Abstract
In Japan, the National Cancer Center and university hospitals have initiated next-generation sequencing-based in vitro diagnostic testing for cancer patients as a method of clinical sequencing. Based on the molecular alterations detected, physicians can provide approved targeted therapy and access to investigational drugs for cancer patients. However, interpretation of the clinical significance of genomic alterations remains the most severe bottleneck of precision medicine in cancer. Although many research institutes in the United States are developing knowledge bases for interpretation of the tumor alterations and clinical decisions, these knowledge bases are unsuited as sources of reference in Japan due to differences in the information on approved drugs and implementation of clinical trials. In this review, we introduce knowledge bases for clinical decision-making based on genomic events in cancer, and discuss the resources of additional information necessary for implementing precision medicine in Japan.
Highlights
Cancer is a disease caused by genetic mutation, with common mutations that occur across cancer types yet vary among individual patients
Cancer Driver Log (CanDL) is an expert-curated database for actionable driver mutations, which has recorded 373 variants in 60 genes. These mutations are categorized into four groups depending on the evidence level and published literature as follows: mutations corresponding to Food and Drug Administration (FDA) approved or The National Comprehensive Cancer Network recommended therapy; mutations with treatment based on evidence from clinical trials, case reports, or exceptional responders; mutations that can predict response or resistance based on evidence in preclinical data; and putative oncogenic driver mutations
Despite many challenges as discussed above, cancer genome therapy is utilized in Japan
Summary
Cancer is a disease caused by genetic mutation, with common mutations that occur across cancer types yet vary among individual patients. CanDL is an expert-curated database for actionable driver mutations, which has recorded 373 variants in 60 genes These mutations are categorized into four groups depending on the evidence level and published literature as follows: mutations corresponding to FDA approved or The National Comprehensive Cancer Network recommended therapy; mutations with treatment based on evidence from clinical trials, case reports, or exceptional responders; mutations that can predict response or resistance based on evidence in preclinical data (in vitro or in vivo); and putative oncogenic driver mutations. This knowledge base provides information on the function of common genomic alterations and their therapeutic implications for about 32 genes important in cancer The contents of this database include overviews on genes and their function, genetic alterations, frequencies and outcomes, therapeutic implications, FDA-approved drugs or investigational therapeutics in clinical trials targeting a pathway, and genotype-selected clinical trials and genotype-relevant clinical trials. Since the schedule for information update is undecided, other sources of information will be needed in the near future to obtain approval information on drugs, which is changing on a daily basis, as well as the latest clinical trial information
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