Роль иммунотерапии в лечении опухолей билиарного тракта: обзор современных данных и собственный опыт

Введение. Опухоли билиарного тракта (ОБТ) представляют собой агрессивные злокачественные новообразования с ограниченными терапевтическими возможностями и низкой общей выживаемостью. В последние годы внедрение иммунотерапии изменило парадигму лечения ОБТ, особенно в сочетании с химиотерапией. В настоящей работе приводится подробный анализ современных данных, а также оценивается эффективность химиоиммунотерапии у пациентов с нерезектабельной и/или метастатической холангиокарциномой в условиях реальной клинической практики.

Цель. Оценить клинические исходы применения комбинированной химиоиммунотерапии (GemCis + дурвалумаб/пембролизумаб) у пациентов с ОБТ в российской практике, включая показатели общей выживаемости (ОВ), выживаемости без прогрессирования (ВБП), частоты объективного ответа (ЧОО) и токсичности.

Материалы и методы. В ретроспективный анализ включены 23 пациента с подтвержденной холангиокарциномой, получившие лечение в трех центрах АО «ГК «МЕДСИ» с 2020 по 2024 г. Основной режим терапии включал гемцитабин, цисплатин и ингибитор PD-1/PD-L1 с последующей поддерживающей иммунотерапией. Оценка эффективности проводилась по критериям RECIST v1.1, статистический анализ выполнялся методом Каплана – Мейера.

Результаты. Медиана ВБП составила 8,0 мес. (95% ДИ: 6,6–9,3), медиана ОВ – 14,0 мес. (95% ДИ: 8,4–19,5). ЧОО составила 25% (5 частичных ответов, полные ответы отсутствовали), частота контроля заболевания – 68,5%. Осложнения 3–4-й степени зарегистрированы у 39% пациентов, включая гематологическую токсичность и редкие иммуноопосредованные реакции.

Выводы. Результаты настоящего анализа подтверждают эффективность химиоиммунотерапии в реальной клинической практике и коррелируют с данными крупных международных исследований. Включение ингибиторов PD-1/PD-L1 в схему первой линии терапии ОБТ демонстрирует клинически значимое улучшение показателей выживаемости и контроля заболевания, особенно у пациентов с благоприятным ответом на терапию.

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