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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/ms2024-536</article-id><article-id custom-type="elpub" pub-id-type="custom">medsovet-8782</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>ТАРГЕТНАЯ ТЕРАПИЯ</subject></subj-group><subj-group subj-group-type="section-heading" xml:lang="en"><subject>TARGET THERAPY OF TUMORS</subject></subj-group></article-categories><title-group><article-title>Палбоциклиб в реальной клинической практике: результаты одноцентрового наблюдательного исследования</article-title><trans-title-group xml:lang="en"><trans-title>Palbociclib in real clinical practice: Results of a single-center observational study</trans-title></trans-title-group></title-group><contrib-group><contrib contrib-type="author" corresp="yes"><contrib-id contrib-id-type="orcid">https://orcid.org/0000-0003-0996-5995</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Султанбаев</surname><given-names>А. В.</given-names></name><name name-style="western" xml:lang="en"><surname>Sultanbaev</surname><given-names>A. V.</given-names></name></name-alternatives><bio xml:lang="ru"><p>Султанбаев Александр Валерьевич, к.м.н., заведующий отделом противоопухолевой лекарственной терапии; доцент кафедры педагогики и психологии</p><p>450054, Уфа, проспект Октября, д. 73/1</p><p>450000, Республика Башкортостан, Уфа, ул. Ленина, д. 3</p></bio><bio xml:lang="en"><p>Alexander V. Sultanbaev, Cand. Sci. (Med.), Head of the Department of Antitumor Drug Therapy; Associate Professor of the Department of Pedagogy and  Psychology</p><p>73/1, Oktyabrya Ave., Ufa, 450054</p><p>3, Lenin St., Ufa, 450000</p></bio><email xlink:type="simple">rkodrb@yandex.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/0000-0002-1124-6802</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Колядина</surname><given-names>И. В.</given-names></name><name name-style="western" xml:lang="en"><surname>Kolyadina</surname><given-names>I. V.</given-names></name></name-alternatives><bio xml:lang="ru"><p>Колядина Ирина Владимировна, д.м.н., профессор кафедры онкологии и паллиативной медицины</p><p>117997, Россия, Москва, ул. Академика Опарина, д. 4</p></bio><bio xml:lang="en"><p>Irina V. Kolyadina, Dr. Sci. (Med.), Professor of the Department of Oncology and Palliative Medicine,</p><p>4, Academician Oparin St., Moscow, 117997</p></bio><email xlink:type="simple">irinakolyadina@yandex.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/0000-0001-8340-7962</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Насретдинов</surname><given-names>А. Ф.</given-names></name><name name-style="western" xml:lang="en"><surname>Nasretdinov</surname><given-names>A. F.</given-names></name></name-alternatives><bio xml:lang="ru"><p>Насретдинов Айнур Фанутович, заведующий отделением противоопухолевой лекарственной терапии №2, врач-онколог</p><p>450054, Россия, Уфа, проспект Октября, д. 73/1</p></bio><bio xml:lang="en"><p>Ainur F. Nasretdinov, Head of the Department of Antitumor Drug Therapy No. 2, Oncologist</p><p>73/1, Oktyabrya Ave., Ufa, 450054</p></bio><email xlink:type="simple">rkodrb@yandex.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/0000-0003-3734-2779</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Меньшиков</surname><given-names>К. В.</given-names></name><name name-style="western" xml:lang="en"><surname>Menshikov</surname><given-names>K. V.</given-names></name></name-alternatives><bio xml:lang="ru"><p>Меньшиков Константин Викторович, к.м.н., врач-онколог отдела химиотерапии; доцент кафедры онкологии с курсами онкологии и патологической анатомии Института дополнительного профессионального образования</p><p>450054, Уфа, проспект Октября, д. 73/1</p><p>450000, Республика Башкортостан, Уфа, ул. Ленина, д. 3</p></bio><bio xml:lang="en"><p>Konstantin V. Menshikov, Cand. Sci. (Med.), Oncologist of  the Chemotherapy Department;  Associate Professor of the Department of Oncology with courses in  Oncology and Pathological Anatomy at the Institute of Additional Professional Education</p><p>73/1, Oktyabrya Ave., Ufa, 450054</p><p>3, Lenin St., Ufa, 450000</p></bio><email xlink:type="simple">kmenshikov80@bk.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/0000-0003-0988-7261</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Аскаров</surname><given-names>В. Е.</given-names></name><name name-style="western" xml:lang="en"><surname>Askarov</surname><given-names>V. E.</given-names></name></name-alternatives><bio xml:lang="ru"><p>Аскаров Вадим Евгеньевич, заведующий амбулаторным отделением противоопухолевой лекарственной терапии, врач-онколог</p><p>450054, Уфа, проспект Октября, д. 73/1</p></bio><bio xml:lang="en"><p>Vadim Е. Askarov, Head of the Outpatient Department of Antitumor Drug Therapy, Oncologist</p><p>73/1, Oktyabrya Ave., Ufa, 450054</p></bio><email xlink:type="simple">rkodrb@yandex.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/0000-0003-1185-977X</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Мусин</surname><given-names>Ш. И.</given-names></name><name name-style="western" xml:lang="en"><surname>Musin</surname><given-names>Sh. I.</given-names></name></name-alternatives><bio xml:lang="ru"><p>Мусин Шамиль Исмагилович, к.м.н., заведующий хирургическим отделением №6</p><p>450054, Уфа, проспект Октября, д. 73/1</p></bio><bio xml:lang="en"><p>Shamil I. Musin, Cand. Sci. (Med.), Head of the Surgical Department No. 6</p><p>73/1, Oktyabrya Ave., Ufa, 450054</p></bio><email xlink:type="simple">musin_shamil@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/0000-0003-0773-1239</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Ахматгареева</surname><given-names>К. Т.</given-names></name><name name-style="western" xml:lang="en"><surname>Akhmetgareeva</surname><given-names>K. T.</given-names></name></name-alternatives><bio xml:lang="ru"><p>Ахматгареева Камила Тагировна, врач-онколог отделения противоопухолевой лекарственной терапии №2</p><p>450054, Уфа, проспект Октября, д. 73/1</p></bio><bio xml:lang="en"><p>Кamila Т. Akhmеtgareeva, Oncologist of the Department of Antitumor Drug Therapy No. 2</p><p>73/1, Oktyabrya Ave., Ufa, 450054</p></bio><email xlink:type="simple">rkodrb@yandex.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/0000-0001-5926-0446</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Султанбаева</surname><given-names>Н. И.</given-names></name><name name-style="western" xml:lang="en"><surname>Sultanbaeva</surname><given-names>N. I.</given-names></name></name-alternatives><bio xml:lang="ru"><p>Султанбаева Надежда Ивановна, врач-онколог отделения противоопухолевой лекарственной терапии №1</p><p>450054, Уфа, проспект Октября, д. 73/1</p></bio><bio xml:lang="en"><p>Nadezda I. Sultanbaeva, Oncologist of the Department of Antitumor Drug Therapy No. 1</p><p>73/1, Oktyabrya Ave., Ufa, 450054 </p></bio><email xlink:type="simple">nd.sultan@rambler.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/0009-0000-8375-3953</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Забелин</surname><given-names>В. М.</given-names></name><name name-style="western" xml:lang="en"><surname>Zabelin</surname><given-names>V. M.</given-names></name></name-alternatives><bio xml:lang="ru"><p>Забелин Вадим Максимович, студент</p><p>117997, Москва, ул. Островитянова, д. 1</p></bio><bio xml:lang="en"><p>Vadim M. Zabelin, Student</p><p>1, Ostrovityanov St., Moscow, 117997</p></bio><email xlink:type="simple">zabelinvm@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/0000-0002-6769-7194</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Аюпов</surname><given-names>Р. Т.</given-names></name><name name-style="western" xml:lang="en"><surname>Ayupov</surname><given-names>R. T.</given-names></name></name-alternatives><bio xml:lang="ru"><p>Аюпов Рустем Талгатович, к.м.н., заместитель главного врача по медицинской части</p><p>450054, Уфа, проспект Октября, д. 73/1 </p></bio><bio xml:lang="en"><p>Rustam Т. Ayupov, Cand. Sci. (Med.), Deputy Chief Medical Officer</p><p>73/1, Oktyabrya Ave., Ufa, 450054 </p></bio><email xlink:type="simple">ru2003@bk.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/0000-0002-8461-9243</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Измайлов</surname><given-names>А. А.</given-names></name><name name-style="western" xml:lang="en"><surname>Izmailov</surname><given-names>A. A.</given-names></name></name-alternatives><bio xml:lang="ru"><p>Измайлов Адель Альбертович, д.м.н., главный врач</p><p>450054, Уфа, проспект Октября, д. 73/1</p></bio><bio xml:lang="en"><p>Adel А. Izmailov, Dr. Sci. (Med.), Chief Medical Officer</p><p>73/1, Oktyabrya Ave., Ufa, 450054</p></bio><email xlink:type="simple">izmailov75@mail.ru</email><xref ref-type="aff" rid="aff-3"/></contrib></contrib-group><aff-alternatives id="aff-1"><aff xml:lang="ru"><institution>Республиканский клинический онкологический диспансер; Башкирский государственный медицинский университет</institution><country>Россия</country></aff><aff xml:lang="en"><institution>Republican Clinical Oncology Dispensary; Bashkir State Medical University</institution><country>Russian Federation</country></aff></aff-alternatives><aff-alternatives id="aff-2"><aff xml:lang="ru"><institution>Российская медицинская академия непрерывного профессионального образования; Национальный медицинский исследовательский центр акушерства, гинекологии и перинатологии имени академика&#13;
В.И. Кулакова</institution><country>Россия</country></aff><aff xml:lang="en"><institution>Russian Medical Academy of Continuous Professional Education; Kulakov National Medical Research Center of Obstetrics</institution><country>Russian Federation</country></aff></aff-alternatives><aff-alternatives id="aff-3"><aff xml:lang="ru"><institution>Республиканский клинический онкологический диспансер</institution><country>Россия</country></aff><aff xml:lang="en"><institution>Republican Clinical Oncology Dispensary</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>2024</year></pub-date><pub-date pub-type="epub"><day>21</day><month>12</month><year>2024</year></pub-date><volume>0</volume><issue>21</issue><fpage>42</fpage><lpage>50</lpage><permissions><copyright-statement>Copyright &amp;#x00A9; Султанбаев А.В., Колядина И.В., Насретдинов А.Ф., Меньшиков К.В., Аскаров В.Е., Мусин Ш.И., Ахматгареева К.Т., Султанбаева Н.И., Забелин В.М., Аюпов Р.Т., Измайлов А.А., 2024</copyright-statement><copyright-year>2024</copyright-year><copyright-holder xml:lang="ru">Султанбаев А.В., Колядина И.В., Насретдинов А.Ф., Меньшиков К.В., Аскаров В.Е., Мусин Ш.И., Ахматгареева К.Т., Султанбаева Н.И., Забелин В.М., Аюпов Р.Т., Измайлов А.А.</copyright-holder><copyright-holder xml:lang="en">Sultanbaev A.V., Kolyadina I.V., Nasretdinov A.F., Menshikov K.V., Askarov V.E., Musin S.I., Akhmetgareeva K.T., Sultanbaeva N.I., Zabelin V.M., Ayupov R.T., Izmailov A.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/8782">https://www.med-sovet.pro/jour/article/view/8782</self-uri><abstract><sec><title>Введение</title><p>Введение. Прорывом в лечении метастатического гормонозависимого (HR+) рака молочной железы (мРМЖ) стала комбинированная эндокринотерапия с CDK4/6-ингибиторами, позволившая существенно пролонгировать время ответа опухоли на лечение и медиану выживаемости до прогрессирования. Эффективность комбинированной эндокринотерапии в условиях реальной практики представляет собой предмет особого внимания ввиду более широкой популяции пациентов с различным соматическим статусом и коморбидностью, нередко не включаемых в рандомизированные исследования.</p></sec><sec><title>Цель</title><p>Цель. Выполнить анализ данных реальной клинической практики по использованию палбоциклиба для лечения пациентов с HR+ HER2- мРМЖ в Республиканском клиническом онкологическом диспансере (г. Уфа).</p></sec><sec><title>Материалы и методы</title><p>Материалы и методы. Были проанализированы данные у 323 пациенток. В нашем исследовании изучена эффективность комбинированной эндокринотерапии с палбоциклибом у пациенток с метастатическим HR+HER2-раком молочной железы. Данные о клинико-патологических характеристиках пациентов и прогрессировании заболевания при приеме палбоциклиба были получены путем анализа клинических данных историй заболевания и отчетов о радиологических/патоморфологических исследованиях.</p></sec><sec><title>Результаты</title><p>Результаты. Медиана возраста пациенток, включенных в исследование, составила 62 года. При оценке противоопухолевого ответа у 54 (16,7%) пациенток был зарегистрирован частичный ответ, у 212 (65,6%) пациенток – стабилизация, у 57 (17,8%) пациенток – прогрессирование. Медиана выживаемости без прогрессирования составила 13 мес. Нежелательные явления 3-й степени были отмечены у 23 пациенток – нейтропения в 21,7% случаев, гепатотоксичность – в 47,8% случаев, кардиотоксичость – в 17,4% случаев, коагулопатия – в 4,3% случаев. Ни одна пациентка не сошла с терапии по причине нежелательных явлений. Лучшие результаты лечения имели пациентки, у которых комбинация палбоциклиба с эндокринным партнером использована в качестве первой линии лечения распространенной стадии.</p></sec><sec><title>Выводы</title><p>Выводы. Настоящий анализ реальных данных о применении палбоциклиба в реальной клинической практике подтверждает данные РКИ относительно эффективности и безопасности использования ингибиторов CDK4/6 для лечения пациентов с HR+ HER2- мРМЖ.</p></sec></abstract><trans-abstract xml:lang="en"><sec><title>Introduction</title><p>Introduction. A breakthrough in the treatment of metastatic hormone-dependent (HR+) breast cancer was combination endocrine therapy with CDK4/6 inhibitors, which significantly prolonged the tumor response time to treatment and the median survival before progression. The effectiveness of combination endocrine therapy in real-life practice is of particular interest due to the wider population of patients with different somatic status and comorbidity, often not included in randomized trials.</p></sec><sec><title>Aim</title><p>Aim. Analyze of palbociclib using for treating patients with HR+/HER2– advanced breast cancer (mBC) at the Republican Clinical Oncology Dispensary.</p></sec><sec><title>Materials and methods</title><p>Materials and methods. Data from 323 patients were analyzed. Our study examined the effectiveness of combination endocrine therapy with palbociclib in patients with metastatic HR+ HER2– breast cancer. Data on the clinicopathological characteristics of patients and disease progression during palbociclib administration were obtained by reviewing clinical data from patient records and radiological/pathological examination reports.</p></sec><sec><title>Results</title><p>Results. The median age of patients included in the study was 62 years. When assessing the antitumor response, a partial response was recorded in 54 patients (16.7%), stabilization in 212 patients (65.6%), and progression in 57 patients (17.8%). The median progression-free survival was 13 months. Grade 3 adverse events were noted in 23 patients: neutropenia in 21.7% of cases, hepatotoxicity in 47.8% of cases, cardiotoxicity in 17.4% of cases, and coagulopathy in 4.3%. No patient discontinued therapy due to adverse events. The best treatment results were achieved by patients who used the combination of palbociclib with an endocrine partner as the first line of treatment for advanced stage.</p></sec><sec><title>Conclusion</title><p>Conclusion. This analysis of real-world data on the use of palbociclib in real-world clinical practice confirms the RCT data on the efficacy and safety of using CDK4/6 inhibitors for the treatment of patients with HR+ HER2- mBC.</p></sec></trans-abstract><kwd-group xml:lang="ru"><kwd>комбинированная эндокринотерапия с палбоциклибом</kwd><kwd>CDK4/6-ингибиторы</kwd><kwd>распространенный люминальный (HR+) рак молочной железы</kwd><kwd>реальная клиническая практика</kwd></kwd-group><kwd-group xml:lang="en"><kwd>palbociclib</kwd><kwd>CDK4/6 inhibitors</kwd><kwd>breast cancer</kwd><kwd>luminal</kwd><kwd>real-world practice</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">Spring LM, Wander SA, Zangardi M, Bardia A. CDK 4/6 Inhibitors in Breast Cancer: Current Controversies and Future Directions. 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