Authors' objectives: To determine the diagnostic accuracy of EarlyCDT-Lung in increasing early-stage lung cancer detection; to determine the effectiveness and safety of EarlyCDT-Lung for lung cancer screening in the high-risk group, with regards to patient outcomes such as mortality, quality of life (QoL), and adverse events or complications; and to determine the economic, organisational, social, ethical and legal implication of using EarlyCDT-Lung in screening setting.

Authors' results and conclusions: The availability of evidence on the diagnostic value differs between autoantibodies for identifying patients at all stages or early-stage of lung cancer. There was fair to good level of retrievable evidence to suggest that EarlyCDT-Lung has low to moderate sensitivity but good specificity as serum diagnostic biomarkers of lung cancer in population screening among high-risk group. A positive EarlyCDT-Lung test followed by LDCT significantly reduced the numbers of late-stage lung cancers and indirectly more early-stage lung were diagnosed as compared with standard clinical care. However, there were no significant differences in lung cancer mortality and all-cause mortality. Given the existing evidence, economic evaluation conducted in countries that implemented LDCT as a screening tool with an addition of EarlyCDT-Lung was found to be cost effective. Future research focusing on novel TAAb panels that offer better diagnostic performance is encouraged. For the implementation of screening program using Early-CDT-Lung, the strategy needed to be in line with the LDCT and biopsy after the test screening. The population screened needed to be monitored closely and the treatment options needed to be considered after the patients tested and confirmation of cancer diagnosis.

Authors' recommendations: Based on the above review, EarlyCDT-Lung has the potential to be used to complement LDCT in population screening for early lung cancer detection among high-risk group in Malaysia. However, its use should take into consideration the availability and acceptability of LDCT as a screening tool. Competitive price of EarlyCDT-Lung may improve the cost-effectiveness of this screening strategy.

Authors' methods: Literature search was developed by the main author and Information Specialist who searched for published articles pertaining to EarlyCDT-Lung test for early lung cancer detection. The following electronic databases were searched through the Ovid interface: Ovid MEDLINE® and Epub Ahead of Print, In-Process & Other Non-Indexed Citations, Daily and Versions® 1946 to January 2022, EBM Reviews - Health Technology Assessment (4th Quarter 2016), EBM Reviews - Cochrane Database of Systematic Review (2005 to January 2022), EBM Reviews - Cochrane Central Register of Controlled Trials (January 2022), and EBM Reviews - NHS Economic Evaluation Database (4th Quarter 2016). Parallel searches were run in PubMed, US FDA and INAHTA database. Search was limited to articles in English and in human. The last search was performed on 10th February 2022. Additional articles were identified from reviewing the references of retrieved articles. An economic evaluation was conducted to assess cost-effectiveness and to calculate ICER of EarlyCDT-Lung compared to no screening among high-risk lung cancer patients in Malaysia using decision analytic modelling. Sensitivity and specificity of EarlyCDT-Lung were obtained from the literature. One-year probability of lung cancer among high-risk group and probability of late-stage diagnosis was calculated based on Malaysia Cancer Registry.

Authors' identified further research: -

Project Status: Completed

Year Published: 2022

URL for published report: https://www.moh.gov.my/moh/resources/Penerbitan/MAHTAS/HTA/EARLY_CANCER_DETECTION_TEST_FOR_LUNG_(Early_CDT-Lung)_Full_Report.pdf

Requestor: Ministry of Health, decision-making committee

English language abstract: An English language summary is available

Publication Type: Full HTA

Country: Malaysia

Organisation Name: Malaysian Health Technology Assessment

Contact Address: Malaysian Health Technology Assessment Section, Ministry of Health Malaysia, Federal Government Administrative Centre, Level 4, Block E1, Parcel E, 62590 Putrajaya Malaysia Tel: +603 8883 1229

Contact Name: htamalaysia@moh.gov.my

Contact Email: htamalaysia@moh.gov.my

Copyright: Malaysian Health Technology Assessment Section (MaHTAS)