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

Author:

Kage Hidenori12ORCID,Shinozaki‐Ushiku Aya34,Ishigaki Kazunaga56,Sato Yusuke7,Tanabe Masahiko8ORCID,Tanaka Shota9,Tanikawa Michihiro1011,Watanabe Kousuke212,Kato Shingo13ORCID,Akagi Kiwamu14,Uchino Keita15,Mitani Kinuko16,Takahashi Shunji17,Miura Yuji1819ORCID,Ikeda Sadakatsu20,Kojima Yasushi21,Watanabe Kiyotaka22,Mochizuki Hitoshi23,Yamaguchi Hironori24,Kawazoe Yoshimasa2526,Kashiwabara Kosuke27,Kohsaka Shinji28ORCID,Tatsuno Kenji29,Ushiku Tetsuo4,Ohe Kazuhiko26,Yatomi Yutaka12,Seto Yasuyuki30,Aburatani Hiroyuki29,Mano Hiroyuki28ORCID,Miyagawa Kiyoshi31,Oda Katsutoshi310ORCID

Affiliation:

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

AbstractComprehensive 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).

Funder

Japan Agency for Medical Research and Development

Sysmex Corporation

Publisher

Wiley

Subject

Cancer Research,Oncology,General Medicine

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