Breder VV, Zhukova LG, Bolotina LV, Demidova IA, Zhulikov YaA, Lubennikova EV, Naskhletashvili DR, Orlov SV, Orlova RV, Romanov IS, Savelov NA, Sarantseva KA, Tyulyandina AS, Fedyanin MYu. Resolution of the advisory board on the topic: “The place of entrectinib in the treatment of adult patients with NTRK-fusion positive solid tumors”. Journal of Modern Oncology. 2023;25(3):295–300. DOI: 10.26442/18151434.2023.3.202441
Резолюция экспертного совета по теме: «Место энтректиниба в лекарственной терапии взрослых пациентов с NTRK-перестроенными солидными опухолями»
Бредер В.В., Жукова Л.Г., Болотина Л.В., Демидова И.А., Жуликов Я.А., Лубенникова Е.В., Насхлеташвили Д.Р., Орлов С.В., Орлова Р.В., Романов И.С., Савелов Н.А., Саранцева К.А., Тюляндина А.С., Федянин М.Ю. Резолюция экспертного совета по теме: «Место энтректиниба в лекарственной терапии взрослых пациентов с NTRK-перестроенными солидными опухолями». Современная Онкология. 2023;25(3):295–300. DOI: 10.26442/18151434.2023.3.202441
Breder VV, Zhukova LG, Bolotina LV, Demidova IA, Zhulikov YaA, Lubennikova EV, Naskhletashvili DR, Orlov SV, Orlova RV, Romanov IS, Savelov NA, Sarantseva KA, Tyulyandina AS, Fedyanin MYu. Resolution of the advisory board on the topic: “The place of entrectinib in the treatment of adult patients with NTRK-fusion positive solid tumors”. Journal of Modern Oncology. 2023;25(3):295–300. DOI: 10.26442/18151434.2023.3.202441
NTRK-перестроенные опухоли являются редкой находкой, при которой таргетная терапия энтректинибом демонстрирует стойкие и длительные системные и интракраниальные ответы. В рамках настоящей резолюции рассмотрены алгоритмы диагностики транслокаций NTRK при различных солидных опухолях и клинические данные по эффективности и безопасности препарата энтректиниб.
Ключевые слова: транслокации генов NTRK, энтректиниб, ингибиторы TRK, молекулярно-генетические исследования при солидных опухолях, секреторные карциномы
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NTRK-fusion positive tumors are a rare finding, but targeted therapy demonstrates persistent and sustained systemic and intracranial responses to entrectinib. This resolution proposes algorithms for diagnosing NTRK translocations in various solid tumors and discuses clinical data on the efficacy and safety of entrectinib.
1. Demetri GD. Updated Integrated Analysis of the Efficacy and Safety of Entrectinib in Patients With NTRK Fusion-Positive Solid Tumors. Clin Cancer Res. 2022;28(7):1302-12.
2. Fischer H. Entrectinib, a TRK/ROS1 inhibitor with anti-CNS tumor activity: differentiation from other inhibitors in its class due to weak interaction with P-glycoprotein. Neuro-Oncology. 2020;22(6):819-29.
3. Krzakowski M. Updated analysis of the efficacy and safety of entrectinib in patients with NTRK fusion-positive solid tumors. J Clin Oncol. 2022;40(16_suppl.):3099.
4. Lozano-Ortega G. Tumour-specific randomized controlled trials in rare oncogene-driven cancers: asking for the impossible. Personalized & Precision Medicine – Methodological & Statistical Research. 2019;22(3):838-9.
5. Krebs MG. Intrapatient comparisons of efficacy in a single-arm trial of entrectinib in tumour-agnostic indications. ESMO Open. 2021;6(2):1-9.
6. Doebele RC. Comparative effectiveness analysis between entrectinib clinical trial and crizotinib real-world data in ROS1+ NSCLC. J Comp Eff Res. 2021;10(17):1271‑82.
7. Krebs MG, Blay JY, Le Tourneau C, et al. Intrapatient comparisons of efficacy in a single-arm trial of entrectinib in tumour-agnostic indications. ESMO Open. 2021;6(2):1-9.
8. Brogaart N. Health technology assessment challenges associated with tumour-agnostic therapies: learnings from the assessments of entrectinib and larotrectinib. OHE Consulting Report, London: Office of Health Economics, 2021.
9. Bowles D. Entrectinib in patients with ntrk fusion-positive (ntrk-fp) thyroid cancer: Updated data from startrk-2. Endocrine Abstracts, 2022.
10. Goto K. An updated analysis of the clinical efficacy and safety of entrectinib in NTRK fusion-positive (NTRK-fp) sarcoma. Japanese Orthopaedic Association – 54th Annual Musculoskeletal Tumor Meeting, 2021.
11. Ogale S, Zerbini CEH, Antoniou M, Freund R. A response to "The potential long-term comparative effectiveness of larotrectinib and entrectinib for second-line treatment of trk fusionpositive metastatic lung cancer. J Manag Care Spec Pharm. 2020;26(12):1616-7.
12. Lu S. Updated analysis of entrectinib in a subset of Chinese (mainland China, Hong Kong, Taiwan) patients with NTRK fusion-positive (fp) solid tumours and ROS1-fp non-small cell lung cancer (NSCLC). ESMO-Asia. 2022:264P.
13. Murakami H. Entrectinib in Japanese patients with locally advanced/metastatic ROS1 fusion-positive (fp) NSCLC and NTRK-fp solid tumours. ESMO-ASIA. 2022:390P.
14. Murphy P. Modelling approaches for histology-independent cancer drugs to inform NICE appraisals: a systematic review and decision-framework. Health Technol Assess. 2021;25(76).
15. Hechtman JF. NTRK insights: best practices for pathologists. Modern Pathol. 2022;35:298-305.
16. Vogel A, Bridgewater J, Edeline J, et al. Biliary tract cancer: ESMO Clinical Practice Guideline for diagnosis, treatment and follow-up. Ann Oncol. 2023;34(2):127-40.
17. Marchiò C, Scaltriti M, Ladanyi M, et al. ESMO recommendations on the standard methods to detect NTRK fusions in daily practice and clinical research. Ann Oncol.
2019;30(9):1417-27.
18. Cervantes A, Adam R, Roselló S, et al. Metastatic colorectal cancer: ESMO Clinical Practice Guideline for diagnosis, treatment and follow-up. Ann Oncol. 2023;34(1):10-32.
19. Sohal D, Kennedy EB, Cinar P, et al. Metastatic Pancreatic Cancer: ASCO Guideline Update. J Clin Oncol. 2020;38(27):3217-30.
20. 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):1491‑505.
21. Haddad RD, Bischoff L, Ball D, et al. Thyroid Carcinoma, Version 2.2022, NCCN Clinical Practice Guidelines in Oncology. J Natl Compr Canc Netw. 2022;20(8):925‑51.
22. Yoshino T, Pentheroudakis G, Mishima S, et al. JSCO-ESMO-ASCO-JSMO-TOS: international expert consensus recommendations for tumour-agnostic treatments in patients with solid tumours with microsatellite instability or NTRK fusions. Ann Oncol. 2020;31(7):861-72.
23. Conde E, Hernandez S, Sanchez E, et al. Pan-TRK Immunohistochemistry: An Example-Based Practical Approach to Efficiently Identify Patients With NTRK Fusion Cancer. Arch Pathol Lab Med. 2021;145(8):1031-40.
24. Siozopoulou V, Smits E, De Winne K, et al. NTRK Fusions in Sarcomas: Diagnostic Challenges and Clinical Aspects. Diagnostics (Basel). 2021;11(3):478.
25. Klug LR, Khosroyani HM, Kent JD, Heinrich MC. New treatment strategies for advanced-stage gastrointestinal stromal tumours. Nat Rew Clin Oncol. 2022;19(5):328-41.
________________________________________________
1. Demetri GD. Updated Integrated Analysis of the Efficacy and Safety of Entrectinib in Patients With NTRK Fusion-Positive Solid Tumors. Clin Cancer Res. 2022;28(7):1302-12.
2. Fischer H. Entrectinib, a TRK/ROS1 inhibitor with anti-CNS tumor activity: differentiation from other inhibitors in its class due to weak interaction with P-glycoprotein. Neuro-Oncology. 2020;22(6):819-29.
3. Krzakowski M. Updated analysis of the efficacy and safety of entrectinib in patients with NTRK fusion-positive solid tumors. J Clin Oncol. 2022;40(16_suppl.):3099.
4. Lozano-Ortega G. Tumour-specific randomized controlled trials in rare oncogene-driven cancers: asking for the impossible. Personalized & Precision Medicine – Methodological & Statistical Research. 2019;22(3):838-9.
5. Krebs MG. Intrapatient comparisons of efficacy in a single-arm trial of entrectinib in tumour-agnostic indications. ESMO Open. 2021;6(2):1-9.
6. Doebele RC. Comparative effectiveness analysis between entrectinib clinical trial and crizotinib real-world data in ROS1+ NSCLC. J Comp Eff Res. 2021;10(17):1271‑82.
7. Krebs MG, Blay JY, Le Tourneau C, et al. Intrapatient comparisons of efficacy in a single-arm trial of entrectinib in tumour-agnostic indications. ESMO Open. 2021;6(2):1-9.
8. Brogaart N. Health technology assessment challenges associated with tumour-agnostic therapies: learnings from the assessments of entrectinib and larotrectinib. OHE Consulting Report, London: Office of Health Economics, 2021.
9. Bowles D. Entrectinib in patients with ntrk fusion-positive (ntrk-fp) thyroid cancer: Updated data from startrk-2. Endocrine Abstracts, 2022.
10. Goto K. An updated analysis of the clinical efficacy and safety of entrectinib in NTRK fusion-positive (NTRK-fp) sarcoma. Japanese Orthopaedic Association – 54th Annual Musculoskeletal Tumor Meeting, 2021.
11. Ogale S, Zerbini CEH, Antoniou M, Freund R. A response to "The potential long-term comparative effectiveness of larotrectinib and entrectinib for second-line treatment of trk fusionpositive metastatic lung cancer. J Manag Care Spec Pharm. 2020;26(12):1616-7.
12. Lu S. Updated analysis of entrectinib in a subset of Chinese (mainland China, Hong Kong, Taiwan) patients with NTRK fusion-positive (fp) solid tumours and ROS1-fp non-small cell lung cancer (NSCLC). ESMO-Asia. 2022:264P.
13. Murakami H. Entrectinib in Japanese patients with locally advanced/metastatic ROS1 fusion-positive (fp) NSCLC and NTRK-fp solid tumours. ESMO-ASIA. 2022:390P.
14. Murphy P. Modelling approaches for histology-independent cancer drugs to inform NICE appraisals: a systematic review and decision-framework. Health Technol Assess. 2021;25(76).
15. Hechtman JF. NTRK insights: best practices for pathologists. Modern Pathol. 2022;35:298-305.
16. Vogel A, Bridgewater J, Edeline J, et al. Biliary tract cancer: ESMO Clinical Practice Guideline for diagnosis, treatment and follow-up. Ann Oncol. 2023;34(2):127-40.
17. Marchiò C, Scaltriti M, Ladanyi M, et al. ESMO recommendations on the standard methods to detect NTRK fusions in daily practice and clinical research. Ann Oncol.
2019;30(9):1417-27.
18. Cervantes A, Adam R, Roselló S, et al. Metastatic colorectal cancer: ESMO Clinical Practice Guideline for diagnosis, treatment and follow-up. Ann Oncol. 2023;34(1):10-32.
19. Sohal D, Kennedy EB, Cinar P, et al. Metastatic Pancreatic Cancer: ASCO Guideline Update. J Clin Oncol. 2020;38(27):3217-30.
20. 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):1491‑505.
21. Haddad RD, Bischoff L, Ball D, et al. Thyroid Carcinoma, Version 2.2022, NCCN Clinical Practice Guidelines in Oncology. J Natl Compr Canc Netw. 2022;20(8):925‑51.
22. Yoshino T, Pentheroudakis G, Mishima S, et al. JSCO-ESMO-ASCO-JSMO-TOS: international expert consensus recommendations for tumour-agnostic treatments in patients with solid tumours with microsatellite instability or NTRK fusions. Ann Oncol. 2020;31(7):861-72.
23. Conde E, Hernandez S, Sanchez E, et al. Pan-TRK Immunohistochemistry: An Example-Based Practical Approach to Efficiently Identify Patients With NTRK Fusion Cancer. Arch Pathol Lab Med. 2021;145(8):1031-40.
24. Siozopoulou V, Smits E, De Winne K, et al. NTRK Fusions in Sarcomas: Diagnostic Challenges and Clinical Aspects. Diagnostics (Basel). 2021;11(3):478.
25. Klug LR, Khosroyani HM, Kent JD, Heinrich MC. New treatment strategies for advanced-stage gastrointestinal stromal tumours. Nat Rew Clin Oncol. 2022;19(5):328-41.
1ФГБУ «Национальный медицинский исследовательский центр онкологии им. Н.Н. Блохина» Минздрава России, Москва, Россия; 2ГБУЗ «Московский клинический научно-практический центр им. А.С. Логинова» Департамента здравоохранения г. Москвы, Москва, Россия; 3Московский научно-исследовательский онкологический институт им. П.А. Герцена – филиал ФГБУ «Национальный медицинский исследовательский центр радиологии» Минздрава России, Москва, Россия; 4ГБУЗ «Московская городская онкологическая больница №62» Департамента здравоохранения г. Москвы, Москва, Россия; 5ФГБОУ ВО «Первый Санкт-Петербургский государственный медицинский университет им. акад. И.П. Павлова» Минздрава России, Санкт-Петербург, Россия; 6ФГБОУ ВО «Санкт-Петербургский государственный университет», Санкт-Петербург, Россия; 7СПб ГБУЗ «Городской клинический онкологический диспансер», Санкт-Петербург, Россия; 8ГБУЗ «Московский многопрофильный клинический центр “Коммунарка”» Департамента здравоохранения г. Москвы, Москва, Россия; 9ФГБУ «Национальный медико-хирургический центр им. Н.И. Пирогова» Минздрава России, Москва, Россия
*vbreder@yandex.ru
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Valeriy V. Breder*1, Liudmila G. Zhukova2, Larisa V. Bolotina3, Irina A. Demidova4, Yaroslav A. Zhulikov1, Elena V. Lubennikova1, David R. Naskhletashvili1, Sergey V. Orlov5, Rashida V. Orlova6,7, Ilya S. Romanov1, Nikita A. Savelov4, Ksenia A. Sarantseva1, Alexandra S. Tyulyandina1, Mikhail Yu. Fedyanin1,8,9
1Blokhin National Medical Research Center of Oncology, Moscow, Russia; 2Loginov Moscow Clinical Scientific Center, Moscow, Russia; 3Hertsen Moscow Oncology Research Institute – branch of the National Medical Research Radiological Centre, Moscow, Russia; 4Moscow City Oncology Hospital №62, Moscow, Russia; 5Pavlov First Saint Petersburg State Medical University, Saint Petersburg, Russia; 6Saint Petersburg State University, Saint Petersburg, Russia; 7City Oncology Center, Saint Petersburg, Russia; 8Moscow Multidisciplinary Clinical Center “Kommunarka”, Moscow, Russia; 9Pirogov National Medical and Surgical Center, Moscow, Russia
*vbreder@yandex.ru