世界標準の子宮頸がん予防対策なぜ日本だけが遅れるのか

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1 HPV

2 HPV HPV

4 WHO position paper 2009 April HPV HPV

5 5 I 1, II III IV (

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8 ( ) 8

Rate per 100,000 120 100 80 60 40 20 0 0 10 20 30 40 50 60

9 Rate per 100, Age 1. Ferlay J et al. Globocan IARCPress 2004.

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13 13

14 Cervical Cancer Screening in Korea Since 1989: for Health Insurance Beneficiaries % Since 1999: for Medicaid women Pap rate Ever screened Including opportunistic screening Data Source: National Health & Nutrition Survey in 1995, 1998, 2001 NCC (telephone survey) in 2004, 2007 Konno R, Shin HR, et al JJCO (in press)

15 Call/Recall 10 Quinn M, Babb P, Jones J et al.: Effect of screening on incidence of and mortality from cancer of cervix in England: evaluation based on routinely collected statistics. BMJ3;318(7188):904-8,

16 HPV Human Papillomavirus) DNA DNA 100 HPV 30~40 HPV 16,18,31,33,35,52,58 16,18 70 HPV 6,11 CIN

17 / % > HPV-18 ( 99 HPV 80 HPV 90 B 60 B 60 C Baseline reference % 0.1 ( B 40 B 90 F.X. Bosch et all. in J. Clin Pathol 2002

18 *CIN: cervical intraepithelial lesion = pre-cancerous lesion 50 1/ Garland S, Cuzick J, Konno R, et al. Vaccine 26. Suppl 12, 2008

19 HPV HPV 80

20 HPV

21 Dr. Papanicolaou Dr. zur Hausen Dr. Frazer

22 HPV Ref: MMWR 1999; 48(12):

23 1. Franco EL, Harper DM. Vaccine. 2005;23: Pagliusi SR, Aguado MT. Vaccine. 2004;23: surrogate marker CIN2,3 AIS HPV Surrogate marker HPV HPV CIN2,3 AIS

24 HPV Onuki M et al. 2009, Cancer Science

25 Development of HPV vaccine Assembly of Virus-Like Particle (VLP)

27 HPV 4 HPV 2 HPV HPV g 20/40/40/20 20/20 L1 VLP Proprietary assembly/reassembly process increasing stability AAHS Amorphous aluminum hydroxyphosphate sulfate (Merck and Co., Inc.) AS04 Aluminum hydroxide + 3-deacetylated monophosphoryl lipid A (MPL, Corixa/GSK) 225 g 500 g/50 g VLP = vaccine-like particle. 1. Villa LL, Costa RLR, Petta CA, et al. Lancet Oncol. 2005;6: Harper DM, Franco EL, Wheeler C, et al. Lancet. 2004;364:

28 1.Konno R, Tamura S, Yoshikawa H.et al. Efficacy of human papillomavirus 16/18 AS04- adjuvanted vaccine in Japanese women aged 20 to 25 years: interim analysis of a phase 2 doubleblind, randomized, controlled trial. Int J Gynecol Cancer (3): Konno R, Tamura S, Yoshikawa H.et al. Efficacy of Human Papillomavirus Type 16/18 AS04- Adjuvanted Vaccine in Japanese Women Aged 20 to 25 Years: Final Analysis of a Phase 2 Double-Blind, Randomized Controlled Trial. Int J Gynecol Cancer (5): Konno R, Tamura S, Yoshikawa H.et al. Immunogenicity, reactogenicity, and safety of human papillomavirus 16/18 AS04-adjuvanted vaccine in Japanese women: interim analysis of a phase II, double-blind, randomized controlled trial at month 7. Int J Gynecol Cancer (5):

29 TVC: total vaccinated cohort TVC-E: total vaccinated cohort for efficacy ATP-E: according to protocol for efficacy

30 Konno R et al. IGCS 2009; 19:

32 HPV-16/18 (12 ) (ASC-US+) CIN1+ CIN2+ N n HPV HAV HPV HAV HPV * HAV HPV HAV HPV HAV (95.5% CI) % LL UL P-value <

33 -HPV (6 ) (12 ) (ASC-US+) CIN1+ CIN2+ N HPV HAV HPV HAV HPV: HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, 68 N= n= n HPV HAV HPV HAV HPV HAV HPV HAV (95.5% CI) % LL UL P-value

34 HPV (N = 519) HAV (N = 521) : 1 (95% CI) (0-29 ) 17.5% ( ) 56.6% ( ) 1.0% ( ) 0.4% ( ) 51.1% ( ) 20.5% ( ) 1.2% ( ) 0.0% ( ) : (%) 1 18 (3.5%) 22 (4.2%) 19 (3.6%) 21 (4.0%)

35 HPV CIN2+ CIN3+ 2 HPV TVC 1 n n, % 96.1% CI p CIN ( ) < CIN ( ) < HPV16/18 CIN2/3 52% 2 * 1. Paavonen J, et al. Lancet 2009; 374:301 14; 2. Smith JS, et al. Int J Cancer 2007; 121: ; 3. WHO/ICO Information Centre on Human Papilloma Virus (HPV) and Cervical Cancer. Available at: (accessed May 2009). 2 : III 39.4 TVC N = 5,449 N = 5,436 p % 96.1% CI ( ) < ( ) < Paavonen J, et al. Lancet 2009; 374:

36 % -72.6% ,000 40,000 60,000 80, ,000 # 36,000 / 100% * ** /

38 HPV-16/18 HPV Kirn JJ, Goldie SJ, et al Vaccine 26S (2008) K76-K86 (herd immunity) 95 HPV-16/18 Brisson M. IPV 2010.

39 HPV HPV

42 MSW HPV

43 1. HPV 2. HPV

44 85% 85% 95 ( / 50% 91 10% 86 50% % % EUROGIN Roadmap toward a consensus S. Franceschi (WHO, IARC) 15, Nov, 2008, EUROGIN2008

45 HPV * ** *** 3 * 10 1 ** ***

46 HPV

47 Global recommendations & reimbursement status Europe Cervarix Gardasil Iceland Cervarix & Gardasil Cervarix & Gardasil Cervarix and/or Gardasil Norway Sweden Liechtenstein Denmark Ireland UK Netherlands Poland Finland Estonia Latvia Lithuania Gibraltar Luxembourg Portugal Spain Belgium Germany Czech Republic Slovakia Austria France Switzerland Hungary Slovenia Italy Croatia Bosnia Serbia Montenegro Bulgaria Macedonia Albania Greece Romania Malta Date of preparation: June 2010 Cervarix not currently licensed

48 HPV 3:Settings for delivery of vaccines HPV Catch-up program % 80% 84% 81% 75% 100% 80% 82% 78% 71% 60% 60% 40% 40% 20% 20% 0% 0% Julia ML B et al.: Commun Dis Intel. 32, , 2008

49 HPV 2 Funding / 1:Recommendation 3:Settings for delivery of vaccines Guideline Recommendation 4:Education / awareness

50 % %

51 HPV CIN Ex. Victorian Cytology Service HPV 16/18, replacement) HPV CIN, 2

53 1. Konno R, Tamura S, Yoshikawa H.et al. Efficacy of human papillomavirus 16/18 AS04- adjuvanted vaccine in Japanese women aged 20 to 25 years: interim analysis of a phase 2 double-blind, randomized, controlled trial. Int J Gynecol Cancer (3): Konno R, Tamura S, Yoshikawa H.et al. Efficacy of Human Papillomavirus Type 16/18 AS04-Adjuvanted Vaccine in Japanese Women Aged 20 to 25 Years: Final Analysis of a Phase 2 Double-Blind, Randomized Controlled Trial. Int J Gynecol Cancer (5): Konno R, Tamura S, Yoshikawa H.et al. Immunogenicity, reactogenicity, and safety of human papillomavirus 16/18 AS04-adjuvanted vaccine in Japanese women: interim analysis of a phase II, double-blind, randomized controlled trial at month 7. Int J Gynecol Cancer (5): Konno R, Sasagawa T, Fukuda T,et al. Cost-effectiveness analysis of prophylactic cervical cancer vaccination in Japanese women. Int J Gynecol Cancer (3): Garland SM, Goldie SJ, Konno R, et al. Recommendations for cervical cancer prevention in Asia Pacific. Vaccine Suppl 12:M Konno R, Shin HR, Kim YT, et al. Human papillomavirus infection and cervical cancer prevention in Japan and Korea. Vaccine Suppl 12:M Garland SM, Park SN, Konno R, et al. The need for public education on HPV and cervical cancer prevention in Asia. Opinions of experts at the AOGIN conference. Vaccine (43): Konno R, Sato S, Yajima A. Progression of squamous cell carcinoma of the uterine cervix from cervical intraepithelial neoplasia infected with human papillomavirus: a retrospective follow-up study by in situ hybridization and polymerase chain reaction. Int J Gynecol Pathol (2):

世界標準の子宮頸がん予防対策なぜ日本だけが遅れるのか

世界標準の子宮頸がん予防対策なぜ日本だけが遅れるのか資料 5-1 子宮頸がん予防 HPV ワクチン自治医科大学附属さいたま医療センター産婦人科今野良 WHO position paper 2009 April 子宮頸がんおよびその他の HPV 関連疾患が世界的な公衆衛生上の問題として重要である国のワクチン接種プログラムにルーチンの HPV ワクチン接種を組み込むことが推奨される欧米の先進諸国マレーシアパナマ GAVI 援助による 26 の発展途上国

世界標準の子宮頸がん予防対策 なぜ日本だけが遅れるのか

世界標準の子宮頸がん予防対策なぜ日本だけが遅れるのか