An Analytical Study of the Recommendations for Molecular Genetic Testing in the Russian and Foreign Clinical Guidelines for Non-Small Cell Lung Cancer

Cover Page


Cite item

Full Text

Open Access Open Access
Restricted Access Access granted
Restricted Access Subscription or Fee Access

Abstract

Background. Molecular genetic tests play an important role in the care of patients with cancer. Prescribing a number of precision medicines requires concomitant diagnostic testing. Clinical guidelines accelerate implementation of approved clinical interventions, including molecular genetic testing.

Aims — to analyze and compare recommendations for ordering molecular genetic testing in non-small cell lung cancer (NSCLC) between Russian and foreign guidelines.

Methods. The study included guidelines published in the Rubricator of Clinical Guidelines of the Ministry of Health of Russia, the European Society of Medical Oncology, the American Society of Clinical Oncology and the National Network of Multidisciplinary Oncological Institutions. Recommendations for genetic testing to identify sensitizing mutations in genes in NSCLC and information on study methods were extracted from the selected guidelines.

Results. This resulted in a list of genes recommended for testing in NSCLC: EGFR, BRAF, ALK, ROS1, NTRK, ERBB2, MET, RET, KRAS. The list of genes recommended for testing was the same in all included guidelines, except the Rubricator guideline. Recommendations for assigning tests to identify gene variants within guidelines for the same association tended to have the same level of evidence. However, for some genes, the level of evidence differed between associations. We found that not all guidelines describe research methods. An analysis of the recommended testing methods has shown that a significant proportion of studies are recommended to be conducted using next-generation sequencing, including using genetic panels.

Conclusions. The results of the analysis show the differences between foreign and Russian guidelines in the approaches to prescribing molecular genetic testing and methods of performing it. Currently, EGFR, BRAF, ALK, ROS1, ERBB2, MET, RET are the main genes recommended for testing, and studies are usually performed in metastatic NSCLC. A significant proportion of studies are recommended to use NGS, including the use of genetic panels.

Full Text

Restricted Access

About the authors

Vitaly V. Omelyanovsky

Center for Expertise and Quality Control of Medical Care; Russian Medical Academy of Continuing Professional Education; Financial Research Institute; N.A. Semashko National Research Institute of Public Health

Email: vvo@rosmedex.ru
ORCID iD: 0000-0003-1581-0703
SPIN-code: 1776-4270

MD, PhD, Professor

Россия, Moscow; Moscow; Moscow; Moscow

Andrey O. Ryzhov

I.M. Sechenov First Moscow State Medical University (Sechenov University)

Author for correspondence.
Email: andreyandreyr@gmail.com
ORCID iD: 0000-0001-9313-2122
SPIN-code: 7983-4460

MD, Health Technology Assessor, Postgraduate Student

Россия, Moscow

Yulia A. Ledovskih

Center for Expertise and Quality Control of Medical Care; Russian Medical Academy of Continuing Professional Education

Email: jledovskih@gmail.com
ORCID iD: 0000-0002-7567-6027
SPIN-code: 9131-7256

MD, PhD, Associate Professor

Россия, Moscow; Moscow

References

  1. Woolf SH, Grol R, Hutchinson A, et al. Clinical guidelines: potential benefits, limitations, and harms of clinical guidelines. BMJ. 1999;318(7182):527–530. doi: https://doi.org/10.1136/bmj.318.7182.527
  2. Schwartzberg L, Kim ES, Liu D, et al. Precision Oncology: Who, How, What, When, and When Not? Am Soc Clin Oncol Educ Book. 2017;37:160–169. doi: https://doi.org/10.1200/edbk_174176
  3. Companion Diagnostics. FDA. 22.09.2023. Available from: https://www.fda.gov/medical-devices/in-vitro-diagnostics/companion-diagnostics
  4. Schrijvers G, Oudendijk N, de Vries P. In search of the quickest way to disseminate health care innovations. Int J Integr Care. 2003;(3):e19.
  5. Mosele F, Remon J, Mateo J, et al. Recommendations for the use of next-generation sequencing (NGS) for patients with metastatic cancers: a report from the ESMO Precision Medicine Working Group. Ann Oncol. 2020;31(11):1491–1505. doi: https://doi.org/10.1016/j.annonc.2020.07.014
  6. Kirchner JAE, Smith JL, Powell BJ, et al. Getting a clinical innovation into practice: An introduction to implementation strategies. Psychiatry Res. 2020;283:112467. doi: https://doi.org/10.1016/j.psychres.2019.06.042
  7. List of Cleared or Approved Companion Diagnostic Devices (In Vitro and Imaging Tools). FDA. 22.09.2023. Available from: https://www.fda.gov/medical-devices/in-vitro-diagnostics/list-cleared-or-approved-companion-diagnostic-devices-in-vitro-and-imaging-tools
  8. Molecular Testing and Biomarkers. ASCO. 20.09.2023. Available from: https://old-prod.asco.org/practice-patients/guidelines/molecular-testing-and-biomarkers
  9. Precision Medicine and Validated Biomarkers. OncologyPRO. 14.07.2023. Available from: https://oncologypro.esmo.org/oncology-in-practice/personalised-medicine/esmo-recommendations-in-precision-medicine
  10. Ковалева М.Ю., Сухоруких О.А. Клинические рекомендации. История создания и развития в Российской Федерации и за рубежом // Ремедиум. Журнал о российском рынке лекарств и медицинской технике. — 2019. — № 1–2. — C. 6–14. [Kovaleva MYu, Suhorukih OA. Clinical guidelines. History of the creation and development in the Russian Federation and abroad. Remedium Journal about the Russian market of medicines and medical equipment. 2019;(1–2):6–14. (In Russ.)] doi: https://doi.org/10.21518/1561-5936-2019-01-02-6-14
  11. Laberge AM, Burke W. Clinical and Public Health Implications of Emerging Genetic Technologies. Semin Nephrol. 2010;30(2):185–194. doi: https://doi.org/10.1016/j.semnephrol.2010.01.009
  12. Mateo J, Chakravarty D, Dienstmann R, et al. A framework to rank genomic alterations as targets for cancer precision medicine: the ESMO Scale for Clinical Actionability of molecular Targets (ESCAT). Ann Oncol. 2018;29(9):1895–1902. doi: https://doi.org/10.1093/annonc/mdy263
  13. Kalemkerian GP, Narula N, Kennedy EB, et al. Molecular testing guideline for the selection of patients with lung cancer for treatment with targeted tyrosine kinase inhibitors: American society of clinical oncology endorsement of the college of American pathologists/ international association for the study of lung cancer/ association for molecular pathology clinical practice guideline update. J Clin Oncol. 2018;36(9);911–919. doi: https://doi.org/10.1200/jco.2017.76.7293
  14. Злокачественное новообразование бронхов и легкого. Рубрикатор КР. 10.05.2023. Available from: https://cr.minzdrav.gov.ru/schema/30_4
  15. eUpdate — Early and Locally Advanced Non-Small-Cell Lung Cancer. European Society for Medical Oncology. 10.05.2023. Available from: https://www.esmo.org/guidelines/guidelines-by-topic/lung-and-chest-tumours/early-stage-and-locally-advanced-non-metastatic-non-small-cell-lung-cancer/eupdate-early-and-locally-advanced-non-small-cell-lung-cancer-nsclc-treatment-recommendations2
  16. Postmus PE, Kerr KM, Oudkerk M, et al. Early and locally advanced non-small-cell lung cancer (NSCLC): ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2017;28(Suppl 4):iv1–iv21. doi: https://doi.org/10.1093/annonc/mdx222
  17. Hendriks LE, Kerr KM, Menis J, et al. Oncogene-addicted metastatic non-small-cell lung cancer: ESMO Clinical Practice Guideline for diagnosis, treatment and follow-up. Ann Oncol. 2023;34(4):339–357. doi: https://doi.org/10.1016/j.annonc.2022.12.009
  18. Pisters K, Kris MG, Gaspar LE, et al. Adjuvant Systemic Therapy and Adjuvant Radiation Therapy for Stage I–IIIA Completely Resected Non-Small-Cell Lung Cancer: ASCO Guideline Rapid Recommendation Update. J Clin Oncol. 2022;40(10):1127–1129. doi: https://doi.org/10.1200/JCO.22.00051
  19. Kris MG, Gaspar LE, Chaft JE, et al. Adjuvant Systemic Therapy and Adjuvant Radiation Therapy for Stage I to IIIA Completely Resected Non-Small-Cell Lung Cancers: American Society of Clinical Oncology/Cancer Care Ontario Clinical Practice Guideline Update. J Clin Oncol. 2017;35(25):2960–2974. doi: https://doi.org/10.1200/JCO.2017.72.4401
  20. Daly ME, Singh N, Ismaila N, et al. Management of Stage III Non-Small-Cell Lung Cancer: ASCO Guideline. J Clin Oncol. 2022;40(12):1356–1384. doi: https://doi.org/10.1200/JCO.21.02528
  21. Singh N, Jaiyesimi IA, Ismaila N, et al. Therapy for Stage IV Non-Small-Cell Lung Cancer with Driver Alterations: ASCO Living Guideline, Version 2023.1. J Clin Oncol. 2023;41(15):e51–e62. doi: https://doi.org/10.1200/JCO.23.00282
  22. Therapy for Stage IV Non-Small Cell Lung Cancer with Driver Alterations Living Guideline. ASCO. 10.05.2023. Available from: https://old-prod.asco.org/practice-patients/guidelines/thoracic-cancer#/150121
  23. Non-Small Cell Lung Cancer. NCCN Guidelines Version 3.2023. 10.05.2023. Available from: https://www.nccn.org/guidelines/guidelines-detail?category=1&id=1450
  24. NCCN Development and Update of Guidelines. NCCN Guidelines. 20.09.2023. Available from: https://www.nccn.org/guidelines/guidelines-process/development-and-update-of-guidelines
  25. Mosele F, Remon J, Mateo J, et al. Recommendations for the use of next-generation sequencing (NGS) for patients with metastatic cancers: a report from the ESMO Precision Medicine Working Group. Ann Oncol. 2020;31(11):1491–1505. doi: https://doi.org/10.1016/j.annonc.2020.07.014
  26. Hellmann MD, Paz-Ares L, Bernabe Caro R, et al. Nivolumab plus Ipilimumab in Advanced Non-Small-Cell Lung Cancer. N Engl J Med. 2019;381(21):2020–2031. doi: https://doi.org/10.1056/NEJMoa1910231
  27. ESCAT: ESMO Scale for Clinical Actionability of molecular Targets. European Society for Medical Oncology. 15.05.2023. Available from: https://www.esmo.org/policy/esmo-scale-for-clinical-actionability-of-molecular-targets-escat

Supplementary files

Supplementary Files
Action
1. JATS XML

Copyright (c) 2024 "Paediatrician" Publishers LLC



This website uses cookies

You consent to our cookies if you continue to use our website.

About Cookies