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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">oncotomsk</journal-id><journal-title-group><journal-title xml:lang="ru">Сибирский онкологический журнал</journal-title><trans-title-group xml:lang="en"><trans-title>Siberian journal of oncology</trans-title></trans-title-group></journal-title-group><issn pub-type="ppub">1814-4861</issn><issn pub-type="epub">2312-3168</issn><publisher><publisher-name>Tomsk National Research Medical Сепtеr of the Russian Academy of Sciences</publisher-name></publisher></journal-meta><article-meta><article-id pub-id-type="doi">10.21294/1814-4861-2019-18-5-18-28</article-id><article-id custom-type="elpub" pub-id-type="custom">oncotomsk-1184</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>КЛИНИЧЕСКИЕ ИССЛЕДОВАНИЯ</subject></subj-group><subj-group subj-group-type="section-heading" xml:lang="en"><subject>CLINICAL STUDIES</subject></subj-group></article-categories><title-group><article-title>ПИЛОТНОЕ КЛИНИЧЕСКОЕ ИССЛЕДОВАНИЕ ПО МОНИТОРИНГУ ЭФФЕКТИВНОСТИ ХИМИОТЕРАПИИ ЗЛОКАЧЕСТВЕННЫХ ОПУХОЛЕЙ У ПАЦИЕНТОВ С ПОМОЩЬЮ МАРКЕРА ЭПИТЕЛИАЛЬНЫХ КАРЦИНОМ СА-62</article-title><trans-title-group xml:lang="en"><trans-title>A PILOT CLINICAL TRIAL TO MONITOR RESPONSE TO CHEMOTHERAPY USING THE CA-62 MARKER OF EPITHELIAL CARCINOMAS</trans-title></trans-title-group></title-group><contrib-group><contrib contrib-type="author" corresp="yes"><contrib-id contrib-id-type="orcid">https://orcid.org/0000-0002-4970-5429</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Хакимова</surname><given-names>Г. Г.</given-names></name><name name-style="western" xml:lang="en"><surname>Khakimova</surname><given-names>G. G.</given-names></name></name-alternatives><bio xml:lang="ru"><p>Хакимова Гульноз Голибовна, аспирант отделения химиотерапии и комбинированного лечения злокачественных опухолей</p><p>г. Москва, 115478, Каширское шоссе, 23</p><p>SPIN-код: 6939-8668</p></bio><bio xml:lang="en"><p>Gulnoz G. Khakimova, Postgraduate, Chemotherapy Department</p><p>23, Kashirskoye Shosse, Moscow, 115478</p></bio><email xlink:type="simple">hgg_doc@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/0000-0002-9074-7233</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Черкасова</surname><given-names>Ж. Р.</given-names></name><name name-style="western" xml:lang="en"><surname>Cherkasova</surname><given-names>Zh. R.</given-names></name></name-alternatives><bio xml:lang="ru"><p>Черкасова Жаннета Рашидовна, кандидат химических наук, ведущий научный сотрудник, заведующая лабораторией онкомаркеров и новых методов диагностики опухолей</p><p>г. Москва, 143026, Б. Бульвар, 42/12 </p><p>SPIN-код: 4166-2280</p><p>Author ID (Scopus): 51162065700</p></bio><bio xml:lang="en"><p>Zhanetta R. Cherkasova, PhD, Leading Researcher, Head of the Laboratory of Cancer Markers and New Diagnostic Methods</p><p>42/1, B. Bulvar, Moscow 143026</p><p>Author ID (Scopus): 51162065700.</p></bio><xref ref-type="aff" rid="aff-2"/></contrib><contrib contrib-type="author" corresp="yes"><contrib-id contrib-id-type="orcid">https://orcid.org/0000-0002-0030-1802</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Цуркан</surname><given-names>С. А.</given-names></name><name name-style="western" xml:lang="en"><surname>Tsurkan</surname><given-names>S. A.</given-names></name></name-alternatives><bio xml:lang="ru"><p>Цуркан Сергей Александрович, кандидат фармацевтических наук, ведущий научный сотрудник лаборатории онкомаркеров и новых методов диагностики опухолей</p><p>г. Москва, 143026, Б. Бульвар, 42/12 </p><p>SPIN-код: 5645-2279</p><p>Author ID (РИНЦ): 947434</p></bio><bio xml:lang="en"><p>Sergey A. Tsurkan, PhD, Leading Researcher, Head of the Laboratory of Cancer Markers and New Diagnostic Methods</p><p>42/1, B. Bulvar, Moscow 143026</p></bio><xref ref-type="aff" rid="aff-2"/></contrib><contrib contrib-type="author" corresp="yes"><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Федчиков</surname><given-names>Г. А.</given-names></name><name name-style="western" xml:lang="en"><surname>Fedchikov</surname><given-names>G. A.</given-names></name></name-alternatives><bio xml:lang="ru"><p>Федчиков Глеб Александрович, инженер-исследователь лаборатории онкомаркеров и новых методов диагностики опухолей</p><p>г. Москва, 143026, Б. Бульвар, 42/12  </p></bio><bio xml:lang="en"><p>Gleb A. Fedchikov, Research engineer, Laboratory of Cancer Markers and New Diagnostic Methods</p><p>42/1, B. Bulvar, Moscow 143026</p></bio><xref ref-type="aff" rid="aff-2"/></contrib><contrib contrib-type="author" corresp="yes"><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Суганов</surname><given-names>Н. В.</given-names></name><name name-style="western" xml:lang="en"><surname>Suganov</surname><given-names>N. V.</given-names></name></name-alternatives><bio xml:lang="ru"><p>Суганов Николай Валерьевич, хирург, врач-исследователь лаборатории онкомаркеров и новых методов диагностики опухолей</p><p>г. Москва, 143026, Б. Бульвар, 42/12  </p></bio><bio xml:lang="en"><p>Nikolay V. Suganov, MD, Surgeon, Laboratory of Cancer Markers and New Diagnostic Methods</p><p>42/1, B. Bulvar, Moscow 143026</p></bio><xref ref-type="aff" rid="aff-2"/></contrib><contrib contrib-type="author" corresp="yes"><contrib-id contrib-id-type="orcid">https://orcid.org/0000-0003-0703-2550</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Горбунова</surname><given-names>В. А.</given-names></name><name name-style="western" xml:lang="en"><surname>Gorbunova</surname><given-names>V. A.</given-names></name></name-alternatives><bio xml:lang="ru"><p>Горбунова Вера Андреевна, доктор медицинских наук, профессор, ведущий научный сотрудник отделения химиотерапии и комбинированного лечения злокачественных опухолей</p><p>г. Москва, 115478, Каширское шоссе, 23</p><p>Author ID (РИНЦ): 140309</p></bio><bio xml:lang="en"><p>Vera A. Gorbunova, MD, DSc, Professor, Leading Researcher, Chemotherapy Department</p><p>23, Kashirskoye Shosse, Moscow, 115478</p></bio><xref ref-type="aff" rid="aff-1"/></contrib></contrib-group><aff-alternatives id="aff-1"><aff xml:lang="ru"><institution>ФГБУ «НМИЦ онкологии имени Н.Н. Блохина» Минздрава России</institution><country>Россия</country></aff><aff xml:lang="en"><institution>N.N. 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>ООО «Джейвис Диагностикс» - Инновационный центр Сколково</institution><country>Россия</country></aff><aff xml:lang="en"><institution>Javis Diagnostics LLC, Skolkovo Innovation Center</institution><country>Russian Federation</country></aff></aff-alternatives><pub-date pub-type="collection"><year>2019</year></pub-date><pub-date pub-type="epub"><day>30</day><month>10</month><year>2019</year></pub-date><volume>18</volume><issue>5</issue><fpage>18</fpage><lpage>28</lpage><permissions><copyright-statement>Copyright &amp;#x00A9; Хакимова Г.Г., Черкасова Ж.Р., Цуркан С.А., Федчиков Г.А., Суганов Н.В., Горбунова В.А., 2019</copyright-statement><copyright-year>2019</copyright-year><copyright-holder xml:lang="ru">Хакимова Г.Г., Черкасова Ж.Р., Цуркан С.А., Федчиков Г.А., Суганов Н.В., Горбунова В.А.</copyright-holder><copyright-holder xml:lang="en">Khakimova G.G., Cherkasova Z.R., Tsurkan S.A., Fedchikov G.A., Suganov N.V., Gorbunova V.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.siboncoj.ru/jour/article/view/1184">https://www.siboncoj.ru/jour/article/view/1184</self-uri><abstract><p>Цель исследования – оценка возможности использования контроля динамики сывороточного инновационного маркера эпителиальных карцином СА-62 для мониторинга лечения, выявления прогрессирования или стабилизации опухолевого процесса, а также для выявления рецидивов у пациентов в процессе химиотерапии.</p><sec><title>Материал и методы</title><p>Материал и методы. Исследование проводилось в течение 12 мес двумя независимыми группами – клиническими онкологами и биохимиками в «двойном ослепленном» режиме. В пилотное клиническое исследование были включены 89 пациентов, имеющих различные солидные опухоли (рак желудка, мелкоклеточный рак легкого, колоректальный рак, нейроэндокринные опухоли и др.), подтвержденные результатами морфологического исследования, с наличием хотя бы одного измеряемого очага по критериям RECIST , состоянием на момент включения по ECOG 0–2 и удовлетворительными лабораторными показателями. Экспрессия онкомаркера СА-62 определялась при помощи опытного образца иммунохемилюминесцентного анализа «ИХА-СА-62», разработанного для выявления онкологических заболеваний эпителиального генеза, методом импульсной хемилюминесценции.</p></sec><sec><title>Результаты</title><p>Результаты. До лечения повышенный уровень биомаркера СА62 наблюдался у 76 % пациентов, который после химиотерапии снизился до нормальных референтных значений (&lt;4600 Ед/мл) у 53 % больных, у 23 % пациентов он оставался повышенным. Из 24 % пациентов с изначально низким уровнем биомаркера (1000–4000 Ед/мл) у 12 % не наблюдалось изменений экспрессии СА-62 в ходе химиотерапии. После начала лечения у 5 % этой группы наблюдалось прогрессирование заболевания, у 7 % пациентов была достигнута стабилизация. У 12 % пациентов с изначально низким уровнем СА-62 наблюдался рост уровня онкомаркера в ходе лечения, что соответствовало прогрессированию заболевания.</p></sec><sec><title>Заключение</title><p>Заключение. Динамика изменений маркера СА-62 в ходе химиотерапии у больных раком желудка, мелкоклеточным раком, колоректальным раком, нейроэндокринными опухолями и раком яичников показала хорошую корреляцию (76–100 % в зависимости от локализации опухоли) с общим состоянием пациентов, согласно критериям RECIST . Показана возможность использования инновационного маркера эпителиальных карцином СА-62 для мониторинга, а также оценки проводимого системного лечения.</p></sec></abstract><trans-abstract xml:lang="en"><p>The objective of the study was to assess the feasibility of using CA -62 marker of epithelial carcinomas for monitoring treatment response and detecting cancer progression or recurrence during chemotherapy.</p><sec><title>Material and Methods</title><p>Material and Methods. A 12-month double-blind clinical trial was conducted by two independent groups: clinical oncologists and biochemists, and involved 89 patients with different cancers confirmed by histopathological findings. The other inclusion criteria were: the presence of at least one measurable lesion according to the RECIST criteria, ECOG performance status 0-2 and satisfactory laboratory parameters. The expression of CA -62 cancer marker was measured by immunochemiluminescent assay used for the detection of epithelial carcinomas.</p></sec><sec><title>Results</title><p>Results. The elevated level of CA -62 marker was observed in 76 patients before starting the treatment. After completion chemotherapy, the level of this marker decreased to the normal reference ranges (&lt;4600 U/ml) in 53 % of patients and remained increased in 24 % of patients. Of 24 % of patients with the initial low level of CA -62 marker (1000–4000 U/ml) before treatment, 12 % had no changes in the level of this marker during chemotherapy; however, 5 % of these patients had disease progression and 7 % had stable disease after starting the treatment. In 12 % of patients with an initial low CA -62 level, it increased during chemotherapy, indicating disease progression.</p></sec><sec><title>Conclusion</title><p>Conclusion. The changes in the level of CA -62 marker during chemotherapy in patients with gastric cancer, small-cell lung cancer, colorectal cancer, neuroendocrine cancer and ovarian cancer showed a high correlation (76–100 % depending on the tumor site) with the performance status of the patients according to RECIST criteria. The CA -62 marker was shown to be feasible for monitoring gastric cancer, small-cell lung cancer, colorectal cancer, neuroendocrine cancer and ovarian cancer as well as for assessing the response to chemotherapy.</p></sec></trans-abstract><kwd-group xml:lang="ru"><kwd>химиотерапия</kwd><kwd>рак желудка</kwd><kwd>мелкоклеточный рак легкого</kwd><kwd>колоректальный рак</kwd><kwd>рак яичников</kwd><kwd>нейроэндокринные опухоли</kwd><kwd>раковый антиген СА-62</kwd><kwd>иммунохемилюминесцентный анализ</kwd><kwd>онкомаркер</kwd><kwd>мониторинг</kwd><kwd>стабилизация</kwd><kwd>прогрессирование</kwd></kwd-group><kwd-group xml:lang="en"><kwd>chemotherapy</kwd><kwd>gastric cancer</kwd><kwd>small-cell lung cancer</kwd><kwd>colorectal cancer</kwd><kwd>neuroendocrine cancer</kwd><kwd>ovarian cancer</kwd><kwd>СА-62 cancer antigen</kwd><kwd>immunochemiluminescent assay</kwd><kwd>cancer marker</kwd><kwd>monitoring</kwd><kwd>stable disease</kwd><kwd>disease progression</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">Jackson S.E., Chester J.D. 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