BACKGROUND: Direct-to-consumer promotion of lung cancer screening has increased, especially low-dose computed tomography (CT). However, screening exposes healthy persons to potential harms, and cumulative false-positive rates for low-dose CT have never been formally reported. OBJECTIVE: To quantify the cumulative risk that a person who participated in a 1- or 2-year lung cancer screening examination would receive at least 1 false-positive result, as well as rates of unnecessary diagnostic procedures. DESIGN: Randomized, controlled trial of low-dose CT versus chest radiography. (ClinicalTrials.gov registration number: NCT00006382) SETTING: Feasibility study for the ongoing National Lung Screening Trial. PATIENTS: Current or former smokers, aged 55 to 74 years, with a smoking history of 30 pack-years or more and no history of lung cancer (n = 3190). INTERVENTION: Random assignment to low-dose CT or chest radiography with baseline and 1 repeated annual screening; 1-year follow-up after the final screening. Randomization was centralized and stratified by age, sex, and study center. MEASUREMENTS: False-positive screenings, defined as a positive screening with a completed negative work-up or 12 months or more of follow-up with no lung cancer diagnosis. RESULTS: By using a Kaplan-Meier analysis, a person's cumulative probability of 1 or more false-positive low-dose CT examinations was 21% (95% CI, 19% to 23%) after 1 screening and 33% (CI, 31% to 35%) after 2. The rates for chest radiography were 9% (CI, 8% to 11%) and 15% (CI, 13% to 16%), respectively. A total of 7% of participants with a false-positive low-dose CT examination and 4% with a false-positive chest radiography had a resulting invasive procedure. LIMITATIONS: Screening was limited to 2 rounds. Follow-up after the second screening was limited to 12 months. The false-negative rate is probably an underestimate. CONCLUSION: Risks for false-positive results on lung cancer screening tests are substantial after only 2 annual examinations, particularly for low-dose CT. Further study of resulting economic, psychosocial, and physical burdens of these methods is warranted. PRIMARY FUNDING SOURCE: National Cancer Institute.
RCT Entities:
BACKGROUND: Direct-to-consumer promotion of lung cancer screening has increased, especially low-dose computed tomography (CT). However, screening exposes healthy persons to potential harms, and cumulative false-positive rates for low-dose CT have never been formally reported. OBJECTIVE: To quantify the cumulative risk that a person who participated in a 1- or 2-year lung cancer screening examination would receive at least 1 false-positive result, as well as rates of unnecessary diagnostic procedures. DESIGN: Randomized, controlled trial of low-dose CT versus chest radiography. (ClinicalTrials.gov registration number: NCT00006382) SETTING: Feasibility study for the ongoing National Lung Screening Trial. PATIENTS: Current or former smokers, aged 55 to 74 years, with a smoking history of 30 pack-years or more and no history of lung cancer (n = 3190). INTERVENTION: Random assignment to low-dose CT or chest radiography with baseline and 1 repeated annual screening; 1-year follow-up after the final screening. Randomization was centralized and stratified by age, sex, and study center. MEASUREMENTS: False-positive screenings, defined as a positive screening with a completed negative work-up or 12 months or more of follow-up with no lung cancer diagnosis. RESULTS: By using a Kaplan-Meier analysis, a person's cumulative probability of 1 or more false-positive low-dose CT examinations was 21% (95% CI, 19% to 23%) after 1 screening and 33% (CI, 31% to 35%) after 2. The rates for chest radiography were 9% (CI, 8% to 11%) and 15% (CI, 13% to 16%), respectively. A total of 7% of participants with a false-positive low-dose CT examination and 4% with a false-positive chest radiography had a resulting invasive procedure. LIMITATIONS: Screening was limited to 2 rounds. Follow-up after the second screening was limited to 12 months. The false-negative rate is probably an underestimate. CONCLUSION: Risks for false-positive results on lung cancer screening tests are substantial after only 2 annual examinations, particularly for low-dose CT. Further study of resulting economic, psychosocial, and physical burdens of these methods is warranted. PRIMARY FUNDING SOURCE: National Cancer Institute.
Authors: H Subramanian; P Viswanathan; L Cherkezyan; R Iyengar; S Rozhok; M Verleye; J Derbas; J Czarnecki; H K Roy; V Backman Journal: Biomed Opt Express Date: 2016-08-31 Impact factor: 3.732
Authors: Ying Liu; Yoganand Balagurunathan; Thomas Atwater; Sanja Antic; Qian Li; Ronald C Walker; Gary T Smith; Pierre P Massion; Matthew B Schabath; Robert J Gillies Journal: Clin Cancer Res Date: 2016-09-23 Impact factor: 12.531
Authors: Andrew V Kossenkov; Rehman Qureshi; Noor B Dawany; Jayamanna Wickramasinghe; Qin Liu; R Sonali Majumdar; Celia Chang; Sandy Widura; Trisha Kumar; Wen-Hwai Horng; Eric Konnisto; Gerard Criner; Jun-Chieh J Tsay; Harvey Pass; Sai Yendamuri; Anil Vachani; Thomas Bauer; Brian Nam; William N Rom; Michael K Showe; Louise C Showe Journal: Cancer Res Date: 2018-11-28 Impact factor: 12.701