| アブストラクト | The present study aimed to assess the utilization of biomarker testing, including companion diagnostics and comprehensive genomic profiling (CGP), in Japan and to highlight the value of large-scale real-world database analysis in precision oncology. Claims data from the Medical Data Vision Co., Ltd. database, covering ~40 million patients across 26% of advanced treatment hospitals in Japan, were retrospectively analyzed. Biomarker tests for five genomic biomarkers (BRAF, BRCA1/2, KRAS/NRAS, homologous recombination deficiency and microsatellite instability (MSI)) were evaluated in patients with a confirmed diagnosis of one of 11 common cancer types, a cancer of unknown primary origin (CUP) or a rare cancer, who underwent at least one biomarker test between December 2018 and March 2022. A total of 41,191 biomarker tests were recorded in 28,382 patients, with test volumes increasing markedly between 2018 and 2021. MSI testing was the most common (70.1% of patients), followed by RASKET-B for KRAS/NRAS (25.5%) and BRAF (23.9%). Patients with colorectal cancer frequently underwent multiple tests (42.8%) and distinct testing sequences were observed in gynecological cancer. CGP was more commonly performed on tissue-based samples than through liquid biopsy, particularly in rare cancer (38.5%) and CUP (11.4%). Notably, ~40% of patients received a new treatment after CGP, whereas only 1.7% initiated indicated therapy after MSI testing. The mean time to subsequent treatment initiation from the index date was 70.4 days. In conclusion, the present nationwide real-world study provides an early comprehensive overview of the prevalence and trends of biomarker testing in Japan, and reveals a gap between testing and treatment implementation. Although testing is increasing, its effective clinical use remains limited. Large-scale database analyses may help identify barriers and support strategies to improve the integration of biomarker testing into treatment decision-making, ultimately advancing precision oncology. |
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| ジャーナル名 | Molecular and clinical oncology |
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| Pubmed追加日 | 2026/11/3 |
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| 投稿者 | Yatabe, Yasushi; Oda, Katsutoshi; Taniguchi, Hiroya; Sunami, Kuniko; Miller, Russell; Yasuoka, Shotaro; Watanabe, Ryosuke |
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| 組織名 | Department of Diagnostic Pathology, National Cancer Center Hospital, Tokyo;104-0045, Japan.;Department of Obstetrics and Gynecology, The University of Tokyo, Tokyo 113-0033,;Japan.;Department of Clinical Oncology, Aichi Cancer Center Hospital, Nagoya, Aichi;464-8681, Japan.;Department of Laboratory Medicine, National Cancer Center Hospital, Tokyo;Syneos Health Japan K.K., Tokyo 100-7012, Japan.;Medical Affairs, MSD K.K., Tokyo 102-8667, Japan.;BeOne Medicines G.K., Minato, Tokyo 105-7114, Japan. |
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| Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/42973950/ |
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