medsovetМедицинский СоветMeditsinskiy sovet = Medical Council2079-701X2658-5790REMEDIUM GROUP Ltd.10.21518/ms2023-240medsovet-7699Research ArticleПРАКТИКАPRACTICEПалбоциклиб: эффективность и безопасность у пациентов старшей возрастной группыPalbociclib: efficacy and safety in older patientshttps://orcid.org/0000-0003-0092-0459КорниецкаяА. Л.KornietskayaA. L.

Корниецкая Анна Леонидовна, к.м.н., ведущий научный сотрудник отдела лекарственного лечения опухолей 

125834, Россия, Москва, 2-й Боткинский проезд, д. 3 

Anna L. Kornietskaya, Cand. Sci. (Med.), Leading Researcher, Department of Drug Treatment of Tumors

3, 2nd Botkinskiy Proezd, Moscow, 125834, Russia 

kornietskaya@mail.ruhttps://orcid.org/0000-0003-4879-2687БолотинаЛ. В.BolotinaL. V.

Болотина Лариса Владимировна, д.м.н., заведующая отделением химиотерапии 

125834, Россия, Москва, 2-й Боткинский проезд, д. 3 

Larisa V. Bolotina, Dr. Sci. (Med.), Head of the Department of Chemotherapy 

3, 2nd Botkinskiy Proezd, Moscow, 125834, Russia 

lbolotina@yandex.ruhttps://orcid.org/0000-0002-1993-3842ЕвдокимоваС. Ф.EvdokimovaS. F.

Евдокимова Сэвиндж Физулиевна, аспирант 

125834, Россия, Москва, 2-й Боткинский проезд, д. 3 

Sevindzh F. Evdokimova, Postgraduate Student 

3, 2nd Botkinskiy Proezd, Moscow, 125834, Russia 

evdokimova.sevindzh@gmail.comhttps://orcid.org/0000-0002-8721-8437СавчинаВ. В.SavchinaV. V.

Савчина Виктория Владимировна, научный сотрудник 

125834, Россия, Москва, 2-й Боткинский проезд, д. 3 

Viktoria V. Savchina, Researcher 

3, 2nd Botkinskiy Proezd, Moscow, 125834, Russia 

savchina_v.v@mail.ruhttps://orcid.org/0000-0003-3196-1368КарагодинаЮ. Б.KaragodinaYu. B.

Карагодина Юлия Борисовна, научный сотрудник

125834, Россия, Москва, 2-й Боткинский проезд, д. 3 

Yulia B. Karagodina, Researcher 

3, 2nd Botkinskiy Proezd, Moscow, 125834, Russia 

yuliaborisovnakaragodina@gmail.comМосковский научный исследовательский онкологический институт имени П.А. Герцена – филиал Национального медицинского исследовательского центра радиологииРоссияHertsen Moscow Oncology Research Institute – Branch of the National Medical Research Radiological CentreRussian Federation202330072023011150157Copyright © Корниецкая А.Л., Болотина Л.В., Евдокимова С.Ф., Савчина В.В., Карагодина Ю.Б., 20232023Корниецкая А.Л., Болотина Л.В., Евдокимова С.Ф., Савчина В.В., Карагодина Ю.Б.Kornietskaya A.L., Bolotina L.V., Evdokimova S.F., Savchina V.V., Karagodina Y.B.This work is licensed under a Creative Commons Attribution 4.0 License.https://www.med-sovet.pro/jour/article/view/7699

Разработка и внедрение в клиническую практику ингибиторов циклинзависимых киназ 4 и 6 (CDK4/6) является одним из фундаментальных достижений последнего десятилетия в лечении метастатического рака молочной железы. Результаты всех рандомизированных исследований продемонстрировали клинически значимую эффективность комбинации гормонотерапии с ингибиторами CDK4/6 в первой и второй линии лечения гормонозависимого Her2-негативного метастатического рака молочной железы. По данному показанию на сегодняшний день одобрено три препарата – палбоциклиб, рибоциклиб и абемациклиб. Несмотря на некоторую разницу в химических, биологических и фармакологических свойствах, а также ряд отличий в популяции пациентов, включенных в клинические исследования, оценивавшие эффективность применения различных ингибиторов CDK4/6 в первой линии, все препараты продемонстрировали абсолютно сопоставимое улучшение выживаемости без прогрессирования с отношением рисков в диапазоне 0,5 вне зависимости от предшествующего лечения. Дальнейшая прослеженность результатов и накопление опыта реальной клинической практики позволили выявить потенциальную разницу не только в общей выживаемости и профиле токсичности, характерном для каждого из препаратов, но и безопасности применения у пациентов старшей возрастной группы. Поскольку пациентки в возрасте старше 75 лет редко включаются в клинические исследования, полученные результаты не могут быть однозначно экстраполированы на эту популяцию пациентов, что, несомненно, определяет ценность клинического опыта для неотобранной популяции пациентов. В статье мы рассматриваем клинические случаи применения палбоциклиба в первой линии терапии гормонозависимого Her2-негативного рака молочной железы у пациенток старше 75 лет с выраженной сопутствующей патологией.

The development and introduction of cyclin-dependent kinases 4/6 (CDK4/6) inhibitors into clinical practice is one of the main achievements over the last 10 years in the treatment of metastatic breast cancer. All randomized trials demonstrated clinically significant efficacy of endocrine therapy plus CDK4/6 inhibitors in the first- and second-line therapy for hormone-dependent Her2-negative metastatic breast cancer. Three drugs are currently approved for this indication: palbociclib, ribociclib, and abemaciclib. Despite some differences in chemical, biological and pharmacological properties, as well as a range of incongruities between the patient populations enrolled in the clinical studies on the efficacy of various CDK4/6 inhibitors in the firstline therapy, all drugs showed a completely comparable improvement in progression-free survival with a hazard ratio of 0.5 regardless of previous treatments. Further traceability of the results and the accumulation of real-world clinical practice experience allowed to identify a potential difference not only in overall survival and the toxicity profiles, which are characteristic of each of the drugs, but also in the safety of use in patients of an older age group. As patients aged over 75 years are rarely enrolled in the clinical trials, the obtained results cannot be unequivocally extrapolated to this patient population, which is the decisive factor in determining the clinical experience value for an unselected patient population. The article considers clinical case reports of the use of palbociclib in the first-line therapy for hormone-dependent Her2-negative breast cancer in patients over 75 years of age with severe comorbidities.

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