BACKGROUND: The Early Lung Cancer Action Project (ELCAP) was designed to evaluate the usefulness of annual computed tomography (CT) screening for lung carcinoma. With the baseline results having been reported previously, the focus of the current study was on the early results of the repeat screenings. METHODS: A cohort of 1000 high-risk individuals was recruited for baseline and annual repeat CT screening. At last follow-up, a total of 1184 annual repeat screenings had been performed. A positive result from the screening test was defined as newly detected, one to six noncalcified pulmonary nodules with interim growth. The diagnostic workup of the individuals was guided by recommendations supplied by the ELCAP investigators to the collaborating clinicians. RESULTS: Of the 1184 repeat CT screenings, the test result was positive in 30 (2.5%). In 2 of these 30 cases, the individual died (of an unrelated cause) before diagnostic workup and the nodule(s) resolved in another 12 individuals. In the remaining 16 individuals, the absence of further growth was documented by repeat CT in 8 individuals and further growth was documented in the remaining 8 individuals. All eight individuals with further nodular growth underwent biopsy and malignancy was diagnosed in seven. Six of these seven malignancies were nonsmall cell carcinomas (five of which were Stage IA and one of which was Stage IIIA) and the one small cell carcinoma was found to be of limited stage. The median size dimension of these malignancies was 8 mm. In another two subjects, symptoms prompted the interim diagnosis of lung carcinoma. Neither of these malignancies was nodule-associated but rather were endobronchial; one was a Stage IIB nonsmall cell carcinoma and the other was a small cell carcinoma of limited stage. CONCLUSIONS: False-positive screening test results are uncommon and usually manageable without biopsy; compared with no screening, such screenings permit diagnosis at substantially earlier and thus more curable stages. Annual repetition of CT screening is sufficient to minimize symptom-prompted interim diagnoses of nodule-associated malignancies.

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PubMed2001

Screening for lung cancer.

Explore the source record for details and available documents.

Humans↗

PubMed2001

Early lung cancer action project: annual screening using single-slice helical CT.

The advent of helical CT imaging held promise for the early diagnosis, and thereby, for enhanced curability of lung cancer--a highly fatal disease. In 1993, the Early Lung Cancer Action Project (ELCAP) was initiated and experimentally screened a cohort of 1,000 high-risk persons. Here we summarize the results of the baseline and annual repeat CT screening of these 1,000 subjects. CT-based screening (compared to traditional radiology) was clearly shown to enhance the detection of lung cancer at earlier and more curable stages. A discussion follows of the meaning of the results and possible future screening protocols.

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PubMed2001

CT screening for lung cancer: coping with nihilistic recommendations.

The practicing radiologist today is well persuaded that earlier diagnosis of lung cancer can be achieved with traditional-type radiography and especially with modern computed tomography. The practitioner also is confident that intervention in the context of earlier diagnosis is more effective in preventing death due to this otherwise fatal disease. The practitioner is thus inclined to consider such screening in a high-risk person with suitably long life expectancy, especially when asked to provide it. On the other hand, the practitioner is aware of official recommendations against lung cancer screening, said to be based on demonstrated lack of effectiveness of traditional radiographic screening. Some researchers have expressed concerns about screening-associated "overdiagnosis." Given this dilemma, the critically thinking practitioner is concerned to understand the foundation of the official nihilism in evidence and reasoning, as she or he suspects that something may be seriously wrong in this. This article is an attempt to help such a practitioner in this effort--an effort that in the end is rewarded by the comforting realization that the nihilistic recommendations and hesitation-provoking cautions are founded on pseudoevidence and specious reasoning.

Humans↗

PubMed2001

Early lung cancer action project: a summary of the findings on baseline screening.

PURPOSE: The Early Lung Cancer Action Project (ELCAP) is designed to evaluate baseline and annual repeat screening by low radiation dose computed tomography (low-dose CT) in persons at high-risk for lung cancer. METHODS: Since starting in 1993, the ELCAP has enrolled 1,000 asymptomatic persons, 60 years of age or older, with at least 10 pack-years (1 pack per day for 10 years, or 2 packs per day for 5 years) of cigarette smoking, no prior cancer, and medically fit to undergo thoracic surgery. After a structured interview and informed consent, baseline chest radiographs and low-dose CT were obtained on each subject. The diagnostic work-up of screen-detected noncalcified pulmonary nodules (NCN) was guided by ELCAP recommendations which included short-term high-resolution CT follow-up for the smallest nodules. Baseline RESULTS: On low-dose CT at baseline compared to chest radiography, NCN were detected three times as commonly (23% versus 7%), malignancies four times as commonly (2.7% versus 0.7%), and stage I malignancies six times as commonly (2.3% versus 0.4%). Of the 27 CT-detected cancers, 96% (26/27) were resectable; 85% (23/27) were stage I, and 83% (19 of the 23 stage I) were not seen on chest radiography. Following the ELCAP recommendations, biopsies were performed on 28 of the 233 subjects with NCN; 27 had a malignant and one a benign NCN. Another three individuals underwent biopsy outside of the ELCAP recommendations; all had benign NCNS: No one had thoracotomy for a benign nodule. CONCLUSION: Baseline CT screening for lung cancer provides for detecting the disease at earlier and presumably more commonly curable stages in a cost-effective manner.

Clinical Trials as Topic↗

PubMed2000

Screening for lung cancer: do we need randomized trials?

In a scientifically ideal randomized controlled trial (RCT) on the efficacy of screening for lung cancer, screening-detected cases would be allocated to immediate intervention or to no action until symptoms lead to diagnostics. The study would provide for learning about the extent to which earlier interventions (defined by disease stage and stage-conditional tumor size) enhance curability, and also about the distributions of disease stage and stage-conditional tumor size at the time of diagnosis under the particular regimen of screening and its associated diagnostics. Because ethics call for randomization to screening or no screening, this contrast no longer provides for studying the curability function of shared concern for all regimens of screening; it addresses only the overall curability advantage specific to the regimen deployed. The same information that is provided by the scientifically ideal RCT is obtainable from a noncomparative study in which each member of the study cohort is subject to both screening and early intervention, so long as the problem of "overdiagnosis" is avoided by documenting growth before biopsy for cytologic or histologic criteria of malignancy and so long as the outcome of intervention is documented by follow-up. The ethically feasible RCT, in addition to compromising the objects of study, involves validity problems of its own and is less efficient by an order of magnitude.

Humans↗

PubMed2000

Screening for lung cancer: can it be cost-effective?

Last year, the Lancet reported on a study concerning a particular, avant-garde regimen of CT-based screening for lung cancer, showing its great superiority relative to the corresponding regimen based on traditional radiography (Lancet 1999;354:99-105). That report was met with great interest in the media, worldwide. It thereby also led to substantial public demand for the state-of-the-art screening, in the United States especially. I here argue that, despite the prevailing official recommendations against any and all screening for lung cancer in the United States and Canada, it actually already is knowable that modern screening, with suitable specifications of both the screening itself and its recipient, not only is effective but can be effective enough to amply justify its cost. It thus is time for authorities to formulate, ever more inclusively, those cost-justifying specifications--and to promote research providing for further expansions of and innovations in them. American authorities, however, have not reacted this way to the new situation and, I dare say, they have been tenaciously irrational (and thereby irresponsible) in their underlying ideas about the nature of the proper knowledge-base for screening practice and of the research serving to advance this. It remains to be seen how timely, and how compellingly rational, the Canadian official reactions will be; and this too matters greatly, as countless lives hang in the balance, within Canada and, especially, in the world at large. Ex Canada lux?

Canada↗

PubMed2000

Screening for lung cancer.

Screening for lung cancer serves to prevent deaths from this disease insofar as earlier resections are associated with higher rates of cure. There is good reason to believe that this is the case: in stage I, the 5-year survival rate with resection is 70%, whereas without resection the corresponding rate is only 10%. Before this evidence emerged, various authoritative organizations and agencies in North America advised against screening for lung cancer on the grounds of the results of several RCTs. As for CXR, I argue that the study results are consistent with up to 40% reduction in the fatality rate. Moreover, modern helical CT screening provides for detecting much smaller tumors than were detected in those studies. It is time to revoke the conclusion that screening for lung cancer does not serve to prevent deaths from this disease, and to quantify the usefulness of CT screening in particular. As for the requisite research, the prevailing orthodoxy has it that RCTs are to be used, but I argue that more meaningful results are obtainable, more rapidly and much less expensively, by the use of noncomparative (and hence unrandomized) studies.

Humans↗

PubMed1999

Early Lung Cancer Action Project: overall design and findings from baseline screening.

BACKGROUND: The Early Lung Cancer Action Project (ELCAP) is designed to evaluate baseline and annual repeat screening by low-radiation-dose computed tomography (low-dose CT) in people at high risk of lung cancer. We report the baseline experience. METHODS: ELCAP has enrolled 1000 symptom-free volunteers, aged 60 years or older, with at least 10 pack-years of cigarette smoking and no previous cancer, who were medically fit to undergo thoracic surgery. After a structured interview and informed consent, chest radiographs and low-dose CT were done for each participant. The diagnostic investigation of screen-detected non-calcified pulmonary nodules was guided by ELCAP recommendations, which included short-term high-resolution CT follow-up for the smallest non-calcified nodules. FINDINGS: Non-calcified nodules were detected in 233 (23% [95% CI 21-26]) participants by low-dose CT at baseline, compared with 68 (7% [5-9]) by chest radiography. Malignant disease was detected in 27 (2.7% [1.8-3.8]) by CT and seven (0.7% [0.3-1.3]) by chest radiography, and stage I malignant disease in 23 (2.3% [1.5-3.3]) and four (0.4% [0.1-0.9]), respectively. Of the 27 CT-detected cancers, 26 were resectable. Biopsies were done on 28 of the 233 participants with non-calcified nodules; 27 had malignant non-calcified nodules and one had a benign nodule. Another three individuals underwent biopsy against the ELCAP recommendations; all had benign non-calcified nodules. No participant had thoracotomy for a benign nodule. INTERPRETATION: Low-dose CT can greatly improve the likelihood of detection of small non-calcified nodules, and thus of lung cancer at an earlier and potentially more curable stage. Although false-positive CT results are common, they can be managed with little use of invasive diagnostic procedures.

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PubMed1999

Ideas and ideals in medicine: fruits of reason or props of power?

Editors of medical journals play a central role in the promotion -- or suppression -- of ideas and ideals in medicine. Recently eminent among these have been the advocacies of the Evidence-based Medicine (EBM) movement and others concerned with evidence and guidelines for health care. With regard to these topics, it still remains for editors of journals either to advance or to retard even the consolidation of the associated core concepts, most notably those of evidence in medicine, scientific medicine, and rational medicine. I present, first, a case study on the conduct of the editors of three medical journals, specifically their assumption of the role of authority on the scholarly fundamentals of evidence in medicine and their responding to propositions on the topic with commentaries well below the intellectual standards that should prevail in the journals of a learned profession. Then, following a brief review of the Flexnerian and EBM ideas and ideals on the practice of medicine, supplemented by observations drawn from medical sociology and the precepts of the philosophy of science, I posit a way of understanding such behaviour by editors of medical journals. They can have a temptation, and apparently some propensity, to play a regressive role in the development of the fundamentals of medicine. This is prone to occur whenever reason constitutes a threat to power, whether solely to the editors' own or to that of the profession at large. A full realization of the dream of reason in medicine requires an immense integrity of its journal editors and of its other intellectual leaders.

Evidence-Based Medicine↗