Tumors of female reproductive systemTumors of female reproductive systemОпухоли женской репродуктивной системы1994-40981999-8627Publishing House ABV Press76510.17650/1994-4098-2020-16-3-37-45MAMMOLOGY. ORIGINAL REPORTSМАММОЛОГИЯ. ОРИГИНАЛЬНЫЕ СТАТЬИCDK4/6 inhibitors in the treatment of metastatic breast cancer. Choosing optimal therapy for estrogen-receptor-positive HER2-negative metastatic breast cancer: analysis of doctors’ preferences (“Prometheus”) in Russia – first results of the surveyИнгибиторы CDK4/6 в терапии метастатического рака молочной железы. Выбор оптимальной терапии эстроген-рецептор-положительного HER2-отрицательного метастатического рака молочной железы: общероссийский анализ предпочтений врачей («Прометей») – первые результаты опросаhttps://orcid.org/0000-0001-7728-9533ArtamonovaE. V.АртамоноваЕ. В.
Russian Federation

23 Kashirskoe Shosse, Moscow 1154781 Ostrovityanova St., Moscow 117997Build. 1, 61/2 Shchepkina St., Moscow 129110

Елена Владимировна Артамонова

115478 Москва, Каширское шоссе, 24117997 Москва, ул. Островитянова, 1129110 Москва, ул. Щепкина, 61/2, корп. 1 

artamonovae@mail.ruhttps://orcid.org/0000-0003-4763-7992KovalenkoE. I.КоваленкоЕ. И.
Russian Federation

23 Kashirskoe Shosse, Moscow 115478

115478 Москва, Каширское шоссе, 24

https://orcid.org/0000-0003-4879-2687BolotinaL. V.БолотинаЛ. В.
Russian Federation

3 2nd Botkinskiy Proezd, Moscow 125284

125284 Москва, 2-й Боткинский проезд, 3

https://orcid.org/0000-0001-5304-9682SteninaM. B.СтенинаМ. Б.
Russian Federation

23 Kashirskoe Shosse, Moscow 115478

115478 Москва, Каширское шоссе, 24

https://orcid.org/0000-0003-4447-9458OrlovaR. V.ОрловаР. В.
Russian Federation

7–9 Universitetskaya Naberezhnaya, Saint-Petersburg 19903456 Veteranov Avenue, Saint-Petersburg 198255

199034 Санкт-Петербург, Университетская набережная, 7–9198255 Санкт-Петербург, проспект Ветеранов, 56

https://orcid.org/0000-0001-5513-037XMukhinaM. A.МухинаМ. А.
Russian Federation

10 Presnenskaya Naberezhnaya, Moscow 123112

123112 Москва, Пресненская набережная, 10

N.N. Blokhin National Medical Research Center of Oncology, Ministry of Health of RussiaФГБУ «Национальный медицинский исследовательский центр онкологии им. Н.Н. Блохина» Минздрава РоссииDepartment of Oncology and Radiation Therapy, N.I. Pirogov Russian National Research Medical University, Ministry of Health of Russiaкафедра онкологии и лучевой терапии ФГБОУ ВО «Российский национальный исследовательский медицинский университет им. Н.И. Пирогова» Минздрава РоссииDepartment of Oncology and Thoracic Surgery, M.F. Vladimirsky Moscow Regional Research and Clinical Instituteкафедра онкологии и торакальной хирургии ФДО ГБУЗ МО «Московский областной научно-исследовательский клинический институт им. М.Ф. Владимирского»P.A. Hertzen Moscow Oncology Research Institute – branch of the National Medical Research Radiological Center, Ministry of Health of RussiaМосковский научно-исследовательский онкологический институт им. П.А. Герцена – филиал ФГБУ «Национальный медицинский исследовательский центр радиологии» Минздрава РоссииSaint-Petersburg State UniversityФГБОУ ВО «Санкт-Петербургский государственный университет»City Clinical Oncological DispensaryСПб ГБУЗ «Городской клинический онкологический диспансер»Pfizer Innovations LLCООО «Пфайзер Инновации»01122020163374512012021120120212020https://ojrs.abvpress.ru/ojrs/article/view/765

The emergence of a new class of drugs – inhibitors of cyclin-dependent kinases 4/6 (CDK4/6) – has changed the paradigm of treatment of patients with luminal HER2 negative metastatic breast cancer. Their effectiveness is confirmed not only by randomized, but also observational studies on a wide heterogeneous population of patients from daily clinical practice; the use of these drugs in the 1st line is significantly expanding in the world. On the territory of the Russian Federation, an observational study of Prometheus was carried out, the purpose of which was to assess the frequency of prescribing CDK4/6 inhibitors, as well as other types of treatment in 1–2nd lines in real clinical practice in Russia, as well as factors and preferences of doctors influencing the choice of therapy. A survey of the target audience, whose answers can be considered reliable and reflecting today’s Russian clinical practice in the treatment of breast cancer, showed that, despite the fact that the overwhelming majority of doctors (78 %) believe that the maximum benefit from the appointment of CDK4/6 inhibitors is expected for the 1st line therapy, in real clinical practice, only 35 % of doctors practice 1 st line prescription. In the 2nd line of therapy, CDK4/6 inhibitors are prescribed by 45 % of experts, in the 3rd (or more) line – 20 %. According to the respondents, the main obstacle to the appointment of CDK4/6 inhibitors is the unresolved issues of the availability of therapy (44 %) and its cost (34 %). Among all the proposed clinical criteria, only the criterion “visceral metastases with impaired function of internal organs” influences the decision not to prescribe a combination of hormonal therapy and a CDK4/6 inhibitor in 1–2nd lines of therapy. Criteria such as ECOG status, menopause status, tumor subtype preceding chemotherapy, timing of progression do not determine the choice when deciding not to prescribe combination therapy.

Появление нового класса препаратов – ингибиторов циклинзависимых киназ 4/6 (CDK4/6) – изменило парадигму лечения пациенток с люминальным HER2-отрицательным метастатическим раком молочной железы (мРМЖ). Высокая эффективность новой стратегии была продемонстрирована в рандомизированных клинических исследованиях как при гормоночувствительном, так и при гормонорезистентном мРМЖ, а затем подтверждена наблюдательными программами, и на сегодняшний день эксперты единодушно называют ингибиторы CDK4/6 обязательным компонентом последовательной терапии, причем большинство отдают предпочтение их назначению в 1-й линии. Однако назначение новых препаратов в реальной клинической практике определяется целым рядом факторов, включая информированность врачей, их личный опыт и субъективные предпочтения, а также финансовое обеспечение и доступность лекарства в конкретном регионе. Для ответа на эти вопросы был проведен опрос «Прометей», целью которого явилась оценка частоты назначения ингибиторов CDK4/6, а также других видов лечения в 1–2-й линиях терапии люминального HER2-отрицательного мРМЖ в реальной клинической практике в России и определение факторов и предпочтений врачей, влияющих на выбор терапии. Опрос целевой аудитории, ответы которой можно считать достоверными и отражающими сегодняшнюю российскую клиническую практику лечения мРМЖ, показал, что подавляющее большинство врачей (78 %) ожидают максимальную пользу от применения ингибиторов CDK4/6 в 1-й линии терапии, однако в реальной клинической практике назначение этих препаратов в 1-й линии практикуют только 35 % респондентов. Во 2-й линии терапии ингибиторы CDK4/6 назначают 45 % опрошенных, в 3-й (и более) линии – 20 %. По мнению ответивших, основными препятствиями к назначению ингибиторов CDK4/6 являются нерешенные вопросы доступности терапии (44 % опрошенных) и ее стоимость (34 %). Среди всех предложенных клинических критериев только критерий «висцеральные метастазы с нарушением функции внутренних органов» влияет на решение не назначать комбинацию гормонотерапии и ингибитора CDK4/6 в 1–2-й линиях терапии. Такие критерии, как статус по шкале ECOG, статус менопаузы, подтип опухоли, предшествующая химиотерапия и сроки прогрессирования, не определяют выбор при принятии решения не назначать комбинированную гормонотаргетную терапию.

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