The completion of the National Lung Screening Trial (NLST), a randomized controlled trial (RCT) of lung cancer screening (LCS), in 2010 provided powerful RCT evidence of the efficacy and safety of computed tomography–based screening; nevertheless, the study had important limitations. Failure to understand these limitations has had substantial adverse effects. Misinterpretation or misrepresentation of the results has led to underestimation of benefits and overestimation of adverse effects. When factored into predictive models, inaccurate estimates have yielded falsely low projections of potential lives saved with national implementation of LCS, exaggerated projected costs, and underestimated cost-effectiveness. When extrapolated estimates were presented to guideline groups and payer panels by screening critics, results included delay in implementation of screening, recommendations to screen only a limited high-risk subgroup, and advice to restrict LCS to otherwise undefined “centers of excellence” able to enter data into a national registry. Finally, despite the formal endorsement of LCS by a large number of prestigious guideline groups, inaccurate extrapolation of NLST data has served to convince payer panels to recommend against insurance coverage for LCS. This article reviews limitations of the NLST study design and compares its results with screening data from many other RCTs and clinical programs, with the intention of providing more accurate and comprehensive information on the benefits, risks, costs, and cost-effectiveness of LCS.
Since the initial public announcement by National Cancer Institute (NCI) director Harold Varmus on November 4, 2010, that the National Lung Screening Trial (NLST) was complete, results have been cited in literally hundreds of publications, guideline and payer deliberative sessions, and media outlets, typically simultaneously omitting reference to evidence from multiple other sources. National implementation of lung cancer (LC) screening (LCS) has been repeatedly delayed as critics of screening have cited low efficacy and substantial adverse effects. This delay ended in December 2013, when the US Preventive Services Task Force (USPSTF) announced a level-B recommendation for computed tomography (CT) LCS in smokers and ex-smokers 55 to 80 years old, with 30-pack-year exposure, and who had quit less than 15 years earlier.[3-5] By federal law, the USPSTF’s ruling meant that private insurers (in most cases) had to provide first-dollar LCS coverage for their clients at risk. On April 30, 2014, the Centers for Medicare and Medicaid Services (CMS) Medicare Evidence Development & Coverage Advisory Committee (MEDCAC), however, recommended against Medicare and Medicaid coverage of LCS.
Unless CMS rejects this advice—and federal law allows it to do so—on January 1, 2015, persons with private healthcare insurance will have coverage for LCS while those with Medicare and Medicaid will not. The implications of this disparity are enormous, since almost 70% of lung cancer deaths occur in people over the age of 65. Furthermore, cigarette smoking and lung cancer are disproportionately greater problems among underserved CMS populations, many of whom are living on fixed incomes, which is another barrier to screening.
It deserves emphasis that many of the critiques of NLST study design and personnel described herein are not retrospective. Concerns regarding rumored design features of NLST were publically discussed at meetings of the International Early Lung Cancer Action Program (I-ELCAP) investigators in 2000. NCI investigators were invited to attend this meeting to discuss and debate alternatives for the design of a large LCS trial, but they declined to do so. When the final NLST design was announced by NCI in 2003, prior concerns became actualized. Paradoxically, over the intervening years there has been relatively little public criticism. Many feared that it would be injudicious to openly criticize NLST. With the passage of time, as anticipated, concerns became real, yet reluctance to openly criticize NLST persisted. Why?
A major concern was that NLST was the only randomized controlled trial (RCT) with sufficient statistical power to demonstrate a reduction in lung cancer–specific mortality (LCSM)—by 20% in the NLST design. Multiple European RCTs with lower accrual numbers (NELSON, Danish, DANTE, etc) would likely each have insufficient power to demonstrate significant LCSM reduction. Thus, the specter arose that frank public discussion of NLST flaws might, should the study prove positive, allow policy and payer groups to view NLST as noncompelling evidence and insist on further delay in order to conduct more optimal studies. Such delay would represent a public health catastrophe since, inevitably, large numbers of unnecessary LC deaths could be anticipated in the interim.
The LCSM and all-cause mortality reductions demonstrated by NLST, in conjunction with results from many other studies, have now convinced many national organizations to issue formal clinical practice guideline recommendations for LCS of high-risk persons, related to current or past smoking, multiple other risk factors, or both.[14-16] Suboptimal NLST results, which will be discussed below, coupled with inaccurate underestimates of benefit and followed by inaccurate predictions of population benefit and harm from modeling studies based on NLST results, have allowed critics of screening to recommend repeatedly that guideline groups and payers delay implementation of LCS and/or restrict its application. Specifically, such recommendations have proposed limiting insurance to cover only those individuals meeting NLST entry criteria, thus excluding many millions of others at high risk. The National Comprehensive Cancer Network (NCCN) lung cancer screening guidelines, for example, includes group 2 (heavy smokers younger than 55 and older than 74, those exposed to asbestos and other carcinogens, those with prior tobacco-caused cancers, those who quit more than 15 years earlier, and many others at high risk). Current recommendations also include restriction of LCS to otherwise undefined “centers of excellence” and centers capable of entering data into computerized registries. Various features of the NLST are discussed below, along with evidence from other research projects that suggest far higher benefits, as well as substantially lower risks from CT screening.
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