RU2017140030A - Прогнозирование ответа на альвоцидиб с помощью анализа профиля митохондрий - Google Patents

Прогнозирование ответа на альвоцидиб с помощью анализа профиля митохондрий Download PDF

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RU2017140030A
RU2017140030A RU2017140030A RU2017140030A RU2017140030A RU 2017140030 A RU2017140030 A RU 2017140030A RU 2017140030 A RU2017140030 A RU 2017140030A RU 2017140030 A RU2017140030 A RU 2017140030A RU 2017140030 A RU2017140030 A RU 2017140030A
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patient
sample
treatment regimen
cancer cells
mcl
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Стивен Л. УОРНЕР
Дэвид Дж. БИРСС
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Толеро Фармасьютикалз, Инк.
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Claims (40)

1. Способ лечения рака у нуждающегося в этом пациента, при этом способ содержит
a) запрос данных профиля BH3 в образце раковых клеток, полученном из костного мозга пациента; и
b) назначение пациенту схемы лечения, включающей прием альвоцидиба, если ответ на обработку NOXA (NOXA priming) в образце раковых клеток составил по меньшей мере 15%.
2. Способ по п. 1, отличающийся тем, что схему лечения назначают пациенту, только если ответ на обработку NOXA в образце раковых клеток составил по меньшей мере 20%.
3. Способ по п. 1, отличающийся тем, что схему лечения назначают пациенту, только если ответ на обработку NOXA в образце раковых клеток составил по меньшей мере 25%.
4. Способ по п. 1, отличающийся тем, что схему лечения назначают пациенту, только если ответ на обработку NOXA в образце раковых клеток составил по меньшей мере 30%.
5. Способ по любому из пп. 1-4, отличающийся тем, что способ дополнительно содержит запрос данных об уровне экспрессии MCL-1, измеренном в образце раковых клеток, и назначение схемы лечения пациенту, только если уровень экспрессии MCL-1 в образце раковых клеток превышает по меньшей мере в 1,1 раз уровень экспрессии MCL-1 в нормальных клетках.
6. Способ по любому из пп. 1-5, отличающийся тем, что схему лечения назначают пациенту только в том случае, если у пациента высокий цитогенетический фактор риска.
7. Способ по любому из пп. 1-6, отличающийся тем, что схему лечения назначают пациенту только в том случае, если у пациента имеется в анамнезе миелодиспластический синдром (МДС).
8. Способ по любому из пп.1-7, в котором данные о профиле BH3 получают с помощью способа, содержащего пермеабилизацию образца раковых клеток, определение изменения потенциала на митохондриальной мембране при контакте пермеабилизированной клетки с одним или несколькими пептидами, содержащими домен BH3; и соотнесение уменьшения потенциала на митохондриальной мембране с хемочувствительностью клетки к апоптоз-индуцирующим химиотерапевтическим средствам.
9. Способ по п. 8, отличающийся тем, что содержащие домен BH3 пептиды представляют собой BIM, BIM2A, BAD, BID, HRK, PUMA, NOXA, BMF, BIK или PUMA2A, или их комбинации.
10. Способ по любому из пп. 8 или 9, отличающийся тем, что содержащий домен BH3 пептид применяют в концентрации от 0,1 мкМ до 200 мкМ.
11. Способ лечения рака у нуждающегося в этом пациента, при этом способ содержит
a) запрос данных об уровне экспрессии MCL-1 в образце раковых клеток, полученном из костного мозга пациента; и
b) назначение пациенту схемы лечения, включающей прием альвоцидиба, если уровень экспрессии MCL-1 в образце раковых клеток превышает по меньшей мере в 1,1 раз уровень экспрессии MCL-1 в нормальных клетках.
12. Способ по п. 11, отличающийся тем, что схему лечения назначают пациенту, только если уровень экспрессии MCL-1 в образце раковых клеток превышает по меньшей мере в 1,5 раз уровень экспрессии MCL-1 в нормальных клетках.
13. Способ по п. 11, отличающийся тем, что схему лечения назначают пациенту, только если уровень экспрессии MCL-1 в образце раковых клеток превышает по меньшей мере в 2 раза уровень экспрессии MCL-1 в нормальных клетках.
14. Способ по п. 11, отличающийся тем, что схему лечения назначают пациенту, только если уровень экспрессии MCL-1 в образце раковых клеток превышает по меньшей мере в 5 раз уровень экспрессии MCL-1 в нормальных клетках.
15. Способ по любому из пп. 11-14, дополнительно содержащий запрос данных профиля BH3 в образце раковых клеток и назначение схемы лечения, только если ответ на обработку NOXA в образце опухоли или раковых клеток составил по меньшей мере 15%.
16. Способ по любому из пп. 11-15, отличающийся тем, что схему лечения назначают пациенту только в том случае, если у пациента высокий цитогенетический фактор риска.
17. Способ по любому из пп. 11-16, отличающийся тем, что схему лечения назначают пациенту только в том случае, если у пациента имеется в анамнезе миелодиспластический синдром (МДС).
18. Способ по любому из пп. 1-17, отличающийся тем, что рак представляет собой гематологический рак.
19. Способ по п. 18, отличающийся тем, что гематологический рак выбирают из острого миелоидного лейкоза (ОМЛ), множественной миеломы, фолликулярной лимфомы, острого лимфобластного лейкоза (ОЛЛ), хронического лимфоцитарного лейкоза или неходжкинской лимфомы.
20. Способ по п. 19, отличающийся тем, что гематологический рак представляет собой острый миелоидный лейкоз (ОМЛ).
21. Способ по п. 18, отличающийся тем, что гематологический рак представляет собой миелодиспластический синдром (МДС).
22. Способ по п. 18, отличающийся тем, что гематологический рак представляет собой хронический лимфоцитарный лейкоз (ХЛЛ).
23. Способ по любому из пп. 1-22, отличающийся тем, что схема лечения включает прием альвоцидиба, цитарабина и митоксантрона (FLAM).
24. Способ по любому из пп. 1-33, отличающийся тем, что образец раковых клеток получают из биопсии не солидной опухоли.
25. Способ по п. 24, отличающийся тем, что образец раковых клеток получают из биопсии пациента с множественной миеломой, острым миелоидным лейкозом, острым лимфоцитарным лейкозом, хроническим миелоидным лейкозом, мантийноклеточной лимфомой, диффузной В-крупноклеточной лимфомой или неходжкинской лимфомой.
26. Способ по п. 25, отличающийся тем, что образец раковых клеток представляет собой клетки множественной миеломы, обогащенные путем отбора из биопсийного образца с помощью антител к CD138, прикрепленных к твердой матрице или шарикам.
27. Способ по п. 26, отличающийся тем, что образец раковых клеток представляет собой клетки острого миелоидного лейкоза, обогащенные за счет связывания с антителами к CD45.
28. Способ по п. 26, отличающийся тем, что образец раковых клеток представляет собой клетки хронического миелоидного лейкоза или диффузной В-крупноклеточной лимфомы, обогащенные с помощью деплеции не В-клеток.
29. Способ определения вероятности ответа пациента на схему лечения, включающую прием альвоцида, при этом способ содержит
контактирование образца пермеабилизированных раковых клеток из костного мозга пациента с одним или несколькими пептидами, содержащими BH3 домен;
измерение ответа клеток на обработку NOXA в образце; и
классификацию пациента как вероятно восприимчивого к схеме лечения, если ответ на обработку NOXA в образце составил не менее 15%.
30. Способ определения вероятности ответа пациента на схему лечения, включающую прием альвоцида, при этом способ содержит
определение уровня экспрессии MCL-1 в образце раковых клеток из костного мозга пациента; и
классификацию пациента как вероятно восприимчивого к схеме лечения, если уровень экспрессии MCL-1 в образце раковых клеток превышает по меньшей мере в 1,1 раз уровень экспрессии MCL-1 в нормальных клетках.
31. Способ по п.29 или 30, дополнительно содержащий назначение схемы лечения пациенту, классифицированному как вероятно восприимчивый пациент.
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