Новая стратегия адъювантной терапии гормонозависимого HER2-негативного рака молочной железы: обновленные результаты исследования абемациклиба при ранних и местнораспространенных стадиях заболевания

Абемациклиб – пероральный ингибитор CDK4/6 – отличается по спектру подавления циклин-зависимых киназ от других препаратов этой группы и доказанно улучшает показатели выживаемости в различных линиях лечения метастатического рака молочной железы (мРМЖ). В рандомизированном клиническом исследовании (РКИ) III фазы у больных с ранним гормонозависимым HER2-негативным (Гр+ HER2-) раком молочной железы (РМЖ) с высоким риском прогрессирования абемациклиб в комбинации со стандартной адъювантной эндокринотерапией (АЭТ) значимо увеличивает выживаемость без инвазивного заболевания (ВБИЗ) и выживаемость без отдаленных метастазов (ВБОМ). Отдаленные результаты исследования monarchE с 5-летним сроком наблюдения за пациентками показали, что добавление абемациклиба к АГТ увеличивает 5-летнюю ВБИЗ с 76,0 до 83,6% (ОР=0,680; 95% ДИ 0,599–0,772; p<0,001) и 5-летнюю ВБОМ с 79,2 до 86,0%. (ОР=0,675; 95% ДИ 0,588–0,774; p<0,001). Нежелательные явления (НЯ) 3-й степени и выше отмечены у 45,5% пациентов на фоне терапии абемациклибом и у 12,7% в группе контроля и преимущественно представлены нейтропенией (18,6 и 0,7%) и диарей (7,6 и 0,1%). Профиль токсичности был ожидаемый и управляемый. Обоснованное снижение дозы абемациклиба не приводило к ухудшению отдаленных результатов лечения

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