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Intervention trial to prevent gastric cancer and its precursors in Linqu

Intervention trial to prevent gastric cancer and its precursors in Linqu. Wei-cheng you Peking University School of Oncology Beijing Cancer Hospital Beijing Institute for Cancer Research.

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Intervention trial to prevent gastric cancer and its precursors in Linqu

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  1. Intervention trial to prevent gastric cancer and its precursors in Linqu Wei-cheng you Peking University School of Oncology Beijing Cancer Hospital Beijing Institute for Cancer Research

  2. ◆ Cancer is the first or second leading cause of death worldwide, and 6,700,000 people die of cancer in 2002 ◆In China, 2,200,000 new cancer cases, and 1,600,000 people die of cancer in 2002 ◆ Cost: 78billions USD per year in USA, and 80 billions RMB in China Background

  3. Cancer Incidence and Mortality in the world in 2002 (Male)

  4. Age-adjusted incidence rate of cancer in China (/100,000) IARC 2002

  5. Cancer Incidence in Beijing from 1998 to 2006 （/10万）

  6. A little improvement in overall cancer treatment in the past two decades Poor quality life of cancer patients Family and social burdens Economic high cost Current problems

  7. What can we do ? Cancer prevention is better than treatment. Cancer prevention is the most effective means of reducing the incidence and mortality of cancer. 21st Century - Cancer Prevention and Quality of Life

  8. Our goals in cancer control: Lower incidence ratesLower mortality rates Better care & quality of lifeBasic Research, Clinical Management, and Prevention Strategy development

  9. ◆The second leading cancer worldwide ◆360,000 people die of GC in China ◆A heavy burden for the family and society ◆Effective prevention is not available Gastric Cancer (GC)

  10. Five year survival rates of gastric cancer

  11. ◆Biological factors: H.pylori infection ◆Diet and Nutrition: salted food, grain moldy, low vitamin C level ◆Alcohol ◆Cigarette Smoking ◆Genetics: gene polymorphisms ◆Others: possible risk factors The Causes of Gastric Cancer

  12. Eradication Intestinal Metaplasia Atrophic Gastritis Dysplasia Carcinoma H. pylori associated gastric carcinogenesis Chronic Gastritis

  13. H. pylori infection and gastric cancer Helicobacter & Cancer Collaboration Group. GUT 2001

  14. ◆ H.pylori accounts for 40-60% of gastric cancers ◆ 1994, International Agency for Research on Cancer (IARC) classified H.pylori as a class I carcinogen.

  15. Gastric cancer control strategy in China ◆Tobacco control ◆H.pylori infection control ◆Early detection ◆Health life-style and dietproject

  16. ◆A rural area of Shandong Province ◆One of the highest GC mortality rates ( 70/105 males and 25/105 females ) ◆Major GC is Intestinal-type Linqu County

  17. The high-risk area is a unique resource in China Advances: ◆Provided direct evidence from human ◆Stable population ◆Representative Epidemiologicalstudy in a high-risk area

  18. To reduce the incidence rate of IM, DYS and GC 1995-Intervention trial Risk of progression to GC 1990-1994Cohort study of precancerous gastric lesions 1989-1990Survey of precancerous gastric lesions Prevalence of lesions Risk and protective factors 1984-1987Case-control study 1983Survey of cancer mortality rate

  19. Site of gastric mucosa biopsy 3400 participants, aged 35-64. 2：Lesser curvature of Body 3：Greater curvature of Body 4：Angulus 5：Anterior wall of Antrum 6：Posterior wall of Antrum 7:Lesser curvature of Antrum 8:Greater curvature of Antrum Body Angulus Anterior Wall Antrum Lesser Curvature Posterior Wall Greater Curvature

  20. ORs for GC according to baseline histopathology (You et al. Int J Cancer 1999, 83:615-619)

  21. DYS GC Angulus IM Lesser curvature of Antrum Lesser curvature of Body Normal/SG Dim2 Posterior wall of Antrum Greater curvature of Body CAG Anterior wall of Antrum ● Greater curvature of Antrum Correspondence analysis between gastric lesions and biopsy sites

  22. ORs for progression to DYS and GC according to H. pylori status at follow-up (You et al. JNCI 2000; 92:1607-1612)

  23. In 1995, 3365 subjects were randomly assigned to receive three interventions or placebos, including an antibiotic treatment of H. pylori. Interventiontrial in Linqu (1)(1995-2003)

  24. Interventions Two-week treatment for H. pylori infection Omeprazole 20mg + Amoxicillin 1g Bid Daily nutritional supplementation VC 250mg + VE 100Iu + Selenium 37.5ug Bid Garlic preparation 400mg Bid

  25. Science 1995; 270:1149-1151

  26. 治疗组 对照组 Geometric means of Vitamin E for treated and placebo groups (ug/dL)

  27. Effects of treatment on the odds of severe CAG/IM/DYS/GC You et al. JNCI, 2006; 98:974-983

  28. Effects of H. pylori treatment on GC p =0.23 You et al. JNCI, 2006; 98:974-983

  29. IF=15.2

  30. H. pylori infection and over-expression of cyclooxygenase-2 (COX-2) areassociated with gastric cancer and its precursors. We evaluated the effect of H. pylori eradication and use of celecoxib aschemoprevention for precursors of gastric lesions. Interventiontrial in Linqu （2） (2002-2006)

  31. Interventions One-week treatment for H. pylori infection Omeprazole 20mg, bid Amoxicillin 1g, bid Clarithromycin 500mg, bid Celecoxibfor 2 years200mg, bid

  32. Compliance

  33. Effects on the precancerous gastric lesions

  34. Changes of COX-2 expression and evolution of precancerous gastric lesions by different interventions

  35. Interventions and changes of PGE2 level

  36. Interventions and changes of COX-2 methylation

  37. Ann Intern Med 2009;151:121-128 Eradication of H. pylori and gastric cancer

  38. Questions ? Because the end point of our two trials was to assess the effect of H. pylori treatment on the precancerous gastriclesions, and the previous five intervention trials yielded mixed results on gastric cancer.It remains for the large trial to demonstrate that H. pylori treatment reduces gastric cancer incidence rate.

  39. A large interventiontrial in Linqu (2009-2015) Peking University School of Oncology International Digestive Cancer Alliance Technische Universität München

  40. Study Design Participants: 200,000 ( aged 25-54 years ) Villages: 500 Intervention: Eradication of H. pylori End point: Reduction 30% of GC

  41. Designs:

  42. Benefit for eradication of H. pylori If eradication of H. pylori could reduce 30% of GC (120,000 new GCs), it can save 800 millions USD per year in China according to incidence of GC.

  43. Funding: Ministry of Science and Technology￥5,030,000 IDCA/TUM $ 1,000,000 Beijing Double-Crane Pharmaceutical Co. LTD

  44. Symposium of Large Trial in Linqu County

  45. To seek a therapy with a high efficacy, low-toxicity and easy administration. A pilot study in Linqu The quadruple therapy regimens Bismuth potassium citrate300 mg (bid) Metronidazole 500mg (tid)Tetracycline 750 mg (tid)Omeprazole 20 mg (bid)

  46. European Journal of Gastroenterology & Hepatology 2009

  47. Initiation in State Guesthouse(2009，6)

  48. Bavarian Delegation Visiting Beijing Cancer Hospital

  49. Further Objectives ◆To study biomarkers and mechanisms of gastric cancer and its precursors ◆A workshop will be held from June 10-13 in Beijing, and more than 30 scientists will be there. ◆Funding will be raised from Government and Industries worldwide.

  50. Molecular Studies Systematical Studies Epidemiological Survey Endoscopic Examination Check Interventions

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