Benefits and Risks of Skin Cancer Screening

Abstract

In 1968, Wilson and Jungner [1] developed a framework for the implementation of screening programs that has been adopted by the World Health Organization (WHO). The principles of this framework are: i) The detectable disease should be an important health problem, and ii) its natural history should be known; iii) There should be a long pre-clinical stage of the disease (latent stage), and iv) a safe, simple, and inexpensive screening test should be available that is acceptable to the population being screened; v) Additionally, there should be a treatment for earlier-stage disease that is more effective than the treatment for later-stage disease; vi) Finally, facilities for diagnosis and treatment should be available [1].Since 1971, Germany has a nationwide program for the early detection of cancer, including skin cancer. However, when the program was first implemented, no screening test for skin cancer was conducted; only growth, discoloration, and hemorrhage of malignant melanomas (MM) were documented by urologists and gynecologists. This procedure detected only 200-300 MM per year. In the late 1980s, the executive body of the German healthcare system, the Federal Joint Committee (Gemeinsamer Bundesausschuss), and in particular its Department of Prevention (Unterausschuss Prävention), decided to improve the National Program for Early Detection of Cancer by promoting primary preventive activities as well as secondary preventive activities. In this context, the scientific validation of early detection of skin cancer was prepared, and several pilot projects were initiated in subsequent years. The largest of these projects was the SCREEN project (Skin Cancer Research to Provide Evidence for Effectiveness of Screening in Northern Germany), a systematic population-based intervention which was conducted in the federal state of Schleswig-Holstein between July 2003 and June 2004 [2]. Finally, in 2008, the Federal Joint Committee decided, based on the principles of screening, to implement a nationwide skin cancer screening program in Germany. This article is aimed at describing the development of the unique German Skin Cancer Screening Program including its preceding pilot projects. Further, the impact of skin cancer screening activities on population-based outcomes is discussed.The burden of skin cancer has increased worldwide over the last decades among light-skinned populations [3-7]. In 2008, the global, age-standardized mortality rate for MM was estimated to be 2.8 per 100,000 inhabitants [8]. In the United States, the lifetime incidence for MM is about 1 in 74 [9]. In Germany, latest reports suggest that skin cancer, including MM and non-melanoma skin cancer (NMSC), has the highest cancer incidence. Thus, skin cancer is the most common cancer in Germany (table 1).The personal burden of skin cancer can be substantial. While NMSC can lead to considerable morbidity and disfigurement [10], the prognosis of MM is highly dependent on stage at diagnosis. If detected at an early stage, 5-year survival rates are over 90%. In contrast, if MM is diagnosed at stage IV, only about 15-20% of patients are still alive 5 years after receiving their diagnosis [11]. In addition to the personal impact, the economic burden of skin cancer is considerable. In Germany, for example, annual hospitalization costs for 2003 amounted to 50-60 million Euros for the treatment of MM and 105-130 million Euros for the treatment of NMSC [4]. The total costs caused by skin cancer, which cover more than the costs for inpatient treatment, are hardly assessable; however, in Sweden, for example, annual direct and indirect costs are estimated to be EUR 142.4 million (EUR 15/inhabitant) [12]. In 2000, the loss of disease-adjusted life years worldwide was estimated to be 345,100-621,200 for MM and 88,100-134,800 for squamous cell carcinoma (SCC) and basal cell carcinoma (BCC) [13].The natural history of skin cancer is known. NMSCs are usually slow-growing tumors with a long preclinical phase. NMSCs therefore predominantly appear in older people. Over 80% of cases occur in people above 60 years [14, 15]. For SCC, actinic keratosis represents the precancerous lesion. Compared with NMSC, MM is a fast growing cancer that often spreads (20-25%) but is also detectable at an early stage.There is mounting evidence that both MM and NMSC are induced by ultraviolet (UV) radiation. This is supported by the International Agency for Research on Cancer (IARC) that recently defined UV radiation as a carcinogen [16]. The increase in skin cancer incidence may therefore be attributed to an increase in life exposure to UV radiation. While higher life expectancy is one of the reasons for the high incidence of skin cancer in older people, with particularly high incidence rates of MM in men 65 years and above [17], changes in behavior are further reasons for the increase in life exposure to UV radiation and possibly the increase in skin cancer incidence. Examples of such changes in behavior include more time spent outdoors without being sufficiently protected by clothes and/or sunscreen, increased use of solaria, and more frequent travelling to regions closer to the equator [18-20].To reduce both the burden of skin cancer and the exposure to UV radiation, primary and secondary preventive activities are important. Primary preventive activities are predominantly aimed at changing people's behavior [21]. Secondary preventive activities are mainly aimed at early detection of skin cancer [2].In response to the increasing incidence rates of MM and NMSC, the Federal Joint Committee, the highest decision-making body that determines the benefit package of statutory health insurance, commissioned the Association of Dermatological Prevention (ADP) to examine the scientific basis for a systematic skin cancer screening program within the existing setting of primary care in Germany. Starting in 1991, the ADP, supported by German Cancer Aid, carried out studies in order to establish a skin cancer screening program. Until 1998, the 2-step screening process (fig. 1) and the training of healthcare professionals were developed and tested. Additionally, the performance of the screening test and the documentation of the screening examination were standardized. 83 physicians in the federal states of Lower Saxony and Hamburg participated in these studies [22].200 physicians in the federal state of Schleswig-Holstein were recruited to participate in the first field study. They completed a newly developed, 8-hour training course. These trained physicians carried out 6,000 screening examinations from 2000 to 2001. The results of the field study were discussed with the Federal Joint Committee and led to the decision to conduct a population-based screening study. A randomized controlled trial (RCT) would have provided the strongest evidence for the feasibility and effectiveness of a population-based skin cancer screening; however, an RCT was not considered necessary by the Committee, since skin cancer had already been part of the statutory early detection program since 1971.After the training course had been revised and adapted, the SCREEN project was conducted in Schleswig-Holstein with 360,288 screenees from July 2003 to June 2004. Almost 2,000 physicians took part in the screening. To date, this project is the largest skin cancer screening study, and the outcomes and evidence provided by the SCREEN project (level of evidence 1c (SIGN)), assigned by independent review) were sufficient to convince the Federal Joint Committee to implement a nationwide systematic screening program for MM, BCC, and SCC [23]. The national statutory skin cancer screening program was launched in July 2008.The aim of the SCREEN project was to assess the feasibility of a population-based skin cancer screening program. The screening was organized as a 2-step process (fig. 1). During a 12-month period, residents of Schleswig-Holstein, aged 20+ years and covered by statutory health insurance, were invited to participate in the study. 1.88 million residents met the eligibility criteria, and 360,288 participants were screened with a visual whole-body examination. This corresponds to a population-based participation rate of 19%. All participating physicians received an 8-hour standardized training. A 98% participation rate among of and among of was The of as well as and of the SCREEN project that had to be screened to one MM MM per This is in with from screening programs of the and of but is than from screening such as the which in to the screening in the SCREEN During a total of were and the to to one MM in men and was The was to be in men aged 65 years and older in their study an rate per newly diagnosed MM of which a in the SCREEN project received training in the early detection of skin which was not the in the study by This may have in and the of training and for physicians part in skin cancer the of an effective population-based cancer screening the total incidence of the disease should increase but cases are detected The incidence should when screening activities of the SCREEN project were and to a federal state of Germany no population-based screening took The incidence of MM increased the SCREEN and when screening activities in Schleswig-Holstein, no such changes in incidence were in A in incidence the SCREEN has also been for and SCC in Schleswig-Holstein, but not in in incidence were also increase in the incidence of MM and took after implementation of the SCREEN at the time the incidence of MM only for This early is with from effective and cancer screening and that the SCREEN project may be an effective screening to reduce MM In a in MM mortality by be in Schleswig-Holstein by in regions and in the of Germany MM mortality (fig. the SCREEN project Schleswig-Holstein had one of the highest MM mortality rates in Germany, and 5 years after the of SCREEN one of the mortality rates if this is only based on and the of evidence is the population-based skin cancer screening the only for the mortality on the results of the SCREEN project and the that visual whole-body examination represents a safe, and well screening test and that the of skin cancer screening not the the Federal Joint Committee decided to a nationwide skin cancer screening program in July to the 2-step procedure in SCREEN (fig. 1) [23]. of Germany are covered by statutory health have the to a standardized visual whole-body examination for NMSC and MM by a a years. Screening is to a health for aged years and In to the SCREEN the population in the national skin cancer screening program residents aged and the of of and of screened are not and documented a high of the screening is for participating physicians to an 8-hour standardized training course. To date, of and of have been The of the training the of the standardized visual examination of the and such as and of skin cancer To the participants are to a and after the training course. The on early detection on skin cancer and in the of skin The of completed available an increase in and with particularly from the training million residents in Germany are aged and are covered by statutory health by that from to million residents with statutory health have participated in the screening program. The participation from to was the participation rates of men and in Schleswig-Holstein were the SCREEN project the to was [2]. These were from of million from to from Schleswig-Holstein by the for the skin cancer screening examination participation rate is to the participation to July of by the National Association of Health However, the were from Schleswig-Holstein a federal state which has several screening to the of the nationwide skin cancer screening program. This have the participation rate in Schleswig-Holstein, and the national participation rate from the participation since the of the a nationwide increase in the incidence for MM and NMSC has been This be a first for an effective skin cancer screening and to be a tumors occur and this lead to a in the SCREEN project represents the largest on skin cancer screening, and evidence that population-based skin cancer screening with training and may be effective in morbidity and The nationwide skin cancer screening program has not been but that the of the German skin cancer screening program is based on the SCREEN project and that the participation rate as well as the by physicians and is screening outcomes can be the skin cancer program should be A more of the program is including and of the screening and development of skin cancer and skin cancer The German skin cancer screening a worldwide unique to more about the of skin cancer July 2008, screening for skin cancer was in Germany. million over the of years are to a skin cancer screening examination years. The primary aim of the screening is the of MM the incidence of MM in is higher than in Germany, the Cancer an MM in 2008, which states with to MM the of evidence as to its effectiveness in mortality population-based screening be are the in and in Germany is no on the effectiveness of skin cancer screening The of skin cancer screening in the Research annual by A scientific in annual by for at high for skin cancer in The Cancer in population-based screening and screening In Germany, statutory health skin cancer screening programs for the of in addition to statutory skin cancer screening. There are screening programs without Thus, can participate in the screening for skin cancer. The a screening of population as screening is for over of the the to the German statutory skin cancer screening. no has the German to screening. are the reasons for this The the of screening for skin a German with a population of The inhabitants the German To the an annual screening for MM is for inhabitants over the of years. is that cases of MM are in this The is based on the rates for incidence and mortality in Germany in are not considered in the Thus, about cases of MM are in this In inhabitants not from newly diagnosed To the MM a screening program is for the inhabitants over the of years. screening, of the MM cases from The MM screening only be effective if at 1 of these MM cases is among the screening For this to have to be The i) participate and ii) test in the screening statutory skin cancer screening in Germany is not an annual screening as in the The that screening programs in Germany, the Federal Joint Committee, a for the screening examination. the to MM is to the in However, can be that the not the German skin cancer screening, since its aim is not only to MM but skin as is therefore to a closer at the of skin cases of skin cancer are in Germany The of of cancer skin cancer to The high of skin cancer cases is as skin cancer is not a unique The of skin cancer are BCC, SCC, and These skin of cases of skin cancer. The of these are in The in are since the of and SCC is The the of cases is skin cancer a in of are to skin cancer in Germany. If only cancer mortality is skin cancer is for of cancer from However, these cases are that are not considered has a most for a A diagnosed with The 5-year survival rate is high at The of the the survival In and not The can be by the population diagnosed with is that this population is than the population in this the cases of skin cancer, to a skin cancer diagnosis is with a survival to the survival the of this disease is not There is no evidence that morbidity is by an of cases per SCC are diagnosed as often as The prognosis is with a 5-year survival rate of The mortality of SCC is national skin cancer only as MM as NMSC are skin without The mortality rate of NMSC is per 100,000 of SCC is the of the are over years at of the years. SCC usually in of the the the of the this skin cancer is that the can a the cancer However, is often by SCC is not for screening. In participation in screening examinations from the of years. if screening for SCC was a benefit would be highly can be that life expectancy in this would not to screening caused by be There is no scientific evidence that screening mortality morbidity from can be that and SCC are not for screening. early detection of MM is the of skin cancer screening. cases per 100,000 MM is a However, the incidence is high to of to MM are in patients over the of 65 years. In to the prognosis is with a 5-year survival rate of 90%. To the of a the German a for the mortality of The is based on the of caused by a cancer. in Germany are to cancer in men and cancer in In MM was on for men and for to MM are in Germany. All have to be to reduce the of from is an important The of MM screening on the of the MM screening, visual whole-body examination is as a screening A visual whole-body examination is a of the skin by a to that MM are well on the skin and are therefore for screening. However, this is a The that MM is well is only in In people have that can malignant This to older The between and malignant tumors by is often usually examine skin by and not on examination. However, is not to be in the German screening for on the of whole-body examination as a screening test are There is a randomized trial skin cancer can be by whole-body examination is there a randomized trial on the of this examination to detection of skin is only one study that a between whole-body examination and of MM This study by a study the time MM diagnosis. was by often cases and had a skin examination in a to the of diagnosis a The evidence of this study is to the of study the of visual whole-body examination. A of years after whole-body examination was cancer MM was diagnosed in The for skin was a of 1 after whole-body examination. For a of a of was A of the of MM diagnosis by a high in from to on the of the and on the population of skin cancer screening was to visual whole-body examination and [23]. of screening participants were for this The participants were first by a and by a was often and skin cancer. A of the results is in The that the of to a skin cancer was only on and of screening be from this since are The examination is as a screening test for early detection of MM in for a German with inhabitants the of visual whole-body examination. are MM screening is by inhabitants over years of there are not primary care physicians also participate in the screening. To is that and primary care physicians MM with the The for the detection of MM by whole-body examination be and the be in of the screening. The results are as If inhabitants participate in the screening, of MM be detected by the screening To these MM, have to be to out This that of the screening participants have to For MM, are MM be If there is a of MM in MM is in only however, can be that not of the inhabitants over years participate in the screening. from a German healthcare that about of for the statutory skin cancer screening the screening examinations In of the screening, is that these of MM cases in The only of the MM cases are Thus, MM in are not detected a are for the MM in that are To be the screening at 1 of these However, since only of MM are within the screening, the is not high with that the screening be to the effectiveness of the screening, has to be examinations of are than by the A considerable of tumors be as malignant by The increase in MM incidence in decades is to the of with skin tumors often The National Cancer states that this the effectiveness of screening is not one randomized trial a in mortality to MM screening studies a benefit of MM screening randomized trial on MM screening was in However, the study was early to a of the survival of study participants have been In the a with conducted an MM for over decades were to examine If detected by received a examination by a on the examination was including were was that of MM and that MM mortality was than However, the of mortality and is not considered to be In a study, MM patients were had their skin and/or had received a skin examination by a to their MM diagnosis A between and and/or examination was was not However, to the study the of a and the of the evidence of this study is In can be that the evidence for the effectiveness of MM screening is The studies not evidence for a in MM mortality to screening. In the the study be in 1 July 2003 to June an intervention study was conducted in Schleswig-Holstein, a federal state in Northern Germany [2]. The intervention of an and a screening. whole-body examination was as the screening was that MM mortality in Schleswig-Holstein by 5 years after the screening intervention There was a in MM mortality in the federal states in The National Cancer a on the intervention study in Northern Germany to the the study has and the evidence for a in MM mortality is are the of the is the of a randomized is not the intervention caused the in The study the intervention to be the of the but this is not at In addition to natural a of reasons for the in mortality be In the the incidence rate of MM was in the of over time is on the and is a to for MM incidence rates considerable in the years 2000 to be that from the was for the in MM incidence. can be that of a population can lead to changes in the incidence of the use of for the of MM mortality a are In the Schleswig-Holstein study, only on the of per were as an The evidence for a in MM mortality is a of the over MM patients from 2003 to was not to in the can be attributed to the cases in the screening is that from MM in the were diagnosed after the screening is that in the from the screening is that of the population no one from MM within the further is the of of the screening. can lead to a of is that MM screening can lead to and would have been to were with the in the study. The incidence of MM in the screening population was per 100,000 the incidence of the population was per 100,000 is highly that were in the screening was not was by the and this may have In is the use of for screening examinations may lead to a in of is that there is no about the of whole-body The screening test is highly important may in an increase in MM There are about the The of and MM are in is was and are not in MM screening a However, to this a is in MM mortality is the for skin cancer screening. The evidence for a in MM mortality to screening is and of the German skin cancer screening are The intervention study in Northern Germany has not increased the The of MM screening no has the German of screening. The statutory skin cancer screening in Germany was on the basis of from the intervention study in Northern Germany. This study can no as an to screening in and have to be on their projects to and screening for skin cancer. The programs conducted include training an increasing of and in skin cancer screening, and people older than years and covered by statutory health to part in screening. were screened in the SCREEN project carried out in Schleswig-Holstein, had to be screened to one MM, and the of to 1 MM was The subsequent nationwide screening program results these a have The most important there a a population based on the in the including skin and If that was the above for the of people to to 1 of MM would be The most important would with screening also be more with to changes in and more to which would the The by the to the the of the screening test is as well as the of skin between screening is by that there is no for skin cancer screening in Germany, a in with the In a provided in that people would have to be screened at time in order to a of provided that people would with screening. In of the of only for visual screening would to be in order to MM and a of In order to at these in a nationwide a of and physicians would have to be in skin cancer screening, and also a of would have to be to MM in with high and In also the of screening on the skin and not to the that screening for skin cancer should be can from these is the of skin cancer skin cancer screening In the of randomized controlled there for and in the of the there is considerable the of screening for skin cancer in Germany. The of skin cancer screening by and including a of would for if screening was the of and screening results would the above to the are the of skin cancer of the of visual screening, a of would have to and be with the In if the more and would be the is the out of this if randomized studies are not the population on in cancer There is no on the by screening to if the incidence of MM is high in a the basis of the above would to the However, well screening of populations would would at high screening programs to well defined should to part in skin cancer in this last be at this the of this that more is necessary in order to effective skin cancer screening The not a of The not have a of to this article of in to this on of the