Abstract
BackgroundSince June 2019, cancer genomic profiling (CGP) tests have been reimbursed by the National Health Insurance system in Japan, with restrictions for government-designated hospitals with a molecular tumor board composed of multidisciplinary specialists, known as an expert panel (EP). The standardization of EPs is a critical challenge for implementing precision oncology in the clinical setting.MethodsData on consecutive cases who underwent the CGP tests at 11 core hospitals between June 2019 and January 2020 were collected. We evaluated the proportions of cases that received genomically matched treatments, including investigational new drugs (INDs) based on CGP results, and/or for which genetic counseling was recommended. Two simulated cases were annotated by each EP. The annotated reports were then centrally assessed.ResultsEach EP mainly discussed the applicability to genomically matched treatments and the necessity of performing genetic counseling. A pre-review of the report by key members in each EP reportedly made the EP conference more interactive and efficient, and thereby saved time. A total of 747 cases underwent CGP tests, 28 cases (3.7%) received genomically matched treatment, and 17 cases (2.3%) were referred for genetic counseling. Annotated reports for the simulated cases varied across the EPs, particularly the number of recommended IND trials, which seemed to be associated with the actual number of participants in IND trials.ConclusionsThis investigation provides reference data for the application of precision oncology in a clinical setting. Further investigations on the standardization of clinical annotations are warranted.
Highlights
Marked advances in precision oncology over the past two decades have made genotyping mandatory for most advanced cancer patients, as it helps to ensure properKuniko Sunami and Yoichi Naito have contributed to this work
Two simulated cases were developed by medical oncologists (KS, YN and TY) at the National Cancer Center Hospital (NCCH) and National Cancer Center Hospital East (NCCHE), which are the most experienced core hospitals and which have performed the largest number of cancer genomic profiling (CGP) tests far
Investigators from each expert panel (EP) demonstrated their daily work at the EP and we recognized that all of the EPs mainly discussed the applicability to genomically matched treatment, including investigational new drugs (INDs) trials, and the necessity of genetic counseling
Summary
Marked advances in precision oncology over the past two decades have made genotyping mandatory for most advanced cancer patients, as it helps to ensure properKuniko Sunami and Yoichi Naito have contributed to this work. The standardization of EPs is a critical challenge for implementing precision oncology in the clinical setting. We evaluated the proportions of cases that received genomically matched treatments, including investigational new drugs (INDs) based on CGP results, and/or for which genetic counseling was recommended. Results Each EP mainly discussed the applicability to genomically matched treatments and the necessity of performing genetic counseling. A total of 747 cases underwent CGP tests, 28 cases (3.7%) received genomically matched treatment, and 17 cases (2.3%) were referred for genetic counseling. Annotated reports for the simulated cases varied across the EPs, the number of recommended IND trials, which seemed to be associated with the actual number of participants in IND trials. Conclusions This investigation provides reference data for the application of precision oncology in a clinical setting. Further investigations on the standardization of clinical annotations are warranted
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