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Атезолизумаб в 1-й линии метастатического немелкоклеточного рака легкого. Клинический опыт применения
Огнерубов Н.А., Антипова Т.С. Атезолизумаб в 1-й линии метастатического немелкоклеточного рака легкого. Клинический опыт применения. Современная Онкология. 2022;24(1):50–60.
DOI: 10.26442/18151434.2022.1.201478
DOI: 10.26442/18151434.2022.1.201478
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Ognerubov NA, Antipova TS. Atezolizumab in the first-line treatment of metastatic non-small cell lung cancer. Clinical experience of the drug application. Case report. Journal of Modern Oncology. 2022;24(1):50–60.
DOI: 10.26442/18151434.2022.1.201478
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Аннотация
Актуальность. Рак легкого по-прежнему занимает лидирующее положение в структуре заболеваемости и смертности как у мужчин, так и у женщин. При этом на долю немелкоклеточного рака легкого (НМРЛ) приходится 85% всех случаев злокачественных опухолей. Исторически лечение местно-распространенного и метастатического рака легкого заключалось в системной цитотоксической терапии. Основной ее целью являлось уничтожение опухолевых клеток, уменьшение степени выраженности проявлений болезни, улучшение качества жизни и продление выживаемости. В последние годы обнаружение мутаций в рецепторе эпидермального фактора роста EGFR и ALK-транслокаций или онкогена ROS1 привело к смене парадигмы и разработке молекулярно-ориентированных терапевтических средств и опций, таких как таргетная терапия, а также иммунотерапия ингибиторами контрольных точек иммунного ответа.
Цель. Представить эффективность применения атезолизумаба в 1-й линии метастатического НМРЛ с высокой экспрессией PD-L1.
Описание клинического случая. Под наблюдением находился пациент в возрасте 64 лет с диагнозом: «Рак правого легкого стадия IV, T1N3M1, метастазы в головной мозг и правый надпочечник». Выполнена биопсия надключичного лимфатического узла справа. При гистологическом исследовании – метастазы плоскоклеточного рака. Активирующих мутаций в гене EGFR и ALK-транслокаций, ROS1 не выявлено (дикий тип). При иммуногистохимическом анализе установлена высокая экспрессия лиганда запрограммированной смерти PD-L1 – 90%. Пациенту проведено лечение в монорежиме атезолизумабом 1200 мг каждый 21-й день. Больной получил 50 введений препарата на протяжении практически 3 лет. Оценка эффекта проводимой терапии осуществлялась посредством гибридной технологии ПЭТ/КТ с 18-фтордезоксиглюкозой. По окончании 14-го цикла лечения получена полная метаболическая регрессия опухоли, которая сохраняется на протяжении всего периода лечения – 36 мес. Среди нежелательных явлений следует отметить нейтропению 2-й степени после 6 и 7 и 30‑го циклов терапии. Иммуноопосредованных нежелательных явлений не зарегистрировано.
Заключение. Применение атезолизумаба в монорежиме обеспечивает длительную общую выживаемость у пациентов с нелеченым EGFR- и ALK-отрицательным метастатическим НМРЛ с высоким уровнем экспрессии PD-L1, а также благоприятный профиль безопасности и качество жизни.
Ключевые слова: немелкоклеточный рак легкого, метастатический, PD-L1, атезолизумаб
Цель. Представить эффективность применения атезолизумаба в 1-й линии метастатического НМРЛ с высокой экспрессией PD-L1.
Описание клинического случая. Под наблюдением находился пациент в возрасте 64 лет с диагнозом: «Рак правого легкого стадия IV, T1N3M1, метастазы в головной мозг и правый надпочечник». Выполнена биопсия надключичного лимфатического узла справа. При гистологическом исследовании – метастазы плоскоклеточного рака. Активирующих мутаций в гене EGFR и ALK-транслокаций, ROS1 не выявлено (дикий тип). При иммуногистохимическом анализе установлена высокая экспрессия лиганда запрограммированной смерти PD-L1 – 90%. Пациенту проведено лечение в монорежиме атезолизумабом 1200 мг каждый 21-й день. Больной получил 50 введений препарата на протяжении практически 3 лет. Оценка эффекта проводимой терапии осуществлялась посредством гибридной технологии ПЭТ/КТ с 18-фтордезоксиглюкозой. По окончании 14-го цикла лечения получена полная метаболическая регрессия опухоли, которая сохраняется на протяжении всего периода лечения – 36 мес. Среди нежелательных явлений следует отметить нейтропению 2-й степени после 6 и 7 и 30‑го циклов терапии. Иммуноопосредованных нежелательных явлений не зарегистрировано.
Заключение. Применение атезолизумаба в монорежиме обеспечивает длительную общую выживаемость у пациентов с нелеченым EGFR- и ALK-отрицательным метастатическим НМРЛ с высоким уровнем экспрессии PD-L1, а также благоприятный профиль безопасности и качество жизни.
Ключевые слова: немелкоклеточный рак легкого, метастатический, PD-L1, атезолизумаб
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Background. Lung cancer is still the leading cause of cancer morbidity and mortality among both men and women. At the same time, non-small cell lung cancer (NSCLC) accounts for 85% of all cases of malignant tumors. Historically, the treatment for locally advanced and metastatic lung cancer was consisted of systemic cytotoxic therapy. The main aim was to destroy tumor cells, to reduce the severity of the disease manifestations, to improve the quality of life and to prolong survival. Recent discovery of mutations in the epidermal growth factor receptor (EGFR) gene and ALK translocations or proto-oncogene 1 (ROS1) has led to a paradigm shift and the development of molecularly oriented therapeutic agents and options, such as targeted therapy as well as immunotherapy using immune checkpoint inhibitors.
Aim. Present the efficacy of atezolizumab application in the first-line treatment of metastatic non-small cell lung cancer associated with high PD-L1 expression.
Clinical case report. A 64-year-old patient with T1N3M1 stage IV right lung cancer, brain and right adrenal metastases was under observation. Right supraclavicular lymph node biopsy was performed. The histological examination showed the metastases of squamous cell carcinoma. EGFR-activating mutations, ALK translocations and ROS1 were not detected (wild-type). The immunohistochemical analysis showed a high expression of programmed cell death ligand (PD-L1) – 90%. The patient was treated using atezolizumab 1200 mg every 21 days in monoregimen. The patient was receiving 50 injections of the drug for almost 3 years. The effect of the therapy was evaluated using hybrid 18-F-fluorodeoxyglucose PET/CT. The complete metabolic regression of the tumor was obtained after 14 cycles of treatment and was persisting throughout the treatment period for 36 months. Grade 2 neutropenia after 6, 7 and 30 cycles of therapy was noted among the adverse effects. Immune-mediated adverse events were not described.
Conclusion. The application of atezolizumab in monoregimen can provide long-term overall survival in patients with untreated metastatic EGFR-negative, ALK-negative NSCLC associated with high PD-L1 expression, as well as a favorable safety profile and quality of life.
Keywords: non-small cell lung cancer, metastatic, PD-L1, atezolizumab
Полный текст
Список литературы
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27. Arcila ME, Chaft JE, Nafa K, et al. Prevalence, clinicopathologic associations, and molecular spectrum of ERBB2 (HER2) tyrosine kinase mutations in lung adenocarcinomas. Clin Cancer Res. 2012;18:4910. DOI:10.1158/1078-0432.CCR-12-0912
28. Nicos M, Krawczyk P, Mlak R, et al. The presence of HER2 exon 20 insertion in patients with central nervous system metastases from non-small lung cancer – a potential application in classification for therapy. Pneumonol Alergol Pol. 2013;81:294-7.
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2. Sequist LV, Neal JW, Lilenbaum RC, Vora SR. Personalized, genotype-directed therapy for advanced non-small cell lung cancer, 2022. Available at: https://www.wolterskluwer.com/en/know/clinical-efficientness-terms. Accessed: 15.02.2022.
3. Sezer A, Kilickap S, Gumus M, et al. Cemiplimab monotherapy for first-line treatment of advanced non-small-cell lung cancer with PD-L1 of at least 50%: a multicentre, open-label, global, phase 3, randomised, controlled trial. Lancet. 2021;397(10274):592-604. DOI:10.1016/S0140-6736(21)00228-2
4. Mok TSK, Wu Y-L, Kudaba I, et al.; KEYNOTE-042 Investigators. Pembrolizumab versus chemotherapy for previously untreated, PD-L1-expressing, locally advanced or metastatic non-small-cell lung cancer (KEYNOTE-042): a randomised, open-label, controlled, phase 3 trial. Lancet. 2019;393:1819-30. DOI:10.1016/S0140-6736(18)32409-7
5. West H, McCleod M, Hussein M, et al. Atezolizumab in combination with carboplatin plus nab-paclitaxel chemotherapy compared with chemotherapy alone as first-line treatment for metastatic non-squamous non-small-cell lung cancer (IMpower130): a multicentre, randomised, open-label, phase 3 trial. Lancet Oncol. 2019;20:924-37.
DOI:10.1016/S1470-2045(19)30167-6
6. Paz-Ares L, Ciuleanu TE, Cobo M, et al. First-line nivolumab plus ipilimumab combined with two cycles of chemotherapy in patients with non-small-cell lung cancer (CheckMate 9LA): an international, randomised, open-label, phase 3 trial. Lancet Oncol. 2021;22:198-211. DOI:10.1016/S1470-2045(20)30641-0
7. Socinski MA, Jotte RM, Cappuzzo F, et al. Atezolizumab for first-line treatment of metastatic nonsquamous NSCLC. N Engl J Med. 2018;378:2288-301.
DOI:10.1056/NEJMoa1716948
8. Herbst RS, Giaccone G, de Marinis F, et al. Atezolizumab for First-Line Treatment of PD-L1-Selected Patients with NSCLC. N Engl J Med. 2020;383:1328-39. DOI:10.1056/NEJMoa1917346
9. Wang Y, Zhou S, Yang F, et al. Wang Treatment-Related Adverse Events of PD-1 and PD-L1 Inhibitors in Clinical Trials A Systematic Review and Meta-analysis. JAMA Oncol. 2019;5(7):1008-19. DOI:10.1001/jamaoncol.2019.0393
10. Brahmer JR, Rodriguez-Abreu D, Robinson AG, et al. LBA51 – KEYNOTE-024 5-year OS update: First-line (1L) pembrolizumab (pembro) vs platinum-based chemotherapy (chemo) in patients (pts) with metastatic NSCLC and PD-L1 tumour proportion score (TPS) ≥50%. Ann Oncol. 2020;31(Suppl. 4):S1142-215. DOI:10.1016/annonc/annonc325
11. Jassem J, de Marinis F, Giaccone G, et al. Updated Overall Survival Analysis From IMpower110: Atezolizumab Versus Platinum-Based Chemotherapy in Treatment-Naive Programmed Death-Ligand 1-Selected NSCLC. J Thorac Oncol. 2021;16(11):1872-82. DOI:10.1016/j.jtho.2021.06.019
12. Bhaumik S, Ahmad F, Das BR. Somatic mutation analysis of KRAS, BRAF, HER2 and PTEN in EGFR mutation-negative non-small cell lung carcinoma: determination of frequency, distribution pattern and identification of novel deletion in HER2 gene from Indian patients. Med Oncol. 2016;33(10):117. DOI:10.1007/s12032-016-0828-7
13. Araujo LH, Lammers PE, Matthews-Smith V, et al. Somatic mutation spectrum of non-small-cell lung cancer in African Americans: a pooled analysis. J Thorac Oncol. 2015;10:1430-6. DOI:10.1097/JTO.0000000000000650
14. Paik PK, Arcila ME, Fara M, et al. Clinical characteristics of patients with lung adenocarcinomas harboring BRAF mutations. J Clin Oncol. 2011;29:2046-51. DOI:10.1200/JCO.2010.33.1280
15. Chatziandreou I, Tsioli P, Sakellariou S, et al. Comprehensive molecular analysis of NSCLC; Clinicopathological Associations. PLoS One. 2015;10:e0133859. DOI:10.1371/journal.pone.0133859
16. Dong YU, Ren W, Qi J, et al. EGFR, ALK, RET, KRAS and BRAF alterations in never-smokers with non-small cell lung cancer. Oncol Lett. 2016;11:2371-8.
DOI:10.3892/ol.2016.4235
17. Chen LF, Chen XY, Yu XB. Correlation of clinicopathologic features and driver gene mutation in non-small cell lung cancer. Zhonghua Bing Li Xue Za Zhi. 2016;45:221‑5 (in Chinese). DOI:10.3760/cma.j.issn.0529-5807.2016.04.002
18. Dearden S, Stevens J, Wu YL, Blowers D. Mutation incidence and coincidence in non small-cell lung cancer: meta-analyses by ethnicity and histology (mutMap). Ann Oncol. 2013;24(9):2371-6. DOI:10.1093/annonc/mdt205
19. Yang H, Liang S-Q, Schmid RA, Peng R-W. New horizons in KRAS-mutant lung cancer: dawn after darkness. Front Oncol. 2019;9:953. DOI:10.3389/fonc.2019.00953
20. Matikas A, Mistriotis D, Georgoulias V, Kotsakis A. Targeting KRAS mutated non-small cell lung cancer: a history of failures and a future of hope for a diverse entity. Crit Rev Oncol Hematol. 2017;110:1-12. DOI:10.1016/j.critrevonc.2016.12.005
21. Shepherd FA, Domerg C, Hainaut P, et al. Pooled analysis of the prognostic and predictive effects of KRAS mutation status and KRAS mutation subtype in early-stage resected non-small-cell lung cancer in four trials of adjuvant chemotherapy. J Clin Oncol. 2013;31(17):2173-81. DOI:10.1200/jco.2012.48.1390
22. Timar J. The clinical relevance of KRAS gene mutation in non-small-cell lung cancer. Curr Opin Oncol. 2014;26(2):138-44. DOI:10.1097/cco.0000000000000051
23. Ghimessy A, Radeczky P, Laszlo V, et al. Current therapy of KRAS-mutant lung cancer. Cancer Metastasis Rev. 2020;39(4):1159-77. DOI:10.1007/s10555-020-09903-9
24. D'Arcangelo M, D'Incecco A, Cappuzzo F. Rare mutations in non-small-cell lung cancer. Future Oncol. 2013;9(5):699-711. DOI:10.2217/fon.13.16
25. Kawaguchi T, Koh Y, Ando M, et al. Prospective Analysis of Oncogenic Driver Mutations and Environmental Factors: Japan Molecular Epidemiology for Lung Cancer Study. J Clin Oncol. 2016;34:2247. DOI:10.1200/JCO.2015.64.2322
26. Shi Y, Au JS, Thongprasert S, et al. A prospective, molecular epidemiology study of EGFR mutations in Asian patients with advanced non-small-cell lung cancer of adenocarcinoma histology (PIONEER). J Thorac Oncol. 2014;9:154. DOI:10.1097/JTO.0000000000000033
27. Arcila ME, Chaft JE, Nafa K, et al. Prevalence, clinicopathologic associations, and molecular spectrum of ERBB2 (HER2) tyrosine kinase mutations in lung adenocarcinomas. Clin Cancer Res. 2012;18:4910. DOI:10.1158/1078-0432.CCR-12-0912
28. Nicos M, Krawczyk P, Mlak R, et al. The presence of HER2 exon 20 insertion in patients with central nervous system metastases from non-small lung cancer – a potential application in classification for therapy. Pneumonol Alergol Pol. 2013;81:294-7.
29. Stephens P, Hunter C, Bignell G, et al. Lung cancer: intragenic ERBB2 kinase mutations in tumours. Nature. 2004;431:525-6. DOI:10.1038/431525b
30. Mazieres J, Peters S, Lepage B, et al. Lung cancer that harbors an HER2 mutation: epidemiologic characteristics and therapeutic perspectives. J Clin Oncol. 2013;31:1997-2003. DOI:10.1200/JCO.2012.45.6095
________________________________________________
1. Globocan cancer observatory, 2020. Available at: https://gco.iarc.fr/. Accessed: 22.01.2022.
2. Sequist LV, Neal JW, Lilenbaum RC, Vora SR. Personalized, genotype-directed therapy for advanced non-small cell lung cancer, 2022. Available at: https://www.wolterskluwer.com/en/know/clinical-efficientness-terms. Accessed: 15.02.2022.
3. Sezer A, Kilickap S, Gumus M, et al. Cemiplimab monotherapy for first-line treatment of advanced non-small-cell lung cancer with PD-L1 of at least 50%: a multicentre, open-label, global, phase 3, randomised, controlled trial. Lancet. 2021;397(10274):592-604. DOI:10.1016/S0140-6736(21)00228-2
4. Mok TSK, Wu Y-L, Kudaba I, et al.; KEYNOTE-042 Investigators. Pembrolizumab versus chemotherapy for previously untreated, PD-L1-expressing, locally advanced or metastatic non-small-cell lung cancer (KEYNOTE-042): a randomised, open-label, controlled, phase 3 trial. Lancet. 2019;393:1819-30. DOI:10.1016/S0140-6736(18)32409-7
5. West H, McCleod M, Hussein M, et al. Atezolizumab in combination with carboplatin plus nab-paclitaxel chemotherapy compared with chemotherapy alone as first-line treatment for metastatic non-squamous non-small-cell lung cancer (IMpower130): a multicentre, randomised, open-label, phase 3 trial. Lancet Oncol. 2019;20:924-37.
DOI:10.1016/S1470-2045(19)30167-6
6. Paz-Ares L, Ciuleanu TE, Cobo M, et al. First-line nivolumab plus ipilimumab combined with two cycles of chemotherapy in patients with non-small-cell lung cancer (CheckMate 9LA): an international, randomised, open-label, phase 3 trial. Lancet Oncol. 2021;22:198-211. DOI:10.1016/S1470-2045(20)30641-0
7. Socinski MA, Jotte RM, Cappuzzo F, et al. Atezolizumab for first-line treatment of metastatic nonsquamous NSCLC. N Engl J Med. 2018;378:2288-301.
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Авторы
Н.А. Огнерубов*1, Т.С. Антипова2
1 ФГБОУ ВО «Тамбовский государственный университет им. Г.Р. Державина», Тамбов, Россия;
2 ООО «ПЭТ-Технолоджи», Тамбов, Россия
*ognerubov_n.a@mail.ru
1 ФГБОУ ВО «Тамбовский государственный университет им. Г.Р. Державина», Тамбов, Россия;
2 ООО «ПЭТ-Технолоджи», Тамбов, Россия
*ognerubov_n.a@mail.ru
________________________________________________
Nikolai A. Ognerubov*1, Tatiana S. Antipova2
1 Derzhavin Tambov State University, Tambov, Russia;
2 LLC "PET-Technology", Tambov, Russia
*ognerubov_n.a@mail.ru
Цель портала OmniDoctor – предоставление профессиональной информации врачам, провизорам и фармацевтам.