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RU2016146129A - Способы лечения раннего рака молочной железы трастузумабом-mcc-dm1 и пертузумабом - Google Patents

Способы лечения раннего рака молочной железы трастузумабом-mcc-dm1 и пертузумабом Download PDF

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RU2016146129A
RU2016146129A RU2016146129A RU2016146129A RU2016146129A RU 2016146129 A RU2016146129 A RU 2016146129A RU 2016146129 A RU2016146129 A RU 2016146129A RU 2016146129 A RU2016146129 A RU 2016146129A RU 2016146129 A RU2016146129 A RU 2016146129A
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pertuzumab
treatment
chemotherapy
preceding paragraphs
breast cancer
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RU2016146129A
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RU2725093C2 (ru
RU2016146129A3 (ru
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Марджори С. ГРИН
Элис Элизабет ГУАРДИНО
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Дженентек, Инк.
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Claims (25)

1. Способ лечения рака молочной железы, включающий
(i) назначение пациенту с HER2-положительным, операбельным, местно-распространенным или отечно-инфильтративным раком молочной железы неоадъювантной терапии комбинацией T-DM1 и пертузумаба, при отсутствии химиотерапии,
(ii) удаление указанного рака молочной железы путем радикального оперативного вмешательства; а также
(iii) назначение указанному пациенту адъювантной терапии комбинацией T-DM1 и пертузумаба, при отсутствии химиотерапии.
2. Способ по п. 1, отличающийся тем, что указанный пациент подвергается адъювантному лечению комбинацией T-DM1 и пертузумаба, при отсутствии химиотерапии, содержащей таксан.
3. Способ по п. 1, отличающийся тем, что указанный пациент подвергается адъювантному лечению комбинацией T-DM1 и пертузумаба, при отсутствии сопутствующей химиотерапии.
4. Способ по п. 3, отличающийся тем, что адъювантное лечение включает химиотерапию до и/или после лечения T-DM1 и пертузумабом.
5. Способ по п. 4, отличающийся тем, что химиотерапия до и/или после лечения T-DM1 и пертузумабом не содержит таксан.
6. Способ по п. 4, отличающийся тем, что применяемая химиотерапия включает химиотерапию на основе антрациклина.
7. Способ по п. 6, отличающийся тем, что применяемая химиотерапия дополнительно содержит трастузумаб.
8. Способ по п. 6, отличающийся тем, что терапия на основе антрациклина содержит один или более из FAC (5-фторурацил, доксорубицин, циклофосфамид), FEC (5-фторурацил, эпирубицин и циклофосфамид) или AC (доксорубицин, циклофосфамид).
9. Способ по любому из пп. 1-8, отличающийся тем, что рак молочной железы > 2 см в диаметре.
10. Способ по любому из пп. 1-8, отличающийся тем, что радикальное оперативное вмешательство проводят по меньшей мере через 14 суток после завершения неоадъювантной терапии.
11. Способ по п. 10, отличающийся тем, что радикальное оперативное вмешательство проводят не позднее, чем через 9 недель после завершения неоадъювантной терапии.
12. Способ по любому из пп. 1-8, отличающийся тем, что протоколы неоадъювантного и адъювантного лечения включают инфузию T-DM1 в дозе 3,6 мг/кг каждые 3 недели и инфузию пертузумаба в нагрузочной дозе 840 мг и в дозе 420 мг каждые 3 недели после этого.
13. Способ по любому из предшествующих пунктов, отличающийся тем, что T-DM1 и пертузумаб вводят одновременно.
14. Способ по п. 13, отличающийся тем, что Т-DM1 и пертузумаб вводят совместно.
15. Способ по п. 13, отличающийся тем, что Т-DM1 и пертузумаб вводят последовательно в любом порядке.
16. Способ по п. 13, отличающийся тем, что введение осуществляют по схеме, представленной в Таблице 5.
17. Способ по любому из предшествующих пунктов, отличающийся тем, что указанное лечение повышает один или более из показателей: частота полного ответа (ПО), БСВ (бессобытийная выживаемость), ВБПЗ (выживаемость без признаков заболевания), ВБПИЗ (выживаемость без признаков инвазивного заболевания) и ОВ (общая выживаемость).
18. Способ по любому из предшествующих пунктов, отличающийся тем, что указанное лечение увеличивает период времени до прогрессирования заболевания.
19. Способ по любому из предшествующих пунктов, отличающийся тем, что неоадъювантное лечение по существу состоит из введения T-DM1 и пертузумаба.
20. Способ по любому из предыдущих пунктов, отличающийся тем, что неоадъювантное лечение состоит из введения T-DM1 и пертузумаба.
21. Способ по любому из предшествующих пунктов, отличающийся тем, что адъювантное лечение по существу состоит из введения T-DM1 и пертузумаба.
22. Способ по любому из предыдущих пунктов, отличающийся тем, что адъювантное лечение состоит из введения T-DM1 и пертузумаба.
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