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Risk-Based Lung Cancer Screening Performance in a Universal Healthcare Setting
abstract
This abstract is available on the publisher's site.
Access this abstract nowGlobally, lung cancer is the leading cause of cancer death. Previous trials demonstrated that low-dose computed tomography lung cancer screening of high-risk individuals can reduce lung cancer mortality by 20% or more. Lung cancer screening has been approved by major guidelines in the United States, and over 4,000 sites offer screening. Adoption of lung screening outside the United States has, until recently, been slow. Between June 2017 and May 2019, the Ontario Lung Cancer Screening Pilot successfully recruited 7,768 individuals at high risk identified by using the PLCOm2012noRace lung cancer risk prediction model. In total, 4,451 participants were successfully screened, retained and provided with high-quality follow-up, including appropriate treatment. In the Ontario Lung Cancer Screening Pilot, the lung cancer detection rate and the proportion of early-stage cancers were 2.4% and 79.2%, respectively; serious harms were infrequent; and sensitivity to detect lung cancers was 95.3% or more. With abnormal scans defined as ones leading to diagnostic investigation, specificity was 95.5% (positive predictive value, 35.1%), and adherence to annual recall and early surveillance scans and clinical investigations were high (>85%). The Ontario Lung Cancer Screening Pilot provides insights into how a risk-based organized lung screening program can be implemented in a large, diverse, populous geographic area within a universal healthcare system.
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Risk-based lung cancer screening performance in a universal healthcare setting
Nat. Med. 2024 Apr 01;30(4)1054-1064, MC Tammemägi, GE Darling, H Schmidt, MJ Walker, D Langer, YW Leung, K Nguyen, B Miller, D Llovet, WK Evans, DN Buchanan, G Espino-Hernandez, U Aslam, A Sheppard, A Lofters, M McInnis, J Dobranowski, S Habbous, C Finley, M Luettschwager, E Cameron, C Bravo, A Banaszewska, K Creighton-Taylor, B Fernandes, J Gao, A Lee, V Lee, B Pylypenko, M Yu, E Svara, S Kaushal, L MacNiven, C McGarry, L Della Mora, L Koen, J Moffatt, M Rey, M Yurcan, L Bourne, G Bromfield, M Coulson, R Truscott, L RabeneckFrom MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine.
Today, lung cancer screening (LCS) is predominately utilized in areas where large randomized clinical trials on screening have been performed, including the US (ie, the National Lung Screening Trial [NLST]) and Europe (ie, the NELSON trial).1,2 In this article, Tammemägi and colleagues report the experience of the Ontario Lung Cancer Screening Pilot in Canada. The Ontario Lung Cancer Screening Pilot is not a clinical trial; rather, the pilot’s prospective cohort is a "real-world" implementation study of LCS, and several aspects of its design and outcomes are noteworthy. First, despite two large trials showing effectiveness of LCS, it remains unclear whether screening programs outside clinical trials can achieve comparable metrics. For example, both the NLST and NELSON trials showed high sensitivity, had low rates of invasive procedures (and associated complications), achieved high rates of adherence to follow-up, and identified most lung cancers in early stages.1,2 Outside clinical trials, LCS implementation studies in the US have reported lower rates of adherence to follow-up3,4 and potentially higher rates of diagnostic procedures and associated complications.5–7 In the Ontario Lung Cancer Screening Pilot, outcomes were comparable to those of the well-known clinical trials, including favorable testing characteristics (sensitivity and specificity 95.3% and 95.5%, respectively), low rates of procedural complications, and high rates of both early-stage lung cancer diagnosis (79.2%) and adherence to follow-up (>85%).
Second, the Ontario Lung Cancer Screening Pilot’s approach incorporates an aspect of screening that was neither utilized in NLST nor in NELSON: patient selection used risk-based prediction models. Whereas the NLST and NELSON identified patients at high-risk of lung cancer via categorical criteria (ie, age, smoking history), the Ontario Lung Cancer Screening Pilot identified eligible patients based on their 6-year risk of developing lung cancer. This estimate was provided by the PLCOm2012noRace prediction model. In prior studies, PLCOm2012 has projected higher sensitivity, identification of more lung cancers, and higher cancer detection rates than the NLST and United States Preventive Services Task Force 2013 selection criteria.8,9 Risk-based models likely provide more accurate estimates of lung cancer risk by including individual patient factors (eg, COPD and personal history of cancer). Further, risk-based screening models may reduce disparities due to sex, race, and ethnicity that are now well-recognized in categorical LCS eligibility criteria.10–12 Notably, the specificity and cancer detection rate in the Ontario pilot are higher than those reported in the NLST (95.5% vs 73.4% and 2.4% vs 1.0% respectively), which may be due to use of risk-based patient selection, utilization of Lung-RADS criteria for screen-detected nodule management13, or a combination.
The pilot nature of the work limits our ability to extrapolate the findings of the Ontario Lung Cancer Screening Pilot. Specifically, the cohort is smaller than the pivotal LCS trial in the US (NLST), data spanned only 2 years (vs median 6.5 years in the NLST), and only three pilot sites participated (with two additional "spoke" sites). Thus, additional work is needed to clarify the longitudinal effects of LCS across an entire health system (or country). It is also uncertain whether the outcomes achieved by Ontario’s LCS pilot can be recreated by programs not practicing in a single-payor health system (eg, in the US).
In sum, the Ontario Lung Cancer Screening Pilot shows that LCS in the "real world" can achieve comparable outcomes to those in large clinical trials. The thorough program description provided by Tammemägi and colleagues provides a blueprint that new or developing LCS programs might utilize. Even more, the project confirms that modern screening techniques (eg, risk-based patient selection) can achieve comparable (or improved) outcomes to patient selection techniques used by the NLST and NELSON trials.
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