Clinical utility of Todai OncoPanel in the setting of approved comprehensive cancer genomic profiling tests in Japan

Hidenori Kage; Aya Shinozaki-Ushiku; Kazunaga Ishigaki; Yusuke Sato; Masahiko Tanabe; Shota Tanaka; Michihiro Tanikawa; Kousuke Watanabe; Shingo Kato; Kiwamu Akagi; Keita Uchino; Kinuko Mitani; Shunji Takahashi; Yuji Miura; Sadakatsu Ikeda; Yasushi Kojima; Kiyotaka Watanabe; Hitoshi Mochizuki; Hironori Yamaguchi; Yoshimasa Kawazoe; Kosuke Kashiwabara; Shinji Kohsaka; Kenji Tatsuno; Tetsuo Ushiku; Kazuhiko Ohe; Yutaka Yatomi; Yasuyuki Seto; Hiroyuki Aburatani; Hiroyuki Mano; Kiyoshi Miyagawa; Katsutoshi Oda

doi:10.1111/cas.15717

Clinical utility of Todai OncoPanel in the setting of approved comprehensive cancer genomic profiling tests in Japan

Cancer Sci. 2023 Apr;114(4):1710-1717. doi: 10.1111/cas.15717. Epub 2023 Jan 17.

Authors

Hidenori Kage^{1

2}, Aya Shinozaki-Ushiku^{3

4}, Kazunaga Ishigaki^{5

6}, Yusuke Sato⁷, Masahiko Tanabe⁸, Shota Tanaka⁹, Michihiro Tanikawa^{10

11}, Kousuke Watanabe^{2

12}, Shingo Kato¹³, Kiwamu Akagi¹⁴, Keita Uchino¹⁵, Kinuko Mitani¹⁶, Shunji Takahashi¹⁷, Yuji Miura^{18

19}, Sadakatsu Ikeda²⁰, Yasushi Kojima²¹, Kiyotaka Watanabe²², Hitoshi Mochizuki²³, Hironori Yamaguchi²⁴, Yoshimasa Kawazoe^{25

26}, Kosuke Kashiwabara²⁷, Shinji Kohsaka²⁸, Kenji Tatsuno²⁹, Tetsuo Ushiku⁴, Kazuhiko Ohe²⁶, Yutaka Yatomi¹², Yasuyuki Seto³⁰, Hiroyuki Aburatani²⁹, Hiroyuki Mano²⁸, Kiyoshi Miyagawa³¹, Katsutoshi Oda^{3

10}

Affiliations

¹ Next-Generation Precision Medicine Development Laboratory, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan.
² Department of Respiratory Medicine, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan.
³ Division of Integrative Genomics, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan.
⁴ Department of Pathology, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan.
⁵ Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan.
⁶ Department of Chemotherapy, The University of Tokyo Hospital, Tokyo, Japan.
⁷ Department of Urology, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan.
⁸ Department of Breast and Endocrine Surgery, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan.
⁹ Department of Neurosurgery, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan.
¹⁰ Department of Obstetrics and Gynecology, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan.
¹¹ Department of Gynecology, Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital, Tokyo, Japan.
¹² Department of Clinical Laboratory, The University Tokyo Hospital, Tokyo, Japan.
¹³ Department of Clinical Cancer Genomics, Yokohama City University Hospital, Kanagawa, Japan.
¹⁴ Department of Molecular Diagnosis and Cancer Prevention, Saitama Cancer Center, Saitama, Japan.
¹⁵ Department of Medical Oncology, NTT Medical Center Tokyo, Tokyo, Japan.
¹⁶ Department of Hematology and Oncology, Dokkyo Medical University, Tochigi, Japan.
¹⁷ Department of Medical Oncology, Cancer Institute Hospital, Japanese Foundation for Cancer Research, Tokyo, Japan.
¹⁸ Department of Medical Oncology and Clinical Genetics Center, Toranomon Hospital, Tokyo, Japan.
¹⁹ Clinical Genetics Center, Toranomon Hospital, Tokyo, Japan.
²⁰ Department of Precision Cancer Medicine, Tokyo Medical and Dental University Hospital, Tokyo, Japan.
²¹ Department of Gastroenterology, National Center for Global Health and Medicine, Tokyo, Japan.
²² Department of Medicine, School of Medicine, Teikyo University, Tokyo, Japan.
²³ Genome Analysis Center, Yamanashi Prefectural Central Hospital, Yamanashi, Japan.
²⁴ Department of Clinical Oncology, Jichi Medical University Hospital, Tochigi, Japan.
²⁵ Department of Artificial Intelligence in Healthcare, The University of Tokyo, Tokyo, Japan.
²⁶ Department of Healthcare Information Management, The University of Tokyo Hospital, Tokyo, Japan.
²⁷ Clinical Research Promotion Center, The University of Tokyo Hospital, Tokyo, Japan.
²⁸ Division of Cellular Signaling, National Cancer Center Research Institute, Tokyo, Japan.
²⁹ Genome Science and Medicine Laboratory, RCAST, The University of Tokyo, Tokyo, Japan.
³⁰ Department of Gastrointestinal Surgery, The University of Tokyo, Tokyo, Japan.
³¹ Laboratory of Molecular Radiology, Center for Disease Biology and Integrative Medicine, The University of Tokyo, Tokyo, Japan.

Abstract

Comprehensive cancer genome profiling (CGP) has been nationally reimbursed in Japan since June 2019. Less than 10% of the patients have been reported to undergo recommended treatment. Todai OncoPanel (TOP) is a dual DNA-RNA panel as well as a paired tumor-normal matched test. Two hundred patients underwent TOP as part of Advanced Medical Care B with approval from the Ministry of Health, Labour and Welfare between September 2018 and December 2019. Tests were carried out in patients with cancers without standard treatment or when patients had already undergone standard treatment. Data from DNA and RNA panels were analyzed in 198 and 191 patients, respectively. The percentage of patients who were given therapeutic or diagnostic recommendations was 61% (120/198). One hundred and four samples (53%) harbored gene alterations that were detected with the DNA panel and had potential treatment implications, and 14 samples (7%) had a high tumor mutational burden. Twenty-two samples (11.1%) harbored 30 fusion transcripts or MET exon 14 skipping that were detected by the RNA panel. Of those 30 transcripts, 6 had treatment implications and 4 had diagnostic implications. Thirteen patients (7%) were found to have pathogenic or likely pathogenic germline variants and genetic counseling was recommended. Overall, 12 patients (6%) received recommended treatment. In summary, patients benefited from both TOP DNA and RNA panels while following the same indication as the approved CGP tests. (UMIN000033647).

Keywords: comprehensive genomic profiling; gene fusion; genomic medicine; germline finding; precision medicine.

MeSH terms

Genomics*
Humans
Japan
Neoplasms* / drug therapy
Neoplasms* / genetics
Precision Medicine

Abstract

MeSH terms

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