Cancer UrologyCancer UrologyОнкоурология1726-97761996-1812Publishing House ABV Press195910.17650/1726-9776-2025-21-2-89-103DIAGNOSIS AND TREATMENT OF URINARY SYSTEM TUMORS. PROSTATE CANCERДИАГНОСТИКА И ЛЕЧЕНИЕ ОПУХОЛЕЙ МОЧЕПОЛОВОЙ СИСТЕМЫ. Рак предстательной железыRole of darolutamide in intensification of treatment of patients with hormone-sensitive prostate cancer: who needs the triplet combination?Роль даролутамида в интенсификации лечения пациентов с метастатическим гормоночувствительным раком предстательной железы: кому нужна тройная комбинация?https://orcid.org/0000-0001-7754-6624VolkovaM. I.ВолковаМ. И.
Russian Federation

Mariya Igorevna Volkova 

Build. 7, 18A Zagorodnoe Shosse, Moscow 117152; Build. 1, 2/1 Barrikadnaya St., Moscow 125993

Мария Игоревна Волкова 

117152 Москва, Загородное шоссе, 18А, стр. 7; 125993 Москва, ул. Баррикадная, 2/1, стр. 1

mivolkova@rambler.ruTurupaevK. A.ТурупаевК. А.
Russian Federation

24 Kashirskoe Shosse, Moscow 115522

115522 Москва, Каширское шоссе, 24

Oncology Center No. 1, Moscow City Hospital named after S.S. Yudin, Moscow Healthcare DepartmentОнкологический центр № 1 ГБУЗ г. Москвы «Городская клиническая больница им. С.С. Юдина Департамента здравоохранения г. Москвы»Russian Medical Academy of Continuing Professional Education, Ministry of Health of RussiaФГБОУ ДПО «Российская медицинская академия непрерывного профессионального образования» Минздрава РоссииN.N. Blokhin National Medical Research Center of Oncology, Ministry of Health of RussiaФГБУ «Национальный медицинский исследовательский центр онкологии им. Н.Н. Блохина» Минздрава России060820252128910305082025https://oncourology.abvpress.ru/oncur/article/view/1959

The article presents a review of the results of the ARASENS registration study of darolutamide in combination with androgen-deprivation therapy (ADT) and docetaxel. This is the only triplet registered in Russia for treatment of metastatic hormone-sensitive prostate cancer. Darolutamide-based triplet showed significant benefits in overall survival and progression-free survival compared to hormone and chemotherapy combination in randomized phase III trial ARASENS, as well as better progression-free survival compared to ADT and androgen signal inhibitor duplets in meta-analyses of phase III randomized trials. Patients with de novo metastatic hormone-sensitive prostate cancer and high metastatic load receive the highest clinical benefit from darolutamide in combination with ADT and docetaxel. Darolutamide-based triplet demonstrated good safety profile comparable to duplet combination of ADT and docetaxel.

Статья представляет собой обзор результатов регистрационного исследования даролутамида в комбинации с андрогендепривационной терапией (АДТ) и доцетакселом ARASENS. Это единственный триплет, зарегистрированный в России для терапии метастатического гормоночувствительного рака предстательной железы. Триплет, основанный на даролутамиде, продемонстрировал значимые преимущества в показателях общей выживаемости и беспрогрессивной выживаемости по сравнению с гормонохимиотерапией в рандомизированном исследовании III фазы ARASENS, а также выигрыш в беспрогрессивной выживаемости по сравнению с дуплетами АДТ и ингибиторов андрогенного сигнала в метаанализах рандомизированных исследований III фаз. Наибольшую клиническую пользу от назначения даролутамида с АДТ и доцетакселом получают пациенты с de novo метастатическим гормоночувствительным раком предстательной железы, имеющие большую метастатическую нагрузку. Триплет, основанный на даролутамиде, продемонстрировал хороший профиль безопасности, сопоставимый с двойной комбинацией АДТ и доцетаксела.

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