Tumors of female reproductive systemTumors of female reproductive systemОпухоли женской репродуктивной системы1994-40981999-8627Publishing House ABV Press45810.17650/1994-4098-2015-11-4-46-52MAMMOLOGY. TREATMENTМАММОЛОГИЯ. ЛЕЧЕНИЕNew prospects in the use of Kadcyla® in breast cancerНовые перспективы применения препарата Кадсила® при раке молочной железыDashyanG. A.ДашянГ. А.
Russian Federation
dgarik@mail.ruSemiglazovV. F.СемиглазовВ. Ф.
Russian Federation
Krivorot’koP. V.КриворотькоП. В.
Russian Federation
PaltuevR. M.ПалтуевР. М.
Russian Federation
TopuzovE. E.ТопузовЭ. Э.
Russian Federation
SemiglazovaT. Yu.СемиглазоваТ. Ю.
Russian Federation
Zhil’tsovaE. K.ЖильцоваЕ. К.
Russian Federation
DonskikhR. V.ДонскихР. В.
Russian Federation
TabaguaT. T.ТабагуаТ. Т.
Russian Federation
ApollonovaV. S.АполлоноваВ. С.
Russian Federation
N.N. Petrov Research Institute of Oncology, Ministry of Health of RussiaФГБУ «Научно-исследовательский институт онкологии им. Н. Н. Петрова» Минздрава России Россия, 197758, Санкт-Петербург, пос. Песочный, ул. Ленинградская, 6868 Leningradskaya St., Pesochnyi Settlement, Saint Petersburg, 197758, RussiaФГБУ «Научно-исследовательский институт онкологии им. Н. Н. Петрова» Минздрава России Россия, 197758, Санкт-Петербург, пос. Песочный, ул. Ленинградская, 6868 Leningradskaya St., Pesochnyi Settlement, Saint Petersburg, 197758, RussiaНУЗ «ДКБ ОАО “РЖД”»N.N. Petrov Research Institute of Oncology, Ministry of Health of RussiaРоссия, 195271, Санкт-Петербург, просп. Мечникова, 2768 Leningradskaya St., Pesochnyi Settlement, Saint Petersburg, 197758, RussiaГБОУ ВПО «Северо-Западный государственный медицинский университет им. И. И. Мечникова»Railway Clinical Hospital, OJSC “RZhD”Минздрава России27 Mechnikov Prosp., Saint Petersburg, 195271, RussiaРоссия, 191015, Санкт-Петербург, ул. Кирочная, 41I.I. Mechnikov North-Western State Medical University, Ministry of Health of RussiaФГБУ «Научно-исследовательский институт онкологии им. Н. Н. Петрова» Минздрава России Россия, 197758, Санкт-Петербург, пос. Песочный, ул. Ленинградская, 6841 Kirochnaya St., Saint Petersburg, 191015, RussiaФГБУ «Научно-исследовательский институт онкологии им. Н. Н. Петрова» Минздрава России Россия, 197758, Санкт-Петербург, пос. Песочный, ул. Ленинградская, 6868 Leningradskaya St., Pesochnyi Settlement, Saint Petersburg, 197758, RussiaN.N. Petrov Research Institute of Oncology, Ministry of Health of Russia2611201511446522511201525112015https://ojrs.abvpress.ru/ojrs/article/view/458

As is known, the HER-2-expressing biological subtype of breast cancer (BC) is characterized by an aggressive course and has a poorprognosis in the absence of specific treatment. Before the emergence of trastuzumab, 5-year overall survival in patients with the disseminated forms of BC was 20 % (median survival, 16–29 months), out of whom only 2–5 % were long-term survivors. Addition of trastuzumab, a humanized monoclonal antibody that binds selectively to HER-2 receptor on the surface of tumor cells, to first-line chemotherapy for HER-2-positive metastatic BC caused a considerable enhancement of therapeutic efficiency. When trastuzumab is incorporated into chemotherapy for metastatic BC, median progression-free survival and overall survival were 7.4 and 25.1 months (4.6 and 20.3 months without trastuzumab), respectively. Kadcyla® (T-DM1), an antibody-drug conjugate, represents a new approach to treating HER-2-positive metastatic BC. T-DM1 is characterized by the innovative and selective mechanism of action on the HER-2-positive tumor cells. Through this mechanism, T-DM1 leads to a double antitumor effect: a trastuzumab-mediated anti-HER-2 effect and a cytotoxic effect due to the selective transport of the potent antimitotic agent DM1 into the cytoplasm. This mechanism of action enhances the efficiency of antitumor therapy and reduces toxicity. Kadcyla® has been approved in the Russian Federation, as well as by the European Medicines Agency and the United States Food and Drug Administration as monotherapy in HER-2-positive inoperable locally advanced or metastatic BC patients previously treated with taxanes and / or trastuzumab.

Как известно, HER-2-экспрессирующий биологический подтип рака молочной железы (РМЖ) характеризуется агрессивным течением и имеет плохой прогноз при отсутствии специфического лечения. До появления трастузумаба 5-летняя общая выживаемость больных распространенными формами РМЖ составляла 20 % (медиана выживаемости 16–29 мес), из которых только 2–5 % имели долгосрочное выживание. Добавление трастузумаба, гуманизированного моноклонального антитела, которое избирательно связывается с рецептором HER-2 на поверхности опухолевых клеток, к химиотерапии 1-й линии HER-2-позитивного метастатического РМЖ привело к значительному повышению эффективности лечения. При добавлении трастузумаба к химиотерапии метастатического РМЖ медиана выживаемости без прогрессирования и общая выживаемость составляют 7,4 мес (4,6 мес без трастузумаба) и 25,1 мес (20,3 мес без трастузумаба) соответственно. Кадсила® (Т-DM1) – конъюгат антитела и лекарственного препарата, реализует новый подход к лечению HER-2-позитивного метастатического РМЖ. Т-DM1 характеризуется инновационным и избирательным механизмом действия на HER-2-положительные опухолевые клетки. С помощью этого механизма Т-DM1 приводит к двойному противоопухолевому эффекту: анти-HER-2 (опосредованному трастузумабом) и цитотоксическому (благодаря селективному транспорту мощного антимитотического агента DM1 в цитоплазму). Данный механизм действия повышает эффективность противоопухолевой терапии, уменьшая при этом токсичность. Препарат Кадсила® одобрен в Российской Федерации, Европейским агентством по лекарственным средствам (European Medicines Agency) и Управлением по контролю за продуктами и лекарствами США (Food and Drug Administration) в качестве монотерапии для лечения больных с HER-2-положительным неоперабельным местно-распространенным или метастатическим РМЖ, которые ранее получали таксаны и / или трастузумаб.

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