medsovetМедицинский СоветMeditsinskiy sovet = Medical Council2079-701X2658-5790REMEDIUM GROUP Ltd.10.21518/2079-701X-2022-16-22-4medsovet-7242Research ArticleТАРГЕТНАЯ ТЕРАПИЯTARGET THERAPY OF TUMORSОпыт применения палбоциклиба в реальной клинической практике в Российской ФедерацииReal clinical practice patterns of palbociclib usage in Russian Federationhttps://orcid.org/0000-0002-8149-0085ФроловаМ. А.FrolovaM. A.

Фролова Мона Александровна – доктор медицинских наук, ведущий научный сотрудник онкологического отделения лекарственных методов лечения (химиотерапевтического) №1.

115478, Москва, Каширское шоссе, д. 24

Mona А. Frolova - Dr. Sci. (Med.), Leading Researcher of the Oncological Department of Medicinal Methods of Treatment (Chemotherapeutic) No. 1.

24, Kashirskoye Shosse, Moscow, 115478

drfrolova@yandex.ruhttps://orcid.org/0000-0001-5304-9682СтенинаМ. Б.SteninaM. В.

Стенина Марина Борисовна - доктор медицинских наук, ведущий научный сотрудник онкологического отделения лекарственных методов лечения (химиотерапевтического) №1.

115478, Москва, Каширское шоссе, д. 24

Marina В. Stenina - Dr. Sci. (Med.), Leading Researcher of the Oncological Department of Medicinal Methods of Treatment (Chemotherapeutic) No. 1.

24, Kashirskoye Shosse, Moscow, 115478

mstenina@mail.ruНациональный медицинский исследовательский центр онкологии имени Н.Н. БлохинаРоссияBlokhin National Medical Research Center of OncologyRussian Federation2022061220220223035Copyright © Фролова М.А., Стенина М.Б., 20222022Фролова М.А., Стенина М.Б.Frolova M.A., Stenina M.В.Данная работа распространяется под лицензией Creative Commons Attribution 4.0.This work is licensed under a Creative Commons Attribution 4.0 License.https://www.med-sovet.pro/jour/article/view/7242Введение

Введение. Современные стандарты лечения метастатического гормонозависимого Нег2-негативного рака молочной железы (РМЖ) включают применение комбинации ингибиторов циклинзависимых киназ 4/6 (ЦЗК 4/6) с гормонотерапией. Этот вид терапии продемонстрировал впечатляющую эффективность в ранних линиях лечения по сравнению с гормонотерапией в монорежиме в рандомизированных клинических исследованиях. Большой интерес представляют исследования реальной клинической практики (РКП) применения ингибиторов ЦЗК 4/6. Данное исследование является первым исследованием РКП использования палбоциклиба в Российской Федерации с большим количеством участников.

Цель

Цель. Провести анализ паттернов назначения палбоциклиба в РКП онкологов РФ.

Материалы и методы

Материалы и методы. В исследование включены 105 пациентов из 12 регионов РФ, которые получали палбоциклиб в комбинации с гормонотерапией с 2017 по 2020 г. Медиана возраста составила 57 (29-75) лет; 29,5% (31/105) больных были моложе 50 лет. У 16 (15,2%) больных был de novo метастатический РМЖ, у 89 больных отмечено прогрессирование болезни в разные сроки после радикального лечения. Наличие висцеральных метастазов на момент начала терапии палбо-циклибом отмечено у 61/105 (58,1%) больных.

Результаты

Результаты. Только 22/105 (21%) больных получали палбоциклиб в первой линии лечения метастатического РМЖ. Большинство больных получали палбоциклиб во второй и третьей линиях лечения (28,5 и 30,5% соответственно). У 26/105 (24,8%) больных палбоциклиб назначался в комбинации с ингибиторами ароматазы (ИА), в остальных случаях -с фулвестрантом. Медиана времени наблюдения составила 6,5 (1,1-31,9) мес., медиана времени до прогрессирования -6,0 (1,0-28,0) мес. Наиболее частыми побочными явлениями были лейкопения, нейтропения и тромбоцитопения. Отмена препарата в связи с токсичностью потребовалась 3 больным.

Выводы

Выводы. Полученные нами результаты говорят о необходимости перемещения палбоциклиба в первые линии лечения, в т. ч. более широко использовать препарат у молодых женщин для получения максимального выигрыша в выживаемости.

Introduction

Introduction. Current treatment of metastatic luminal Her2-negative breast cancer includes combination of endocrine therapy (ET) with CDK4/6 inhibitors. This type of therapy demonstrated impressive efficacy over mono ET in early lines of treatment in phase III randomized clinical trials. Treatment patterns in real clinical practice (RCP) are of great interest. We represent the first available local data for all CDK 4/6 inhibitors in RCP in Russian Federation in accordance with the number of patients (pts).

Aim

Aim. Analysis of the patterns of palbociclib administration in RCP.

Materials and methods

Materials and methods. One hundred and 5 pts from 12 regions of Russian Federation were included in this analysis and received palbociclib in combination with ET from 2017 to 2020. Median age was 57 years (29-75), 31/105 (29.5%) of pts were < 50. De novo metastatic disease was observed in 16 (15.2%) pts, 89 pts progressed after radical treatment. Visceral metastases (mts) at palbociclib initiation had 61/105 (58.1%) of pts.

Results

Results. Only 22/105 (21%) of pts received palbociclib as 1st line treatment of metastatic disease. The majority of pts was treated with palbociclib in 2nd and 3rd lines (28.5% and 30.5% respectively). In 26/105 (24.8%) pts palbociclib was combined with aromatase inhibitors, in other cases - with fulvestrant. Median follow-up time was 6.5 (1.1-31.9) months, median progression free survival - 6.0 (1.0-28.0) months. Most common adverse events (AE) were leukopenia, neutropenia and thrombocytopenia. Only in 3 cases palbociclib was completely stopped due to toxicity.

Conclusions

Conclusions. Our data indicates that there is a need to move palbociclib initiation in first two lines of treatment to get maximal improvement in survival and to increase its usage in young women.

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