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Клинический случай длительного применения осимертиниба при лечении EGFR-положительной аденокарциномы легкого
Для цитирования: Одинцова С.В., Свириденко М.А., Черемных А.О. и др. Клинический случай длительного применения осимертиниба при лечении EGFR-положительной аденокарциномы легкого. Современная Онкология. 2020; 22 (2): 108–111.
DOI: 10.26442/18151434.2020.2.200153
DOI: 10.26442/18151434.2020.2.200153
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Odintsova S.V., Sviridenko M.A., Cheremnykh A.O. Clinical case of long-term use of osimertinib in the treatment of EGFR mutation-positive lung adenocarcinoma. Journal of Modern Oncology. 2020; 22 (2): 108–111. DOI: 10.26442/18151434.2020.2.200153
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Аннотация
В данной статье рассмотрены клинический случай EGFR-положительного немелкоклеточного рака легкого и его лечение препаратом осимертиниб. Таргетные препараты, ингибирующие тирозинкиназу рецептора эпидермального фактора роста (EGFR), были одобрены для терапии немелкоклеточного рака легкого более 15 лет назад*. Обновленные результаты крупного многоцентрового рандомизированного исследования FLAURA показали, что осимертиниб, необратимый селективный ингибитор тирозинкиназы III поколения, более эффективен, чем ингибиторы тирозинкиназы EGFR I поколения, не только в отношении выживаемости без прогрессирования, но и продолжительности ответа и общей выживаемости. Причем статистически и клинически значимое преимущество по этим показателям достигается без ухудшения переносимости и качества жизни. Статья посвящена описанию клинического случая пациентки, принимавшей участие в данном клиническом исследовании. Поскольку пациентка стала одной из первых, кто начал получать терапию осимертинибом в России, этот опыт представляется интересным, так как позволяет оценить отдаленные результаты применения препарата: достигнутый эффект сохраняется более 50 мес с хорошей переносимостью терапии.
Ключевые слова: немелкоклеточный рак легкого, ингибиторы тирозинкиназы рецептора эпидермального фактора роста, осимертиниб, рецептор эпидермального фактора роста.
Ключевые слова: немелкоклеточный рак легкого, ингибиторы тирозинкиназы рецептора эпидермального фактора роста, осимертиниб, рецептор эпидермального фактора роста.
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This article reviews clinical case of epidermal growth factor receptor (EGFR) mutation-positive non-small cell lung cancer and the usage of osimertinib for its treatment. Targeted drugs, EGFR tyrosine kinase inhibitors were approved for the treatment of non-small cell lung cancer more than 15 years ago*. Updated results of the large multicenter randomized FLAURA trial showed that osimertinib, a third-generation irreversible selective epidermal growth factor receptor tyrosine kinase inhibitor, was more effective than first-generation EGFR tyrosine kinase inhibitors, not only in terms of progression-free survival, but in terms of duration of response and overall survival. Furthermore, statistically and clinically significant benefit is achieved without deterioration of tolerance and quality of life. This article presents a clinical case of a woman who has taken part in this clinical trial. In light of the fact that this patient has been one of the first to receive this therapy in Russia, this experience appears to be interesting, because it allows assess the long-term results of the therapy: the achieved response duration is more than 50 months with good tolerance of therapy.
Key words: non-small cell lung cancer, epidermal growth factor receptor tyrosine kinase inhibitors, osimertinib, epidermal growth factor receptor.
Полный текст
Список литературы
1. Sequist LV, Waltman BA, Dias-Santagata D et al. Genotypic and histological evolution of lung cancers acquiring resistance to EGFR Inhibitors. Sci Transl Med 2011; 3: 75ra26.
2. Miller VA, Hirsh V, Cadranel J et al. Afatinib versus placebo for patients with advanced, metastatic non-small-cell lung cancer after failure of erlotinib, gefitinib, or both, and one or two lines of chemotherapy (LUX-Lung 1): a phase 2b/3 randomised trial. Lancet Oncol 2012; 13: 528–38.
3. Camidge DR et al. Acquired Resistance to TKIs in Solid Tumours: Learning From Lung Cancer. Nat Rev Clin Oncol 2014; 11: 473–81.
4. Soria J-C, Ohe Y, Vansteenkiste J et al. Osimertinib in Untreated EGFR-mutated advanced non–small-cell lung cancer. N Engl J Med 2017; 378: 113–25.
5. Ramalingam SS, Vansteenkiste J, Planchard D et al. Overall survival with osimertinib in untreated, EGFR-mutated advanced NSCLC. N Engl J Med 2019. DOI: 10.1056/NEJMoa1913662
6. Dagogo-Jack I, Shaw AT. Tumour heterogeneity and resistance to cancer therapies. Nat Rev Clin Oncol 2018; 15: 81–94.
7. Arcila ME et al. Rebiopsy of Lung Cancer Patients With Acquired Resistance to EGFR Inhibitors and Enhanced Detection of the T790M Mutation Using a Locked Nucleic Acid-Based Assay. Clin Cancer Res 2011; 17: 1169–80.
8. Yoon HJ et al. Repeat Biopsy for Mutational Analysis of Non-Small Cell Lung Cancers Resistant to Previous Chemotherapy: Adequacy and Complications. Radiology 2012; 265: 939–48.
9. Chouaid C et al. Feasibility and Clinical Impact of Re-Biopsy in Advanced Non Small-Cell Lung Cancer: A Prospective Multicenter Study in a Real-World Setting (GFPC Study 12-01). Lung Cancer 2014; 86: 170–3.
10. Набор для тестирования cobas® EGFR Mutation Test v2. Инструкция по использованию. Indianapolis, IN: Roche Molecular Systems, Inc. 2016.
[Nabor dlia testirovaniia cobas® EGFR Mutation Test v2. Instruktsiia po ispol'zovaniiu. Indianapolis, IN: Roche Molecular Systems, Inc. 2016 (in Russian).]
11. Oxnard GR et al. Association Between Plasma Genotyping and Outcomes of Treatment With Osimertinib (AZD9291) in Advanced Non-Small-Cell Lung Cancer. J Clin Oncol 2016; 34: 3375–82.
12. Jenkins S et al. Plasma ctDNA Analysis for Detection of the EGFR T790M Mutation in Patients With Advanced Non-Small Cell Lung Cancer. J Thorac Oncol 2017; 12: 1061–70.
13. Wu YL, Jenkins S, Ramalingam S et al. MA08.03 Osimertinib vs Platinum-Pemetrexed for T790M-Mutation Positive Advanced NSCLC (AURA3): Plasma ctDNA Analysis. J Thorac Oncol 2017; 12: S386.
14. Roeper J, Falk M, Tiemannet M et al. Risk of not receiving 2nd line therapy is high in EGFR mt+ pts: real world data of certified lung cancer centers on treatment sequence in EGFR mt+ pts. J Clin Oncol 2018; 36 (15 Suppl.).
15. Reckamp KL, Nieva J, Taylor A et al. US real-world management of EGFR-mutated advanced NSCLC: prescribing and attrition data from first-to-second-line treatment. Presented at: IASLC 2019 WCLC; September 7–10, 2019; Barcelona, Spain.
16. Seto T, Nogami N, Yamamoto N et al. Real-world EGFR T790M testing in advanced non-small-cell lung cancer: a prospective observational study in Japan. Oncol Ther 2018; 6: 203–15.
17. Chiang AC, Fernandes AW, Pavilack M et al. Real world biomarker testing and treatment patterns in patients with advanced NSCLC receiving EGFR-TKIs. Presented at: IASLC 19th WCLC; September 23–26, 2018; Toronto, Canada.
18. Chua B, Tan EH, Lim DW et al. Real world data on epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors (TKI) use in advanced/metastatic non-small cell lung cancer. Ann Oncol 2018; 29 (Suppl. 9): ix150–ix169. Abs 523P.
19. https://clinicaltrials.gov/ct2/show/NCT03778229?term=savannah&draw=2&rank=1
20. https://clinicaltrials.gov/ct2/show/NCT03944772?term=ORCHARD&draw=2&rank=1
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[Laktionov K.K., Artamonova E.V., Breder V.V. et al. Prakticheskie rekomendatsii po lekarstvennomu lecheniiu nemelkokletochnogo raka legkogo. Zlokachestvennye opukholi. Prakticheskie rekomendatsii RUSSCO #3s2. 2019; 9: 32–48 (in Russian).]
23. Практические рекомендации ассоциации онкологов России 2020. http://oncology-association.ru/clinical-guidelines
[Prakticheskie rekomendatsii assotsiatsii onkologov Rossii 2020. http://oncology-association.ru/clinical-guidelines (in Russian).]
24. Qinghua Xu et al. First-line continual EGFR-TKI plus local ablative therapy demonstrated survival benefit in EGFR-mutant NSCLC patients with oligoprogressive disease. J Cancer 2019; 10 (2): 522–9.
25. Park K et al. First-Line Erlotinib Therapy Until and Beyond Response Evaluation Criteria in Solid Tumors Progression in Asian Patients With Epidermal Growth Factor Receptor Mutation-Positive Non-Small-Cell Lung Cancer: The ASPIRATION Study. JAMA Oncol 2016; 2 (3): 305–12.
26. Моисеенко В.М. и др. Опыт использования гефитиниба у больных неоперабельным неплоскоклеточным раком легкого с активирующими мутациями EGFR. Вопросы онкологии. 2015; 61 (2): 259–64.
[Moiseenko V.M. et al. Opyt ispol'zovaniia gefitiniba u bol'nykh neoperabel'nym neploskokletochnym rakom legkogo s aktiviruiushchimi mutatsiiami EGFR. Voprosy onkologii. 2015; 61 (2): 259–64 (in Russian).]
27. Reck 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.
28. Leighl NB et al. Patient-reported outcomes from FLAURA: Osimertinib versus erlotinib or gefitinib in patients with EGFR-mutated advanced non-small-cell lung cancer. Eur J Cancer 2020; 125: 49–57.
2. Miller VA, Hirsh V, Cadranel J et al. Afatinib versus placebo for patients with advanced, metastatic non-small-cell lung cancer after failure of erlotinib, gefitinib, or both, and one or two lines of chemotherapy (LUX-Lung 1): a phase 2b/3 randomised trial. Lancet Oncol 2012; 13: 528–38.
3. Camidge DR et al. Acquired Resistance to TKIs in Solid Tumours: Learning From Lung Cancer. Nat Rev Clin Oncol 2014; 11: 473–81.
4. Soria J-C, Ohe Y, Vansteenkiste J et al. Osimertinib in Untreated EGFR-mutated advanced non–small-cell lung cancer. N Engl J Med 2017; 378: 113–25.
5. Ramalingam SS, Vansteenkiste J, Planchard D et al. Overall survival with osimertinib in untreated, EGFR-mutated advanced NSCLC. N Engl J Med 2019. DOI: 10.1056/NEJMoa1913662
6. Dagogo-Jack I, Shaw AT. Tumour heterogeneity and resistance to cancer therapies. Nat Rev Clin Oncol 2018; 15: 81–94.
7. Arcila ME et al. Rebiopsy of Lung Cancer Patients With Acquired Resistance to EGFR Inhibitors and Enhanced Detection of the T790M Mutation Using a Locked Nucleic Acid-Based Assay. Clin Cancer Res 2011; 17: 1169–80.
8. Yoon HJ et al. Repeat Biopsy for Mutational Analysis of Non-Small Cell Lung Cancers Resistant to Previous Chemotherapy: Adequacy and Complications. Radiology 2012; 265: 939–48.
9. Chouaid C et al. Feasibility and Clinical Impact of Re-Biopsy in Advanced Non Small-Cell Lung Cancer: A Prospective Multicenter Study in a Real-World Setting (GFPC Study 12-01). Lung Cancer 2014; 86: 170–3.
10. Набор для тестирования cobas® EGFR Mutation Test v2. Инструкция по использованию. Indianapolis, IN: Roche Molecular Systems, Inc. 2016.
[Nabor dlia testirovaniia cobas® EGFR Mutation Test v2. Instruktsiia po ispol'zovaniiu. Indianapolis, IN: Roche Molecular Systems, Inc. 2016 (in Russian).]
11. Oxnard GR et al. Association Between Plasma Genotyping and Outcomes of Treatment With Osimertinib (AZD9291) in Advanced Non-Small-Cell Lung Cancer. J Clin Oncol 2016; 34: 3375–82.
12. Jenkins S et al. Plasma ctDNA Analysis for Detection of the EGFR T790M Mutation in Patients With Advanced Non-Small Cell Lung Cancer. J Thorac Oncol 2017; 12: 1061–70.
13. Wu YL, Jenkins S, Ramalingam S et al. MA08.03 Osimertinib vs Platinum-Pemetrexed for T790M-Mutation Positive Advanced NSCLC (AURA3): Plasma ctDNA Analysis. J Thorac Oncol 2017; 12: S386.
14. Roeper J, Falk M, Tiemannet M et al. Risk of not receiving 2nd line therapy is high in EGFR mt+ pts: real world data of certified lung cancer centers on treatment sequence in EGFR mt+ pts. J Clin Oncol 2018; 36 (15 Suppl.).
15. Reckamp KL, Nieva J, Taylor A et al. US real-world management of EGFR-mutated advanced NSCLC: prescribing and attrition data from first-to-second-line treatment. Presented at: IASLC 2019 WCLC; September 7–10, 2019; Barcelona, Spain.
16. Seto T, Nogami N, Yamamoto N et al. Real-world EGFR T790M testing in advanced non-small-cell lung cancer: a prospective observational study in Japan. Oncol Ther 2018; 6: 203–15.
17. Chiang AC, Fernandes AW, Pavilack M et al. Real world biomarker testing and treatment patterns in patients with advanced NSCLC receiving EGFR-TKIs. Presented at: IASLC 19th WCLC; September 23–26, 2018; Toronto, Canada.
18. Chua B, Tan EH, Lim DW et al. Real world data on epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors (TKI) use in advanced/metastatic non-small cell lung cancer. Ann Oncol 2018; 29 (Suppl. 9): ix150–ix169. Abs 523P.
19. https://clinicaltrials.gov/ct2/show/NCT03778229?term=savannah&draw=2&rank=1
20. https://clinicaltrials.gov/ct2/show/NCT03944772?term=ORCHARD&draw=2&rank=1
21. NCCN Clinical practice guidelines. NSCLC v2.2020.
22. Лактионов К.К., Артамонова Е.В., Бредер В.В. и др. Практические рекомендации по лекарственному лечению немелкоклеточного рака легкого. Злокачественные опухоли. Практические рекомендации RUSSCO #3s2. 2019; 9: 32–48.
[Laktionov K.K., Artamonova E.V., Breder V.V. et al. Prakticheskie rekomendatsii po lekarstvennomu lecheniiu nemelkokletochnogo raka legkogo. Zlokachestvennye opukholi. Prakticheskie rekomendatsii RUSSCO #3s2. 2019; 9: 32–48 (in Russian).]
23. Практические рекомендации ассоциации онкологов России 2020. http://oncology-association.ru/clinical-guidelines
[Prakticheskie rekomendatsii assotsiatsii onkologov Rossii 2020. http://oncology-association.ru/clinical-guidelines (in Russian).]
24. Qinghua Xu et al. First-line continual EGFR-TKI plus local ablative therapy demonstrated survival benefit in EGFR-mutant NSCLC patients with oligoprogressive disease. J Cancer 2019; 10 (2): 522–9.
25. Park K et al. First-Line Erlotinib Therapy Until and Beyond Response Evaluation Criteria in Solid Tumors Progression in Asian Patients With Epidermal Growth Factor Receptor Mutation-Positive Non-Small-Cell Lung Cancer: The ASPIRATION Study. JAMA Oncol 2016; 2 (3): 305–12.
26. Моисеенко В.М. и др. Опыт использования гефитиниба у больных неоперабельным неплоскоклеточным раком легкого с активирующими мутациями EGFR. Вопросы онкологии. 2015; 61 (2): 259–64.
[Moiseenko V.M. et al. Opyt ispol'zovaniia gefitiniba u bol'nykh neoperabel'nym neploskokletochnym rakom legkogo s aktiviruiushchimi mutatsiiami EGFR. Voprosy onkologii. 2015; 61 (2): 259–64 (in Russian).]
27. Reck 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.
28. Leighl NB et al. Patient-reported outcomes from FLAURA: Osimertinib versus erlotinib or gefitinib in patients with EGFR-mutated advanced non-small-cell lung cancer. Eur J Cancer 2020; 125: 49–57.
________________________________________________
1. Sequist LV, Waltman BA, Dias-Santagata D et al. Genotypic and histological evolution of lung cancers acquiring resistance to EGFR Inhibitors. Sci Transl Med 2011; 3: 75ra26.
2. Miller VA, Hirsh V, Cadranel J et al. Afatinib versus placebo for patients with advanced, metastatic non-small-cell lung cancer after failure of erlotinib, gefitinib, or both, and one or two lines of chemotherapy (LUX-Lung 1): a phase 2b/3 randomised trial. Lancet Oncol 2012; 13: 528–38.
3. Camidge DR et al. Acquired Resistance to TKIs in Solid Tumours: Learning From Lung Cancer. Nat Rev Clin Oncol 2014; 11: 473–81.
4. Soria J-C, Ohe Y, Vansteenkiste J et al. Osimertinib in Untreated EGFR-mutated advanced non–small-cell lung cancer. N Engl J Med 2017; 378: 113–25.
5. Ramalingam SS, Vansteenkiste J, Planchard D et al. Overall survival with osimertinib in untreated, EGFR-mutated advanced NSCLC. N Engl J Med 2019. DOI: 10.1056/NEJMoa1913662
6. Dagogo-Jack I, Shaw AT. Tumour heterogeneity and resistance to cancer therapies. Nat Rev Clin Oncol 2018; 15: 81–94.
7. Arcila ME et al. Rebiopsy of Lung Cancer Patients With Acquired Resistance to EGFR Inhibitors and Enhanced Detection of the T790M Mutation Using a Locked Nucleic Acid-Based Assay. Clin Cancer Res 2011; 17: 1169–80.
8. Yoon HJ et al. Repeat Biopsy for Mutational Analysis of Non-Small Cell Lung Cancers Resistant to Previous Chemotherapy: Adequacy and Complications. Radiology 2012; 265: 939–48.
9. Chouaid C et al. Feasibility and Clinical Impact of Re-Biopsy in Advanced Non Small-Cell Lung Cancer: A Prospective Multicenter Study in a Real-World Setting (GFPC Study 12-01). Lung Cancer 2014; 86: 170–3.
10. Nabor dlia testirovaniia cobas® EGFR Mutation Test v2. Instruktsiia po ispol'zovaniiu. Indianapolis, IN: Roche Molecular Systems, Inc. 2016 (in Russian).
11. Oxnard GR et al. Association Between Plasma Genotyping and Outcomes of Treatment With Osimertinib (AZD9291) in Advanced Non-Small-Cell Lung Cancer. J Clin Oncol 2016; 34: 3375–82.
12. Jenkins S et al. Plasma ctDNA Analysis for Detection of the EGFR T790M Mutation in Patients With Advanced Non-Small Cell Lung Cancer. J Thorac Oncol 2017; 12: 1061–70.
13. Wu YL, Jenkins S, Ramalingam S et al. MA08.03 Osimertinib vs Platinum-Pemetrexed for T790M-Mutation Positive Advanced NSCLC (AURA3): Plasma ctDNA Analysis. J Thorac Oncol 2017; 12: S386.
14. Roeper J, Falk M, Tiemannet M et al. Risk of not receiving 2nd line therapy is high in EGFR mt+ pts: real world data of certified lung cancer centers on treatment sequence in EGFR mt+ pts. J Clin Oncol 2018; 36 (15 Suppl.).
15. Reckamp KL, Nieva J, Taylor A et al. US real-world management of EGFR-mutated advanced NSCLC: prescribing and attrition data from first-to-second-line treatment. Presented at: IASLC 2019 WCLC; September 7–10, 2019; Barcelona, Spain.
16. Seto T, Nogami N, Yamamoto N et al. Real-world EGFR T790M testing in advanced non-small-cell lung cancer: a prospective observational study in Japan. Oncol Ther 2018; 6: 203–15.
17. Chiang AC, Fernandes AW, Pavilack M et al. Real world biomarker testing and treatment patterns in patients with advanced NSCLC receiving EGFR-TKIs. Presented at: IASLC 19th WCLC; September 23–26, 2018; Toronto, Canada.
18. Chua B, Tan EH, Lim DW et al. Real world data on epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors (TKI) use in advanced/metastatic non-small cell lung cancer. Ann Oncol 2018; 29 (Suppl. 9): ix150–ix169. Abs 523P.
19. https://clinicaltrials.gov/ct2/show/NCT03778229?term=savannah&draw=2&rank=1
20. https://clinicaltrials.gov/ct2/show/NCT03944772?term=ORCHARD&draw=2&rank=1
21. NCCN Clinical practice guidelines. NSCLC v2.2020.
22. Laktionov K.K., Artamonova E.V., Breder V.V. et al. Prakticheskie rekomendatsii po lekarstvennomu lecheniiu nemelkokletochnogo raka legkogo. Zlokachestvennye opukholi. Prakticheskie rekomendatsii RUSSCO #3s2. 2019; 9: 32–48 (in Russian).
23. Prakticheskie rekomendatsii assotsiatsii onkologov Rossii 2020. http://oncology-association.ru/clinical-guidelines (in Russian).
24. Qinghua Xu et al. First-line continual EGFR-TKI plus local ablative therapy demonstrated survival benefit in EGFR-mutant NSCLC patients with oligoprogressive disease. J Cancer 2019; 10 (2): 522–9.
25. Park K et al. First-Line Erlotinib Therapy Until and Beyond Response Evaluation Criteria in Solid Tumors Progression in Asian Patients With Epidermal Growth Factor Receptor Mutation-Positive Non-Small-Cell Lung Cancer: The ASPIRATION Study. JAMA Oncol 2016; 2 (3): 305–12.
26. Moiseenko V.M. et al. Opyt ispol'zovaniia gefitiniba u bol'nykh neoperabel'nym neploskokletochnym rakom legkogo s aktiviruiushchimi mutatsiiami EGFR. Voprosy onkologii. 2015; 61 (2): 259–64 (in Russian).
27. Reck 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.
28. Leighl NB et al. Patient-reported outcomes from FLAURA: Osimertinib versus erlotinib or gefitinib in patients with EGFR-mutated advanced non-small-cell lung cancer. Eur J Cancer 2020; 125: 49–57.
Авторы
С.В. Одинцова*, М.А. Свириденко, А.О. Черемных, Е.А. Филиппова, М.А. Уртенова, С.В. Орлов
ФГБОУ ВО «Первый Санкт-Петербургский государственный медицинский университет им. акад. И.П. Павлова» Минздрава России, Санкт-Петербург, Россия
*odin-svet@yandex.ru
ФГБОУ ВО «Первый Санкт-Петербургский государственный медицинский университет им. акад. И.П. Павлова» Минздрава России, Санкт-Петербург, Россия
*odin-svet@yandex.ru
________________________________________________
Svetlana V. Odintsova*, Mariia A. Sviridenko, Antonina O. Cheremnykh, Elena A. Filippova, Magaripa A. Urtenova, Sergei V. Orlov
Pavlov First Saint Petersburg State Medical University, Saint Petersburg, Russia
*odin-svet@yandex.ru
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