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Cost-effectiveness of an autoantibody test (EarlyCDT-Lung) as an aid to early diagnosis of lung cancer in patients with incidentally detected pulmonary nodules.

ABSTRACT: Patients who have incidentally detected pulmonary nodules and an estimated intermediate risk (5-60%) of lung cancer frequently are followed via computed tomography (CT) surveillance to detect nodule growth, despite guidelines for a more aggressive diagnostic strategy. We examined the cost-effectiveness of an autoantibody test (AABT)-Early Cancer Detection Test-Lung (EarlyCDT-LungTM)-as an aid to early diagnosis of lung cancer among such patients.We developed a decision-analytic model to evaluate use of the AABT versus CT surveillance alone. In the model, patients with a positive AABT-because they are at substantially enhanced risk of lung cancer-are assumed to go directly to biopsy, resulting in diagnosis of lung cancer in earlier stages than under current guidelines (a beneficial stage shift). Patients with a negative AABT, and those scheduled for CT surveillance alone, are assumed to have periodic CT screenings to detect rapid growth and thus to have their lung cancers diagnosed-on average-at more advanced stages.Among 1,000 patients who have incidentally detected nodules 8-30 mm, have an intermediate-risk of lung cancer, and are evaluated by CT surveillance alone, 95 (9.5%) are assumed to have lung cancer (local, 73.6%; regional, 22.0%; distant, 4.4%). With use of the AABT set at a sensitivity/specificity of 41%/93% (stage shift = 10.8%), although expected costs would be higher by $949,442 ($949 per person), life years would be higher by 53 (0.05 per person), resulting in a cost per life-year gained of $18,029 and a cost per quality-adjusted life year (QALY) gained of $24,330. With use of the AABT set at a sensitivity/specificity of 28%/98% (stage shift = 7.4%), corresponding cost-effectiveness ratios would be $18,454 and $24,833.Under our base-case assumptions, and reasonable variations thereof, using AABT as an aid in the early diagnosis of lung cancer in patients with incidentally detected pulmonary nodules who are estimated to be at intermediate risk of lung cancer and are scheduled for CT surveillance alone is likely to be a cost-effective use of healthcare resources.

SUBMITTER: Edelsberg J

PROVIDER: S-EPMC5963796 | biostudies-other | 2018

REPOSITORIES: biostudies-other

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Cost-effectiveness of an autoantibody test (EarlyCDT-Lung) as an aid to early diagnosis of lung cancer in patients with incidentally detected pulmonary nodules.

Edelsberg John J Weycker Derek D Atwood Mark M Hamilton-Fairley Geoffrey G Jett James R JR

PloS one 20180522 5

<h4>Objective</h4>Patients who have incidentally detected pulmonary nodules and an estimated intermediate risk (5-60%) of lung cancer frequently are followed via computed tomography (CT) surveillance to detect nodule growth, despite guidelines for a more aggressive diagnostic strategy. We examined the cost-effectiveness of an autoantibody test (AABT)-Early Cancer Detection Test-Lung (EarlyCDT-LungTM)-as an aid to early diagnosis of lung cancer among such patients.<h4>Methods</h4>We developed a d ...[more]

PMID: 29787590

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Project description:ImportanceWhether guideline-concordant lung nodule evaluations lead to better outcomes remains unknown.ObjectiveTo examine the association between the intensity of lung nodule diagnostic evaluations and outcomes, safety, and health expenditures.Design, setting, and participantsThis comparative effectiveness research study analyzed health plan enrollees at Kaiser Permanente Washington in Seattle, Washington, and Marshfield Clinic in Marshfield, Wisconsin, with an incidental lung nodule detected between January 1, 2005, and December 31, 2015. Included patients were 35 years or older, had no high suspicion of infection, had no history of malignant neoplasm, and had no evidence of advanced lung cancer on nodule detection. Data analysis was conducted from January 7 to August 19, 2020.ExposuresWith the 2005 Fleischner Society guidelines (selected for their applicability to the time frame under investigation) as the comparator, 2 other intensities of lung nodule evaluation were defined. Guideline-concordant evaluation followed the guidelines. Less intensive evaluation was the absence of recommended testing, longer-than-recommended surveillance intervals, or less invasive testing than recommended. More intensive evaluation consisted of testing when the guidelines recommended no further testing, shorter-than-recommended surveillance intervals, or more invasive testing than recommended.Main outcomes and measuresThe main outcome was the proportion of patients with lung cancer who had stage III or IV disease, radiation exposure, procedure-related adverse events, and health expenditures 2 years after nodule detection.ResultsAmong the 5057 individuals included in this comparative effectiveness research study, 1925 (38%) received guideline-concordant, 1863 (37%) less intensive, and 1269 (25%) more intensive diagnostic evaluations. The entire cohort comprised 2786 female patients (55%), and the mean (SD) age was 67 (13) years. Adjusted analyses showed that compared with guideline-concordant evaluations, less intensive evaluations were associated with fewer procedure-related adverse events (risk difference [RD], -5.9%; 95% CI, -7.2% to -4.6%), lower mean radiation exposure (-9.5 milliSieverts [mSv]; 95% CI, -10.3 mSv to -8.7 mSv), and lower mean health expenditures (-$10 916; 95% CI, -$16 112 to -$5719); no difference in stage III or IV disease was found among patients diagnosed with lung cancer (RD, 4.6%; 95% CI, -22% to +31%). More intensive evaluations were associated with more procedure-related adverse events (RD, +8.1%; 95% CI, +5.6% to +11%), higher mean radiation exposure (+6.8 mSv; 95% CI, +5.8 mSv to +7.8 mSv), and higher mean health expenditures ($20 132; 95% CI, +$14 398 to +$25 868); no difference in stage III or IV disease was observed (RD, -0.5%; 95% CI, -28% to +27%).Conclusions and relevanceThis study found inconclusive evidence of an association between less intensive diagnostic evaluations and more advanced stage at lung cancer diagnosis compared with guideline-concordant care; higher intensities of diagnostic evaluations were associated with greater procedural complications, radiation exposure, and expenditures. These findings underscore the need for more evidence on better ways to evaluate lung nodules and to avoid unnecessarily intensive diagnostic evaluations of lung nodules.

Project description:ObjectivesTo validate the performances of two prediction models (Brock and Lee models) for the differentiation of minimally invasive adenocarcinoma (MIA) and invasive pulmonary adenocarcinoma (IPA) from preinvasive lesions among subsolid nodules (SSNs).DesignA retrospective cohort study.SettingA tertiary university hospital in South Korea.Participants410 patients with 410 incidentally detected SSNs who underwent surgical resection for the pulmonary adenocarcinoma spectrum between 2011 and 2015.Primary and secondary outcome measuresUsing clinical and radiological variables, the predicted probability of MIA/IPA was calculated from pre-existing logistic models (Brock and Lee models). Areas under the receiver operating characteristic curve (AUCs) were calculated and compared between models. Performance metrics including sensitivity, specificity, accuracy, positive predictive value (PPV) and negative predictive value (NPV) were also obtained.ResultsFor pure ground-glass nodules (n=101), the AUC of the Brock model in differentiating MIA/IPA (59/101) from preinvasive lesions (42/101) was 0.671. Sensitivity, specificity, accuracy, PPV and NPV based on the optimal cut-off value were 64.4%, 64.3%, 64.4%, 71.7% and 56.3%, respectively. Sensitivity, specificity, accuracy, PPV and NPV according to the Lee criteria were 76.3%, 42.9%, 62.4%, 65.2% and 56.3%, respectively. AUC was not obtained for the Lee model as a single cut-off of nodule size (≥10 mm) was suggested by this model for the assessment of pure ground-glass nodules. For part-solid nodules (n=309; 26 preinvasive lesions and 283 MIA/IPAs), the AUC was 0.746 for the Brock model and 0.771 for the Lee model (p=0.574). Sensitivity, specificity, accuracy, PPV and NPV were 82.3%, 53.8%, 79.9%, 95.1% and 21.9%, respectively, for the Brock model and 77.0%, 69.2%, 76.4%, 96.5% and 21.7%, respectively, for the Lee model.ConclusionsThe performance of prediction models for the incidentally detected SSNs in differentiating MIA/IPA from preinvasive lesions might be suboptimal. Thus, an alternative risk calculation model is required for the incidentally detected SSNs.

Project description:BackgroundMajor issues in the implementation of screening for lung cancer by means of low-dose computed tomography (CT) are the definition of a positive result and the management of lung nodules detected on the scans. We conducted a population-based prospective study to determine factors predicting the probability that lung nodules detected on the first screening low-dose CT scans are malignant or will be found to be malignant on follow-up.MethodsWe analyzed data from two cohorts of participants undergoing low-dose CT screening. The development data set included participants in the Pan-Canadian Early Detection of Lung Cancer Study (PanCan). The validation data set included participants involved in chemoprevention trials at the British Columbia Cancer Agency (BCCA), sponsored by the U.S. National Cancer Institute. The final outcomes of all nodules of any size that were detected on baseline low-dose CT scans were tracked. Parsimonious and fuller multivariable logistic-regression models were prepared to estimate the probability of lung cancer.ResultsIn the PanCan data set, 1871 persons had 7008 nodules, of which 102 were malignant, and in the BCCA data set, 1090 persons had 5021 nodules, of which 42 were malignant. Among persons with nodules, the rates of cancer in the two data sets were 5.5% and 3.7%, respectively. Predictors of cancer in the model included older age, female sex, family history of lung cancer, emphysema, larger nodule size, location of the nodule in the upper lobe, part-solid nodule type, lower nodule count, and spiculation. Our final parsimonious and full models showed excellent discrimination and calibration, with areas under the receiver-operating-characteristic curve of more than 0.90, even for nodules that were 10 mm or smaller in the validation set.ConclusionsPredictive tools based on patient and nodule characteristics can be used to accurately estimate the probability that lung nodules detected on baseline screening low-dose CT scans are malignant. (Funded by the Terry Fox Research Institute and others; ClinicalTrials.gov number, NCT00751660.).

Dataset Information

Cost-effectiveness of an autoantibody test (EarlyCDT-Lung) as an aid to early diagnosis of lung cancer in patients with incidentally detected pulmonary nodules.

Publications

Cost-effectiveness of an autoantibody test (EarlyCDT-Lung) as an aid to early diagnosis of lung cancer in patients with incidentally detected pulmonary nodules.

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