Ebi Hiromichi, Bando Hideaki
Division of Molecular Therapeutics, Aichi Cancer Center Research Institute, Nagoya, Japan.
Precision Medicine Center, Aichi Cancer Center, Nagoya, Japan.
JCO Precis Oncol. 2019 Dec 11;3. doi: 10.1200/PO.19.00291. eCollection 2019.
Although precision oncology is transforming clinical management of patients with cancer, many hospitals face challenges to effectively implement precision oncology. In addition, the cost and time exerted for genomic profiling needs to be balanced with expectations of benefit for each patient. This article summarizes the effort to implement precision oncology in Japan. The most promising development is that tests to profile the genomes of select cancers are now fully covered by the national health insurance system. In May 2019, two gene panels were approved with reimbursement: FoundationOne CDx Cancer Genomic Profile and OncoGuide NCC Oncopanel System, the latter of which was developed in Japan. To make better use of scarce resources, the reimbursement is restricted to patients with solid tumors that have progressed on standard chemotherapy, rare tumors, or tumors of unknown primary. To centralize Japanese precision oncology, the government designated approximately 170 hospitals and stratified them to three layers on the basis of their roles. In addition, Japan's National Cancer Center launched a Center for Cancer Genomics and Advanced Therapeutics (C-CAT) that collects genomic information and clinical characteristics of patients who received genomic profiling tests. C-CAT is expected to be the central data repository, to match patients with clinical trials, and to assist translational research. The centralized system under the national health insurance system could be a double-edged sword. Although tight regulation may make it hard to keep up with the rapid development of precision oncology, a federated ecosystem for sharing clinical and genomic data will be a precious asset and allow for shared access to data. Access to unapproved drugs and administrative support from C-CAT will be keys for Japanese precision oncology to meet its full potential.
尽管精准肿瘤学正在改变癌症患者的临床管理，但许多医院在有效实施精准肿瘤学方面面临挑战。此外，基因组分析所花费的成本和时间需要与对每位患者的获益期望相平衡。本文总结了日本实施精准肿瘤学的努力。最有前景的进展是，特定癌症基因组分析检测现已被纳入国家医疗保险体系全额报销范围。2019年5月，两个基因检测组合获得了报销批准：FoundationOne CDx癌症基因组分析和OncoGuide NCC肿瘤检测系统，后者是在日本研发的。为了更好地利用稀缺资源，报销仅限于那些在标准化疗后病情进展的实体瘤患者、罕见肿瘤患者或原发灶不明的肿瘤患者。为了集中管理日本的精准肿瘤学，政府指定了约170家医院，并根据其作用将它们分为三层。此外，日本国立癌症中心成立了癌症基因组学与先进治疗中心（C-CAT），该中心收集接受基因组分析检测患者的基因组信息和临床特征。预计C-CAT将成为核心数据存储库，为患者匹配临床试验，并协助转化研究。国家医疗保险体系下的集中系统可能是一把双刃剑。尽管严格的监管可能使其难以跟上精准肿瘤学的快速发展，但一个用于共享临床和基因组数据的联合生态系统将是一项宝贵资产，并允许共享数据访问。获得未获批药物以及C-CAT的行政支持将是日本精准肿瘤学充分发挥潜力的关键。
