tumorsMalignant tumoursMalignant tumours2224-50572587-6813Rosoncoweb10.18027/2224-5057-2019-9-4-25-31tumors-697Research ArticleОРИГИНАЛЬНЫЕ ИССЛЕДОВАНИЯORIGINAL REPORTSСравнение иммуногистохимических тестов в рамках исследования CLOVER Российского общества клинической онкологииComparison of immunohistochemical tests in the CLOVER study by Russian society of clinical oncologyЗавалишинаЛ. Э.ZavalishinaL. E.

д. б. н., профессор кафедры патологической анатомии,

Москва

MD, DSc Biol, Professor, Anatomic Pathology Department

Moscow

zavalishina1@mail.ruПовилайтитеП. Э.PovilaititeP. E.

д. б. н.,

Ростов-на-Дону

MD, DSc Biol

Rostov-on-Don

СавеловН. А.SavelovN. A.

Заведующий патологоанатомическим отделением, врач-патологоанатом высшей квалификационной категории,

Москва

Head of the Pathology Department, Pathologist of the highest qualification category 

 Moscow

АндрееваЮ. Ю.AndreevaYu. Yu.

д. м. н., врач-патологоанатом, профессор кафедры патологической анатомии,

Москва

MD, PhD, DSc, Anatomic Pathologist, Professor, Anatomic Pathology Department

 Moscow

ПетровА. В.PetrovA. V.

Ростов-на-Дону

MD

Rostov-on-Don

РаскинГ. А.RaskinG. A.

д. м. н., руководитель отдела патологической анатомии,

Санкт-Петербург

MD, PhD, DSc, Head of Anatomic Pathology Department

Saint Petersburg

ХаритоноваЕ. А.KharitonovaE. A.

руководитель медицинского отдела,

Москва

Head of Medical Department

Moscow

ПугачИ. М.PugachI. M.

Москва

Moscow

РумянцевА. А.RumyantsevA. A.

врач-онколог отделения клинической фармакологии и химиотерапии,

Москва

MD, medical oncologist, Clinical Pharmacology and Chemotherapy

Moscow

ФранкГ. А.FrankG. A.

д. м. н., проф., акад. РАМН, заведующий кафедрой патологической анатомии,

Москва

MD, PhD, DSc, Professor, Academician of Russian Academy of Medical Sciences, Head of Anatomic Pathology Department

Moscow

ИмянитовЕ. Н.ImyanitovE. N.

член-корреспондент РАН, д. м. н., профессор, Руководитель отдела биологии опухолевого роста лаборатории молекулярной онкологии,

Санкт-Петербург

MD, PhD, DSc, Professor, Corresponding Member of the Russian Academy of Sciences, Head of the Department of Tumor Growth Biology, Laboratory of Molecular Oncology

Saint Petersburg

ТимофеевИ. В.TsimafeyeuI. V.

директор Бюро,

Санкт-Петербург

MD, Director

Moscow

ТюляндинС. А.TjulandinS. A.

д. м. н., проф., заведующий отделением клинической фармакологии и химиотерапии, заместитель директора по научной работе,

Москва

MD, PhD, DSc, Professor, Head of Clinical Pharmacology and Chemotherapy

Moscow

ФГБОУ ДПО «РМАНПО» Министерства Здравоохранения Российской ФедерацииРоссияRussian Medical Academy of Continuous Medical EducationRussian FederationГБУ Ростовской области «Патолого-анатомическое бюро»РоссияState Budgetary Institution of Rostov Region, Anatomic Pathology BureauRussian FederationГБУЗ «Московская городская онкологическая больница № 62 Департамента здравоохранения г. Москвы»РоссияMoscow City Oncology Hospital No. 62, Moscow Department of HealthRussian FederationФГБУ «Российский научный центр радиологии и хирургических технологий имени академика А.М. Гранова» Минздрава РоссииРоссияRussian Scientific Center of Radiology and Surgical Technologies named after Acad. A. M. GranovRussian FederationОбщероссийская общественная организация «Российское общество клинической онкологии»РоссияRussian Society of Clinical OncologyRussian FederationФГБУ «НМИЦ онкологии им. Н.Н. Блохина» Минздрава РоссииРоссияN. N. Blokhin Russian Cancer Research CenterRussian FederationФГБУ «НМИЦ онкологии им. Н.Н. Петрова» Минздрава РоссииРоссияNational Medical Research Center of Oncology named after N. N. PetrovRussian FederationАНО «Бюро по изучению рака почки»РоссияKidney Cancer Research BureauRussian Federation201903042020942531Copyright © Завалишина Л.Э., Повилайтите П.Э., Савелов Н.А., Андреева Ю.Ю., Петров А.В., Раскин Г.А., Харитонова Е.А., Пугач И.М., Румянцев А.А., Франк Г.А., Имянитов Е.Н., Тимофеев И.В., Тюляндин С.А., 20202020Завалишина Л.Э., Повилайтите П.Э., Савелов Н.А., Андреева Ю.Ю., Петров А.В., Раскин Г.А., Харитонова Е.А., Пугач И.М., Румянцев А.А., Франк Г.А., Имянитов Е.Н., Тимофеев И.В., Тюляндин С.А.Zavalishina L.E., Povilaitite P.E., Savelov N.A., Andreeva Y.Y., Petrov A.V., Raskin G.A., Kharitonova E.A., Pugach I.M., Rumyantsev A.A., Frank G.A., Imyanitov E.N., Tsimafeyeu I.V., Tjulandin S.A.Данная работа распространяется под лицензией Creative Commons Attribution 4.0.This work is licensed under a Creative Commons Attribution 4.0 License.https://www.malignanttumors.org/jour/article/view/697Введение

Введение. Целью исследования CLOVER, проведенного Российским обществом клинической онкологии, было попарное сравнение трех валидированныхиммуногистохимических (ИГХ) тестов PD-L1 (Ventana SP142, Ventana SP263, Dako 22C3) на одной и той же популяции пациентов с немелкоклеточным раком легкого (НМРЛ). Данное исследование — это первое крупное росийское сравнительное исследование по оценке определения уровней экспрессии PD-L1 методами иммуногистохимии.

Материалы и методы

Материалы и методы. Работа проведена на 473 образцах НМРЛ, полученных из Биобанка. Иммуногистохимическое исследование проведено с использованием 3 клонов антител. Четыре подготовленных патологоанатома независимо оценивали процентное содержание положительно окрашенных опухолевых клеток (ОК) и иммунных клеток (ИК). Для оценки корреляции ОК и ИК между различными анализами и прогностических свойств одного теста для другого был проведен конкордантный анализ.

Результаты

Результаты. Число PD-L1-позитивных клеток (1% и более) было выше среди ИК по сравнению с ОК во всех трех иммуногистохимических исследованиях. Коэффициенты корреляции Пирсона (PCC) для ОК составили 0,71, 0,87 и 0,75 между 22C3/SP142, 22C3/SP263 и SP263/SP142 соответственно. Значения PCC для ИК составили 0,45, 0,61 и 0,68 для тех же пар. Было получено высокое совпадение положительных и отрицательных результатов (>91%) между окрашиванием, полученным с антителами 22C3 и SP263 для иммуноонкологических препаратов в 1 линии.

Выводы

Выводы. Наиболее высокая корреляция ИГХ анализов была получена при попарном сравнении 22C3 и SP263. Клон 22C3 можно рассматривать в качестве замены SP263 при лечении НМРЛ в первой линии. Клон SP142 показал более слабую экспрессию в ОК и ИК по сравнению с двумя другими анализами у пациентов с плоскоклеточным раком.

Introduction

Introduction. The goal of the CLOVER study performed by the Russian Society of Clinical Oncology, was a pairwise comparison of three validated PD-L1 immunohistochemical (IHC) tests (Ventana SP142, Ventana SP263, Dako 22C3) in the patient population with non-small cell lung cancer (NSCLC). This study is the first large Russian comparative study to evaluate PD-L1 expression levels using immunohistochemistry methods.

Materials and methods

Materials and methods. The study was conducted on 473 NSCLC samples from Biobank. The IHC tests were carried out with 3 antibody clones. Four trained pathologists independently evaluated the percentage of positively stained tumor cells (TC) and immune cells (IC). To assess the correlation of TC and IC between different runs and the prognostic values of one test for another, a concordant analysis was used.

Results

Results. The number of PD-L1‑positive cells (≥1 %) was higher among IC compared with TC in all three IHC tests. Pearson correlation coefficients (PCC) for TCs were 0.71, 0.87, and 0.75 for 22C3 / SP142, 22C3 / SP263 and SP263 / SP142, respectively. PCC values for ICs were 0.45, 0.61, and 0.68 for the same pairs. A high coincidence of positive and negative results (>91 %) was obtained between the staining with antibodies 22C3 and SP263 of immunooncological agents in the 1st line.

Conclusions

Conclusions. The highest correlation between IHC tests was obtained by pairwise comparison of 22C3 and SP263. Clone 22C3 can be considered as a substitute for SP263 in the first-line treatment of NSCLC. Clone SP142 showed weaker expression in TC and IC compared to the other two tests in patients with non-small cell lung cancer.

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The authors declare that there are no conflicts of interest present.