Chronological improvement in precision oncology implementation in Japan

Abstract

In Japan, comprehensive genomic profiling (CGP) tests for refractory cancer patients have been approved since June 2019, under the requirement that all cases undergoing CGP tests are annotated by the molecular tumor board (MTB) at each governmentdesignated hospital. To investigate improvement in precision oncology, we evaluated and compared the proportion of cases receiving matched treatments according to CGP results and those recommended to receive genetic counseling at all core hospitals between the first period (11 hospitals, June 2019 to January 2020) and second

Human resources for administrative work to carry out a comprehensive genomic profiling test in Japan

“…Many institutions that carry out CGP testing have MTBs available, 13 and most have reported on MTBs done at single institutions 15–20 . The MTBs encompassing multiple institutions are reported less frequently, 21 and reports on multiple MTBs are rare 22–24 . We have for the first time, to our knowledge, quantified the time spent on each administrative step necessary to undergo CGP testing in Japan, excluding the clinical steps.…”

“…Decreasing the burden of hospitals and health‐care professionals is necessary to improve survival and maintain quality of life of advanced cancer patients. In Japan, 7.7% of the patients have been reported to undergo genomically matched treatment 24 . This will likely improve if CGP tests can be given before standard treatment is expected to finish, because: (1) more patients will be physically strong enough to receive subsequent treatment, and (2) many clinical trials limit the number of previous treatments given as an inclusion/exclusion criterion.…”

Molecular pathology quality control in Southeast Asia: Results of a multiregional quality assurance study from MASTER KEY Asia

“…Similarly, a nationwide re-examination of sample preparation methods was conducted after the start of national health insurance coverage for cancer genomic testing in Japan. 6,13,14 Specific guidelines were issued by The Japanese Society of Pathology to raise the quality level of FFPE handling throughout the country. However, the assessment of tissue FFPE specimens has not been thoroughly examined for laboratories from Asian hospitals.…”

“…These factors are known to directly affect the quality of the FFPE specimens, thus affecting the DNA and RNA (Table S2). Similarly, a nationwide re‐examination of sample preparation methods was conducted after the start of national health insurance coverage for cancer genomic testing in Japan 6,13,14 . Specific guidelines were issued by The Japanese Society of Pathology to raise the quality level of FFPE handling throughout the country.…”

Current Clinical Practice of Precision Medicine Using Comprehensive Genomic Profiling Tests in Biliary Tract Cancer in Japan

“…Confirmatory germline testing is not reimbursed by public insurance and patients have to pay for the test fee out of pocket. In fact, among 2891 Japanese patients with advanced cancer who underwent FoundationOne ® CDx, PGPVs were found in 239 patients (10%); however, less than 30% of patients with PGPVs proceeded to confirmatory germline testing, and pathogenic germline variants were confirmed in only 35 patients (1%) [ 82 ]. This figure is much lower compared to the published studies reporting an approximate 10% prevalence of pathogenic germline variants in CGP tests [ 79 , 80 , 81 ] and more patients with true pathogenic germline variants are likely to be missed in CGP tests in Japan.…”