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Cancer Genomics and Diagnostics / Lung Cancer Treatments and Mutations / Lung Cancer Diagnosis and Treatment · Journal article
Cancer Science · August 7, 2026
Reinforces what was already believed, rather than introducing something new.
This retrospective cohort study of 24,047 Japanese patients with Stage IV NSCLC documents a significant shift from single-gene to multigene testing (≥5 genes rose sharply from late 2021; 6-7 gene testing increased markedly from mid-2023), and increased testing for rare drivers (MET, RET, KRAS, HER2). Despite improved diagnostic coverage, first-line targeted therapy remained plateaued at just under 30%, and approximately 30% of patients remained untested, indicating a persistent diagnostic-to-treatment implementation gap.
Retrospective cohort study. Patients with Stage IV NSCLC who underwent diagnostic lung biopsies across 300 hospitals in Japan.. Intervention: Comprehensive multigene testing for oncogenic drivers (EGFR, ALK, ROS1, PD-L1, MET, RET, KRAS, HER2) and first-line targeted therapy.. Compared with: Single-gene testing (baseline comparator for trend analysis); targeted therapy vs. non-targeted therapy regimens.. n = 24,047. Japan (nationwide, 300 hospitals).
Testing for ≥5 genes rose sharply from late 2021, with marked increase in 6-7 gene testing from mid-2023. Testing for rare drivers (MET, RET, KRAS, HER2) increased substantially over the 5-year period. Approximately 30% of patients remained untested regardless of region or age.
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Clinicians should recognize that multigene testing adoption in Japan is accelerating and increasingly captures rare driver mutations, yet approximately 30% of eligible patients remain untested and treatment initiation lags diagnostic capability. This suggests need for improved shared decision-making and implementation strategies to close the diagnostic-therapeutic gap.
A large retrospective cohort study documenting real-world trends in biomarker testing adoption and treatment patterns in advanced NSCLC, confirming expected shifts toward multigene testing while identifying a persistent care gap.
As stated by the source record.
Quoted from the source exactly as published.
Clinicians should recognize that multigene testing adoption in Japan is accelerating and increasingly captures rare driver mutations, yet approximately 30% of eligible patients remain untested and treatment initiation lags diagnostic capability. This suggests need for improved shared decision-making and implementation strategies to close the diagnostic-therapeutic gap.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
Although multigene testing for advanced non-small cell lung cancer (NSCLC) is reimbursed in Japan, optimizing its real-world clinical impact remains challenging. This study updates nationwide testing trends and evaluates the treatment gap between diagnostic results and first-line therapeutic interventions. We conducted a retrospective cohort study using the Diagnosis Procedure Combination database (April 2019 to May 2024). The analysis included 24,047 patients with Stage IV NSCLC across 300 hospitals who underwent diagnostic lung biopsies. Comprehensive multigene testing shifted significantly; testing for ≥ 5 genes rose sharply from late 2021, followed by a marked increase in 6-7 gene testing from mid-2023. Testing for rare drivers (MET, RET, KRAS, HER2) increased substantially. However, approximately 30% of patients remained untested regardless of region or age. While the proportion of patients receiving first-line targeted therapy plateaued at just under 30%, the use of targeted therapies for rare drivers showed a steady increase. In conclusion, multigene testing has rapidly replaced single-gene testing in Japan, narrowing the diagnostic gap for rare oncogenic drivers. Nevertheless, the persistent 30% untested rate emphasizes the need for better shared decision-making to ensure all patients receive comprehensive biomarker evaluation.
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