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Secondary Prevention of Cancer: an Overview

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Secondary Prevention of Cancer: an Overview Bulletin of the World Health Organization, 64 (3): 421-429 (1986) © World Health Organization 1986 Secondary prevention of cancer: an overview DAVID M. EDDY 1 Secondary prevention ofcancer (screening) involves the use oftests to detect a cancer before the appearance of signs or symptoms. Before starting such a programme, the available evidence should be analysed to estimate the effectiveness of the proposed activities. Essential requirements are an understanding of the natural history of the particular cancer, availability of a test that can detect it, effective treatment for it, good evidence that early detection reduces the incidence and/or mortality, and that the expected benefits of screening outweigh the risks and costs. A screening programme should be limited to significant cancers and applied selectively, and should be integrated into the total health care programme. Programmes should take into account the risks, costs and expected benefits; provide quality assurance as well as facilities to follow, diagnose, and treat people with positive test results; maintain all records; and keep costs to a minimum. Ideally the effectiveness of screening should be demonstrated by randomized controlled trials showing a reduction in mortality, but this type of evidence exists for few cancers. Often an estimate of the effectiveness ofscreening must rest on other types of evidence, such as observations that the tests can detect the cancer before the appearance ofsigns or symptoms; that the tests can find a greater proportion ofcancers in early stages; and that the patients with cancers detected through screening have higher survival rates after diagnosis and treatment although it must be recognized that these observations may be biased. This article discusses the available evidence on the effectiveness ofscreening for eight cancers, and gives estimates of the potential impact ofsecondary prevention for the year 2000. Secondary prevention of cancer, or screening, in- or through mass screening of large populations, can volves the use of examinations and tests to detect a be risky and expensive; specially trained personnel cancer as early as possible, before signs and symptoms and special facilities are often required. Since health would cause a patient to seek care. In some cases, the care resources are precious, a secondary prevention disease can be detected in a premalignant state (e.g., programme should be initiated only when certain leukoplakia of the mouth, dysplasia of the cervix, conditions like those given below, are satisfied. and adenomas of the colon). More commonly, the 1. A formal analysis should be performed to lesion has already developed into a cancer by the time estimate the effectiveness, risks, and costs of screen- it is discovered and the value of early detection lies in ing the selected population. the possibility of detecting the cancer when it is still 2. The screening programme should be planned as localized and more easily curable. Other benefits of part of an integrated health care programme. For secondary prevention are the possibility of simpler example, if one has only US$10 of health care and less expensive treatment as well as less pain, dis- resources to spend on a person, it would not make figurement and disability. sense to screen him for colorectal cancer if he is dying of malnutrition or drinking from a polluted water CRITERIA FOR DESIGNING SECONDARY supply. PREVENTION PROGRAMMES 3. Screening should be limited to circumstances in which (a) the disease is a significant cause of mor- The early detection of cancers,a whether by bidity and mortality, (b) the natural history is well individual practitioners in an office or clinic setting, understood, (c) there is a test that can detect the disease prior to the onset of signs and symptoms, (d) ' Director, WHO Collaborating Centre for Research in Cancer Policy, Duke University, Box GM, Duke Station, Durham, NC there is an effective treatment, (e) there is good 27706, USA. Preparation ofthis paper was supported by WHO and a evidence that early detection and treatment reduce grant from the Charles A. Dana Foundation. morbidity and mortality, and (f) the expected " "Early detection" refers to the detection of a cancer by a special benefits of early detection exceed the risks and costs. examination or test before the patient seeks care for signs or symptoms. "Early detection" does not imply an early stage (e.g., in 4. Screening should be applied selectively to those situ or local). people most likely to benefit. Selection might be 4631 -421- 422 D. M. EDDY based on a person's age, sex, medical history, occu- reduction in mortality from screening for breast pation, family history, race, national origin, or other cancer, which has an annual incidence rate of about factors. 150 per 100 000 women, required a total sample size 5. The risks as well as the expected benefits of of 60 000 women and that still left a 50% chance that screening should be explained to the prospective sub- the RCT would fail to detect the 30%o reduction (1). jects. The risks include any possible complications of In most countries, the incidence and mortality for the examination procedures, and the possibility of most cancers are much lower, and the sample size false-positive and false-negative test results. must be proportionately higher. 6. The programme should be organized to ensure While theoretically the RCTM can provide the best the quality of the examinations, and to minimize evidence about the mortality benefits of early costs. detection, this type of information simply will not be 7. Facilities should be available to follow, available for most cancers. If this type of evidence diagnose, and treat people who have positive were strictly required, it would not be possible at examinations. present to justify screening for any cancers except 8. Records should be kept to monitor the pro- cancer of the breast. Not even cancer of the cervix gramme's quality and success. would pass this test. Clinical observations and uncontrolled trials DOES SECONDARY PREVENTION REDUCE MORTALITY? Because of the above-mentioned limitations of randomized controlled trials, the justification of Randomized controlled trials (RCTs) screening for most cancers must rest on other types of evidence. Three of the most obvious are the obser- Of the criteria just listed, one of the most vations that (1) the tests are capable of detecting important and one of the most difficult to verify is cancers before the appearance of signs or symptoms, that early detection and treatment will decrease (2) these tests appear to find a greater proportion of mortality. Ideally, before recommending a cancer cancers in early stages, and (3) patients with cancers screening test one would like to have its effectiveness detected through screening have higher survival rates demonstrated by at least one randomized controlled and tend to live longer after diagnosis and treatment. trial that used mortality as an outcome measure It is important to understand the value and the limi- (RCTM), and many observers demand that several tations of these types of evidence. RCTMs be done. Unfortunately, this type of On the one hand, the mere observation that a test evidence (that early detection reduces mortality) is can detect some cancers before signs and symptoms available for extremely few cancers. More impor- appear, or that screening appears to find cancers in tantly, it will not be possible to obtain this type of early stages and to deliver higher case-survival rates evidence for most other cancers. can be misleading. It is possible for these outcomes to First, in an RCTM for even the more common occur in screening programmes even when screening cancers, tens of thousands of people have to be has no actual effect on mortality. For example, a examined and followed for many years in order to lead-time bias, a length bias, a patient selection bias, detect enough cases to give statistically significant and overdiagnosis could all cause a screening pro- results. Costs exceeding one million (US) dollars a gramme to appear to prolong life, without the pro- year should be anticipated, and the trials should gramme actually having any effect on how long the continue for at least 10 years. Second, diagnostic and cancer patients actually live.b It is because of these treatment technologies can change rapidly and it is quite possible that the particular screening test being b The lead-time bias occurs because early detection advances the examined in an RCTM will change before a 10- to 15- time of diagnosis which, by itself, makes it appear that patients live longer and have higher short-term survival probabilities. Cancers year study is completed. Third, ethical problems can detected in an early detection programme tend to have longer arise if (1) a screening procedure is believed to be intervals than average before clinical manifestation, which may imply slower growth rates, a lower grade of malignancy, and longer effective and it is not offered to the control group; or survival than average. The length bias can occur if only the survival (2) a procedure is not believed to be effective, and it is of patients with cancers detected by early detection tests is examined, and cases that are discovered in the intervals between examinations recommended for the screened group. But the main are ignored. People who receive early detection tests may be different problem is that RCTMs cannot be conducted for from those who do not, or may be different from the general popu- most cancers simply because of their low frequencies. lation, in ways that could affect their survival from a disease such as cancer (patient selection bias). Because there is no sharp boundary The frequencies of most cancers are so low that between nonmalignant and malignant cells, it is possible to diagnose RCTMs would require at least tens of thousands, and as a very early cancer a lesion that is not cancer and would never become cancer.
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