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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">tumors</journal-id><journal-title-group><journal-title xml:lang="ru">Malignant tumours</journal-title><trans-title-group xml:lang="en"><trans-title>Malignant tumours</trans-title></trans-title-group></journal-title-group><issn pub-type="ppub">2224-5057</issn><issn pub-type="epub">2587-6813</issn><publisher><publisher-name>Rosoncoweb</publisher-name></publisher></journal-meta><article-meta><article-id pub-id-type="doi">10.18027/2224-5057-2019-9-1-10-15</article-id><article-id custom-type="elpub" pub-id-type="custom">tumors-604</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>ОРИГИНАЛЬНЫЕ ИССЛЕДОВАНИЯ</subject></subj-group><subj-group subj-group-type="section-heading" xml:lang="en"><subject>ORIGINAL REPORTS</subject></subj-group></article-categories><title-group><article-title>Оценка экспрессии PD-L1 у пациентов с уротелиальным раком, имеющих противопоказания к назначению препаратов платины</article-title><trans-title-group xml:lang="en"><trans-title>Assessment of PD-L1 expression in patients with urothelial cancer with contraindications to platinum based therapy</trans-title></trans-title-group></title-group><contrib-group><contrib contrib-type="author" corresp="yes"><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Завалишина</surname><given-names>Л. Э.</given-names></name><name name-style="western" xml:lang="en"><surname>Zavalishina</surname><given-names>L. E.</given-names></name></name-alternatives><bio xml:lang="ru"><p>Лариса Э. Завалишина, доктор биологических наук, профессор кафедры патологической анатомии </p><p>Москва</p></bio><bio xml:lang="en"><p>Larisa E. Zavalishina, MD, DSc Biol, Professor, Anatomic Pathology Department </p><p>Moscow</p></bio><email xlink:type="simple">zavalishina1@mail.ru</email><xref ref-type="aff" rid="aff-1"/></contrib><contrib contrib-type="author" corresp="yes"><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Повилайтите</surname><given-names>П. Е.</given-names></name><name name-style="western" xml:lang="en"><surname>Povilaitite</surname><given-names>P. E.</given-names></name></name-alternatives><bio xml:lang="ru"><p>Патриция Э. Повилайтите, доктор биологических наук, руководитель </p><p>Ростов-на-Дону</p></bio><bio xml:lang="en"><p>Patricia E. Povilaitite, MD, DSc Biol</p><p>Rostov-on‑Don</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>Раскин</surname><given-names>Г. А.</given-names></name><name name-style="western" xml:lang="en"><surname>Raskin</surname><given-names>G. A.</given-names></name></name-alternatives><bio xml:lang="ru"><p>Григорий А. Раскин, доктор медицинских наук, руководитель отдела патологической анатомии </p><p>Санкт-Петербург</p><p> </p></bio><bio xml:lang="en"><p>Grigori A. Raskin, MD, PhD, DSc, Head of Anatomic Pathology Department </p><p>Saint Petersburg</p></bio><xref ref-type="aff" rid="aff-3"/></contrib><contrib contrib-type="author" corresp="yes"><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Андреева</surname><given-names>Ю. Ю.</given-names></name><name name-style="western" xml:lang="en"><surname>Andreeva</surname><given-names>Yu. Yu.</given-names></name></name-alternatives><bio xml:lang="ru"><p>Юлия Ю. Андреева, доктор медицинских наук, врач-патологоанатом, профессор кафедры патологической анатомии </p><p>Москва</p><p> </p></bio><bio xml:lang="en"><p>Yulia Yu. Andreeva, MD, PhD, DSc, Anatomic Pathologist, Professor, Anatomic Pathology Department </p><p>Moscow</p></bio><xref ref-type="aff" rid="aff-1"/></contrib><contrib contrib-type="author" corresp="yes"><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Петров</surname><given-names>А. В.</given-names></name><name name-style="western" xml:lang="en"><surname>Petrov</surname><given-names>A. V.</given-names></name></name-alternatives><bio xml:lang="ru"><p>Алексей В. Петров, врач-патологоанатом</p><p>Ростов-на-Дону</p></bio><bio xml:lang="en"/><xref ref-type="aff" rid="aff-2"/></contrib><contrib contrib-type="author" corresp="yes"><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Харитонова</surname><given-names>Е. А.</given-names></name><name name-style="western" xml:lang="en"><surname>Kharitonova</surname><given-names>E. A.</given-names></name></name-alternatives><bio xml:lang="ru"><p>Екатерина А. Харитонова, руководитель медицинского отдела</p><p>Москва</p><p> </p></bio><bio xml:lang="en"><p>Ekaterina A. Kharitonova, Medical Department Head</p><p>Moscow</p></bio><xref ref-type="aff" rid="aff-4"/></contrib><contrib contrib-type="author" corresp="yes"><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Пугач</surname><given-names>И. М.</given-names></name><name name-style="western" xml:lang="en"><surname>Pugach</surname><given-names>I. M.</given-names></name></name-alternatives></contrib><contrib contrib-type="author" corresp="yes"><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Франк</surname><given-names>Г. А.</given-names></name><name name-style="western" xml:lang="en"><surname>Frank</surname><given-names>G. A.</given-names></name></name-alternatives><bio xml:lang="ru"><p>Георгий А. Франк, доктор медицинских наук, профессор, академик РАМН, заведующий кафедрой патологической анатомии </p><p>Москва</p></bio><bio xml:lang="en"><p>Georgy A. Frank, MD, PhD, DSc, Professor, Academician of Russian Academy of Medical Sciences, Head of Anatomic Pathology Department </p><p>Moscow</p></bio><xref ref-type="aff" rid="aff-1"/></contrib><contrib contrib-type="author" corresp="yes"><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>Алексей А. Румянцев, врач-онколог отделения клинической фармакологии и химиотерапии </p><p>Москва</p></bio><bio xml:lang="en"><p>Aleksey A. Rumyantsev, oncologist, Clinical Pharmacology and Chemotherapy Unit </p><p>Moscow</p></bio><xref ref-type="aff" rid="aff-6"/></contrib><contrib contrib-type="author" corresp="yes"><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Тимофеев</surname><given-names>И. В.</given-names></name><name name-style="western" xml:lang="en"><surname>Tsimafeyeu</surname><given-names>I. S.</given-names></name></name-alternatives><bio xml:lang="ru"><p>Илья В. Тимофеев, директор Бюро по изучению рака почки, директор Российского общества клинической онкологии</p><p>Москва</p></bio><bio xml:lang="en"><p> </p><p>Ilya V. Tsimafeyeu, Director of Renal Cancer Research Bureau, Director of Russian Society of Clinical Oncology</p><p>Moscow</p></bio><xref ref-type="aff" rid="aff-4"/></contrib><contrib contrib-type="author" corresp="yes"><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>Tjulandin</surname><given-names>S. А.</given-names></name></name-alternatives><bio xml:lang="ru"><p>Сергей А. Тюляндин, доктор медицинских наук, профессор, заведующий отделением клинической фармакологии и химиотерапии, заместитель директора по научной работе</p><p>Москва</p><p> </p></bio><bio xml:lang="en"><p>Sergey A. Tjulandin, MD, PhD, DSc, Professor, Head of Clinical Pharmacology and Chemotherapy Unit</p><p>Moscow</p></bio><xref ref-type="aff" rid="aff-6"/></contrib></contrib-group><aff-alternatives id="aff-1"><aff xml:lang="ru"><institution>ФГБОУ ДПО «РМАНПО» Министерства здравоохранения Российской Федерации</institution><country>Россия</country></aff><aff xml:lang="en"><institution>Russian Medical Academy of Continuous Medical Education</institution><country>Russian Federation</country></aff></aff-alternatives><aff-alternatives id="aff-2"><aff xml:lang="ru"><institution>ГБУ Ростовской области «Патолого-анатомическое бюро»</institution><country>Россия</country></aff><aff xml:lang="en"><institution>State Budgetary Institution of Rostov Region Anatomic Pathology Bureau</institution><country>Russian Federation</country></aff></aff-alternatives><aff-alternatives id="aff-3"><aff xml:lang="ru"><institution>ФГБУ «Российский научный центр радиологии и хирургических технологий имени академика А. М. Гранова» Минздрава России</institution><country>Россия</country></aff><aff xml:lang="en"><institution>Russian Scientific Center of Radiology and Surgical Technologies named after Academician A. M. Granov</institution><country>Russian Federation</country></aff></aff-alternatives><aff-alternatives id="aff-4"><aff xml:lang="ru"><institution>Общероссийская общественная организация «Российское общество клинической онкологии»</institution><country>Россия</country></aff><aff xml:lang="en"><institution>Russian Society of Clinical Oncology</institution><country>Russian Federation</country></aff></aff-alternatives><aff-alternatives id="aff-5"><aff xml:lang="ru"><institution>ФГБУ «Национальный медицинский исследовательский центр онкологии им. Н. Н. Блохина» Минздрава России</institution><country>Russian Federation</country></aff><aff xml:lang="en"><institution>N. N. Blokhin Russian Cancer Research 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>29</day><month>03</month><year>2019</year></pub-date><volume>9</volume><issue>1</issue><fpage>10</fpage><lpage>15</lpage><permissions><copyright-statement>Copyright &amp;#x00A9; Завалишина Л.Э., Повилайтите П.Е., Раскин Г.А., Андреева Ю.Ю., Петров А.В., Харитонова Е.А., Пугач И.М., Франк Г.А., Румянцев А.А., Тимофеев И.В., Тюляндин С.А., 2019</copyright-statement><copyright-year>2019</copyright-year><copyright-holder xml:lang="ru">Завалишина Л.Э., Повилайтите П.Е., Раскин Г.А., Андреева Ю.Ю., Петров А.В., Харитонова Е.А., Пугач И.М., Франк Г.А., Румянцев А.А., Тимофеев И.В., Тюляндин С.А.</copyright-holder><copyright-holder xml:lang="en">Zavalishina L.E., Povilaitite P.E., Raskin G.A., Andreeva Y.Y., Petrov A.V., Kharitonova E.A., Pugach I.M., Frank G.A., Rumyantsev A.A., Tsimafeyeu I.S., Tjulandin S.А.</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.malignanttumors.org/jour/article/view/604">https://www.malignanttumors.org/jour/article/view/604</self-uri><abstract><p>Уротелиальный рак мочевого пузыря во всем мире находится на 7 и </p><sec><title>Введение</title><p>Введение. Уротелиальный рак во всем мире находится на 7 и 17 местах среди всех злокачественных опухолей у мужчин и женщин соответственно. Появление новых иммунотерапевтических препаратов открывает новые возможности для лечения таких пациентов, особенно учитывая группу пациентов, имеющих противопоказания к назначению препаратов платины. Применение иммуноонкологических препаратов требует определения экспрессии PD-L1, для которого используются различные диагностические системы. Актуальным является вопрос о сопоставлении результатов определения экспрессии PD-L1 разными методами.</p></sec><sec><title>Материалы и методы</title><p>Материалы и методы. Исследования проведено на 100 образцах операционного и биопсийного материала уротелиального рака. Для исследования были использованы два клона антител 22C3 и SP142 с соответствующими системами детекции. Оценивалась экспрессия PD-L1 в опухолевых и иммунных клетках.</p></sec><sec><title>Результаты</title><p>Результаты. Исследование показало высокое совпадение негативного PD-L1 статуса опухоли, выявленного при использовании обоих диагностикумов (92% и 97%) и низкое совпадение результатов по позитивному PD-L1 статусу (67% и 43%).</p></sec><sec><title>Выводы</title><p>Выводы. Таким образом, при получении негативного результата PD-L1 статуса уротелиального рака любым из исследованных диагностикумов не требуется повторное тестирование с другим антителом. При обнаружении позитивного статуса по одному тесту пациент может иметь негативный статус по другому тесту, что позволяет рекомендовать повторное тестирование в пограничных случаях с тестом, рекомендованным для предполагаемого для лечения препарата.</p></sec></abstract><trans-abstract xml:lang="en"><sec><title>Background</title><p>Background. Urothelial cancer ranks 7th and 17th of all the malignant tumors in males and females, respectively. Development of new immunotherapeutic drugs provides new possibilities in treatment of such patients, especially the patient population in whom platinum‑based therapy is contraindicated. Administration of immunooncology drugs requires determination of PD-L1, for which various diagnostic systems are used. The question regarding correlation of results of determination of PD-L1 expression remains of concern.</p></sec><sec><title>Materials and Methods</title><p>Materials and Methods. The study was performed on 100 samples of surgical and biopsy samples of urothelial cancer. Two clones of 22C3 and SP142 with corresponding detection systems were used for the study. PD-L1 expression was assessed in tumor and immune cells.</p></sec><sec><title>Results</title><p>Results. The study demonstrated a high correlation of negative PD-L1 tumor status determined using both diagnostic agents (92 % and 97 %) and low correlation of results of positive PD-L1 status (67 % and 43 %).</p></sec><sec><title>Conclusions</title><p>Conclusions. Thus, if a negative result of PD-L1 status of urothelial cancer is obtained using any of the diagnostic agents studied, repeated test with the other antibody is not required. If positive status is obtained in one test, the patient may have a negative status in the other test, which allows recommending a repeated testing in borderline cases using a test, recommended for the medicinal product untended for treatment.</p></sec></trans-abstract><kwd-group xml:lang="ru"><kwd>уротелиальный рак</kwd><kwd>оценка экспрессии PD-L1</kwd><kwd>ингибиторы контрольных точек</kwd><kwd>непереносимость препаратов платины</kwd></kwd-group><kwd-group xml:lang="en"><kwd>urothelial cancer</kwd><kwd>PD-L1 expression assessment</kwd><kwd>checkpoint inhibitors</kwd><kwd>platinum based treatment intolerance</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">Tsimafeyeu I, Tjulandin S. First line checkpoint inhibitors in PD-L1 positive patients with advanced urothelial carcinoma. BJU Int. 2018 Nov 20. doi: 10.1111/bju.14627. 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