Abstract
ObjectivePatients 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.MethodsWe 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.ResultsAmong 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.ConclusionsUnder 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.
Highlights
The widespread use of chest computerized tomography (CT) to investigate intrathoracic diseases commonly results in the incidental detection of pulmonary nodules
With use of the autoantibody test (AABT) set at a sensitivity/specificity of 41%/93%, 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
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
Summary
The widespread use of chest computerized tomography (CT) to investigate intrathoracic diseases commonly results in the incidental detection of pulmonary nodules. Because the probability of malignancy is directly proportional to nodule diameter, the prevalence of lung cancer is high among incidentally detected solid pulmonary nodules in this size range. Recent guidelines for nodules >8 mm from the Fleischner Society are quite general, suggesting CT, positron emission tomography (PET) coupled with CT (PET-CT), or tissue sampling at 3 months, “depending on size, morphology, comorbidity, and other factors,” with additional diagnostic testing at 9 and 24 months for those patients with prior negative results [2]. Guidelines from the American College of Chest Physicians (ACCP) for nodules in this size range are more detailed [3]. For solid nodules >8 mm with a 5–60% predicted probability of malignancy (as determined intuitively or via a risk equation), PET or PET-CT is recommended, with immediate biopsy for patients with a positive scan (since this result greatly increases the probability that the nodule is malignant) and, for patients with negative scans, periodic CT follow-up over 24 months to detect rapid growth
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