peter malfertheiner klinik für gastroenterologie
TRANSCRIPT
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Global screening and eradication of Helicobacter pylori
Peter MalfertheinerKlinik für Gastroenterologie, Hepatologie und Infektiologie
Otto‐von‐Guericke‐Universität Magdeburg
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Points to consider
• Size of the problem• Options for solution• H.pylori screening and eradication
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Alcohol
Main effect on the esophagus!
No ? influence on gastric carcinogenesis
Franke DigDis 2005
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Global burden of cancer• 7.9 million (= 13% of all deaths) worldwide in 2007• 72% of all cancer deaths in 2007 occurred in low- and middle-income
countries• Gastrointestinal- represent highest contingent
• Gastric cancer „ranks“ sadly second concerning death rate
WHO Fact sheet N° 297, July 2008
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Age-standardized Incidence Rates for Gastric Cancer Data shown per 100,000
Parkin DM et al. Global Cancer Statistics, 2002
• Geographic distribution of gastric shows wide international variations.
• High-risk areas (ASR in men, >20 per 100,000) include East Asia (China, Japan), Eastern Europe, and parts of Central and South America.
• Incidence rates are low (<10 per 100,000 in men) in Southern Asia, North and East Africa, North America, and Australia and New Zealand
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40% of patients with no dyspeptic symptoms
• Dyspepsia
• nausea and vomit
• Epigastric pain
• no appetite
• weight loss
GASTRIC CANCERVariable symptoms,usually as red flags in advanced stage
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Points to consider
• Size of the problem
•Options for solution other than• H.pylori screening and eradication
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Gastric cancer prevention
•Options for solution• Diet change• Stop smoking• chemoprevention
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Vegetables / citrus fruits
• Protective effect?– High content of anti-oxidants, Vit A / E / C– Vegetables „possibly“ and fruits „likely“ protective– Garlic: 1 positive meta-analysis, overall: contrary results
Gonzalez Int J Cancer 2006Bae Gastric Cancer 2008
0.72 [0.64 – 0.81]
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Salt• Increased risk in case of higher
salt intake (up to 2.5-fold)• Heterogenous results• Influence decreasing in
Western countries (refridgerators, modern means of food conservation)
Interference with the mucosal barrier
Higher occurence of nitroso-compounds
Peleteiro BrJCanc 2011Sjödahl CancEpidBiomPrev 2008Tsugane CancSci 2005Fox&Wang NEJM 2001
! Influence only in case of pre-existing gastric mucosal damage
H. pylori !
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Slide withheld at request of author
Online Lecture Library
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Slide withheld at request of author
Online Lecture Library
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Chemo-Prevention
• Antioxidants (H. pylori lower bio-availability of Vit C)
• COX- inhibitors (ASA, NSAIDs, COX-2-Inhib.)
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Points to consider
• Size of the problem• Options for solution• H.pylori screening and eradication
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Screen and treat H. pylori in prevention of gastric cancer
RATIONALE behind
H. pylori infection and gastric cancer link ••Epidemiology
•Histological cascade
• Molecular events in gastric carcinogenesis
• Experimental models (cell biology, animal models)
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Cases – Controls
n 68 n 360
Exclusion: T4 gastric cancerSerum taken > 90 day following gastrectomyCag A not considered if H. pylori negative
H. pylori + Cag - OR 3,7 18,3
H. pylori + Cag + OR 5,7 28,4
Brenner et al., Am J Epidemiol 2004, 159:252-258
Necessary condition for gastric cancer development
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H.pylori and Gastric Cancer
EpidemiologyHow relevant is the location?distal versus proximal
How relevant is the histological type?intestinal versus diffuse
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Gastric cancer
Siewert Br J Surg 1998
proximal
distal
AEG: Adenocacrinoma of the oesophagogastric junction
Tumor allocation
AEG IIAEG IIIProx. 1/3 corpus
Dist. 2/3 corpusAntrum
H.pylori infection with similar association in proximal AEG I-II and distal gastric cancerBornschein et al DDW 2009
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Gastric cancer
in corpus
intestinal type
Gastric cancersubcardialintestinal type
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Screen and treat H. pylori in prevention of gastric cancer
H. pylori infection and gastric cancer link
••Role of host genes
•Bacterial virulence factors
• Ambiental and nutritional factors
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El Omar et al Gastroenterology 2000
0
5
10
15
20
25
30
35
Hypochlorhydria Atrophy
27%
34%
relatives of gastric cancer patients (n100), H. pylori prevalence 63%
3% 5%
control subjects (n 100) ), H. pylori prevalence 64%%
of s
ubje
cts
H.pylori plusgeneticpre-
disposition..IL 1 –beta polymorphisms
H. pylori and gastric cancer
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Increased polymorphisms of pro-inflammatory genes and risk of non-cardia gastric cancer
Polymorphisms of IL-1β(o), IL-1 receptor antagonist, TNFα, and IL-10 conferred a greater risk for gastric cancer
ORs (95% CI) •Single gene 2.8 (1.6-5.1) •Two genes 5.4 (2.7-10.6)•Three or four genes 27.3 (7.4-99.8)
El-Omar EM, et al. Gastroenterology,2003;124:1193-201
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H. pylori virulence factors
increase the risk of gastric cancer
Cag A, Vac A and others
cause stronger inflammatory reaction-preneoplastic conditions
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Pro-inflammatory cytokine gene polymorphismsIL-1B-511*TIL-1RN*2*2IL-10 ATA haplotypeTNF-A-308*A
Innate immune response gene polymorphismsTLR4+896*G
Bacterial factorsCag AVac A s1/i1/m1
Environmental factorssmokingdiet
Bacterial-Host- Environmental factors
in H. pylori-related gastric cancer
Gastric cancer
SUMMARY
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H. pylori infection and gastric cancer: A prospective endoscopy study
• 1526 patients with NUD, DU, GU or gastrichyperplasia (GH)
• Endoscopy: enrollment and every 1-3
years Uemura et al, N Engl J Med 2001; 345:784
Hp- Hp+ NUD GU GH DU
0
2,9
4,7
3,4
2,2
00
1
2
3
4
5Incidence of gastric cancer (%)
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• Metaanalysis 6 studies >6000 patients
Fuccio et al Ann Int Med 2009
H.pylori eradication and gastric cancer prevention
Number needed to treat 227!
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7
11
0
10
20%
OAM Placebo
OAM Placebo
P=0.95
0
5
0
10
20%
OAM Placebo
OAM Placebo
6
Gastric cancerGastric cancer in subjects with no preneoplastic changes on entry
Eradication H. pylori infection In a general population prevents gastric cancer:
A 7-year prospective randomized placebo-controlled study
Wong et al. JAMA2004
p=0.025
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Where is the point of no return?
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Probability of regression of the pre-neoplastic lesions
Gastric cancer
Prob
abili
ty o
f reg
ress
ion
Infection with H.pylori
Atrophic gastritisIntestinal
metaplasia
Dysplasia
months years decades
Chronic active gastritis
H. pylori and gastric cancer
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Fukase et al Lancet 2008
H.pylori eradication after EMR of early gastric cancer=never to late!!!!!!
• 3 year follow up:
• gastric cancer relapse– controls: 24– After eradication: 9
•OR for metachronous NPL0.353 (95% CI 0.161-0.775)
•HR (intent. to treat)0.339 (95% CI 0.157-0.729)
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Does H. pylori eradication therapy for PUD prevent gastric cancer ?
Mabe et al. World J Gastroenterol 2009;15(34):4290-97
„Yamagata Prefecture, Japan“Study 2000-2007, follow up 5,6 years
4133 patients with PUD
Gastric cancer
0,21 %/year
Gastric cancer
0,50 %/year
Eradication therapy no Eradication therapy
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Mabe et al. World J Gastroenterol 2009;15(34):4290-97
Proportion free of gastric cancer in the eradication group was compared according to results of eradication therapy, using Kaplan-Meier analysis.
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H. pylori eradication in the prevention of gastric cancer
ERADICATIONNNT 227
But consider additional benefits:Ulcer prevention,cure of dyspepsia,extragastric disease
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Global screening andH.pylori eradication?
NoBut……
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Surveillance for gastric cancer –DECISION MODEL
Yearly endoscopy for 10 years after newly detected gastric IM in 10.000 Americans
- estimated gastric cancer incidence 1,8%/year
- 556 (3738) endoscopies for detection of 1 gastric cancer
- US $ 72.519 per life year gained
Hassan et al Helicobacter 2010; 15:221
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Geographic differences in gastric cancer incidence explained by differences between H. pylori strains
Yamaoka Y. et al. Internal Medicine. 2008; 47(12):1077-83
Present distribution of six main H. pylori genotypes
The circles coincide with countries in which the H. pylori genotypes have been
examined
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Gastric cancer
Actions to take
Screening for early gastric cancer
Screening & treating H.pylori
Surveillance of chronic gastritis and IM
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Gastric cancer screening and subsequent risk of gastric cancer
Population 42.150 36 % screened by photofluorography
2 fold decrease in gastric cancer mortality in screened vs non screened
13 years follow up
Lee KJ et al, Int. J. Cancer 2006;118,9
Gastric cancer screening associated with reduced risk of mortality
RR 0.54CI 0.36-0.74
179 cancer deaths
636incident cancer
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Gastric cancer
studies from Japan show a twofold risk reduction for gastric cancer mortality
Lee at al. Int J Cancer 2006
Significant higher number of early gastric cancer with screening endoscopy
Hosokawa et al. Scand J Gastroenterol 2008
Nam et al. Europ J Gastroenterol Hepatol 2009
•Population based screening
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How to select subjects at risk
for gastric cancer development?
At presentNo role for determinationof cytokine related gene polymorphisms
No role for determination of bacterial virulence
What about histology???
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Risk gastritisWell established
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Multifocal atrophyaccompaniedby intest. metaplasia
Auto immune Corpus-predominant with antrum normal
Initial infection
Antrum predominant,Minimal corpus Involvement
gastriccancerGastric Cancer
Chronic gastritis phenotypein gastric cancer
Host susceptibilty. Bacterial strain virulenceenvironment
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Chronic atrophic gastritis
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Atropphy and Intestinal Metaplasia
Narrow band imaging
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Atrophic gastritis
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Atrophic border
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Atrophie
mit intestinaler Metaplasie
Atrophic gastritis an IM
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HistologyAbnormalities atBase Line
All HP+Patients(n=1246)
HP+ Patientswith Gastric Ca
(n=36)
Relative Risk(95% CI)*
Grade of atrophyNone or mild 381 3 (0.8) 1.0Moderate 657 18 (2.7) 1.7 (0.8–3.7)
Severe 208 15 (7.2) 4.9 (2.8–19.2)
Distribution of gastritisAntrum predominant 699 2 (0.3) 1.0Pangastritis 337 14 (4.2) 15.6 (6.5–36.8)
Corpus predominant 210 20 (9.5) 34.5 (7.1–166.7)
N Uemura. N Engl J Med 2001; 345:794-9Follow up period 7-8 yrs
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H. pylori infection – Surveillance Risk assessment of gastritis progression to gastric cancer
1
2
Operative link for gastritis assessment (OLGA)
Rugge et al. APT 2010;31:1104
OLGIM for surveillancede Vries et al. Helicobacter2010;15:259
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Adapted from Vauhkonen et al. Best Pract. and Res. Clin. Gastroenterol. 20,4,2006
diffuse gastric cancer intestinal gastric cancer
adenomadysplasia
atrophic gastritisintestinal metaplasia
Chronicactive gastritisH. pylori
normal
„genetic disposition“transmitted CHD1-mutation
Methylation: CDH1, DAP-K,HRASLS, LOX, MGMT,p14, RAR-ßAmplification: C-MET, K-SAMMutation: CHD1, TP53Expression: hTERT
CIMP/Microsatellite-InstabilityMethylation: p16, COX-2, GSTP1, hMLH1, MGMT, RASSF1A, RUNX3, TFF1Amplification: ERBB2Mutation: K-RAS, TP53LOH: APC, MCC, TP53
Expression: CDX1/2, COX-2, hTERT
Mutation: APC, TP53Methylation: APC, CDH1, DAP-K, hMLH1, p14, THBS1, TIMP-3Expression: EGFR, TGF-
adenoma
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Endoscopic surveillance of gastric premalignant lesions improves cancer survival
Whiting et al. Gut 2002; 50: 278-81
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Surveillance practice of pre-malignant gastric lesions- a long term nationwide study in the Netherlands
Cohort study 1991-2004
90,316 patients
-24% atrophic gastrits-67% intest. Metaplasia-9% dysplasia
Follow up 2005
25,793 patients1.7 % gastric cancer
-3.4% initial atrophic gastritis-7% initial intest. Metaplasia-17% initial mild/moder. dysplasia-68% initial severe dysplasia
Surveillance!!de Vries et al. Gastroenterology 2008
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Surveillance for gastric cancer
Cost effectivness for endoscopy based surveillancerequires malignancy to occur
at a prevalence of > 6%
Yeh et al. Gastrointest Endosc. 2010 Jul;72(1):33-43
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•Single life time screening at age 20,30,40
• single life time screening and rescreening of individuals with negative results
• universal treatment for H. pylori infection at age 20,30,40
Yeh et al. Int J Cancer 2009
H. pylori infection & prevention of gastric cancer
Three models tested in China
GC risk reduction by 15 %
‐ 1500 US$/live year saved
GC risk reduction by 17 %
‐ 2500 US$/live year saved
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Screening/Surveillance for gastric cancer
correlation of low pepsinogen I
with corpus prevalent atrophic gastritis
94%
PEPSINOGEN combined with H. pylori antibodies best option
Lombardo et al. Clin Chem Lab Med. 2010 Sep;48(9):1327-32
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Serological markers
• Screening for preneoplastic conditions
Gastrin 17
Pepsinogen I + IIPI/II-Ratio
H.pylori-Antibodies+
„Gastropanel“
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Watabe et al. Gut 2005; 54: 764-8
The annual incidence of gastric cancer in a Japanese cohort in relation to H. pylori and pepsinogens at baseline
0,4 0,6
3,5
6
0
1
2
3
4
5
6
7
Hp-neg Hp-pos Hp-pos Hp-neg
Normal pepsinogens Low pepsinogens
0/00N=9293
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Rationale ofScreening Methods
Endoscopy
Best detection rate (up to 87%)
Most expensive
Most invasive
Gastro-Panel
Less invasive
Relatively cheap
Alone not sufficient(preselects for endoscopy)
13C-UBT
Cheap
Non invasive
„Only“ H.pylori detected, not mucosal lesions
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PGI PGII PGI/II G17B G17S HpAB
Atrophic gastritis in corpus low low highAtrophic gastritis in antrum low low highAtrophic gastritis in both a / c low low low low
Non-atrophic gastritis high
Non-atrophic gastritis, H.pylori high high
(GERD) (Low
http://www.gastropanel.net/ Condition of gastric mucosa - atrophic gastritis especially of
corpus and antrum (normal, gastritis / atrophic gastritis) & H. pylori infection
PG I, PG II and gastrin-17 levels describe structure & function More severe atrophic gastritis in corpus, the lower the
pepsinogen I and ratio of pepsinogen I / II More severe atrophic gastritis of antrum, the lower is gastrin-17
GastroPanel®: Diagnosis by an antibody test
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Atrophy and Intestinal Metaplasia
Pepsinogen lowGastrin highH.Pylori serology negativeCag A positive
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H. pylori and Gastric Cancer
How to proceed in practice?
• Family history• Gastropanel
•Endoscopy plus histology
• Bacterial virulence factors
• Inflammatory Gen- Polymorphisms
• nutrition habits
• smoking
Risk gastritis
Follow up
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H.pylori-Eradication and GC-Prevention Hazards
Lee and Moss, Expert Opin Ther Targets 2007; Malfertheiner et al, AJG 2005; Meyer et al, Ann Intern Med 2002
Limitations of Eradication Therapy for GC-Prevention
Complex therapy (multi-agent) Compliance?
Availability(Developing countries) strict indication
Increasing resistance(Clarithromycin/Metronidazole)
Critical point of timefor eradication
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Maastricht 3
Statement: H. pylori infection is the most common proven
risk factor for human non-cardia gastric cancer.
Level of Evidence: n.a. Grade of Recommendation: A
97,7
2,30
25
50
75
100
I agree I don't agree
97,7
2,30
25
50
75
100
I agree I don't agreeValues in percentage
Gut 2007
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Maastricht 3
Statement: H. pylori eradication has the potential to prevent gastric
cancer gastric cancer.
Level of Evidence: n.a. Grade of Recommendation: A
97,7
2,30
25
50
75
100
I agree I don't agree
97,7
2,30
25
50
75
100
I agree I don't agreeValues in percentage
Malfertheiner et al Gut 2007
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Malfertheiner et al J. Dig. Dis. 2010
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The incidence of gastric cancer in the community to be targeted
Screening reserved for risk groups and risk populations
Identifying high risk groups
Concluding considerations
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„ it is not enough to know,it must also be put into practice“