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. 2021 Sep;112(9):3911-3917.
doi: 10.1111/cas.15022. Epub 2021 Jul 12.

Appropriate use of cancer comprehensive genome profiling assay using circulating tumor DNA

Kuniko Sunami #  1 , Hideaki Bando #  2 , Yasushi Yatabe  3 , Yoichi Naito  4 , Hideaki Takahashi  5 , Katsuya Tsuchihara  6 , Shinichi Toyooka  7 , Koshi Mimori  8 , Shinji Kohsaka  9 , Hiroyuki Uetake  10 , Ichiro Kinoshita  11 , Keigo Komine  12 , Masayuki Takeda  13 , Tetsu Hayashida  14 , Kenji Tamura  15 , Kazuto Nishio  16 , Noboru Yamamoto  17 ; Working Group of a Joint Task Force of Three Academic Societies for the Promotion of Cancer Genomic Medicine
Affiliations

Appropriate use of cancer comprehensive genome profiling assay using circulating tumor DNA

Kuniko Sunami et al. Cancer Sci. 2021 Sep.

Abstract

Comprehensive genomic profiling (CGP) is being increasingly used for the routine clinical management of solid cancers. In July 2018, the use of tumor tissue-based CGP assays became available for all solid cancers under the universal health insurance system in Japan. Several restrictions presently exist, such as patient eligibility and limitations on the opportunities to perform such assays. The clinical implementation of CGP based on plasma circulating tumor DNA (ctDNA) is also expected to raise issues regarding the selection and use of tissue DNA and ctDNA CGP. A Joint Task Force for the Promotion of Cancer Genome Medicine comprised of three Japanese cancer-related societies has formulated a policy proposal for the appropriate use of plasma CGP (in Japanese), available at https://www.jca.gr.jp/researcher/topics/2021/files/20210120.pdf, http://www.jsco.or.jp/jpn/user_data/upload/File/20210120.pdf, and https://www.jsmo.or.jp/file/dl/newsj/2765.pdf. Based on these recommendations, the working group has summarized the respective advantages and cautions regarding the use of tissue DNA CGP and ctDNA CGP with reference to the advice of a multidisciplinary expert panel, the preferred use of plasma specimens over tissue, and multiple ctDNA testing. These recommendations have been prepared to maximize the benefits of performing CGP assays and might be applicable in other countries and regions.

Keywords: cancer comprehensive genome profiling assay; circulating tumor DNA; liquid biopsy; next-generation sequencer; plasma.

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Conflict of interest statement

Hideaki Bando has received lecture fees from Eli Lilly Japan and Taiho Pharmaceutical. Shinji Kohsaka has received research funds (≥1 million yen per year) from AstraZeneca, Boehringer Ingelheim, Eisai, and Chordia Therapeutics and has received a scholarship endowment from Daiichi‐Sankyo. Yasushi Yatabe has received a speaker’s honorarium from Chugai Pharma. Yoichi Naito has received lecture fees, honoraria, or other fees (≥500 000 yen per year) from Chugai, Pfizer, Eli Lilly, and Novartis and has received manuscript fees (≥500 000 yen per year) from Daiichi‐Sankyo, Taiho, Pfizer, and Boehringer Ingelheim. Kenji Tamura has received research funds (≥1 million yen per year) from Daiichi Sankyo, Pfizer, and Chugai. Hiroyuki Uetake has received lecture fees, honoraria, or other fees (≥500 000 yen per year) from Taiho, Chugai, and Sanofi. Kazuto Nishio has received lecture fees, honoraria, or other fees (≥500 000 yen per year) from Chugai and has received research funds from Ignyta. Noboru Yamamoto has received lecture fees, honoraria, or other fees (≥500 000 yen per year) from Pfizer, AstraZeneca, Eli Lilly, ONO, Chugai, Sysmex, Eisai, and Daiichi‐Sankyo and has received research funds from Astellas, Chugai, Eisai, Taiho, BMS, Pfizer, Novartis, Eli Lilly, AbbVie, Daiichi‐Sankyo, Bayer, Boehringer Ingelheim, Kyowa‐Hakko Kirin, Takeda, ONO, Janssen Pharma, MSD, MERCK, GSK, Sumitomo Dainippon, Chiome Bioscience, and Otsuka. All the remaining authors have no conflicts of interest to declare.

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