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 PDFInfo
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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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- Prior art keywords
- pertuzumab
- treatment
- chemotherapy
- preceding paragraphs
- breast cancer
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- 229960002087 pertuzumab Drugs 0.000 title claims 15
- 206010006187 Breast cancer Diseases 0.000 title claims 5
- 208000026310 Breast neoplasm Diseases 0.000 title claims 5
- 238000000034 method Methods 0.000 claims 22
- 229960001612 trastuzumab emtansine Drugs 0.000 claims 14
- 238000002512 chemotherapy Methods 0.000 claims 9
- 238000009098 adjuvant therapy Methods 0.000 claims 7
- 238000009099 neoadjuvant therapy Methods 0.000 claims 6
- AOJJSUZBOXZQNB-TZSSRYMLSA-N Doxorubicin Chemical compound O([C@H]1C[C@@](O)(CC=2C(O)=C3C(=O)C=4C=CC=C(C=4C(=O)C3=C(O)C=21)OC)C(=O)CO)[C@H]1C[C@H](N)[C@H](O)[C@H](C)O1 AOJJSUZBOXZQNB-TZSSRYMLSA-N 0.000 claims 4
- 230000004083 survival effect Effects 0.000 claims 4
- CMSMOCZEIVJLDB-UHFFFAOYSA-N Cyclophosphamide Chemical compound ClCCN(CCCl)P1(=O)NCCCO1 CMSMOCZEIVJLDB-UHFFFAOYSA-N 0.000 claims 3
- 229960004397 cyclophosphamide Drugs 0.000 claims 3
- 201000010099 disease Diseases 0.000 claims 3
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 claims 3
- 238000011470 radical surgery Methods 0.000 claims 3
- GHASVSINZRGABV-UHFFFAOYSA-N Fluorouracil Chemical compound FC1=CNC(=O)NC1=O GHASVSINZRGABV-UHFFFAOYSA-N 0.000 claims 2
- 229940123237 Taxane Drugs 0.000 claims 2
- 229940045799 anthracyclines and related substance Drugs 0.000 claims 2
- 229960004679 doxorubicin Drugs 0.000 claims 2
- 229960002949 fluorouracil Drugs 0.000 claims 2
- 238000001802 infusion Methods 0.000 claims 2
- AOJJSUZBOXZQNB-VTZDEGQISA-N 4'-epidoxorubicin Chemical compound O([C@H]1C[C@@](O)(CC=2C(O)=C3C(=O)C=4C=CC=C(C=4C(=O)C3=C(O)C=21)OC)C(=O)CO)[C@H]1C[C@H](N)[C@@H](O)[C@H](C)O1 AOJJSUZBOXZQNB-VTZDEGQISA-N 0.000 claims 1
- HTIJFSOGRVMCQR-UHFFFAOYSA-N Epirubicin Natural products COc1cccc2C(=O)c3c(O)c4CC(O)(CC(OC5CC(N)C(=O)C(C)O5)c4c(O)c3C(=O)c12)C(=O)CO HTIJFSOGRVMCQR-UHFFFAOYSA-N 0.000 claims 1
- 101001012157 Homo sapiens Receptor tyrosine-protein kinase erbB-2 Proteins 0.000 claims 1
- 102100030086 Receptor tyrosine-protein kinase erbB-2 Human genes 0.000 claims 1
- 229960001904 epirubicin Drugs 0.000 claims 1
- DKPFODGZWDEEBT-QFIAKTPHSA-N taxane Chemical class C([C@]1(C)CCC[C@@H](C)[C@H]1C1)C[C@H]2[C@H](C)CC[C@@H]1C2(C)C DKPFODGZWDEEBT-QFIAKTPHSA-N 0.000 claims 1
- 238000002560 therapeutic procedure Methods 0.000 claims 1
- 229960000575 trastuzumab Drugs 0.000 claims 1
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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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RU2725093C2 (ru) | 2020-06-29 |
RU2016146129A3 (ru) | 2018-12-18 |
IL248487A0 (en) | 2016-12-29 |
RU2020120593A (ru) | 2020-09-01 |
MX2016014007A (es) | 2017-01-11 |
SG10201809411PA (en) | 2018-11-29 |
BR112016024789A2 (pt) | 2017-10-24 |
EP3581586A1 (en) | 2019-12-18 |
AU2021200109A1 (en) | 2021-03-18 |
CN106163558A (zh) | 2016-11-23 |
US20170035907A1 (en) | 2017-02-09 |
KR20160141857A (ko) | 2016-12-09 |
WO2015164665A1 (en) | 2015-10-29 |
AU2015249633A1 (en) | 2016-11-17 |
AU2015249633A8 (en) | 2016-12-01 |
SG11201608912VA (en) | 2016-11-29 |
JP2017513901A (ja) | 2017-06-01 |
EP3134440A1 (en) | 2017-03-01 |
JP2020172487A (ja) | 2020-10-22 |
CA2946860A1 (en) | 2015-10-29 |
AU2015249633B2 (en) | 2020-10-15 |
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