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<article article-type="research-article" dtd-version="1.3" xmlns:mml="http://www.w3.org/1998/Math/MathML" xmlns:xlink="http://www.w3.org/1999/xlink" xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance" xml:lang="ru"><front><journal-meta><journal-id journal-id-type="publisher-id">medsovet</journal-id><journal-title-group><journal-title xml:lang="ru">Медицинский Совет</journal-title><trans-title-group xml:lang="en"><trans-title>Meditsinskiy sovet = Medical Council</trans-title></trans-title-group></journal-title-group><issn pub-type="ppub">2079-701X</issn><issn pub-type="epub">2658-5790</issn><publisher><publisher-name>REMEDIUM GROUP Ltd.</publisher-name></publisher></journal-meta><article-meta><article-id pub-id-type="doi">10.21518/2079-701X-2022-16-9-77-83</article-id><article-id custom-type="elpub" pub-id-type="custom">medsovet-6919</article-id><article-categories><subj-group subj-group-type="heading"><subject>Research Article</subject></subj-group><subj-group subj-group-type="section-heading" xml:lang="ru"><subject>ОНКОГИНЕКОЛОГИЯ</subject></subj-group><subj-group subj-group-type="section-heading" xml:lang="en"><subject>ONCOGYNECOLOGY</subject></subj-group></article-categories><title-group><article-title>Олапариб в первой линии терапии BRCA-ассоциированного рака яичников: собственный опыт использования в программе расширенного доступа</article-title><trans-title-group xml:lang="en"><trans-title>Olaparib maintenance therapy after frontline chemotherapy in patients with BRCA-mutated ovarian cancer: real-world results in expanded access program</trans-title></trans-title-group></title-group><contrib-group><contrib contrib-type="author" corresp="yes"><contrib-id contrib-id-type="orcid">https://orcid.org/0000-0003-4443-9974</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Румянцев</surname><given-names>А. А.</given-names></name><name name-style="western" xml:lang="en"><surname>Rumyantsev</surname><given-names>A. A.</given-names></name></name-alternatives><bio xml:lang="ru"><p>Румянцев Алексей Александрович – кандидат медицинских наук, старший научный сотрудник онкологического отделения лекарственных методов лечения (химиотерапевтического) №4 отдела лекарственного лечения НИИ клинической онкологии имени академика РАН и РАМН Н.Н. Трапезникова.</p><p>115478, Москва, Каширское шоссе, д. 24.</p></bio><bio xml:lang="en"><p>Alexey А. Rumyantsev - Cand. Sci. (Med.), Senior Research Associate, Department of Chemotherapy No. 4, Blokhin National Medical Research Center of Oncology.</p><p>24, Kashirskoye Shosse, Moscow, 115478.</p></bio><email xlink:type="simple">alexeymma@gmail.com</email><xref ref-type="aff" rid="aff-1"/></contrib><contrib contrib-type="author" corresp="yes"><contrib-id contrib-id-type="orcid">https://orcid.org/0000-0002-6104-7473</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Тюляндина</surname><given-names>А. С.</given-names></name><name name-style="western" xml:lang="en"><surname>Tyulyandina</surname><given-names>A. S.</given-names></name></name-alternatives><bio xml:lang="ru"><p>Тюляндина Александра Сергеевна - доктор медицинских наук, заведующая отделением лекарственных методов лечения (химиотерапевтического) №4 отдела лекарственного лечения НИИ клинической онкологии имени академика РАН и РАМН Н.Н. Трапезникова, НМИЦ онкологии им. Н.Н. Блохина; профессор кафедры онкологии института клинической медицины имени Н.В. Склифосовского, ПМГМУ им. И.М. Сеченова (Сеченовский Университет).</p><p>115478, Москва, Каширское шоссе, д. 24; 119991, Москва, ул. Большая Пироговская, д. 6, стр. 1.</p></bio><bio xml:lang="en"><p>Alexandra S. Tyulyandina - Dr. Sci. (Med.), Head of the Department, Department of Chemotherapy No. 4, Blokhin National Medical Research Center of Oncology; Professor of the Department of Oncology, Institute of Clinical Medicine named after N.V. Sklifosovsky, Sechenov First Moscow State Medical University (Sechenov University).</p><p>24, Kashirskoye Shosse, Moscow, 115478; 6, Bldg. 1, Bolshaya Pirogovskaya St., Moscow, 119991.</p></bio><email xlink:type="simple">atjulandina@mail.ru</email><xref ref-type="aff" rid="aff-2"/></contrib><contrib contrib-type="author" corresp="yes"><contrib-id contrib-id-type="orcid">https://orcid.org/0000-0001-9864-3837</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Покатаев</surname><given-names>И. А.</given-names></name><name name-style="western" xml:lang="en"><surname>Pokataev</surname><given-names>I. A.</given-names></name></name-alternatives><bio xml:lang="ru"><p>Покатаев Илья Анатольевич – доктор медицинских наук, руководитель службы химиотерапевтического лечения.</p><p>117152, Москва, Загородное шоссе, д. 18а.</p></bio><bio xml:lang="en"><p>Ilya А. Pokataev - Dr. Sci. (Med.), Head of the Medical Oncology Department, Moscow City Clinical Cancer Hospital No. 1.</p><p>18, letter A, Zagoronoe Shosse, Moscow, 117152.</p></bio><email xlink:type="simple">pokia@mail.ru</email><xref ref-type="aff" rid="aff-3"/></contrib><contrib contrib-type="author" corresp="yes"><contrib-id contrib-id-type="orcid">https://orcid.org/0000-0002-6666-549X</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Исраелян</surname><given-names>Э. Р.</given-names></name><name name-style="western" xml:lang="en"><surname>Israelyan</surname><given-names>E. R.</given-names></name></name-alternatives><bio xml:lang="ru"><p>Исраелян Эдгар Рудикович - ординатор кафедры онкологии ФДПО.</p><p>117997, Москва, ул. Островитянова, д. 1.</p></bio><bio xml:lang="en"><p>Edgar R. Israelyan - Clinical Resident, Department of Oncology, Pirogov Russian National Research Medical University.</p><p>1, Ostrovityanov St., Moscow, 117997.</p></bio><email xlink:type="simple">e.israelyan@yandex.ru</email><xref ref-type="aff" rid="aff-4"/></contrib><contrib contrib-type="author" corresp="yes"><contrib-id contrib-id-type="orcid">https://orcid.org/0000-0003-4754-2352</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Абрамов</surname><given-names>М. Е.</given-names></name><name name-style="western" xml:lang="en"><surname>Abramov</surname><given-names>M. Е.</given-names></name></name-alternatives><bio xml:lang="ru"><p>Абрамов Михаил Евгеньевич - кандидат медицинских наук, старший научный сотрудник онкологического отделения лекарственных методов лечения (химиотерапевтического) №4 отдела лекарственного лечения НИИ клинической онкологии имени академика РАН и РАМН Н.Н. Трапезникова.</p><p>115478, Москва, Каширское шоссе, д. 24.</p></bio><bio xml:lang="en"><p>Mikhail Е. Abramov - Cand. Sci. (Med.), Senior Research Associate, Department of Chemotherapy No. 4, Blokhin National Medical Research Center of Oncology.</p><p>24, Kashirskoye Shosse, Moscow, 115478.</p></bio><email xlink:type="simple">abramovm67@mail.ru</email><xref ref-type="aff" rid="aff-1"/></contrib><contrib contrib-type="author" corresp="yes"><contrib-id contrib-id-type="orcid">https://orcid.org/0000-0002-2624-3030</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Луд</surname><given-names>А. Н.</given-names></name><name name-style="western" xml:lang="en"><surname>Lud</surname><given-names>H. N.</given-names></name></name-alternatives><bio xml:lang="ru"><p>Луд Анна Николаевна – кандидат медицинских наук, научный сотрудник онкологического отделения лекарственных методов лечения (химиотерапевтического) №4 отдела лекарственного лечения НИИ клинической онкологии имени академика РАН и РАМН Н.Н. Трапезникова.</p><p>115478, Москва, Каширское шоссе, д. 24.</p></bio><bio xml:lang="en"><p>Hanna N. Lud - Cand. Sci. (Med.), Research Associate, Department of Chemotherapy No. 4, Blokhin National Medical Research Center of Oncology.</p><p>24, Kashirskoye Shosse, Moscow, 115478.</p></bio><email xlink:type="simple">lud.anna.18@gmail.com</email><xref ref-type="aff" rid="aff-1"/></contrib><contrib contrib-type="author" corresp="yes"><contrib-id contrib-id-type="orcid">https://orcid.org/0000-0001-9807-2229</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Тюляндин</surname><given-names>С. А.</given-names></name><name name-style="western" xml:lang="en"><surname>Tyulyandin</surname><given-names>S. A.</given-names></name></name-alternatives><bio xml:lang="ru"><p>Тюляндин Сергей Алексеевич – доктор медицинских наук, профессор, главный научный сотрудник отделения лекарственных методов лечения (химиотерапевтического) №2 отдела лекарственного лечения НИИ клинической онкологии имени академика РАН и РАМН Н.Н. Трапезникова.</p><p>115478, Москва, Каширское шоссе, д. 24.</p></bio><bio xml:lang="en"><p>Sergey А. Tyulyandin - Dr. Sci. (Med.), Chief Scientific Associate, Department of Chemotherapy No. 2, Blokhin National Medical Research Center of Oncology.</p><p>24, Kashirskoye Shosse, Moscow, 115478.</p></bio><email xlink:type="simple">stjulandin@gmail.com</email><xref ref-type="aff" rid="aff-1"/></contrib></contrib-group><aff-alternatives id="aff-1"><aff xml:lang="ru"><institution>Национальный медицинский исследовательский центр онкологии имени Н.Н. Блохина</institution><country>Россия</country></aff><aff xml:lang="en"><institution>Blokhin National Medical Research Center of Oncology</institution><country>Russian Federation</country></aff></aff-alternatives><aff-alternatives id="aff-2"><aff xml:lang="ru"><institution>Национальный медицинский исследовательский центр онкологии имени Н.Н. Блохина; Первый Московский государственный медицинский университет имени И.М. Сеченова (Сеченовский Университет)</institution><country>Россия</country></aff><aff xml:lang="en"><institution>Blokhin National Medical Research Center of Oncology; Sechenov First Moscow State Medical University (Sechenov University)</institution><country>Russian Federation</country></aff></aff-alternatives><aff-alternatives id="aff-3"><aff xml:lang="ru"><institution>Городская клиническая онкологическая больница №1</institution><country>Россия</country></aff><aff xml:lang="en"><institution>Moscow City Clinical Cancer Hospital No. 1</institution><country>Russian Federation</country></aff></aff-alternatives><aff-alternatives id="aff-4"><aff xml:lang="ru"><institution>Российский национальный исследовательский медицинский университет имени Н.И. Пирогова</institution><country>Россия</country></aff><aff xml:lang="en"><institution>Pirogov Russian National Research Medical University</institution><country>Russian Federation</country></aff></aff-alternatives><pub-date pub-type="collection"><year>2022</year></pub-date><pub-date pub-type="epub"><day>18</day><month>06</month><year>2022</year></pub-date><volume>0</volume><issue>9</issue><fpage>77</fpage><lpage>83</lpage><permissions><copyright-statement>Copyright &amp;#x00A9; Румянцев А.А., Тюляндина А.С., Покатаев И.А., Исраелян Э.Р., Абрамов М.Е., Луд А.Н., Тюляндин С.А., 2022</copyright-statement><copyright-year>2022</copyright-year><copyright-holder xml:lang="ru">Румянцев А.А., Тюляндина А.С., Покатаев И.А., Исраелян Э.Р., Абрамов М.Е., Луд А.Н., Тюляндин С.А.</copyright-holder><copyright-holder xml:lang="en">Rumyantsev A.A., Tyulyandina A.S., Pokataev I.A., Israelyan E.R., Abramov M.Е., Lud H.N., Tyulyandin S.A.</copyright-holder><license xml:lang="ru" license-type="creative-commons-attribution" xlink:href="https://creativecommons.org/licenses/by/4.0/" xlink:type="simple"><license-p>Данная работа распространяется под лицензией Creative Commons Attribution 4.0.</license-p></license><license xml:lang="en" license-type="creative-commons-attribution" xlink:href="https://creativecommons.org/licenses/by/4.0/" xlink:type="simple"><license-p>This work is licensed under a Creative Commons Attribution 4.0 License.</license-p></license></permissions><self-uri xlink:href="https://www.med-sovet.pro/jour/article/view/6919">https://www.med-sovet.pro/jour/article/view/6919</self-uri><abstract><sec><title>Введение</title><p>Введение. Олапариб - единственный представитель класса ингибиторов PARP, одобренный в России для поддерживающей терапии BRCA-позитивного рака яичников после первой линии химиотерапии. Была проанализирована эффективность и безопасность применения олапариба по данному показанию в рамках реальной клинической практики.</p><p>Цель исследования - оценить эффективность ингибиторов PARP в реальной клинической практике.</p></sec><sec><title>Материалы и методы</title><p>Материалы и методы. В исследование включались пациентки с III-IV стадией BRCA-ассоциированного рака яичников, которым проводилась терапия олапарибом в рамках программы расширенного доступа с марта 2019 г. по декабрь 2020 г. Краткие критерии включения в исследование: серозный или эндометриоидный рак яичников, патогенная мутация в генах BRCA1/2, первичная или интервальная циторедукция, полный или частичный эффект после платиносодержащей химиотерапии. Терапия олапарибом проводилась в дозе 300 мг 2 раза в сутки ежедневно до завершения 2-летнего периода терапии, по окончанию которого могло быть принято решение о продолжении терапии препаратом. Первичной конечной точкой исследования была выживаемость без прогрессирования (ВБП), вторичные конечные точки включали общую выживаемость (ОВ) и безопасность терапии. Статистическая обработка данных проводилась при помощи программного обеспечения R и RStudio.</p></sec><sec><title>Результаты и обсуждение</title><p>Результаты и обсуждение. Всего в исследование было включено 23 пациентки, медиана возраста которых составила 49 лет. У всех пациенток гистологический тип опухоли соответствовал серозной аденокарциноме высокой степени злокачественности, полная циторедукция была выполнена у 30% пациенток. С медианой наблюдения в 22 мес. медианы ВБП и ОВ не были достигнуты. Показатели 2-летней ВБП и ОВ составили 65 и 84% соответственно. В период применения препарата развитие нежелательных явлений 3-4-й степени было отмечено у 7 (30,4%) пациенток.</p></sec><sec><title>Заключение</title><p>Заключение. Результаты проведенного исследования демонстрируют высокую эффективность олапариба в реальной клинической практике и поддерживают результаты регистрационного исследования применения препарата при BRCA-ассоциированном РЯ после завершения первой линии противоопухолевой терапии.</p></sec></abstract><trans-abstract xml:lang="en"><sec><title>Introduction</title><p>Introduction. Olaparib is the only PARP inhibitor approved in Russia for the maintenance therapy for BRCA-positive ovarian cancer after frontline chemotherapy. We conducted a real-world analysis of olaparib efficacy and safety for this indication.</p></sec><sec><title>Aim</title><p>Aim. To assess the efficacy of PARP inhibitors in real-world clinical practice.</p></sec><sec><title>Materials and methods</title><p>Materials and methods. Patients with stage III-IV BRCA-mutated ovarian cancer who received olaparib maintenance therapy in expanded access program in 03.2019-12.2020 timeframe. Briefly, key inclusion criteria were: serous or endometrioid highgrade ovarian cancer; pathogenic BRCA1/2 mutation; primary or interval debulking; complete or partial response to frontline platinum-based therapy. Olaparib was administered as tablets (300 mg BID) up to 2-years, disease progression or unacceptable toxicity, whichever occurred first. The primary endpoint of the study was progression-free survival (PFS), overall survival (OS) and safety were key secondary endpoints. Statistical analysis was done with R and RStudio software.</p></sec><sec><title>Results and discussion</title><p>Results and discussion. 23 patients were enrolled. Median age was 49 years, all patients had high-grade serous adenocarcinoma histology. Complete debulking at primary or interval surgery was achieved in 30% of patients. With median follow-up time equal to 22 months, median PFS and OS were not reached. The 2-year PFS and OS were 65 and 84%, respectively. Grade 3-4 adverse events was detected in 7 (30.4%) patients.</p></sec><sec><title>Conclusion</title><p>Conclusion. Our results supports high efficacy of olaparib in real clinical practice setting reported in the SOLO1 trial.</p></sec></trans-abstract><kwd-group xml:lang="ru"><kwd>олапариб</kwd><kwd>рак яичников</kwd><kwd>BRCA</kwd><kwd>поддерживающая терапия</kwd><kwd>ингибиторы PARP</kwd><kwd>клиническая практика</kwd><kwd>real-world evidence (RWE)</kwd></kwd-group><kwd-group xml:lang="en"><kwd>olaparib</kwd><kwd>ovarian cancer</kwd><kwd>BRCA</kwd><kwd>maintenance therapy</kwd><kwd>PARP inhibitors</kwd><kwd>clinical practice</kwd><kwd>real-world evidence (RWE)</kwd></kwd-group></article-meta></front><back><ref-list><title>References</title><ref id="cit1"><label>1</label><citation-alternatives><mixed-citation xml:lang="ru">Henderson J.T., Webber E.M., Sawaya G.F. Screening for Ovarian Cancer: Updated Evidence Report and Systematic Review for the US Preventive Services Task Force. 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