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

Int J Clin Oncol. 2021 Feb;26(2):233-283. doi: 10.1007/s10147-020-01831-6. Epub 2020 Nov 29.


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.

Keywords: Cancer genomic profiling test; Clinical practice guidance; Next-generation sequencing; Solid cancer.

MeSH terms

  • High-Throughput Nucleotide Sequencing*
  • Humans
  • Medical Oncology
  • Neoplasms* / diagnosis
  • Neoplasms* / genetics
  • Neoplasms* / therapy
  • Patient Selection
  • Precision Medicine