PSY1-1 The framework of cancer precision medicine in Japan

Abstract

The year 2019 was considered to be the first year of cancer precision medicine in Japan because three NGS gene-panel tests (Oncomine DxTT, FoundationOne CDx, and the NCC OncoPanel) were approved by the government and have been introduced in clinical practice. Ahead of this approval, the Japanese government organized a framework to promote precision medicine using CGP testing. Currently, 12 'core' institutes, 33 base hospitals, and 161 cooperative hospitals were designated as implementing cancer genomic medicine. Although the cost of Oncomine DxTT can be reimbursed in any patients with advanced lung cancer, the two CGP tests, F1CDx and the NCC OncoPanel can be implemented only within the hospitals under this framework, and the only core and base hospitals can order a CGP test. Another characteristic of this framework is the collection of all genome data with clinical information to the Center for Cancer Genomics and Advanced Therapeutics (C-CAT). This center functions as a hub for aggregating and managing nationwide efforts in precision cancer medicine, as well as utilizing these data to enhance the quality of treatment and develop new therapies in collaboration with research facilities and industrial partners. A primary aim of this program is to enable access to selected unapproved drugs based on the genome profile, so the target of this program is limited to the patients who completed or are expected to complete standard therapy, to whom treatments with unapproved drugs are allowed according to the advice of the institutional multidisciplinary expert panel. In addition to the current restriction of precision cancer medicine to the limited patients, a host-spot panel test (Oncomine DxTT) is not widely used, and multiple single-gene testing was still dominated in 2019. This situation might be associated with the consideration that EGFR mutations cannot be missed because of the high frequency in Japanese.