Adaptation to the Progress in Cancer Genomic Medicine by a Japanese Community Hospital
Keywords:Cancer genomic medicine, gene panel test, third party certification, multi-disciplinary team, pathology system, human resource development, patient support system
Background: Remarkable progress in cancer genomic medicine (CGM) has been made with the advent of next-generation sequencing and advanced computational data analysis approaches. In Japan gene panel testing has been covered by the National Health Insurance System since June 2019. Although Nagoya Memorial Hospital has been designated as a regional medical support hospital, their medical staff are unfamiliar with CGM and generally experience difficulty in explaining the genetic testing to cancer patients.
Methods: A multi-disciplinary CGM team was created in July 2019 to adapt to the clinical application of gene panel testing. Hospital functions were then maintained focusing on the following three aspects: a pathology system for handling genetic information, human resource development related to CGM, and a patient support system, including genetic counseling.
Results: Third party ISO15189 (International Organization for Standardization) certification was acquired for the Department of Pathology to establish a quality-assured laboratory. Here, we report on 21 cancer patients who consulted and received information from the CGM outpatient department of our hospital. Among them 14 patients were introduced into a group of certified hospitals by the Japanese Ministry of Health, Labour, and Welfare and 10 patients underwent gene panel tests.
Conclusions: As a regional medical support hospital dealing with many cancer patients, we will further improve hospital functions to match the progress in CGM.
Berger MF, Mardis ER. The emerging clinical relevance of genomics in cancer medicine. Nat Rev Clin Oncol 2018; 15: 353-365. https://doi.org/10.1038/s41571-018-0002-6 DOI: https://doi.org/10.1038/s41571-018-0002-6
Tsimberidou AM, Fountzilas E, Nikanjam M, et al. Review of Precision Cancer Medicine: Evolution of the Treatment Paradigm. Cancer Treat Rev 2020; 86: 102019. https://doi.org/10.1016/j.ctrv.2020.102019 DOI: https://doi.org/10.1016/j.ctrv.2020.102019
Jennings LJ, Arcila ME, Coreless C, et al. Guidelines for validation of next-generation sequencing-based oncology panels. J Mol Diagn 2017; 19: 341-65. https://doi.org/10.1016/j.jmoldx.2017.01.011 DOI: https://doi.org/10.1016/j.jmoldx.2017.01.011
Sicklick JK, Kato S, Okamura R, et al. Molecular profiling of cancer patients enables personalized combination therapy: The I-PREDICT study. Nat Med 2019; 25: 744-50. https://doi.org/10.1038/s41591-019-0407-5 DOI: https://doi.org/10.1038/s41591-019-0407-5
Middleton G, Robbins H, Andre F, et al. A state-of-the-art review of stratified medicine in cancer: towards a future precision medicine strategy in cancer. Ann Oncol 2022; 33: 143-157. https://doi.org/10.1016/j.annonc.2021.11.004 DOI: https://doi.org/10.1016/j.annonc.2021.11.004
Easton DF, Pharoah PDP, Antoniou AC, et al. Gene-Panel Sequencing and the Prediction of Breast-Cancer Risk. N Engl J Med 2015; 372: 2243-2257. https://doi.org/10.1056/NEJMsr1501341 DOI: https://doi.org/10.1056/NEJMsr1501341
Kim M, Tolkunov D, Zhong H, et al. Clinical actionability of comprehensive genomic profiling for management of rare or refractory cancers. Oncologist 2016; 21: 1315-25. https://doi.org/10.1634/theoncologist.2016-0049 DOI: https://doi.org/10.1634/theoncologist.2016-0049
Sunami K, Ichikawa H, Kubo T, et al. Feasibility and utility of a panel testing for 114 cancer-associated genes in a clinical setting: A hospital-based study. Cancer Sci 2019; 110: 1480-90. https://doi.org/10.1111/cas.13969 DOI: https://doi.org/10.1111/cas.13969
von Hoff DD, Stephenson JJ Jr, Rosen P, et al. Pilot study using molecular profiling of patients’ tumors to find potential targets and select treatments for their refractory cancers. J Clin Oncol 2010; 28: 4877-83. https://doi.org/10.1200/JCO.2009.26.5983 DOI: https://doi.org/10.1200/JCO.2009.26.5983
Tsimberidou AM, Iskander NG, Hong DS, et al. Personalized medicine in a phase 1 clinical trials program: The M.D. Anderson Cancer Center Initiative. Clin Cancer Res 2012; 18: 6373-83. https://doi.org/10.1158/1078-0432.CCR-12-1627 DOI: https://doi.org/10.1158/1078-0432.CCR-12-1627
Tourneau CLT, Goncalves A, Gavollie C, et al. Molecularly targeted therapy based on tumor molecular profiling versus conventional therapy for advanced cancer (SHIVA): a multicenter, open-label, proof-of-concept, randomized, controlled phase 2 trial. Lancet Oncol 2015. https://doi.org/10.1016/S1470-2045(15)00188-6 DOI: https://doi.org/10.1016/S1470-2045(15)00188-6
Fink JL, Jaradi B, Stone N, et al. Minimizing sample failure rates for challenging clinical tumor samples. J Mol Diagn 2023; S1525-1578823)00024-7. https://doi.org/10.1016/j.jmoldx.2023.01.008 DOI: https://doi.org/10.1016/j.jmoldx.2023.01.008
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