Assistive AI in Lung Cancer Screening: A Retrospective Multinational Study in the United States and Japan

Lung cancer is the leading cause of cancer death world-wide with 1.8 million deaths in 20201. Studies have concluded that low-dose computed tomography lung cancer screening can reduce mortality by up to 61%2 and updated 2021 US guidelines expanded eligibility. As screening efforts rise, AI can play an important role, but must be unobtrusively integrated into existing clinical workflows. In this work, we introduce a state-of-the-art, cloud-based AI system providing lung cancer risk assessments without requiring any user input. We demonstrate its efficacy in assisting lung cancer screening under both US and Japanese screening settings using different patient populations and screening protocols. Technical improvements over a previously described system include a focus on earlier cancer detection for improved accuracy, introduction of an effective assistive user interface, and a system designed to integrate into typical clinical workflows. The stand-alone AI system was evaluated on 3085 individuals achieving area under the curve (AUC) scores of 91.7% (95%CI [89.6, 95.2]), 93.3% (95%CI [90.2, 95.7]), and 89.1% (95%CI [77.7, 97.3]) on three datasets (two from US and one from Japan), respectively. To evaluate the system’s assistive ability, we conducted two retrospective multi-reader multi-case studies on 627 cases read by experienced board certified radiologists (average 20 years of experience [7,40]) using local PACS systems in the respective US and Japanese screening settings. The studies measured the reader’s level of suspicion (LoS) and categorical responses for scores and management recommendations under country-specific screening protocols. The radiologists’ AUC for LoS increased with AI assistance by 2.3% (95%CI [0.1-4.5], p=0.022) for the US study and by 2.3% (95%CI [-3.5-8.1], p=0.179) for the Japan study. Specificity for recalls increased by 5.5% (95%CI [2.7-8.5], p<0.0001) for the US and 6.7% (95%CI [4.7-8.7], p<0.0001) for the Japan study. No significant reduction in other metrics occured. This work advances the state-of-the-art in lung cancer detection, introduces generalizable interface concepts that can be applicable to similar AI applications, and demonstrates its potential impact on diagnostic AI in global lung cancer screening with results suggesting a substantial drop in unnecessary follow-up procedures without impacting sensitivity.