Осимертиниб и рутинная практика: опыт применения препарата в различных клинических ситуациях при метастатическом немелкоклеточном раке легкого с мутацией в гене EGFR

Орлов С.В., Балдин П.Л., Дюжева Н.В., Кречетова А.В., Мордовский А.А., Московченко А.Н., Мусаева Н.Э., Романчук О.В. Осимертиниб и рутинная практика: опыт применения препарата в различных клинических ситуациях при метастатическом немелкоклеточном раке легкого с мутацией в гене EGFR. Современная Онкология. 2022;24(1):41–49. DOI: 10.26442/18151434.2022.1.201491

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Orlov SV, Baldin PL, Diuzeva NV, Krechetova AV, Mordovskiy AA, Moskovchenko AN, Musaeva NE, Romanchuk OV. Osimertinib and routine practice: the experience of the drug application in different clinical situations in case of metastatic non-small cell lung cancer with an EGFR mutation. Case report. Journal of Modern Oncology. 2022;24(1):41–49. DOI: 10.26442/18151434.2022.1.201491

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Аннотация

После внедрения новых опций лечения всегда важно увидеть, как результаты регистрационных исследований транслируются в рутинную клиническую практику. Клинические исследования помогают оценить эффективность, безопасность терапии и провести ее объективное сравнение с действующим стандартом лечения. Однако в них невозможно учесть все то многообразие ситуаций, с которыми онкологи сталкиваются в своей ежедневной работе. В настоящее время применение таргетной терапии при наличии определенных генетических нарушений, в частности драйверных мутаций в гене рецептора эпидермального фактора роста (EGFR), является неотъемлемой частью ведения пациентов с распространенным немелкоклеточным раком легкого (НМРЛ). Первые ингибиторы тирозинкиназы (ИТК) EGFR существенно изменили наши возможности в лечении этой группы пациентов, а сегодня мы уже используем ИТК EGFR III поколения. В обзоре проанализирован опыт применения ИТК EGFR III поколения осимертиниба через призму вопросов, которыми задаются практикующие врачи: оценка эффективности лечения в рутинной практике, ведение сложных категорий пациентов, в частности пациентов с метастазами в кости, головной мозг, пациентов с первично-множественными опухолями, тактика ведения пациентов с учетом пандемии COVID-19 и связанных с этим перерывов в лечении. Обзор литературных источников и международного опыта дополнен клиническими примерами из разных регионов Российской Федерации.

Ключевые слова: метастатический немелкоклеточный рак легкого, мутации гена EGFR, ингибиторы тирозинкиназы, осимертиниб

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After the introduce of new treatment options is always important to see how the results of the registered studies will be putted into routine clinical practice. Clinical studies help to assess the efficacy and safety of therapy and to conduct the objective comparison of the current standard of treatment. However, it is impossible to take into account all the variety of situations that oncologists can face in their daily work. Nowadays, the use of targeted therapy in the presence of the specific genetic disorders, in particular, driver mutations in the epidermal growth factor receptor (EGFR) gene, is an integral part of the management of patients with advanced non-small cell lung cancer (NSCLC). The first EGFR tyrosine kinase inhibitors (TKIs) have significantly changed our possibility of the treatment in this group of patients, and today we are already using the third-generation EGFR TKIs. The review analyzes the experience of using the third-generation EGFR TKIs – osimertinib, through the prism of questions, asking by the practitioners: evaluation of the efficacy of treatment in routine practice, the management of difficult patients, in particular, the patients with bone and brain metastases, the patients with multiple primary tumors, the management tactics of patient taking into account the COVID-19 pandemic and related treatment interruptions. The literature and international experience review is completed by clinical cases from different regions of the Russian Federation.

Keywords: metastatic non-small cell lung cancer, EGFR gene mutations, tyrosine kinase inhibitors, osimertinib

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Список литературы

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1. Ramalingam SS, Vansteenkiste J, Planchard D, et al. Overall Survival with Osimertinib in Untreated, EGFR-Mutated Advanced NSCLC. N Engl J Med. 2020;382(1):41-50. DOI:10.1056/NEJMoa1913662
2. Lee CK, Davies L, Wu Y, et al. Gefitinib or Erlotinib vs Chemotherapy for EGFR Mutation-Positive Lung Cancer: Individual Patient Data Meta-Analysis of Overall Survival. J Natl Cancer Inst. 2017;109(6):1-13. DOI:10.1093/jnci/djw279
3. Wu Y-L, Zhou C, Liam C-K, et al. First-line erlotinib versus gemcitabine/cisplatin in patients with advanced EGFR mutation-positive non-small-cell lung cancer: analyses from the phase III, randomized, open-label, ENSURE study. Ann Oncol. 2015;26:1883-9. DOI:10.1093/annonc/mdv270
4. Zhou C, Wu Y-L, Chen G, et al. Final overall survival results from a randomised, phase III study of erlotinib versus chemotherapy as first-line treatment of EGFR mutation-positive advanced non-small-cell lung cancer (OPTIMAL, CTONG-0802). Ann Oncol. 2015;26:1877-83. DOI:10.1093/annonc/mdv276
5. Fukuoka M, Wu Y-L, Thongprasert S, et al. Biomarker analyses and final overall survival results from a phase III, randomized, open-label, first-line study of gefitinib versus carboplatin/paclitaxel in clinically selected patients with advanced non-small-cell lung cancer in Asia (IPASS). J Clin Oncol. 2011;29:2866‑74. DOI:10.1200/JCO.2010.33.4235
6. Inoue A, Kobayashi K, Maemondo M, et al. Updated overall survival results from a randomized phase III trial comparing gefitinib with carboplatin-paclitaxel for chemo-naïve non-small cell lung cancer with sensitive EGFR gene mutations (NEJ002). Ann Oncol. 2013;24:54-9. DOI:10.1093/annonc/mds214
7. Yoshioka H, Shimokawa M, Seto T, et al. Final overall survival results of WJTOG3405, a randomized phase III trial comparing gefitinib versus cisplatin with docetaxel as the first-line treatment for patients with stage IIIB/IV or postoperative recurrent EGFR mutation-positive non-small-cell lung cancer. Ann Oncol. 2019; 30(12):1978-84. DOI:10.1093/annonc/mdz399
8. Yang J C-H, Wu Y-L, Schuler M, et al. Afatinib versus cisplatin-based chemotherapy for EGFR mutation-positive lung adenocarcinoma (LUX-Lung 3 and LUX-Lung 6): analysis of overall survival data from two randomised, phase 3 trials. Lancet Oncol. 2015;16:141-51. DOI:10.1016/S1470-2045(14)71173-8
9. Paz-Ares L, Tan EH, O’Byrne K, et al. Afatinib versus gefitinib in patients with EGFR mutation-positive advanced non-small-cell lung cancer: overall survival data from the phase IIb LUX-Lung 7 trial. Ann Oncol. 2017;28(2):270‑7. DOI:10.1093/annonc/mdw611
10. Planchard D, Popat S, Kerr K, et al. Metastatic non-small cell lung cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2018;29(Suppl. 4):iv192-237. Updated version published 15 September 2020 by the ESMO Guidelines Committee. Available at: https://www.esmo.org/content/download/347819/6934778/1/ESMO-CPGmNSCLC-15SEPT2020.pdf/ Accessed: 24.01.2022. DOI:10.1093/annonc/mdy275
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12. Laktionov KK, Artamonova EV, Breder VV, et al. Prakticheskie rekomendatsii po lekarstvennomu lecheniiu nemelkokletochnogo raka legkogo. Malignant Tumours. 2020;10(3s2-1):40-59 (in Russian). DOI:10.18027/2224-5057-2020-10-3s2-02
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15. Lorenzi M, Ferro A, Cecere F, et al. First-Line Osimertinib in Patients with EGFR-Mutant Advanced Non-Small Cell Lung Cancer: Outcome and Safety in the Real World: FLOWER Study. Oncologist. 2021. DOI:10.1002/onco.13951
16. Brown H, Vansteenkiste J, Nakagawa K, et al. Programmed Cell Death Ligand 1 Expression in Untreated EGFR Mutated Advanced NSCLC and Response to Osimertinib Versus Comparator in FLAURA. J Thorac Oncol. 2020;15(1):138-43. DOI:10.1016/j.jtho.2019.09.009
17. Lisberg A, Cummings A, Goldman JW, et al. A Phase II Study of Pembrolizumab in EGFR-Mutant, PD-L1+, Tyrosine Kinase Inhibitor Naive Patients With Advanced NSCLC. J Thorac Oncol. 2018;13(8):1138-45. DOI:10.1016/j.jtho.2018.03.035
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20. Igawa S, Kasajima M, Ono T, et al. A Prospective Observational Study of Osimertinib for Chemo-Naive Elderly Patients with EGFR Mutation-Positive Non-Small Cell Lung Cancer. Cancer Manag Res. 2021;13:8695-705. DOI:10.2147/CMAR.S339891
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23. Rangachari D, Yamaguchi N, VanderLaan PA, et al. Brain metastases in patients with EGFR-mutated or ALK-rearranged non-small-cell lung cancers. Lung Cancer. 2015;88(1):108-11. DOI:10.1016/j.lungcan.2015.01.020
24. Li Y-S, Jiang B-Y, Yang J-J, et al. Leptomeningeal Metastases in Patients with NSCLC with EGFR Mutations. J Thorac Oncol. 2016;11(11):1962-9. DOI:10.1016/j.jtho.2016.06.029
25. Varrone A, Varnas K, Jucaite A, et al. A PET study in healthy subjects of brain exposure of 11 C-labelled osimertinib – A drug intended for treatment of brain metastases in non-small cell lung cancer. J Cereb Blood Flow Metab. 2020;40(4):799-807. DOI:10.1177/0271678X19843776
26. Vansteenkiste J, Reungwetwattana T, Nakagawa K, et al. CNS response to osimertinib vs standard of care (SoC) EGFR-TKI as first-line therapy in patients (pts) with EGFR-TKI sensitising mutation (EGFRm)-positive advanced non-small cell lung cancer (NSCLC): data from the FLAURA study (LBA5). In: European Society of Medical Oncology Asia Congress; 2017 Nov 17-19; Singapore. Abstract 2136. Available at: https://oncologypro.esmo.org/meeting-resources/esmo-asia-2017-congress/CNS-response-to-osimertinib-v... Accessed: 24.01.2022.
27. Reungwetwattana T, Nakagawa K, Chul Cho B, et al. CNS Response to Osimertinib Versus Standard Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitors in Patients With Untreated EGFR-Mutated Advanced Non-Small-Cell Lung Cancer. J Clin Oncol. 2018;JCO2018783118. DOI:10.1200/JCO.2018.78.3118
28. Yang J C-H, Wu Y-L, Hirsh V, et al. Competing central nervous system or systemic progression analysis for patients with EGFR mutation-positive NSCLC receiving afatinib in LUX-Lung 3, 6, and 7. In: European Lung Cancer Congress (ELCC); 2018 April 11-14; Geneva, Switzerland. Poster 143PD. Available at: https://www.inoncology.com/sites/default/files/poster/elcc_2018_cns_activity_poster.pdf/ Accessed: 24.01.2022.
29. Wu Y-L, Tsuboi M, He J, et al. Osimertinib in Resected EGFR-Mutated Non-Small-Cell Lung Cancer. N Eng J Med. 2020;383(18):1711-23. DOI:10.1056/NEJMoa2027071
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31. Brouns A, Dursun S, Bootsma G, et al. Reporting of Incidence and Outcome of Bone Metastases in Clinical Trials Enrolling Patients with Epidermal Growth Factor Receptor Mutated Lung Adenocarcinoma-A Systematic Review. Cancers (Basel). 2021;13:3144. DOI:10.3390/cancers13133144
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Авторы

С.В. Орлов*1, П.Л. Балдин2, Н.В. Дюжева3, А.В. Кречетова4, А.А. Мордовский5, А.Н. Московченко6, Н.Э. Мусаева4, О.В. Романчук7

1 ФГБОУ ВО «Первый Санкт-Петербургский государственный медицинский университет им. акад. И.П. Павлова» Минздрава России, Санкт-Петербург, Россия;
2 ГАУЗ «Республиканский клинический онкологический диспансер» Минздрава Республики Татарстан – филиал ГАУЗ «Республиканский клинический онкологический диспансер Минздрава Республики Татарстан им. проф. М.З. Сигала», Набережные Челны, Россия;
3 ОГБУЗ «Костромской онкологический диспансер», Кострома, Россия;
4 КГБУЗ «Красноярский краевой клинический онкологический диспансер им. А.И. Крыжановского», Красноярск, Россия;
5 БУ Ханты-Мансийского автономного округа – Югры «Сургутская окружная клиническая больница»,, Сургут, Россия;
6 ГБУ РО «Онкологический диспансер», Таганрог, Россия;
7 ГБУЗ «Городская клиническая больница №40» Департамента здравоохранения г. Москвы, Москва, Россия
*orloff-sv@mail.ru

________________________________________________

Sergey V. Orlov*1, Pavel L. Baldin2, Natalia V. Diuzeva3, Anastasia V. Krechetova4, Aleksey A. Mordovskiy5, Aleksandr N. Moskovchenko6, Natalia E. Musaeva4, Olga V. Romanchuk7

1 Pavlov First Saint Petersburg State Medical University, Saint Petersburg, Russia;
2 Republican Clinical Oncological Dispensary, Naberezhnye Chelny, Russia;
3 Kostroma Oncological Dispensary, Kostroma, Russia;
4 Kryzhanovsky Krasnoyarsk Regional Clinical Oncological Dispensary, Krasnoyarsk, Russia;
5 Surgut District Clinical Hospital, Surgut, Russia;
6 Oncological Dispensary, Taganrog, Russia;
7 City Clinical Hospital №40, Moscow, Russia
*orloff-sv@mail.ru

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