Новости онкологии

25.09.2019

Практические рекомендации MASCC/ISOO/ASCO по лечению остеонекроза челюсти, вызванного лекарственными препаратами

Опубликованы в Journal of Clinical Oncology 37, no. 25 (September 2019).

Введение

Лекарственный остеонекроз челюсти (ЛОНЧ) – это состояние, продолжающееся не менее 8 недель, при котором кость челюсти обнажается либо ее можно прощупать сквозь внутриротовой(-ые) или внеротовой(-ые) свищ(и) челюстно-лицевой области. Оно возникает у пациентов, получающих препараты, модифицирующие костную ткань (ПМКТ, остеомодифицирующие агенты), или у пациентов, получающих ингибиторы ангиогенеза, у которых в анамнезе отсутствует облучение области головы и шеи [1, 2]. Данное явление может затрагивать как верхнюю, так и нижнюю челюсть. ПМКТ, которые ассоциируются с развитием ЛОНЧ, – это, главным образом, бисфосфонаты и деносумаб. ПМКТ являются ключевым компонентом терапии онкологических пациентов с метастазами в кости. Эти препараты обладают рядом клинических преимуществ, в частности, они снижают риск возникновения нежелательных явлений со стороны скелета (например, патологических переломов или компрессии спинного мозга) и снижают потребность в лучевой терапии и хирургическом вмешательстве на костях. Применение ПМКТ ассоциируется с развитием ЛОНЧ, частота которого у пациентов с распространенным раком составляет примерно от 1% до 9% (таблица 1). Зачастую ЛОНЧ плохо поддается терапии и может быть причиной выраженной боли и снижения качества жизни. В многочисленных исследованиях было установлено, что методы профилактической санации полости рта в сочетании с правильным уходом за полостью рта ассоциируются с более низкой частотой возникновения ЛОНЧ [15-28].

Таблица 1. Препараты, модифицирующие костную ткань, и риск развития ЛОНЧ.

Препарат Показание Путь введения Доза, мг Режим приема Частота ЛОНЧ*
Памидронат Костные метастазы
при солидных опухолях
в/в 90 Каждые 3-4 недели 3,2-5,0 [3, 4]
Множественная миелома        
Золедроновая кислота Костные метастазы
при солидных опухолях
в/в 4 Каждые 3-4 недели
или 12 недель
1,0-8,0 [5, 6]
Множественная миелома        
Адъювантная терапия в/в 4 Каждые 3-6 месяцев 0-1,8 [7-9]
Деносумаб Костные метастазы
при солидных опухолях
п/к 120 Каждые 4 недели 0,7-6,9** [10-12]
Адъювантная терапия п/к 60 Каждые 6 месяцев 0 [13]

Сокращения: в/в – внутривенно; ЛОНЧ – лекарственный остеонекроз челюсти; п/к – подкожно.
* Риск ЛОНЧ различается в зависимости от длительности лечения.
** Показатель 6,9% взят из двух исследований III фазы [10]. Этот показатель приведен без поправки на длительность лечения в пациенто-годах и без учета периода последующего наблюдения. Данный показатель не включает случаи, когда явление возникало во время слепой фазы лечения. После поправки на пациенто-годы частота подтвержденного ОНЧ составила 1,1% в период первого года лечения деносумабом, 37% во время второго года лечения и 4,6% в каждый последующий год [14].

Настоящие рекомендации фокусируются на профилактике и лечении ЛОНЧ у онкологических пациентов, получающих ПМКТ в связи с онкологическим заболеванием. В рекомендациях не рассматриваются ситуации, когда пациенты получают ПМКТ для лечения остеопороза. В последнем случае эти препараты назначаются в более низких дозах, при которых риск возникновения ЛОНЧ снижается [29]. Также в рекомендациях не разбираются методы профилактики и лечения ЛОНЧ, возникающего при применении препаратов, не относящихся к ПМКТ. Были сообщения о возникновении ЛОНЧ у пациентов, получавших другие препараты [30, 31], в том числе в широко понимаемом смысле ЛОНЧ может возникать на фоне применения факторов, ингибирующих ангиогенез [2], однако информация о профилактике и лечении ЛОНЧ при применении иных препаратов, нежели ПМКТ, является недостаточной. В настоящем руководстве подчеркивается важность сотрудничества команды специалистов по лечению рака, врачей-стоматологов и узких специалистов в области стоматологии.


Рекомендации

Клинический вопрос 1. Каково определение остеонекроза челюсти (верхней и нижней), возникающего на фоне применения лекарственных препаратов у пациентов с онкологическими заболеваниями, и какой термин предпочтительнее использовать для данного состояния?

  • Рекомендация 1.1. Если речь идет об остеонекрозе на фоне применения лекарственных препаратов, рекомендуется использовать термин «лекарственный остеонекроз челюсти» (тип рекомендации: формальный консенсус; уровень достоверности: недостаточный; сила рекомендации: слабая).
  • Рекомендация 1.2. Для установления диагноза ЛОНЧ врачу следует убедиться, что присутствуют все три из нижеперечисленных критериев диагностики: 1) пациент получал или получает в настоящий момент терапию ПМКТ или ингибитором ангиогенеза; 2) кость обнажена или прощупывается через внутриротовой или внеротовой свищ челюстно-лицевой области, данное состояние отмечается на протяжении более 8 недель; 3) отсутствие в анамнезе лучевой терапии в области челюстей и метастазов в челюсти (тип рекомендации: формальный консенсус; уровень достоверности: недостаточный; сила рекомендации: слабая).

Клинический вопрос 2. Какие шаги следует предпринять для снижения риска развития ЛОНЧ?

  • Рекомендация 2.1: Правильное планирование лечения пациента. Онкологическим пациентам, которые получают терапию вне отделений неотложной помощи, до начала терапии следует провести диагностику состояния полости рта (в том числе, по возможности, детальное обследование у стоматолога, пародонтолога и рентгенологическое исследование). В зависимости от полученных результатов может потребоваться план стоматологического лечения. Схема терапии пациента должна быть согласована между стоматологом и онкологом таким образом, чтобы необходимые стоматологические процедуры проводились до начала терапии ПМКТ. Далее стоматолог должен осуществлять регулярное наблюдение за состоянием пациента, например, каждые 6 месяцев после начала терапии ПМКТ (тип рекомендации: научно обоснованные данные; уровень достоверности: низкий/средний; сила рекомендации: средняя).
  • Рекомендация 2.2. Управляемые факторы риска: специалисты междисциплинарной команды должны как можно ранее начать внедрение стратегии по снижению факторов риска ЛОНЧ у пациента. Факторы риска включают, в частности, неудовлетворительное состояние полости рта, инвазивные стоматологические процедуры, плохо подобранные зубные протезы, неконтролируемый сахарный диабет, курение (тип рекомендации: формальный консенсус; уровень достоверности: недостаточный; сила рекомендации: средняя).
  • Рекомендация 2.3. Элективная дентоальвеолярная хирургия: в период активной терапии ПМКТ в дозе, необходимой для онкологического лечения, не следует проводить элективные дентоальвеолярные хирургические процедуры (например, удаление зуба по немедицинским показаниям, альвеолопластику, установку имплантов). Исключением могут быть случаи, когда специалист-стоматолог, компетентный в лечении и профилактике ЛОНЧ, взвесил все риски и пользу планируемой инвазивной процедуры и обсудил их с пациентом и командой онкологических специалистов (тип рекомендации: научно обоснованные данные; уровень достоверности: средний; сила рекомендации: средняя).
  • Рекомендация 2.4. Контроль над состоянием пациента после дентоальвеолярной хирургии: после проведения дентоальвеолярной хирургии специалист (стоматолог/челюстно-лицевой хирург) должен регулярно и достаточно часто проводить оценку состояния пациента (например, каждые 6-8 недель) до момента полного восстановления слизистой в области хирургического вмешательства. При этом желательно держать врача-онколога в курсе того, как проходит процесс заживления, особенно если в дальнейшем планируется назначение ПМКТ (таблица 2) (тип рекомендации: формальный консенсус; уровень достоверности: недостаточный; сила рекомендации: средняя).
  • Рекомендация 2.5. Временное прекращение применения ПМКТ перед проведением дентоальвеолярного хирургического вмешательства: существует ограниченное количество данных относительно того, следует ли прекращать применение ПМКТ перед проведением дентоальвеолярного хирургического вмешательства у онкологических пациентов, получающих ПМКТ в дозе, необходимой для онкологического лечения. Применение ПМКТ может быть прервано по усмотрению лечащего врача, при этом решение следует обсудить с пациентом и стоматологом (тип рекомендации: неформальный консенсус; уровень достоверности: недостаточный; сила рекомендации: слабая).

Клинический вопрос 3. Каковы стадии развития ЛОНЧ?

  • Рекомендация 3.1. Для определения степени тяжести и стадии ЛОНЧ, а также принятия решений о выборе терапии необходимо руководствоваться разработанной системой классификации. В частности, можно применять систему классификации 2014 г. Американской ассоциации челюстно-лицевых хирургов, Общие терминологические критерии нежелательных явлений, версия 5.0, и классификацию ЛОНЧ 2017 г. Международной рабочей группы по остеонекрозу челюсти. На протяжении всего курса лечения пациента должна использоваться одна и та же система классификации. В дополнение к этим системам классификации можно использовать данные методов диагностической визуализации (тип рекомендации: формальный консенсус; уровень достоверности: недостаточный; сила рекомендации: слабая).
  • Рекомендация 3.2. Желательно, чтобы определение стадии заболевания проводил врач с опытом ведения пациентов с ЛОНЧ (тип рекомендации: формальный консенсус; уровень достоверности: недостаточный; сила рекомендации: слабая).

Клинический вопрос 4. Какова тактика лечения ЛОНЧ?

  • Рекомендация 4.1: Начальная терапия ЛОНЧ. Начинать терапию ЛОНЧ следует с консервативных методов лечения. Консервативные меры могут включать антибактериальное полоскание полости рта, антибиотикотерапию по клиническим показаниям, эффективные способы гигиены полости рта и консервативное хирургическое вмешательство, например, удаление поверхностных костных спикул (тип рекомендации: формальный консенсус; уровень достоверности: недостаточный; сила рекомендации: средняя).
  • Рекомендация 4.2: Терапия рефрактерного ЛОНЧ. Агрессивное хирургическое вмешательство (например, пластика лоскутом слизистой оболочки, блоковая резекция некротизированной костной ткани или ушивание мягких тканей) может применяться в случаях, если, несмотря на проведение консервативной терапии, симптомы ЛОНЧ сохраняются или нарушают функционирование. Не рекомендуется проводить агрессивное хирургическое вмешательство при бессимптомном обнажении кости. Перед проведением агрессивного хирургического вмешательства медицинским специалистам междисциплинарной команды вместе с пациентом следует обсудить риски и пользу планируемого вмешательства (тип рекомендации: формальный консенсус; уровень достоверности: недостаточный; сила рекомендации: слабая).

Клинический вопрос 5. Следует ли на время прекратить терапию ПМКТ после того, как был установлен диагноз ЛОНЧ?

  • Рекомендация 5. Существует ограниченное количество данных относительно того, следует ли прекращать применение ПМКТ пациентам, у которых был диагностирован ЛОНЧ на фоне терапии ПМКТ. Применение ПМКТ может быть прервано по усмотрению лечащего врача, при этом решение следует обсудить с пациентом и стоматологом (тип рекомендации: формальный консенсус; уровень достоверности: недостаточный; сила рекомендации: слабая).

Клинический вопрос 6. Какие критерии оценки исхода заболевания следует использовать в клинической практике для определения ответа на лечение при ЛОНЧ?

  • Рекомендация 6. При проведении курса лечения ЛОНЧ стоматолог/узкий специалист в области стоматологии должен информировать врача-онколога об объективном и субъективном статусе места поражения: состояние разрешилось, улучшилось, стабилизировалось или прогрессирует. В зависимости от того, как протекает ЛОНЧ, может потребоваться проведение/изменение местной и/или системной терапии в связи с прекращением или возобновлением ПМКТ (тип рекомендации: формальный консенсус; уровень достоверности: недостаточный; сила рекомендации: слабая).

По мнению организаций MASCC/ISOO и ASCO, онкологические клинические исследования необходимы для принятия ответственных медицинских решений и для улучшения качества онкологического лечения. Все пациенты должны иметь возможность принять участие в клинических исследованиях.


Дополнительная информация

Более подробная информация, в том числе дополнительные данные с таблицами, презентации, набор клинических инструментов и ссылки на источники, содержится на сайте www.asco.org/supportive-care-guidelines. Информацию для пациентов можно найти на сайте www.cancer.net.


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