823 Stomach 1.113 Thyroid 2.940Skin 820 Endometrium 1.108 Lung 2.520Colon 632 Ovary 1.074 Stomach 2.380Lung 631 Colon 927 Colon 2.205Cervix 623 Lung 855 Ovary 2.114Brain 611 Hematologic 840 Hematologic 2.110Hematologic 587 Brain 838 Endometrium 1.883Rectum 540 Cervix 708 Cervix 1.855 Ministry of Health data
  7. 7. Cancer Incidence (All women per 100.000, 2006) Type of Cancer Brain, Neural System Uterine Cervix Non-Hodgkin Lymphoma Ovarium Stomach Trachea, Lung, and Bronch Uterine Corpus Thyroid Colorectal Breast IncidenceSource: Department of Cancer Control
  8. 8. Cervical Cancer Incidence in Turkey Incidence of the ICCs 2002-2008 5,00 4,76 4,8 4,50 4,4 4,4 4,5 4,00 3,96 4,3Incidence (100.000) 3,50 3,00 2,50 2,00 2002 2003 2004 2005 2006 2007 2008 *Incidence rates of 2007&2008 are estimated
  9. 9. National Cancer Control Programme of Turkey 2009-2015: Headlines for Cervical Cancer• Prevention – Tobacco legislations and nicotine replacement therapies – Measures for preventing sexual transmitted diseases – HPV Vaccination • Annual cost efficiency analysis • Governmental reimbursement is in close future once a cost efficient price can be reached• Screening – Free of charge through Cancer Early Detection, Screening and Education Centers (KETEMs) upon invitations – Population based + Opportunistic (Total 20% coverage rate)• Treatment – Free of charge to all citizens whatever the social security coverage
  10. 10. Current Cervical Cancer Screening Programme• Screening Test: Pap smear• Target Age Group: 30-65 years• Screening Interval: 5 years• Population based screening through KETEMs (free of charge) + Opportunistic screening• EU Quality guidelines are implemented with on site monitorization and evaluation• KETEMs have consultant Ob&Gyn specialist in addition to other experts. If smear is abnormal, these consultations, treatment after screenings and follow up of patients are free fo charge without any strict referral rules
  11. 11. Monitoring, Evaluation and Partners• Monitoring and Evaluation Team exist• On site evaluation• Hard copy screening data are collected for 3 months interval• On site PAX system data collection system is under construction with EU IPA project• Partners – Turkish Society of Gynecologic Oncology – Turkish Society for Cervical Pathology and Colposcopy – Turkish Federation Breast Disease – Turkish Society of Radiology – Patient advocacy groups, NGOs, UICC
  12. 12. Turkey’s Capacity for Cervical CancerScreening: Challenges and Lessons Learned Pathologists: 1.140 Cytopathologists: None Target Population (30-65): 14 million Coverage Rate: 20%
  13. 13. Number of Pathologists in Turkey Goverment Hospitals 702 University Total Hospitals 316 1.140 Private 122
  14. 14. Smear Number Per Day for One Pathologist in Turkey Estimated smear per day/pathologist Mainly Pap smear evaluation 20-25 Pap smears a day
  15. 15. How Many Smear Can be Analized in One Year? screened Population has to be 1.140 Pathologists220 Working days per year 220 x 25= 5.500 x 5.500 1.140= 6.270.000 ?
  16. 16. Target Population Only 35 Yrs 628.000 30-65 Yrs 14.419.711 35-65 Yrs 11.549.122 20-65 Yrs 21.715.000 20-70 Yrs 22.642.000
  17. 17. Sanliurfa Study: Study Objectives • To see cervical cancer incidence in rural parts • To evaluate the feasibility of VIA and VILI screening • To determine a national standard for Turkish population based screening programme19.05.2011 Türk Jinekolojik Onkoloji Derneği Toplantısı İstanbul
  18. 18. Results of Sanliurfa StudyAbnormalities N (%)ASC-US 144 (1.60)ASC-H 6 (0.06)AGC 5 (0.05)LGSIL 7 (0.07)HGSIL 2 (0.02)Invasive Cancer 1 (0.01) Total smear number: 9,079
  19. 19. Results of Umudum’s Study Abnormalities % ASC-US 4.00 LGSIL 0.40 HGSIL 0.19 Total smear number: 180,000Umudum H, Int Cythopathology Congress, 2006
  20. 20. Turkish Cervical Cancer and Cervical Cytology Research GroupAbnormal smears 1.76%ASC-US 1.07%ASC-H 0.07%AGC 0.07%LGSIL 0.3%HGSIL 0.17%Invasive Cancer 0.062% Total smear number: 140,334/33 centers
  21. 21. Results of Hacettepe StudyHPV positivity 41 (4%)ASCUS 9 (1.07%)AGCUS 2 (0.2%)LGSIL 2 (0.2%)HGSIL 1 (0.1%) Total case: 1.032
  22. 22. Potential Role of HPV Testing in Cervical Screening• Primary Screening – Adjunct to Cytology • Higher Sensitivity • Longer Screening Interval • Reduced Inadequate Rate – Sole Primary Test • Use of Cytology for Triage – Self Sampling • Improved Coverage
  23. 23. “Is HPV Testing at Least as Good..?” WHO via IARC has stated “There is sufficient evidence, based on surrogate markers, that the efficacy of HPV testing, using a validated system, as the primary screening modality can be expected to be at least as good as that of conventional cytology.”WHO: World Health OrganisationIARC: International Agency for Research on Cancer
  24. 24. Cytology Sensitivity for CIN2+ (All ages) CIN 2+ HART Tuebingen Hannover Jena French PublicFrench Private Seattle Canada Combined 0% 10% 30% 50% 70% 90% 100% Cytology Positivity
  25. 25. HPV Sensitivity for CIN2+ (All ages) CIN 2+ HART Tuebingen Hannover Jena French PublicFrench Private Seattle Canada Combined 0% 10% 30% 50% 70% 90% 100% HPV Positivity
  26. 26. Summary of HPV vs Cytology Sensitivity and Specificty Sensitivity SpecificityCytology 53% 97%HPV testing 96% 92%
  27. 27. Hazard Ratios of Cervical Cancer Death RatesStudy Groups Rate/100.000 HR (95% CI)Control 25.8 1.00HPV 12.7 0.52 (0.33-0.83)Cytology 21.5 0.89 (0.62-1.27)VIA 20.9 0.86 (0.60-1.25)Sankaranarayanan R, N Engl J Med, 2009
  28. 28. Efficacy of Laboratory Performance: Cytology vs HPV Testing (CCCaST Study) PAP HPV PAP HPV 100% 90% 80% PAP laboratory 1 70% PAP laboratory 2 60% PAP laboratory 3 50% 40% HPV laboratory 1 30% HPV laboratory 2 20% 10% 0% Sensitivity SpecificityMayrand MH, Unpublished Data
  29. 29. Detection Ratio of CIN3+ After One Negative Test Groups Years CIN3+ Cytology 3 0.51% (0.23 – 0.77) HPV 5 0.27% (0.12 – 0.45)Ronco G, Lancet Oncol, 2010
  30. 30. Conclusion for Why HPV• The risk of CIN2+ following a negative HPV test is extremely low for at least 5-6 years• HPV testing offers improved protection from CIN2+ and invasive cancer after a negative test compared to the protection afforded from a normal cytology• HPV-based screening is more effective than cytology in preventing invasive cervical cancer, by detecting persistent high-grade lesions earlier and providing a longer low-risk period. However, in younger women, HPV screening leads to over-diagnosis of regressive CIN2.
  31. 31. Performance of the HPV Testings for CIN2+ Best testingCuzick J, J Med Virol, 2010
  32. 32. Performance of the HPV Testings for CIN3+ Best testingCuzick J, J Med Virol, 2010
  33. 33. Conclusion for Performance of the HPV Testings• Five tests have sensitivity for CIN3+ ≥ 95% – Hybrid Capture II (Qiagen), RealTime HR HPV (Abbott), APTIMA (Gen-Probe), Amplicor (Roche), Linear Array (Roche)• Of these five tests, Hybrid Capture II showed higher sensitivity and lower specificity than the other four tests. APTIMA and RealTime HR HPV were also more specific than Cobas and BD HPV• Differences in specificity may be partly due to different analytic cutoffs leading also to differences in sensitivity• PreTect HPV-Proofer is less sensitive much more specific• Performance of p16INK4a was between PreTect HPV- Proofer and the highly sensitive tests for both specificity and sensitivityCuzick J, J Med Virol, 2010
  34. 34. HPV-Based Screening Program “Proposed New Screening Algorithm - Population Aged 30-64” HPV (-) HPV (+) %92.4 %7.76 1.153.577 Wmn Cytology Normal 5-Year recall Normal or Borderline %6 ≥ Mild %1.6 HPV Testing & Cytology Colposcopy at 6 -12 months Cytology (-) HPV (-) HPV (+) Cytology < mild Cytology ≥ mild HPV (-) Cytology Borderline HPV Testing & Cytology Colposcopy Normal at 6 -12 months 5-Year recall %2.9 %2.5 %0.6Wright TC Jr, EUROGIN, 2003 Paris; Cuzick J, Vaccine, 2008
  35. 35. HPV-Based Primary Screening Program Completion of 1st screening round for all women eligible at baseline – by Nov 2015Launch of new programNov 2011 Phase III (Full coverage phase – 3-4mill capacity by Nov 2014) Phase IV All KETEMs fully Phase II (Extension Phase – 2+ mill capacity - Nov 2013) operational and offering HPV screening services Phase I (Kick Off Phase - nationwide 1 mill capacity –2011) 2011 2012 2013 2014 2015 1 mill 3 mill 6 mill 9-10 mill 14 mill Cumulative number women screened with HPV primary screening test
  36. 36. Way Forward/Future Plans
  37. 37. Way Forward/Future Plans
  38. 38. New Turkish Cervical Cancer Control Strategy HPV PRECANCER CANCER 15 Y 30 Y 35 Y 40 Y 45 Y 60 Y 65 Y Current Cytology StrategyNew HPV HPV DNA HPV DNA Test 1 Test 2 Screening will continue for HPV (+)!Strategy Vaccination
  39. 39. Thank You for Your Attention!
  40. 40. The Most Frequent Cancers In Women Worldwide (In Thousands of New Cases Per Year) Developed Developing Breast 692 691 Colon/Rect 338 232 Cervix Uteri 77 453 Lung 242 272 Stomach 102 247 Corpus Utery 142 145 Liver 40 186 Ovary 100 125 Thyroid 74 89 N-H lymphoma 85 71 Oesophagus 18 138 Leukaemia 62 93 Pancreas 81 52 Brain, Nervous S. 40 71 Kidney 68 35 Melanoma of skin 82 15 Lip, Oral cavity 29 64IARC, Globocan 2008
  41. 41. Incidence Rates of Cervical Cancer in Europe Age-standardized incidence rate per 100,000 and year ICC cases/yr: 54,323 ICC deaths/yr: 25,102
  42. 42. The Most Frequent Women Cancers in EuropeIARC, Globocan 2008
  43. 43. According to 2006 Estimates of the International Agency for Research on CancerBreast Cancer• 331,000 cases• 90,000 deathsCervical Cancer• 36,500 cases• 15,000 deathsColorectal cancer• 140,000 cases in women and 170,000 in men• 68,000 deaths in women and 78,000 in men
  44. 44. Cancer Incidence and Mortality in Europe (All Women) Incidence Mortality Breast 66.6 Breast 16.9 Colorectum 23.7 Lung 10.7 Lung 13.1 Colorectum 10.5 Corpus uteri 12.6 Ovary 5.4 Cervix uteri Ovary 10.5 10.2 5th Stomach Pancreas 5.4 5.0 Melanoma of skin 7.6 Cervix uteri 3.9 7 th Thyroid 7.1 Brain, nervous system 3.1 Stomach 7.0 Leukaemia 3.0Non-Hodgkin lymphoma 5.8 Corpus uteri 2.6 0 20 40 60 80 0 20 40 60 80 Annual age−standardized rates per 100,000 women (all ages) IARC, Globocan 2008
  45. 45. Cancer Incidence and Mortality in Europe (15-44 Year-old Women) Incidence Mortality Breast 29.9 Breast 4.7 nd Cervix uteri Thyroid 7.0 11.1 2nd Cervix uteri Brain, nervous system 2.4 1.4 2 Melanoma of skin 6.7 Lung 1.3 Ovary 4.7 Colorectum 1.2 Colorectum 3.7 Ovary 1.2 Hodgkin lymphoma 3.0 Stomach 1.2 Brain, nervous system 2.7 Leukaemia 1.1Non-Hodgkin lymphoma 2.3 Melanoma of skin 0.6 Lung 2.2 Non-Hodgkin lymphoma 0.5 0 20 40 60 80 0 20 40 60 80 Annual age−specific rates per 100,000 women (15-44 Yrs) IARC, Globocan 2008
  46. 46. Incidence of Cancer in Turkey 300 256,4 271,7 275,4 246,5Incidence (100.000) 236,3 250 200 168,69 158,1 166,8 169,9 154,15 142,9 149,7 150 127,92 113,03 100 50 0 2002 2003 2004 2005 2006 2007 2008 Kadın Women Erkek Men
  47. 47. Primary Screening Pap vs HPV Test % (%95 CI) Pap 55.4 (33.6-77.2) Sensitivity HPV 94.6 (84.2-100) Pap 96.8 (96.3-97.3) Specificsity HPV 94.1 (93.4-94.8) Pap 7.1 (4.8-10.3) PPV HPV 6.4 (5.0-8.0) Pap 99.8 (99.7-99.9) NPV HPV 100 (98.6-100) *CCCaST: Canadian Cervical Cancer Screening Trial; Case # 10.171, 30-69 Y, CIN2+Mayrand MH, N Engl J Med, 2007
  48. 48. Efficacy of HPV Testing for the Detection of CIN • The New Technologies for Cervical Cancer (NTCC) Screening Study • Case # 128.285 • FU 5-6 Yrs • Randomization and second round after one year – HPV testing group – Cytology group • Age intervals of analysis; 25-34 and 35-60 Yrs HPV group Cytology group RDRound one 206 101 2.03Round two 16 32 0.51Two rounds 221 133 1.66Ronco G, Lancet Oncol, 2010
  49. 49. NTCC: the Detection of ICCs HPV group Cytology group p All ages Round one 7 9 0.62 Round two 0 9 0.004 Total 7 18 0.028 35-60 Yrs Round one 6 8 0.61 Round two 0 7 0.016 Total 6 15 0.052 25-34 Yrs Round one 1 1 1.00 Round two 0 2 0.50 Total 1 3 0.37Ronco G, Lancet Oncol, 2010
  50. 50. Sensitivity of the HPV Testings Test (Producer) CIN2+ (%) CIN3+ (%) Cytology; mild+ 88.5 92.3 Hybrid Capture II (Qiagen) 96.5 97.5 BD HPV (BD-ProExC) 94.8 95.8 Cobas (Roche) 95.5 96.1 PreTect HPV-Proofer (NorChip) 74.7 78.5 APTIMA (Gen-Probe) 95.0 97.1 RealTime HR HPV (Abbott) 93.0 95.0 p16INK4a (mtm Lab) 85.9 89.1Cuzick J, J Med Virol, 2010

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