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<article 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" xmlns:ali="http://www.niso.org/schemas/ali/1.0/" article-type="other" dtd-version="1.2" xml:lang="en"><front><journal-meta><journal-id journal-id-type="publisher-id">Tumors of female reproductive system</journal-id><journal-title-group><journal-title xml:lang="en">Tumors of female reproductive system</journal-title><trans-title-group xml:lang="ru"><trans-title>Опухоли женской репродуктивной системы</trans-title></trans-title-group></journal-title-group><issn publication-format="print">1994-4098</issn><issn publication-format="electronic">1999-8627</issn><publisher><publisher-name xml:lang="en">Publishing House ABV Press</publisher-name></publisher></journal-meta><article-meta><article-id pub-id-type="publisher-id">1169</article-id><article-id pub-id-type="doi">10.17650/1994-4098-2023-19-4-104-113</article-id><article-categories><subj-group subj-group-type="toc-heading" xml:lang="en"><subject>GYNECOLOGY. ORIGINAL REPORTS</subject></subj-group><subj-group subj-group-type="toc-heading" xml:lang="ru"><subject>ГИНЕКОЛОГИЯ. ОРИГИНАЛЬНЫЕ СТАТЬИ</subject></subj-group><subj-group subj-group-type="article-type"><subject></subject></subj-group></article-categories><title-group><article-title xml:lang="en">Efficacy and safety of lenvatinib and pembrolizumab in the treatment of endometrial cancer: data from routine clinical practice in Russia</article-title><trans-title-group xml:lang="ru"><trans-title>Эффективность и безопасность ленватиниба и пембролизумаба в лечении рака эндометрия: данные реальной клинической практики в России</trans-title></trans-title-group></title-group><contrib-group><contrib contrib-type="author"><contrib-id contrib-id-type="orcid">https://orcid.org/0000-0003-4443-9974</contrib-id><name-alternatives><name xml:lang="en"><surname>Rumyantsev</surname><given-names>A. A.</given-names></name><name xml:lang="ru"><surname>Румянцев</surname><given-names>А. А.</given-names></name></name-alternatives><address><country country="RU">Russian Federation</country></address><bio xml:lang="en"><p>Aleksey Aleksandrovich Rumyantsev</p><p>24 Kashirskoe Shosse, Moscow 115522</p></bio><bio xml:lang="ru"><p>Алексей Александрович Румянцев</p><p>115522 Москва, Каширское шоссе, 24</p></bio><email>alexeymma@gmail.com</email><xref ref-type="aff" rid="aff1"/></contrib><contrib contrib-type="author"><contrib-id contrib-id-type="orcid">https://orcid.org/0000-0001-7930-8048</contrib-id><name-alternatives><name xml:lang="en"><surname>Protasova</surname><given-names>A. E.</given-names></name><name xml:lang="ru"><surname>Протасова</surname><given-names>А. Э.</given-names></name></name-alternatives><address><country country="RU">Russian Federation</country></address><bio xml:lang="en"><p>7–9 Universitetskaya Naberezhnaya, Saint Petersburg 199034;</p><p>41 Kirochnaya St., Saint Petersburg 191015;</p><p>2 Akkuratova St., Saint Petersburg 197341;</p><p>Bld. 2, 4 Ilyushina St., Saint Petersburg 196634</p></bio><bio xml:lang="ru"><p>199034 Санкт-Петербург, Университетская набережная, 7–9;</p><p>191015 Санкт-Петербург, ул. Кирочная, 41;</p><p>197341 Санкт-Петербург, ул. Аккуратова, 2;</p><p>196634 Санкт-Петербург, ул. Ильюшина, 4, корп. 2</p></bio><xref ref-type="aff" rid="aff2"/><xref ref-type="aff" rid="aff3"/><xref ref-type="aff" rid="aff4"/><xref ref-type="aff" rid="aff5"/></contrib><contrib contrib-type="author"><contrib-id contrib-id-type="orcid">https://orcid.org/0009-0008-4392-0700</contrib-id><name-alternatives><name xml:lang="en"><surname>Sheremet</surname><given-names>M. 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Kh.</given-names></name><name xml:lang="ru"><surname>Абдулоева</surname><given-names>Н. Х.</given-names></name></name-alternatives><address><country country="RU">Russian Federation</country></address><bio xml:lang="en"><p>68A Leningradskaya St., Pesochnyy Settlement, Saint Petersburg 197758</p></bio><bio xml:lang="ru"><p>197758 Санкт-Петербург, пос. Песочный, Ленинградская ул., 68А</p></bio><xref ref-type="aff" rid="aff28"/></contrib><contrib contrib-type="author"><contrib-id contrib-id-type="orcid">https://orcid.org/0009-0002-0240-6656</contrib-id><name-alternatives><name xml:lang="en"><surname>Lebedinets</surname><given-names>A. A.</given-names></name><name xml:lang="ru"><surname>Лебединец</surname><given-names>А. 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Ильюшина, 4, корп. 2</p></bio><xref ref-type="aff" rid="aff5"/></contrib><contrib contrib-type="author"><name-alternatives><name xml:lang="en"><surname>Semenov</surname><given-names>L. K.</given-names></name><name xml:lang="ru"><surname>Семенов</surname><given-names>Л. К.</given-names></name></name-alternatives><address><country country="RU">Russian Federation</country></address><bio xml:lang="en"><p>37–39 Liteynyy Prospect, Saint Petersburg 191104</p></bio><bio xml:lang="ru"><p>191104 Санкт-Петербург, Литейный проспект, 37–39</p></bio><xref ref-type="aff" rid="aff14"/></contrib><contrib contrib-type="author"><name-alternatives><name xml:lang="en"><surname>Bolieva</surname><given-names>M. B.</given-names></name><name xml:lang="ru"><surname>Болиева</surname><given-names>М. Б.</given-names></name></name-alternatives><address><country country="RU">Russian Federation</country></address><bio xml:lang="en"><p>2 Zortova St., Vladikavkaz 362002</p></bio><bio xml:lang="ru"><p>362002 Владикавказ, ул. Зортова, 2</p></bio><xref ref-type="aff" rid="aff29"/></contrib><contrib contrib-type="author"><name-alternatives><name xml:lang="en"><surname>Aydaeva</surname><given-names>F. Z.</given-names></name><name xml:lang="ru"><surname>Айдаева</surname><given-names>Ф. З.</given-names></name></name-alternatives><address><country country="RU">Russian Federation</country></address><bio xml:lang="en"><p>81 Leonova St., Grozny 364029</p></bio><bio xml:lang="ru"><p>364029 Грозный, ул. Леонова, 81</p></bio><xref ref-type="aff" rid="aff13"/></contrib></contrib-group><aff-alternatives id="aff1"><aff><institution xml:lang="en">N.N. Blokhin National Medical Research Center of Oncology, Ministry of Health of Russia</institution></aff><aff><institution xml:lang="ru">ФГБУ «Национальный медицинский исследовательский центр онкологии им. Н.Н. Блохина» Минздрава России</institution></aff></aff-alternatives><aff-alternatives id="aff2"><aff><institution xml:lang="en">Saint Petersburg State University</institution></aff><aff><institution xml:lang="ru">ФГБОУ ВО «Санкт-Петербургский государственный университет»</institution></aff></aff-alternatives><aff-alternatives id="aff3"><aff><institution xml:lang="en">I.I. Mechnikov North-Western State Medical University, Ministry of Health of Russia</institution></aff><aff><institution xml:lang="ru">ФГБОУ ВО «Северо-Западный государственный медицинский университет им. И.И. Мечникова» Минздрава России</institution></aff></aff-alternatives><aff-alternatives id="aff4"><aff><institution xml:lang="en">V.A. Almazov National Medical Research Centre, Ministry of Health of Russia</institution></aff><aff><institution xml:lang="ru">ФГБУ «Национальный медицинский исследовательский центр им. В.А. Алмазова» Минздрава России</institution></aff></aff-alternatives><aff-alternatives id="aff5"><aff><institution xml:lang="en">AVA-PETER LLC</institution></aff><aff><institution xml:lang="ru">ООО «АВА-ПЕТЕР»</institution></aff></aff-alternatives><aff-alternatives id="aff6"><aff><institution xml:lang="en">Clinical Oncology Dispensary No. 1, Ministry of Health of Krasnodar Region</institution></aff><aff><institution xml:lang="ru">ГБУЗ «Клинический онкологический диспансер № 1» Минздрава Краснодарского края</institution></aff></aff-alternatives><aff-alternatives id="aff7"><aff><institution xml:lang="en">Kuban State Medical University</institution></aff><aff><institution xml:lang="ru">ФГБОУ ВО «Кубанский государственный медицинский университет» Минздрава России</institution></aff></aff-alternatives><aff-alternatives id="aff8"><aff><institution xml:lang="en">Moscow City Oncology Hospital No. 62, Moscow Healthcare Department</institution></aff><aff><institution xml:lang="ru">ГБУЗ «Московская городская онкологическая больница № 62 Департамента здравоохранения г. Москвы»</institution></aff></aff-alternatives><aff-alternatives id="aff9"><aff><institution xml:lang="en">Federal Research and Clinical Center for Specialized Medical Care and Medical Technologies, Federal Biomedical Agency of the Russian&#13;
Federation</institution></aff><aff><institution xml:lang="ru">ФГБУ «Федеральный научно-клинический центр специализированных видов медицинской помощи и  медицинских технологий Федерального медико-биологического агентства России»</institution></aff></aff-alternatives><aff-alternatives id="aff10"><aff><institution xml:lang="en">Academy of Postgraduate Education, Federal Research and Clinical Center for Specialized Medical Care and Medical Technologies, Federal Biomedical Agency of the Russian Federation</institution></aff><aff><institution xml:lang="ru">Академия последипломного образования ФГБУ «Федеральный научно-клинический центр специализированных видов медицинской помощи и медицинских технологий Федерального медико-биологического агентства России»</institution></aff></aff-alternatives><aff-alternatives id="aff11"><aff><institution xml:lang="en">Moscow Regional Oncology Dispensary</institution></aff><aff><institution xml:lang="ru">КДЦ ГБУЗ МО «Московский областной онкологический диспансер»</institution></aff></aff-alternatives><aff-alternatives id="aff12"><aff><institution xml:lang="en">Lyubertsy Oncology Dispensary</institution></aff><aff><institution xml:lang="ru">ГБУЗ МО «Люберецкий онкологический диспансер»</institution></aff></aff-alternatives><aff-alternatives id="aff13"><aff><institution xml:lang="en">Republican Oncology Dispensary, Ministry of Health of Chechen Republic</institution></aff><aff><institution xml:lang="ru">ГБУ «Республиканский онкологический диспансер» Минздрава Чеченской Республики</institution></aff></aff-alternatives><aff-alternatives id="aff14"><aff><institution xml:lang="en">Leningrad Regional Clinical Oncology Dispensary</institution></aff><aff><institution xml:lang="ru">ГБУЗ «Ленинградский областной клинический онкологический диспансер»</institution></aff></aff-alternatives><aff-alternatives id="aff15"><aff><institution xml:lang="en">Moscow Multidisciplinary Clinical Center “Kommunarka”, Moscow Healthcare Department</institution></aff><aff><institution xml:lang="ru">Московский многопрофильный клинический центр «Коммунарка» Департамента здравоохранения г. Москвы</institution></aff></aff-alternatives><aff-alternatives id="aff16"><aff><institution xml:lang="en">City Clinical Oncology Hospital No. 1, Moscow Healthcare Department</institution></aff><aff><institution xml:lang="ru">ГБУЗ «Городская клиническая онкологическая больница № 1 Департамента здравоохранения г. Москвы»</institution></aff></aff-alternatives><aff-alternatives id="aff17"><aff><institution xml:lang="en">A.S. Loginov Moscow Clinical Research Center, Moscow Healthcare Department</institution></aff><aff><institution xml:lang="ru">ГБУЗ «Московский клинический научный центр им. А.С. Логинова Департамента здравоохранения г. Москвы»</institution></aff></aff-alternatives><aff-alternatives id="aff18"><aff><institution xml:lang="en">Oncology Dispensary of Shakhty</institution></aff><aff><institution xml:lang="ru">ГБУ РО «Онкодиспансер» в г. Шахты</institution></aff></aff-alternatives><aff-alternatives id="aff19"><aff><institution xml:lang="en">Mozhaisk Central District Hospital</institution></aff><aff><institution xml:lang="ru">ГБУЗ МО «Можайская центральная районная больница»</institution></aff></aff-alternatives><aff-alternatives id="aff20"><aff><institution xml:lang="en">National Medical Research Center, Treatment and Rehabilitation Center, Ministry of Health of Russia</institution></aff><aff><institution xml:lang="ru">ФГАУ «Национальный медицинский исследовательский центр «Лечебно-реабилитационный центр» Минздрава России</institution></aff></aff-alternatives><aff-alternatives id="aff21"><aff><institution xml:lang="en">B.V. Petrovskiy Russian Research Center of Surgery</institution></aff><aff><institution xml:lang="ru">ФГБНУ «Российский научный центр хирургии им. акад. Б.В. Петровского»</institution></aff></aff-alternatives><aff-alternatives id="aff22"><aff><institution xml:lang="en">Domodedovo Hospital</institution></aff><aff><institution xml:lang="ru">ГБУЗ МО «Домодедовская больница»</institution></aff></aff-alternatives><aff-alternatives id="aff23"><aff><institution xml:lang="en">Dr. Laskov’s Clinic</institution></aff><aff><institution xml:lang="ru">Клиника доктора Ласкова</institution></aff></aff-alternatives><aff-alternatives id="aff24"><aff><institution xml:lang="en">S.P. Botkin City Clinical Hospital, Moscow Healthcare Department</institution></aff><aff><institution xml:lang="ru">ГБУЗ «Городская клиническая больница им. С.П. Боткина Департамента здравоохранения г. Москвы»</institution></aff></aff-alternatives><aff-alternatives id="aff25"><aff><institution xml:lang="en">City Hospital No. 1</institution></aff><aff><institution xml:lang="ru">МБУЗ «Городская больница № 1»</institution></aff></aff-alternatives><aff-alternatives id="aff26"><aff><institution xml:lang="en">Tula Regional Oncology Dispensary</institution></aff><aff><institution xml:lang="ru">ГУЗ «Тульский областной онкологический диспансер»</institution></aff></aff-alternatives><aff-alternatives id="aff27"><aff><institution xml:lang="en">Regional Clinical Oncology Dispensary</institution></aff><aff><institution xml:lang="ru">ГБУЗ «Областной клинический онкологический диспансер»</institution></aff></aff-alternatives><aff-alternatives id="aff28"><aff><institution xml:lang="en">N.P. Napalkov Saint Petersburg Clinical Research and Practical Center for Specialized Medical Care (Oncology)</institution></aff><aff><institution xml:lang="ru">ГБУЗ «Санкт-Петербургский клинический научно-практический центр специализированных видов медицинской помощи (онкологический) им. Н.П. Напалкова»</institution></aff></aff-alternatives><aff-alternatives id="aff29"><aff><institution xml:lang="en">Republican Oncology Dispensary, Ministry of Health of the Republic of North Ossetia – Alania</institution></aff><aff><institution xml:lang="ru">ГБУЗ «Республиканский онкологический диспансер» Минздрава Республики Северная Осетия – Алания</institution></aff></aff-alternatives><pub-date date-type="pub" iso-8601-date="2023-12-20" publication-format="electronic"><day>20</day><month>12</month><year>2023</year></pub-date><volume>19</volume><issue>4</issue><issue-title xml:lang="en"/><issue-title xml:lang="ru"/><fpage>104</fpage><lpage>113</lpage><history><date date-type="received" iso-8601-date="2024-01-20"><day>20</day><month>01</month><year>2024</year></date><date date-type="accepted" iso-8601-date="2024-01-20"><day>20</day><month>01</month><year>2024</year></date></history><permissions><copyright-year>2023</copyright-year><ali:free_to_read xmlns:ali="http://www.niso.org/schemas/ali/1.0/"/></permissions><self-uri xlink:href="https://ojrs.abvpress.ru/ojrs/article/view/1169">https://ojrs.abvpress.ru/ojrs/article/view/1169</self-uri><abstract xml:lang="en"><p><bold>Aim</bold>. To assess the efficacy and safety of lenvatinib and pembrolizumab for the treatment of mismatch repair-proficient endometrial cancer (EC) in routine clinical practice in Russia.<bold>Materials and methods</bold>. This multicenter, retrospective, cohort study included patients with recurrent and metastatic EC from 37 cancer centers in Russia treated between May 2020 and April 2023. Patients with histologically verified EC without microsatellite instability who received ≥1 course of pembrolizumab/lenvatinib therapy were included in the study. The primary endpoint was progression-free survival; the clinical characteristics of the patients were additionally analyzed, the objective response rate and the toxicity profile of therapy were assessed.<bold>Results</bold>. The study included 100 patients. Median age was 65 (30–83) years. The most common histologic tumor subtype was endometrioid adenocarcinoma (68 %); serous adenocarcinoma was diagnosed in 22 % of cases, other types of tumor – 10 % of cases. All patients had pMMR/microsatellite-stable tumors. The median progression-free survival was 7.75 months (95 % confidence interval 0.7–33.8), and a partial response to therapy was observed in 24 % of patients. Almost half of the patients (44 %) required dose reduction due to adverse events. The most common adverse events included fatigue (n = 26; 26 %), hypertension (n = 20; 20 %), and hypothyroidism (n = 14; 14 %).<bold>Conclusion</bold>. This study confirms the clinical efficacy of lenvatinib and pembrolizumab in patients with recurrent and metastatic EC without mismatch repair system deficiency (pMMR-tumors) in routine clinical practice.</p></abstract><trans-abstract xml:lang="ru"><p><bold>Цель исследования</bold> – оценить эффективность и безопасность терапии ленватинибом и пембролизумабом для лечения рака эндометрия (РЭ) с профицитом системы репарации (proficient mismatch repair, pMMR) в рутинной практике в России.<bold>Материалы и методы</bold>. Проведено многоцентровое ретроспективное когортное исследование, включившее данные лечения рецидивирующего и метастатического РЭ пациенток из 37 онкологических центров в России с мая 2020 г. по апрель 2023 г. Включались пациентки с гистологически верифицированным РЭ без признаков микросателлитной нестабильности, получившие ≥1 курса терапии пембролизумабом/ленватинибом. Первичной конечной точкой исследования была выживаемость без прогрессирования, дополнительно проанализированы клинические характеристики пациенток, оценены частота объективного ответа и профиль токсичности терапии.<bold>Результаты</bold>. В исследование было включено 100 пациенток. Медиана возраста составила 65 (30–83) лет. Наиболее частым гистологическим подтипом опухоли была эндометриоидная аденокарцинома (68 %); серозная аденокарцинома отмечена в 22 % случаев, другие типы опухоли – в 10 %. Все пациентки имели профицит системы репарации/ микросателлитно-стабильную опухоль. Медиана выживаемости без прогрессирования составила 7,75 мес (95 % доверительный интервал 0,7–33,8), частичный ответ на терапию отмечен у 24 % пациенток. Во время лечения частота редукции дозы по причине нежелательных явлений составила 44 %. Наиболее частыми нежелательными явлениями были слабость у 26 (26 %) пациенток, артериальная гипертензия у 20 (20 %) пациенток и гипотиреоз у 14 (14 %) пациенток.<bold>Выводы</bold>. В проведенном исследовании реальной клинической практики в России у больных рецидивирующим и метастатическим РЭ без дефицита системы репарации (pMMR-опухоли), прошедших терапию ленватинибом и пембролизумабом, получено подтверждение клинической эффективности и управляемости лечением.</p></trans-abstract><kwd-group xml:lang="en"><kwd>targeted therapy</kwd><kwd>pembrolizumab</kwd><kwd>lenvatinib</kwd><kwd>endometrial cancer</kwd><kwd>routine clinical practice</kwd></kwd-group><kwd-group xml:lang="ru"><kwd>иммунотаргетная терапия</kwd><kwd>пембролизумаб</kwd><kwd>ленватиниб</kwd><kwd>рак эндометрия</kwd><kwd>реальная клиническая практика</kwd></kwd-group><funding-group><funding-statement xml:lang="en">The article was published with the financial support of Eisai Co., Ltd.</funding-statement><funding-statement xml:lang="ru">Данная публикация выпущена при финансовой поддержке ООО «Эйсай».</funding-statement></funding-group></article-meta></front><body></body><back><ref-list><ref id="B1"><label>1.</label><citation-alternatives><mixed-citation xml:lang="en">Malignant tumors in Russia in 2021 (incidence and mortality). 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