medsovetМедицинский СоветMeditsinskiy sovet = Medical Council2079-701X2658-5790REMEDIUM GROUP Ltd.10.21518/2079-701X-2021-4S-103-107medsovet-6216Research ArticleКЛИНИЧЕСКОЕ НАБЛЮДЕНИЕCLINICAL OBSERVATIONАлпелисиб как новая возможность лечения пациентов с мутацией PIK3CA. Эффективность и переносимость терапии на примере клинического случаяAlpelisib as a new treatment option for patients with the PIK3CA mutation. The effectiveness and tolerability of therapy on the example of a clinical casehttps://orcid.org/0000-0003-4763-7992КоваленкоЕ. И.KovalenkoЕ. I.

Коваленко Елена Игоревна, к.м.н., старший научный сотрудник отделения химиотерапии № 1

115478, Москва, Каширское шоссе, д. 24 

Elena I. Kovalenko, Cand. Sci. (Med.), Senior Researcher of the Department of Chemotherapy No. 1

24, Kashirskoye Shosse, Moscow, 115478

АртамоноваЕ. В.ArtamonovaЕ. V.

Артамонова Елена Владимировна, д.м.н., профессор, заведующая отделением химиотерапии № 1;  профессор кафедры кафедра онкологии и лучевой терапии лечебного факультета

115478, Москва, Каширское шоссе, д. 24 

117997, Москва, ул. Островитянова, д. 1 

Elena V. Artamonova, Dr. Sci. (Med.), Professor, Head of the Department of Chemotherapy No. 1, N.N. ; Professor of the Department of Oncology and Radiation Therapy, Faculty of Medicine

24, Kashirskoye Shosse, Moscow, 115478

1, Ostrovityanov St., Moscow, 117997

Национальный медицинский исследовательский центр онкологии имени Н.Н. БлохинаРоссияBlokhin National Medical Research Center of OncologyRussian FederationНациональный медицинский исследовательский центр онкологии имени Н.Н. Блохина; Российский национальный исследовательский медицинский университет имени Н.И. ПироговаРоссияBlokhin National Medical Research Center of Oncology;  Pirogov Russian National Research Medical UniversityRussian Federation20211206202104S103107Copyright © Коваленко Е.И., Артамонова Е.В., 20212021Коваленко Е.И., Артамонова Е.В.Kovalenko Е.I., Artamonova Е.V.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/6216

Путь PI3K/AKT/mTOR играет одну из ключевых ролей в регулировании пролиферации, роста и выживания клеток. Было обнаружено, что мутация PIK3CA – онкогена, кодирующего каталитическую изоформу p110α киназы PI3K, – является одной из наиболее частых соматических мутаций при раке молочной железы: она обнаруживается примерно в 20–50% всех случаев, наиболее часто – при ЭР+ HER2– подтипе. Как показали исследования, наличие мутации PIK3CA ассоциируется с повышенным риском рецидива, прогрессирования или смерти. Более глубокое понимание роли мутации PIK3CA в росте и выживании раковых клеток привело к разработке таргетных терапевтических агентов, направленных на прямое ингибирование пути PI3K. Алпелисиб – единственный на сегодняшний день ингибитор PI3K, успешно прошедший клинические испытания и одобренный для лечения ЭР+ HER2– метастатического рака молочной железы у пациентов с мутацией PIK3CA, которые ранее получали гормонотерапию. В статье приводится клинический случай лечения алпелисибом, подробно рассматриваются вопросы эффективности препарата, в т. ч. после ингибиторов CDK 4/6, а также переносимости и управления нежелательными явлениями. Алпелисиб не только расширяет возможности лечения у пациентов с наличием мутации PIK3CA, но и является наглядным примером персонализации терапии. 

The PI3K / AKT / mTOR pathway plays a key role in the regulation of cell proliferation, growth and survival. It was found that the PIK3CA mutation, an oncogene encoding the catalytic isoform of PI3K kinase p110α, is one of the most frequent somatic mutations in breast cancer: it is found in about 20-50% of all cases, most often in the ER + HER2 subtype. Studies have shown that the presence of the PIK3CA mutation is associated with an increased risk of recurrence, progression, or death. A deeper understanding of the role of the PIK3CA mutation in the growth and survival of cancer cells has led to the development of targeted therapeutic agents aimed at directly inhibiting the PI3K pathway. Alpelisib is the only PI3K inhibitor to date that has successfully passed clinical trials and is approved for the treatment of ER + HER2– metastatic breast cancer in patients with the PIK3CA mutation who have previously received hormonal therapy. The article presents a clinical case of treatment with Alpelisib, discusses in detail the issues of drug efficacy, including after CDK 4/6 inhibitors, as well as tolerance and management of adverse events. Alpelisib not only expands the treatment options for patients with the PIK3CA mutation, but is also a clear example of therapy personalization. 

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