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Following you find teasers and selected full articles of the media coverage regarding the European Confernence on Colon Cancer Prevention 2007:

 

13.07.2007, Der Gastroenterologe: The Prevention of Colon Cancer and European Health Policy

Colm Ó’Moráin


Epidemiology
Colorectal cancer affects both men and women with a slight predominance among males. There are over one million cases reported worldwide each year and of these over half die of this condition.  Over a quarter of colorectal cancers worldwide occur in the 27 member states of the European Union and accounts for 150,000 deaths a year.  This should be a health priority for the E.U. as colorectal cancer can be prevented.  There are differences within Europe in terms of incidence and mortality.  In Greece for example the age standardized rate of death in males is 9.7 compared to 34.0 in the Czech Republic (1) .


Trends in Incidence
The Europreval Project has shown that many countries in the E.U., including Italy, France, Poland, Slovakia, Estonia, Netherlands Slovenia and Spain, had increasing incidence of colorectal cancer particularly in the last decade. (2) 

However some countries such as Scotland, Germany, Iceland, Denmark, Sweden, U.K., Finland, Switzerland, and Austria show the incidence to be constant or a slight decrease. This contrasted to the United States data where the incidence is higher but has shown a decrease in incidence since 1985.  This fall coincides with a screening programme in the U.S. for detecting cancer at an early stage or a precancerous stage. (3) 


Survival from Colorectal Cancer
In 2003 a co-operative study was published showing dramatic differences in the 1 year and 5 year survival from colorectal cancer in the member states of the E.U.  In Poland, Czech Republic, Estonia and Slovakia the survival rate is only 40% at 5 years whereas in Austria, France, Finland, Spain and Sweden the survival rate is greater than 50% at 5 years. (4)  

The survival rates in Europe from CRC are less than in the U.S.  European countries outside the E.U. such as Iceland, Norway and Switzerland have a higher survival rate than the E.U. member states.  This inequality needs to be examined and addressed.  However, in some countries there is an improvement in survival such as the U.K., Finland and Italy.  The explanation can be due to failure of early detection and screening. 

The difference overall for one year survival rates could be explained by the budget spent on health and correlating this with gross internal product.  Countries such as Poland, Estonia, Slovakia, Slovenia and Czech Republic who have a relatively low gross internal product spend less as a percentage on their health budget compared to other countries who have a higher gross internal product and spend more of a percentage on their health budget.  The amount spent on the health budget correlated with a better 5 year survival rate of all cancers.  This should influence government policy to spend more on health to improve survival rates from cancer in which there are 2.3 million new cases and over one million cancer deaths per year in Europe. (4)  


European Commission Activities in Colorectal Cancer Screening
The Amsterdam Treaty was the first step in developing a public health programme for Europe.  The articles pertaining to public health stated:   
§      a high level of human health protection in the development of all community policies,
§      to take actions to improve public health in the E.U. to prevent human illnesses and diseases to alleviate human illnesses and to obviate sources of danger to human health,
§      to provide independent and transparent risk through SANCO scientific committees,
§      to implement the Public Health Programme.
The principle of subsidiarity recognised that the Community must not undertake or regulate what can be managed more efficiently at national or regional levels. 




E.U. Action
The Commissions policy in relation to cancer is:
§      to facilitate data collection to allow comparison of incidence and mortality from cancer throughout Europe,
§      to promote healthy lifestyle to prevent cancer,
§      to motivate citizens to participate in screening,
§      to develop and disseminate evidence-based consensus on screening. 

This will be achieved through the E.U. Public Health Programme which was launched in 2002 for a six year period.  This programme is to complement national policies, to protect and improve public health.  There are three strategies involved:  health information, health threats and health determinants.  In 2003 recommendations were made that all citizens should be offered screening for cervical cancer by Pap smear, breast cancer with mammography and colon cancer by faecal occult blood screening in quality assured programmes.

A contract has been signed and will be available by 2007 regarding quality assurance in colorectal cancer.  The project will be co-ordinated by a multidisciplinary editorial board promoting a Pan-European network.  Implementation of this report on cancer screening occurs during the Slovenian presidency in 2008.  

The European Structural Fund for regional development can be ulitised to develop cancer registry and screening centres in countries that lack these facilities.  A training programme could be funded by the European Social Fund.  The E.U. has a major role to play in prioritising colorectal cancer screening throughout Europe.

In the last twenty years considerable efforts have been made to validate screening methods to detect early colorectal cancer and decrease mortality and incidence of colorectal cancer.  Currently the most evaluated screening test is Guaiac faecal occult blood test (FOBT) followed by a colonoscopy if the stool test was positive for blood. 

Currently the evidence in favour of FOBT comes from case control studies.  These are hypothetically based and implies 100% compliance which is never the case in practice.  They show a decrease in mortality varying between 30% and 40%.

However these results are in agreement with those of controlled studies when they are performed in the general population.  The results that the case controls are in agreement with decreased mortality between 30% and 40% in patients who participate in the study.  (5), (6), (7), (8)           

The success of the screening programme depends on the participation rate in the screening test.  The compliance rates are particularly high in Nordic countries.  In the Danish and U.K. studies there was a decrease in participation rates in the subsequent rounds of screening.  However, this was not seen in the French study when all of the original invitees were asked to participate in subsequent rounds of tests, i.e. inviting those who did and did not participate in the first round.  In European countries it is possible to have a participation rate of 50% to 65%.  In order to improve participation rates it is important to have the involvement of a family doctor.  Having the family doctor invite the patients was superior than using a postal invitation in the French studies.  Postal invitations only succeeded in 34% of patients complying compared to 91% when approached by the family doctor. (9)  

Acceptability of the test is important when considering the reduction in mortality and the cost per year of life saved.  If the participation rate is 55% after 20 years, mortality would be decreased by 18% resulting in a cost per year life saved of €3,357.  If the participation rate was improved to 65%, mortality would improve by 22% with a decrease cost per year life saved of 20%.  If the participation rate is 45% the mortality rate is decreased to 13% but the cost per year life saved increases by 31%.  If the participation rate is 35% as in some studies, the mortality rate is decreased by 9% and the cost per year life saved is increased by 86%. (10)  

There is one study from the United States which shows a decreased incidence of colorectal cancer between 17% and 20% depending if it was annual or biannual screening. (7)  

The results of these studies have led to the E.U. Council recommendation of the European Code against Cancer in which it states “Men and women from 50 years of age should participate in colorectal screening.  This should be within programmes with built-in quality assurance procedures” and “Faecal occult blood testing is actually the only recommended screening strategy”.  The Expert Group recommended this in 1999 but will not be acted upon by the European Parliament until 2007.  This illustrates that it takes a considerable amount of time to get public health measures into practice.

The French Pilot Programme depends on meticulous organisation with a local co-ordination group in each department in charge of implementing CRC and breast cancer screening.  The inclusion criteria are for patients between the ages of 50 and 74 years and have an FOBT performed every two years.  Patients who had a close relative with index cases less than 65 years, or who had a personal history of CRC or adenoma or who had a normal colonoscopy during the last five years are excluded.  Local Family Practitioners are informed and were crucial in its implementation.  Tests are evaluated centrally.  The strategy involved: an invitation letter, information brochures, a press campaign and posters in the Family Practitioners waiting room;  the Family Practitioners distributed and explained the test in the first six months;  a reminder letter with a questionnaire on the exclusion criteria sent after three months and in the subsequent rounds non-participants for the first round were contacted again.  The study has been rolled out since 2003 and it is expected to have 90% coverage of the population by the end of 2007.  There is variability in the participation rate within France from over 50% (which is the expected rate) to lower rates of 32%.  This low compliance is due to shortcomings in the local infrastructure.  The first results of the French Pilot Programme, which involved four different departments, 9.8% were excluded with a compliance rate of 52%.  Of these 3% were positive and 84% had a subsequent colonoscopy, 10% were found to have cancers and 33% were found to have adenomas.  This proves that a screening test is feasible and effective. 

The faecal immunochemical test may be the preferred option in the future.  This test when used in Japan for 21,850 asymptomatic subjects had a higher positivity rate of 5.7%.  The sensitivity of the test per CRC was 65.8%.  This test has a higher sensitivity set but a lower specificity and positive predictive value.  The test can be analysed by an automated machine.  However it is not clear if a year or 3 year testing is the ideal or what is an acceptable positive cut off point. (11)  

Another new test is a stool test that uses probes that detect DNA alterations. (12)   However the positive predictive value is low at 51% and is very costly.  The current price in the U.S. is $800.  Up to now the haemocult test (Guaiac Test) has been intensively studied and is felt to be effective.  It needs a compliance rate of over 50% and remain high in subsequent rounds of testing.  A colonoscopy must be performed in the case of a positive test.


Efficacy of Endoscopic Studies
There are no large scale randomized trials available to validate endoscopy as a screening method.  However there are several ongoing large scale studies of evaluating sigmoidoscopy in the U.K., Italy, Norway and the U.S. These were initiated more than ten years ago involving thousands of subjects and the results are awaited.  There are observational epidemiological studies showing that endoscopy mainly using sigmoidoscopy from both Europe and the U.S. decreases mortality and incidence of CRC.  The risk reduction for both incidence and mortality varies between 60% and 90% for those who attended for the test.

In a recent review paper summarising evidence shows that colonoscopy is effective in reducing mortality and incidence by 70%, sigmoidoscopy by 50% and FOBT by 38% for those who agreed to participate in the programme.   The effectiveness depends on compliance.  It is reasonable to expect 60% compliance and this would result in a reduction of incidence and mortality of 42% for colonoscopy, 30% for sigmoidoscopy and 23% for FOBT. (13)  

Cost effectiveness is important to consider when political decisions are made.  This means that cost effectiveness includes the cost of prevention minus costs averted / quality of life years saved.  This gives a cost effectiveness of 8.840 US dollars for colonoscopies, 18,869 for sigmoidoscopies and 13,334 U.S. dollars for faecal occult blood test.  A summary of these results show that FOBT, sigmoidoscopy and colonoscopy are all cost effective and compare favourably with other screening programmes such as breast screening but a single optimal strategy is not yet clear as is the optimal age or intervals for screening cannot be determined. (14), (13)    The cost calculations are based on assumptions based on recommendations from guidelines that sigmoidoscopy should be performed at 5 year intervals, colonoscopy at 10 year intervals and that surveillance intervals after polypectomy should be 3 years and there is the same reduction for both proximal and distal CRC and the same schedules apply to both women and men.


Reducing Costs of Endoscopic Screening
There is further potential to enhance cost effectiveness of endoscopic screening by optimising screening and surveillance intervals, and enhance risk adaptation and screening schedule.  This can be illustrated through an epidemiological study that is ongoing in Germany which is a population based case controlled study of 22 clinics and the controls are from population registries.  There is no upper age limit to recruitment.  Already 1,600 cases and 1,800 controls have been recruited and an interim report of 600 cases and 1,400 controls has been published.  
The first question addressed to when does a colonoscopy need to be repeated if the first colonoscopy was clear but this study showed that those patients who had a colonoscopy at 10 to 19 years previously had very little risk of developing cancer. (15)     However if the interval was greater than 20 years the risk was not significantly reduced.  The data was further analysed according to age if the colonoscopy was performed in patients less than 55 the risk of developing a CRC subsequently was minimal.  Another important question is when to re-schedule a colonoscopy after finding a polyp.  There is little risk of developing from this a CRC if the repeat colonoscopy interval was 5 years and this was not dependant on the finding of the type of polyp even if the polyp was associated with a higher risk of transforming to cancer.  The recommendations from this study are that the interval between screening colonoscopy can be extended to 20 years.  Once in a life time colonoscopy at age 55-60 is highly cost effective.  The interval between screening colonoscopy if a polyp is found can be extended to 5 years.  Increasing the intervals between screening colonoscopy may enhance compliance and cost effectiveness of the programme. (16)  

The potential to increase cost effectiveness by enhanced risk adaptation was deducted from a Polish study in which 50,148 participants had a screening colonoscopy. (17)   The number needed to screen to detect a CRC were analysed according to age and sex, and also family history.  The number needed to screen among men was lower to detect cancer than women so that a different protocol could be applied according to gender. (18)   That women both develop an incidence and mortality of CRC some 5 years later than man has been shown from studies from both the U.S. and Europe.   However, screening programmes show that women have higher participation rates than men but adapting a strategy according to gender and family history has the potential to increase cost effectiveness of a screening programme.  

In conclusion endoscopic screening for colorectal cancer has very high efficacy if offered at high levels of quality.  Endoscopic screening can have high effectiveness with high population coverage and has consistently been found to be cost-effective in multiple studies.  Cost-effectiveness of endoscopic screening may be further enhanced by optimization of screening/surveillance intervals and by better adaptation of screening offers to individual risks (e.g. family history, gender) (Figure 3).  It could be a powerful tool to reduce the burden of colorectal cancer as more than 160,000 cases and 80,000 deaths might potentially be prevented in Europe each year.

There is no doubt that screening for a colorectal cancer is a priority issue for Europe where there is a high incidence of the condition.  There is a need for developing the infrastructure to support a screening programme.  A two step approach with a faecal-based test allows a gradual increase in the cost involved.  Endoscopic screening has advantages but there is doubt about compliance and it is expensive.  The European Commission has a role to play to encourage politicians to support a programme, increase public awareness and assure the quality of these programmes.  The important message is to promote colorectal cancer as a preventable disease.


References

1.         Parkin DM, Bray F, Ferlay J, Pisani P.  Global Cancer Statistics, 2002.  CA Cancer J Clin 2005; 55: 
74-108. 

2.         Capaccia R, Colonna M., Corazziari L, De Angelis R., Francisci S., Micheli A., Mugno E.:  EUROPREVAL Working Group.  Measuring Cancer prevalence in Europe:  The EUROPREVAL project.  Ann Oncol. 2002 13(6):831-9.

3.         Surveillance, Epidemiology and End Results programme of the National Cancer Institute, U.S.A.

4.         Micheli, A., Baili P., Quinn M., Mugno E., Capocaccia R., Grosclaude P;  EUROCARE Working Group.  Life Expectancy and cancer survival in the EUROCARE-3 cancer registry areas.  Ann Oncol. 2003; 14  Suppl 5:v28-40.

5.         Kronborg O, Fenger C., Olsen J., Jørgensen OD, Søndergaard O.  Randomising study of screening for colorectal cancer with faecal-occult-blood test.  Lancet.  1996.  348: 1467-71.

6.         Faivre J, Dancourt V, Lejeune C, Tazi MA, Lamour J, Gerard D, Dassonville F, Bonithon-Kopp C.  Reduction in colorectal cancer mortality by fecal occult blood screening in a French controlled study.  Gastroenterology. 2004.  126:1674-80.

7.         Mandel JS, Church TR, Bond JH, Ederer F, Geisser MS, Mongin SJ, Snover DC, Schuman LM.  The effect of fecal occult-blood screening on the incidence of colorectal cancer.  N Engl J Med. 2000 30;343:1603-7.

8.         Hardcastle JD, Chamberlain JO, Robinson MH, Moss SM, Amar SS, Balfour TW, James PD, Mangham CM.  Randomised controlled trial of faecal-occult-blood screening for colorectal cancer.  Lancet.  1996. 348: 1472-7.

9.         Tazi MA, Faivre J, Dassonville F, Lamour J, Milan C, Durand G.  Participation in faecal occult blood screening for colorectal cancer in a well defined French population: results of five screening rounds from 1988 to 1996.  J Med Screen. 1997:147-51.

10.        Lejeune C, Arveuz P, Dancourt V, Béjean S, Bonithon-Kopp C, Faivre J.  Cost-effectiveness anlaysis of fecal occult blood screening for colorectal cancer.  Int J Technol Assess Health Care.  2004.  20:434-9.

11.        Morikawa P, Kato J, Yamaji Y, Wada R, Mitsushima T, Shiratori Y.  A comparison of the immunochemical faecal occult blood test and total colonoscopy in the asymptomatic population.  Gastroenterology 2005.  129, vol. 2:422-8.

12.        Imperiale TF, Ransohoff DF, Itzkowitz SH, Turnbull BA, Ross ME; Colorectal Cancer Study Group.  Fecal DNA versus fecal occult blood for colorectal-cancer screening in an average-risk population.  N Engl J Med. 2004.  351:2704-14.

13.        Maciosek MV, Solberg LI, Coffield AB, Edwards NM, Goodman MJ.  Colorectal cancer screening: health impact and cost effectiveness.  Am J Prev Med. 2006 31:80-9.

14.        Pignone M, Saha S, Hoerger T, Mandelblatt J.  Cost-effectiveness analyses of colorectal cancer screening: a systematic review for the U.S. Preventive Services Task Force.  Ann Intern Med. 2002;137:96-104.

15.        Brenner H, Chang-Claude J, Seiler CM, Sturmer T, Hoffmeister M.  Does a negative screening colonoscopy ever need to be repeated?  Gut. 2006, 55:1145-50.

16.        Brenner H, Chang-Claude J, Seiler CM, Sturmer T, Hoffmeister M.  Case-Control Study Supports Extension of Surveillance Interval After Colonoscopic Polypectomy to at Least 5 Yr.  Am J Gastroenterol. 2007

17.        Regula J, Rupinski M, Kraszewska E, Polkowski M, Pachlewski J, Orlowska J, Nowacki MP, Butruk E.  Colonoscopy in colorectal-cancer screening for detection of advanced neoplasia.  N Engl J Med.  2006. 355:1863-72.

18.        Brenner H, Hoffmeister M, Arndt V, Haug U.  Gender differences in colorectal cancer: implications for age at initiation of screening.  Br J Cancer. 2007.  12;828-31.

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