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
- 作者: Orlov S.1, Baldin P.2, Diuzeva N.3, Krechetova A.4, Mordovskiy A.5, Moskovchenko A.6, Musaeva N.4, Romanchuk O.7
-
隶属关系:
- Pavlov First Saint Petersburg State Medical University
- Republican Clinical Oncological Dispensary
- Kostroma Oncological Dispensary
- Kryzhanovsky Krasnoyarsk Regional Clinical Oncological Dispensary
- Surgut District Clinical Hospital
- Oncological Dispensary
- City Clinical Hospital №40
- 期: 卷 24, 编号 1 (2022)
- 页面: 41-49
- 栏目: CLINICAL ONCOLOGY
- URL: https://journals.rcsi.science/1815-1434/article/view/106798
- DOI: https://doi.org/10.26442/18151434.2022.1.201491
- ID: 106798
如何引用文章
全文:
详细
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.
作者简介
Sergey Orlov
Pavlov First Saint Petersburg State Medical University
Email: orloff-sv@mail.ru
ORCID iD: 0000-0001-6080-8042
D. Sci. (Med.), Corr. Memb. RAS, Leading Res. Officer
俄罗斯联邦, Saint PetersburgPavel Baldin
Republican Clinical Oncological Dispensary
Email: pavelbaldin83@mail.ru
ORCID iD: 0000-0001-5987-670X
Department Head, Republican Clinical Oncological Dispensary
俄罗斯联邦, Naberezhnye ChelnyNatalia Diuzeva
Kostroma Oncological Dispensary
Email: 89106613895@mail.ru
ORCID iD: 0000-0001-5843-4635
Department Head
俄罗斯联邦, KostromaAnastasia Krechetova
Kryzhanovsky Krasnoyarsk Regional Clinical Oncological Dispensary
Email: AnastasiaKrechetova@yandex.ru
ORCID iD: 0000-0003-0249-3956
oncologist
俄罗斯联邦, KrasnoyarskAleksey Mordovskiy
Surgut District Clinical Hospital
编辑信件的主要联系方式.
Email: mordovskiy@mail.ru
ORCID iD: 0000-0002-8220-0027
oncologist
俄罗斯联邦, SurgutAleksandr Moskovchenko
Oncological Dispensary
Email: Moskit74@gmail.com
ORCID iD: 0000-0002-4865-6856
Deputy Chief doctor
俄罗斯联邦, TaganrogNatalia Musaeva
Kryzhanovsky Krasnoyarsk Regional Clinical Oncological Dispensary
Email: musa-eva100@mail.ru
ORCID iD: 0000-0002-1999-0847
oncologist
俄罗斯联邦, KrasnoyarskOlga Romanchuk
City Clinical Hospital №40
Email: olga99995566@mail.ru
ORCID iD: 0000-0003-3505-6736
Department Head
俄罗斯联邦, Moscow参考
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®). Non-Small Cell Lung Сancer. V.2.2021. Available at: https://www.nccn.org/guidelines/guidelines-detail?category=1&id=1450/ Accessed: 24.01.2022.
- Лактионов К.К., Артамонова Е.В., Бредер В.В., и др. Практические рекомендации по лекарственному лечению немелкоклеточного рака легкого. Злокачественные опухоли. 2020;10(3s2-1):40-59 [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
- Клинические рекомендации. Злокачественное новообразование бронхов и легкого,2021. Режим доступа: https://cr.minzdrav.gov.ru/recomend/30_1/ Ссылка активна на 24.01.2022 [Klinicheskie rekomendatsii. Zlokachestvennoe novoobrazovanie bronkhov i legkogo. 2021. Available at: https://cr.minzdrav.gov.ru/recomend/30_1/ Accessed: 24.01.2022 (in Russian)].
- Lilenbaum RC, Cashy J, Hensing TA, et al. Prevalence of poor performance status in lung cancer patients: implications for research. J Thorac Oncol. 2008;3:125-9. doi: 10.1097/JTO.0b013e3181622c17
- 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
- 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
- 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
- Gettinger S, Rizvi NA, Chow LQ, et al. Nivolumab Monotherapy for First-Line Treatment of Advanced Non-Small-Cell Lung Cancer. J Clin Oncol. 2016;34(25):2980-7. doi: 10.1200/JCO.2016.66.9929
- Reck M, Mok TSK, Nishio M, et al. Atezolizumab plus bevacizumab and chemotherapy in non-small-cell lung cancer (IMpower150): key subgroup analyses of patients with EGFR mutations or baseline liver metastases in a randomised, open-label phase 3 trial. Lancet Respir Med. 2019;7(5):387-401. doi: 10.1016/S2213-2600(19)30084-0
- 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
- Han G, Bi J, Tan W, et al. A retrospective analysis in patients with EGFR-mutant lung adenocarcinoma: is EGFR mutation associated with a higher incidence of brain metastasis? Oncotarget. 2016;7(35):56998-7010. doi: 10.18632/oncotarget.10933
- Stanic K, Zwitter M, Hitij NT, et al. Brain metastases in lung adenocarcinoma: impact of EGFR mutation status on incidence and survival. Radiol Oncol. 2014;48(2):173-83. doi: 10.2478/raon-2014-0016
- 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
- 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
- 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
- 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-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/ Accessed: 24.01.2022.
- 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
- 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.
- 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
- Ekman S, Cselenyi Z, Varrone A, et al. A PET and MRI study exploring osimertinib brain exposure and efficacy in EGFRm NSCLC CNS metastases. In: WCLC 2020; 2021 January 28-31; Singapore. Poster P76.72. Available at: https://www.jto.org/article/S1556-0864(21)01171-0/fulltext/ Accessed: 24.01.2022. doi: 10.1016/j.jtho.2021.01.1129
- 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
- Tanjak P, Suktitipat B, Vorasan N, et al. Risks and cancer associations of metachronous and synchronous multiple primary cancers: a 25-year retrospective study. BMC Cancer. 2021;21(1):1045. doi: 10.1186/s12885-021-08766-9
- Vogt A, Schmid S, Heinimann K, et al. Multiple primary tumours: challenges and approaches, a review. ESMO Open. 2017;2(2):e000172. doi: 10.1136/esmoopen-2017-000172
- Практические рекомендации Российского общества клинической онкологии по оказанию онкологической помощи в условиях пандемии COVID-19. Режим доступа: https://www.rosoncoweb.ru/standarts/COVID-19/ Ссылка активна на 24.01.2022 [Prakticheskie rekomendatsii Rossiiskogo obshchestva klinicheskoi onkologii po okazaniiu onkologicheskoi pomoshchi v usloviiakh pandemii COVID-19. Available at: https://www.rosoncoweb.ru/standarts/COVID-19/ Accessed: 24.01.2022 (in Russian)].
- NCCN COVID-19 Resources. Available at: https://www.nccn.org/covid-19/ Accessed: 24.03.2022.
- Cancer patient management during the COVID-19 pandemic. Available at: https://www.esmo.org/covid-19-and-cancer/covid-19-resource-centre/cancer-patient-management-during-the-covid-19-pandemic/ Accessed: 24.03.2022.
- ESMO management and treatment adapted recommendations in the COVID-19 era: lung cancer. Available at: https://www.esmo.org/guidelines/cancer-patient-management-during-the-covid-19-pandemic/lung-cancer-in-the-covid-19-era/ Accessed: 24.01.2022
- Lung Cancer Study Group, Chinese Thoracic Society, Chinese Medical Association; Chinese Respiratory Oncology Collaboration Expert recommendations on the management of patients with advanced non-small cell lung cancer during epidemic of coronavirus disease 2019 (Trial version) (in Chinese). Zhonghua Jie He He Hu Xi Za Zhi. 2020;43(4):297-301. doi: 10.3760/cma.j.cn112147-20200221-00138