Частина ІІІ. Оптимальне використання бендамустину при гематологічних захворюваннях: рекомендації по  лікуванню Міжнародної Погоджувальної Комісії – оновлення

Bruce D. Cheson, a , * Wolfram Brugger, b Gandhi Damaj, c Martin Dreyling, d Brad Kahl, e Eva Kimby, f Michinori Ogura,g Eckhart Weidmann, h Clemens-Martin Wendtner, i and Pier Luigi Zinzani j

Інформація про авторів статті

LEUKEMIA & LYMPHOMA, 2016 VOL. 57, NO. 4, 766–782
Journal List Taylor & Francis Open Select PMC4840280

Частина ІІІ (Частину ІІ див. http://vista-mediclub.com/ua/oncology-news-ua/1689-optimalne-vikoristannja-bendamustinu-pri-gematologichnih-zahvorjuvannjah-rekomendacii-po-likuvannju-mizhnarodnoi-pogodzhuvalnoi-komisii-onovlennja-chastina-ii)

Хронічний лімфолейкоз

Застосування бендамустину при рецидивуючих/рефрактерних формах

Ранні дослідження продемонстрували ефективність застосування бендамустину в якості монотерапії у пацієнтів з рецидивуючим або рефрактерним ХЛЛ. Згодом Фішер і співавтори з німецької групи з вивчення ХЛЛ у підгрупі з 78 пацієнтів застосовували в якості терапії схему BR, яка продемонструвала 45,5% ORR у флударабин-рефрактерних пацієнтів  і 60,5% ORR в групі флударабин-чутливих пацієнтів, при цьому медіана безподійної виживаності склала 14,7 місяців. Таким чином, комбінацію BR слід вважати ефективною схемою терапії пацієнтів, за винятком пацієнтів «17p» (з наявністю мутації del17p) або рефрактерних до FCR при рецидивах / рефрактерних формах, особливо, якщо бендамустин не використовувався раніше, або якщо була досягнута стійка ремісія при попередньому використанні бендамустину (читайте про особливості повторних курсів застосування бендамустину далі у випусках).

Комбінації бендамустину з таргетними препаратами

Поточні клінічні дослідження вивчають комбінації бендамустину з представниками другого покоління анти- CD20 моноклональних антитіл (МКА), такими як офатумумаб (ofatumumab) (дослідження OMB115991 і дослідження GIMEMA CLL0809 [NCT01244451]) і обінутузумаб (obinutuzumab) (GA101) (дослідження GALTON [NCT01300247]) в якості схеми терапії першої лінії. Крім того, BR служить хіміотерапевтичною основою для комбінацій з інгібітором ВТК, ібрутінібом (ibrutinib) (PCYC1108 дослідження), PI3K- delta-інгібіторами, іделалізібом (idelalisib) (пацієнти з рецидивом NCT01569295; неліковані хворі NCT01980888); BH3 міметиками, венетоклаксом (venetoclax) та іншими.

Рекомендації погоджувальної групи: хронічний лімфолейкоз

•  Перша лінія терапії:
1) Для пацієнтів ≥ 65 років BR є кращею у порівнянні з FCR;
2) Для літніх і пацієнтів з вираженою супутньою патологією зменшена доза бендамустина (70 мг / м2) рекомендується на строк до шести циклів;
3) Для молодших пацієнтів з мутаціями IGHV-генів терапія FCR може бути недостатньо ефективною:
- з del17p - BR може бути корисна для початкової "циторедукціі", але не для конкретного лікування; кращим в даному випадку є ібрутиніб (ibrutinib);
- деякі молоді пацієнти з ХЛЛ з підтвердженими генними мутаціями можуть бути "проліковані" FCR, але повинен враховуватися ризик розвитку вторинних «флударабин-асоційованих» пухлин: таким чином і в цьому випадку BR є підходящою альтернативою, а FCR є альтернативним варіантом для пацієнтів без наявності генних мутацій;
4) Для хворих з серйозними супутніми захворюваннями, BR є альтернативою схемі іделалізіб/ритуксімаб (idelalisib/ rituximab):
-  за наявності ниркової або печінкової недостатності,
- за «кумулятивним рейтингом шкали захворювання» (Cumulative Illness Rating Scale) > 6 або з вираженими порушеннями кліренсу креатиніну,
-  аутоімунною гемолітичною анемією або імунною тромбоцитопенією;

•  При рецидивах або рефрактерних ХЛЛ:
1) Зниження дози бендамустину (70 мг / м2) в дні 1-й та 2-й, не більше чотирьох циклів BR;
2) Необхідно обов'язково враховувати якість реакції та переносимість на попередніх етапах лікування;
3) Повторна терапія BR є розумною, якщо попередня ремісія тривала ≥ 12 місяців;
4) Бендамустин не показаний для del17p та / або p53 пацієнтів, де більш кращими будуть нові агенти;
5) Для пацієнтів з рецидивом після FCR (проте, якщо рецидив виникає після періоду ≥ 3 років, повторна терапія FCR може бути розглянута);
6) Комбінації з новими таргетними препаратами не повинні використовуватися, доки не доведено їхню безпеку та ефективність у клінічних випробуваннях.

З медичною інструкцією Бендамустин-Віста можна ознайомитись за посиланням http://vista-mediclub.com/preparaty-vista/1650-bendamustinvista-bendamustinvista.

Інформацію про наявність в аптеках України і ціну можна дізнатись на http://medbrowse.com.ua/bendamustin-vista-cena/ukraina

Інформація про авторів статті

aLombardi Comprehensive Cancer Center, Georgetown University Hospital, Washington, DC, USA
bSchwarzwald-Baar Clinic, University of Freiburg, Villingen-Schwenningen, Germany
cUniversity Hospital, University of Basse-Normandie, Caen, France
dMedical Clinic, University Hospital of Munich, Munich, Germany
eUniversity of Wisconsin School of Medicine and Public Health, Madison, WI, USA
fCenter for Hematology, Department of Medicine Huddinge, Karolinska Institutet, Stockholm, Sweden
gDepartment of Hematology, Tokai Central Hospital, Gifu, Japan
hDepartment of Oncology and Hematology, Krankenhaus Nordwest, Frankfurt, Germany
iKlinikum Schwabing, Academic Teaching Hospital of University of Munich, Munich, Germany
jInstitute of Hematology, University of Bologna, Bologna, Italy
CONTACT Professor Bruce D. Cheson ; Email: ude.nwotegroeg@4cdb, Georgetown University Hospital, Lombardi Comprehensive Cancer Center, 3800 Reservoir Road, NW, Washington, DC, USA

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