Feasibility study of cancer genome alterations identified by next generation sequencing: ABC study

Naito, Yoichi; Takahashi, Hideaki; Shitara, Kohei; Okamoto, Wataru; Bando, Hideaki; Kuwata, Takeshi; Kuboki, Yasutoshi; Matsumoto, Shingo; Izumi, Mitsuru; Yamanaka, T.; Watanabe, Atsushi; Kojima, Masaru

doi:10.1093/jjco/hyy052

Cited by 10 publications

(7 citation statements)

References 19 publications

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“…In previous reports of research-based genomic screening projects, 3–20% of patients received genomically matched treatment on the basis of their CGP test results [ 25 – 34 ]. Our study showed that 3.7% of patients received genomically matched treatment; this percentage seems to be lower in comparison to previous reports.…”

Section: Discussionmentioning

confidence: 99%

The initial assessment of expert panel performance in core hospitals for cancer genomic medicine in Japan

et al. 2021

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Background Since 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. Methods Data 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. Results Each 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. 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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Section: Discussionmentioning

confidence: 99%

The initial assessment of expert panel performance in core hospitals for cancer genomic medicine in Japan

et al. 2021

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“…It was examined by using it for analyses of 230 patients with advanced solid tumors, all of whom were also analyzed for the matching non‐tumor samples. In addition to this project, some marked research on clinical sequencing for CGM has also been conducted in Japan 8‐10 …”

Section: Implementation Of Cgm In Japanmentioning

confidence: 99%

Establishment and implementation of Cancer Genomic Medicine in Japan

Mukai

Ueno²

2021

Cancer Science

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Approximately 1 in 2 Japanese people are estimated to be diagnosed with cancer during their lifetime. Cancer still remains the leading cause of death in Japan, therefore the government of Japan has decided to develop a better cancer control policy and launched the Cancer Genomic Medicine (CGM) program. The Ministry of Health, Labour, and Welfare (MHLW) held a consortium at their headquarters with leading academic authorities and the representatives of related organizations to discuss ways to advance CGM in Japan. Based on the report of the consortium, the CGM system under the national health insurance system has gradually been realized. Eleven hospitals were designated in February 2018 as core hospitals for CGM; subsequently, the MHLW built the Center for Cancer Genomics and Advanced Therapeutics (C‐CAT) as an institution to aggregate and manage genomic and clinical information on cancer patients, and support appropriate secondary use of the aggregated information to develop research aimed at medical innovation. As the first step in Japan's CGM in routine practice, in June 2019 the MHLW started reimbursement of 2 types of tumor profiling tests for advanced solid cancer patients using the national insurance system. Japan's CGM has swiftly been spreading nationwide with the collaboration of 167 hospitals and patients. The health and research authorities are expected to embody personalized cancer medicine and promote CGM utilizing state‐of‐the‐art technologies.

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“…Cancer gene panel testing may provide information on drugs, therapies, and clinical studies/trials that are suitable for a patient. However, the likelihood that it will actually reveal an actionable mutation is 27-36% according to reports from other countries and 45-60% according to reports from Japan, although this depends on the type of panel used [3,[13][14][15][16][17]. Moreover, the likelihood that the results will lead to a corresponding treatment is 6-11% according to reports from other countries and 8-13% according reports from Japan.…”

Section: Benefits and Limitations Of Cancer Gene Panel Testingmentioning

confidence: 99%

Clinical practice guidance for next-generation sequencing in cancer diagnosis and treatment (edition 2.1)

et al. 2020

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Background To promote precision oncology in clinical practice, the Japanese Society of Medical Oncology, the Japanese Society of Clinical Oncology, and the Japanese Cancer Association, jointly published “Clinical practice guidance for next-generation sequencing in cancer diagnosis and treatment” in 2017. Since new information on cancer genomic medicine has emerged since the 1st edition of the guidance was released, including reimbursement for NGS-based multiplex gene panel tests in 2019, the guidance revision was made. Methods A working group was organized with 33 researchers from cancer genomic medicine designated core hospitals and other academic institutions. For an impartial evaluation of the draft version, eight committee members from each society conducted an external evaluation. Public comments were also made on the draft. The finalized Japanese version was published on the websites of the three societies in March 2020. Results The revised edition consists of two parts: an explanation of the cancer genomic profiling test (General Discussion) and clinical questions (CQs) that are of concern in clinical practice. Particularly, patient selection should be based on the expectation that the patient's post-test general condition and organ function will be able to tolerate drug therapy, and the optimal timing of test should be considered in consideration of subsequent treatment plans, not limited to treatment lines. Conclusion We expect that the revised version will be used by healthcare professionals and will also need to be continually reviewed in line with future developments in cancer genome medicine.

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Feasibility study of cancer genome alterations identified by next generation sequencing: ABC study

Abstract: We confirmed the feasibility of NGS-based amplicon sequencing using biopsy samples, making the basis for nationwide genome screening for cancer patients using biopsy samples.

Cited by 10 publications

References 19 publications

The initial assessment of expert panel performance in core hospitals for cancer genomic medicine in Japan

The initial assessment of expert panel performance in core hospitals for cancer genomic medicine in Japan

Establishment and implementation of Cancer Genomic Medicine in Japan

Clinical practice guidance for next-generation sequencing in cancer diagnosis and treatment (edition 2.1)

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