RU2694259C2 - Method of castration-resistant prostate cancer treatment - Google Patents
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- RU2694259C2 RU2694259C2 RU2017136381A RU2017136381A RU2694259C2 RU 2694259 C2 RU2694259 C2 RU 2694259C2 RU 2017136381 A RU2017136381 A RU 2017136381A RU 2017136381 A RU2017136381 A RU 2017136381A RU 2694259 C2 RU2694259 C2 RU 2694259C2
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- 238000011282 treatment Methods 0.000 title claims abstract description 14
- 206010060862 Prostate cancer Diseases 0.000 title claims abstract description 12
- 208000000236 Prostatic Neoplasms Diseases 0.000 title claims abstract description 12
- 238000000034 method Methods 0.000 title claims abstract description 6
- KDYFGRWQOYBRFD-UHFFFAOYSA-N succinic acid Chemical compound OC(=O)CCC(O)=O KDYFGRWQOYBRFD-UHFFFAOYSA-N 0.000 claims abstract description 23
- 239000003814 drug Substances 0.000 claims abstract description 10
- 239000001384 succinic acid Substances 0.000 claims abstract description 10
- 239000000203 mixture Substances 0.000 claims abstract description 8
- BMQGVNUXMIRLCK-OAGWZNDDSA-N cabazitaxel Chemical compound O([C@H]1[C@@H]2[C@]3(OC(C)=O)CO[C@@H]3C[C@@H]([C@]2(C(=O)[C@H](OC)C2=C(C)[C@@H](OC(=O)[C@H](O)[C@@H](NC(=O)OC(C)(C)C)C=3C=CC=CC=3)C[C@]1(O)C2(C)C)C)OC)C(=O)C1=CC=CC=C1 BMQGVNUXMIRLCK-OAGWZNDDSA-N 0.000 claims abstract description 7
- 229960001573 cabazitaxel Drugs 0.000 claims abstract description 7
- 238000001802 infusion Methods 0.000 claims abstract description 6
- MBBZMMPHUWSWHV-BDVNFPICSA-N N-methylglucamine Chemical compound CNC[C@H](O)[C@@H](O)[C@H](O)[C@H](O)CO MBBZMMPHUWSWHV-BDVNFPICSA-N 0.000 claims abstract description 4
- 238000001990 intravenous administration Methods 0.000 claims abstract description 3
- 229940079593 drug Drugs 0.000 claims description 7
- 238000002560 therapeutic procedure Methods 0.000 claims description 2
- 229940095453 prednisone 10 mg Drugs 0.000 claims 1
- 238000002512 chemotherapy Methods 0.000 abstract description 5
- 238000002360 preparation method Methods 0.000 abstract description 5
- 230000000694 effects Effects 0.000 abstract description 4
- 229940066263 prednisolone 10 mg Drugs 0.000 abstract description 3
- 229940079920 digestives acid preparations Drugs 0.000 abstract 1
- 239000000126 substance Substances 0.000 abstract 1
- 230000001225 therapeutic effect Effects 0.000 abstract 1
- 206010028980 Neoplasm Diseases 0.000 description 8
- 231100000331 toxic Toxicity 0.000 description 6
- 230000002588 toxic effect Effects 0.000 description 6
- 201000011510 cancer Diseases 0.000 description 5
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 description 5
- ZDZOTLJHXYCWBA-VCVYQWHSSA-N N-debenzoyl-N-(tert-butoxycarbonyl)-10-deacetyltaxol Chemical compound O([C@H]1[C@H]2[C@@](C([C@H](O)C3=C(C)[C@@H](OC(=O)[C@H](O)[C@@H](NC(=O)OC(C)(C)C)C=4C=CC=CC=4)C[C@]1(O)C3(C)C)=O)(C)[C@@H](O)C[C@H]1OC[C@]12OC(=O)C)C(=O)C1=CC=CC=C1 ZDZOTLJHXYCWBA-VCVYQWHSSA-N 0.000 description 4
- 229940123237 Taxane Drugs 0.000 description 4
- 201000010099 disease Diseases 0.000 description 4
- 229960003668 docetaxel Drugs 0.000 description 4
- 229960004618 prednisone Drugs 0.000 description 3
- XOFYZVNMUHMLCC-ZPOLXVRWSA-N prednisone Chemical compound O=C1C=C[C@]2(C)[C@H]3C(=O)C[C@](C)([C@@](CC4)(O)C(=O)CO)[C@@H]4[C@@H]3CCC2=C1 XOFYZVNMUHMLCC-ZPOLXVRWSA-N 0.000 description 3
- 206010021143 Hypoxia Diseases 0.000 description 2
- 230000015572 biosynthetic process Effects 0.000 description 2
- 210000004027 cell Anatomy 0.000 description 2
- 210000001035 gastrointestinal tract Anatomy 0.000 description 2
- 230000036039 immunity Effects 0.000 description 2
- 230000001965 increasing effect Effects 0.000 description 2
- 208000015181 infectious disease Diseases 0.000 description 2
- 230000002458 infectious effect Effects 0.000 description 2
- 208000004235 neutropenia Diseases 0.000 description 2
- 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 description 2
- 231100000419 toxicity Toxicity 0.000 description 2
- 230000001988 toxicity Effects 0.000 description 2
- 206010006002 Bone pain Diseases 0.000 description 1
- 208000008964 Chemical and Drug Induced Liver Injury Diseases 0.000 description 1
- 206010012735 Diarrhoea Diseases 0.000 description 1
- 102000029749 Microtubule Human genes 0.000 description 1
- 108091022875 Microtubule Proteins 0.000 description 1
- 208000000112 Myalgia Diseases 0.000 description 1
- 206010047700 Vomiting Diseases 0.000 description 1
- 238000009098 adjuvant therapy Methods 0.000 description 1
- 239000003242 anti bacterial agent Substances 0.000 description 1
- 230000000259 anti-tumor effect Effects 0.000 description 1
- 229940088710 antibiotic agent Drugs 0.000 description 1
- 239000008280 blood Substances 0.000 description 1
- 210000004369 blood Anatomy 0.000 description 1
- KDYFGRWQOYBRFD-NUQCWPJISA-N butanedioic acid Chemical compound O[14C](=O)CC[14C](O)=O KDYFGRWQOYBRFD-NUQCWPJISA-N 0.000 description 1
- 230000007969 cellular immunity Effects 0.000 description 1
- 238000006243 chemical reaction Methods 0.000 description 1
- 150000001875 compounds Chemical class 0.000 description 1
- 231100000433 cytotoxic Toxicity 0.000 description 1
- 230000001472 cytotoxic effect Effects 0.000 description 1
- 208000035475 disorder Diseases 0.000 description 1
- 150000004625 docetaxel anhydrous derivatives Chemical class 0.000 description 1
- 230000037149 energy metabolism Effects 0.000 description 1
- 230000002708 enhancing effect Effects 0.000 description 1
- 230000003394 haemopoietic effect Effects 0.000 description 1
- 230000007954 hypoxia Effects 0.000 description 1
- 230000001146 hypoxic effect Effects 0.000 description 1
- 210000000987 immune system Anatomy 0.000 description 1
- 230000002401 inhibitory effect Effects 0.000 description 1
- 230000005764 inhibitory process Effects 0.000 description 1
- 210000004185 liver Anatomy 0.000 description 1
- 230000003211 malignant effect Effects 0.000 description 1
- 230000002503 metabolic effect Effects 0.000 description 1
- 210000004688 microtubule Anatomy 0.000 description 1
- 230000004065 mitochondrial dysfunction Effects 0.000 description 1
- 230000002438 mitochondrial effect Effects 0.000 description 1
- 230000011278 mitosis Effects 0.000 description 1
- 230000000394 mitotic effect Effects 0.000 description 1
- KKZJGLLVHKMTCM-UHFFFAOYSA-N mitoxantrone Chemical compound O=C1C2=C(O)C=CC(O)=C2C(=O)C2=C1C(NCCNCCO)=CC=C2NCCNCCO KKZJGLLVHKMTCM-UHFFFAOYSA-N 0.000 description 1
- 229960001156 mitoxantrone Drugs 0.000 description 1
- 208000013465 muscle pain Diseases 0.000 description 1
- 230000000771 oncological effect Effects 0.000 description 1
- 238000007911 parenteral administration Methods 0.000 description 1
- 230000007170 pathology Effects 0.000 description 1
- 210000001428 peripheral nervous system Anatomy 0.000 description 1
- 208000033808 peripheral neuropathy Diseases 0.000 description 1
- 230000008092 positive effect Effects 0.000 description 1
- 230000002265 prevention Effects 0.000 description 1
- 210000002307 prostate Anatomy 0.000 description 1
- 208000016691 refractory malignant neoplasm Diseases 0.000 description 1
- 238000001356 surgical procedure Methods 0.000 description 1
- 238000003786 synthesis reaction Methods 0.000 description 1
- 230000009897 systematic effect Effects 0.000 description 1
- 230000009885 systemic effect Effects 0.000 description 1
- 235000013619 trace mineral Nutrition 0.000 description 1
- 239000011573 trace mineral Substances 0.000 description 1
- 238000011269 treatment regimen Methods 0.000 description 1
- 230000004614 tumor growth Effects 0.000 description 1
- 230000003313 weakening effect Effects 0.000 description 1
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/33—Heterocyclic compounds
- A61K31/335—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin
- A61K31/337—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having four-membered rings, e.g. taxol
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
- A61K31/19—Carboxylic acids, e.g. valproic acid
- A61K31/194—Carboxylic acids, e.g. valproic acid having two or more carboxyl groups, e.g. succinic, maleic or phthalic acid
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/56—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
- A61K31/57—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone
- A61K31/573—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone substituted in position 21, e.g. cortisone, dexamethasone, prednisone or aldosterone
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P35/00—Antineoplastic agents
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- Veterinary Medicine (AREA)
- Life Sciences & Earth Sciences (AREA)
- Chemical & Material Sciences (AREA)
- General Health & Medical Sciences (AREA)
- Medicinal Chemistry (AREA)
- Epidemiology (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Organic Chemistry (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Abstract
Description
Изобретение относится к хирургии, онкологии, урологии, фармакологии, к области лечения злокачественных заболеваний предстательной железы.The invention relates to surgery, Oncology, urology, pharmacology, to the field of treatment of malignant diseases of the prostate gland.
Рак простаты является тяжелым и распространенным заболеванием в старшей возрастной группе мужской субпопуляции. Кастрационно-устойчивый рак является результатом развития опухоли на фоне неэффективного лечения и требует дорогостоящих методик ведения больного. В последнее время на рынок выведены высокоэффективные препараты для терапии кастрационно-устойчивых форм этого заболевания, например, таксаны. Препараты этой группы нарушают синтез микротрубочек митоза, препятствуя делению раковых клеток. Одним из таких препаратов является доцетаксель, появившийся на рынке лекарственных средств с 2004-го года (библиографическая ссылка: Ronald de Wit. Shifting paradigms in prostate cancer; docetaxel plus low-dose prednisone - finally an effective chemotherapy. European Journal of Cancer 41 (2005) 502-507). Однако, несмотря на то, что доцеткасель до сих пор считается «золотым стандартом» лечения тяжелых форм рака простаты, опухоль довольно часто приобретает резистентность к этому таксану. К тому же введение доцетакселя сопровождается тяжелыми побочными эффектами токсического плана - расстройства желудочно-кишечного тракта, угнетение кроветворения, ослабление иммунитета, периферические нейропатии и дерматологические реакции. В настоящий момент ведутся поиски и внедрение более совершенных производных доцетакселя и других таксанов.Prostate cancer is a severe and common disease in the older age group of the male subpopulation. Castration-resistant cancer is the result of the development of a tumor against the background of ineffective treatment and requires expensive methods of patient management. Recently, highly effective drugs have been introduced to the market for the treatment of castration-resistant forms of this disease, for example, taxanes. Drugs in this group disrupt the synthesis of mitotic microtubules by inhibiting the division of cancer cells. One of these drugs is docetaxel, which appeared on the drug market since 2004 (bibliography: Ronald de Wit. Shifting paradigms in prostate cancer; docetaxel plus low-dose prednisone - finally effective chemotherapy. European Journal of Cancer 41 (2005 ) 502-507). However, despite the fact that docetselsel is still considered the “gold standard” for the treatment of severe forms of prostate cancer, the tumor quite often becomes resistant to this taxane. In addition, the introduction of docetaxel is accompanied by severe side effects of the toxic plan - disorders of the gastrointestinal tract, hematopoietic depression, weakening of the immune system, peripheral neuropathy and dermatological reactions. Currently, searches and introduction of more advanced derivatives of docetaxel and other taxanes are underway.
Препараты янтарной кислоты давно и широко используются в лечении обширного круга внутренних, кожных и системных заболеваний, являясь средством адьювантной терапии и существенно снижая стоимость лечения (библиографическая ссылка: Мазина Н.К, «Системный подход к обоснованию применения регуляторов энергетического метаболизма в схемах фармакотерапии и оздоровления». Автореферат дисс. на соискание уч. степени доктора медицинских наук Томск, 2007). Для парентерального применения препараты янтарной кислоты широко назначаются в виде метилглюкаминовых смесей. В онкологической практике метглюкаминовые смеси янтарной кислоты использовались для смягчения токсических эффектов химиотерапии опухолей (в частности, для профилактики токсических гепатитов на фоне назначений цитостатиков, библиографическая ссылка: Мазина Н.К., Мазин П.В. Метааналитический подход к оценке клинической эффективности инфузионного сукцинатсодержащего препарата ремаксола при патологии печени разного генеза. Антибиотики и химиотерапия, 2015, том 60, №11-12, с. 43-49). Однако свойства сочетанного применения препаратов янтарной кислоты в схемах с таксанами нового поколения не изучались, научные сообщения такого рода отсутствуют.Preparations of succinic acid have long been widely used in the treatment of a wide range of internal, skin and systemic diseases, being a means of adjuvant therapy and significantly reducing the cost of treatment (bibliography link: Mazina N.К., “A systematic approach to justifying the use of energy metabolism regulators "Abstract of thesis for the degree of Doctor of Medical Sciences Tomsk, 2007). For parenteral administration, succinic acid preparations are widely prescribed in the form of methyl glucamine mixtures. In oncological practice, metglucamine mixtures of succinic acid were used to mitigate the toxic effects of chemotherapy of tumors (in particular, for the prevention of toxic hepatitis on the background of cytotoxic drugs, bibliography link: Mazina N.К., Mazin PV Remaxol in liver pathology of different genesis. Antibiotics and chemotherapy, 2015, volume 60, No. 11-12, p. 43-49). However, the properties of the combined use of succinic acid preparations in the schemes with taxans of the new generation have not been studied, such scientific reports are absent.
Наиболее близким по технической сущности к предлагаемому является способ, при котором после неудачных циклов доцетакселя назначается препарат таксанового ряда кабазитаксель с преднизолоном из расчета дозировок кабазитаксель 25 мг/м2 поверхности тела 1 раз в 3 недели + преднизолон 10 мг ежесуточно (библиографическая ссылка: de Bono JS, Oudard S, Ozquroglu M, Hansen S et al. Prednisone plus cabazitaxel or mitoxantrone for metastatic castration-resistant prostate cancer progressing after docetaxel treatment: a randomised open-label trial. Lancet 2010; 376: 1147-54.). Данная схема лечения отличается высокой эффективностью, но сопровождается тяжелыми токсическими эффектами (угнетение красного, белого и тромбоцитарного ростков крови, инфекционные осложнения на фоне нейтропении и др). Способы уменьшения возрастающей токсичности от использования данного таксана и при лечении рака простаты недостаточно разработаны, что и является самым крупным недостатком данной схемы.The closest in technical essence to the present invention is a method in which, after unsuccessful docetaxel cycles, a taxanic drug called cabazitaxel with prednisone is prescribed at the rate of cabazitaxel 25 mg / m 2 of body surface 1 dose every 3 weeks + prednisolone 10 mg daily (bibliography link: de Bono JS, Oudard S, Ozquroglu M, Hansen S et al., Prednisone plus cabazitaxel or mitoxantrone for cancer treatment after randomization treatment: a randomized open label trial, Lancet 2010; 376: 1147-54.). This treatment regimen is distinguished by high efficiency, but is accompanied by severe toxic effects (inhibition of red, white and platelet blood sprouts, infectious complications on the background of neutropenia, etc.). Ways to reduce the increasing toxicity from the use of this taxane and in the treatment of prostate cancer are not well developed, which is the biggest drawback of this scheme.
Техническим результатом предлагаемого изобретения является повышение эффективности и безопасности лечения тяжелых форм рака простаты, кастрационно-устойчивого рака простаты.The technical result of the invention is to increase the effectiveness and safety of treatment of severe forms of prostate cancer, castration-resistant prostate cancer.
Поставленный технический результат достигается тем, что для лечения кастрационно-устойчивого рака простаты дополнительно к комбинации кабазитаксель 25 мг/м2 поверхности тела 1 раз в 3 недели + преднизолон 10 мг ежесуточно производят ежедневное внутривенное капельное вливание лекарственного раствора янтарной кислоты в виде метилглюкаминовых смесей или соединений из расчета 5-6 г янтарной кислоты на 1 литр инфузионной смеси с длительностью курса данной терапии в течение 3-х недель.The technical result is achieved by the fact that for treating castration-resistant prostate cancer, in addition to the cabazitaxel 25 mg / m 2 body surface, once every 3 weeks + prednisolone 10 mg daily produce daily intravenous drip infusion of a medicinal solution of succinic acid in the form of methyl glucamine mixtures or compounds at the rate of 5-6 g of succinic acid per 1 liter of infusion mixture with the duration of the course of this therapy for 3 weeks.
Кабазитаксель нарушает митоз раковых клеток, однако при этом негативно влияет на кроветворение, на пищеварительный тракт, периферическую нервную систему, иммунитет и баланс микроэлементов. Усиление эффективности, таким образом, сопровождается и ростом токсичности, которая может приводить к угрожающим жизни осложнениям (диарея, нейтропения, тошнота и рвота, боли в скелете и мышцах, инфекционные осложнения и др). Янтарная кислота не только препятствует развитию токсических эффектов через устранение их гипоксической составляющей и купирование митохондриальных дисфункций, но и замедляет рост опухоли через усиление противоопухолевого звена Т-иммунитета.Cabazitaxel violates the mitosis of cancer cells, but at the same time it negatively affects blood formation, the digestive tract, the peripheral nervous system, immunity and the balance of trace elements. Increased efficacy is thus accompanied by an increase in toxicity, which can lead to life-threatening complications (diarrhea, neutropenia, nausea and vomiting, skeletal and muscle pain, infectious complications, etc.). Succinic acid not only prevents the development of toxic effects by eliminating their hypoxic component and arresting mitochondrial dysfunctions, but also slows down tumor growth through the enhancement of the antitumor link of T immunity.
Повышение эффективности лечения рака простаты, а так же уменьшение побочных токсических эффектов химиотерапии с увеличением качества жизни онкобольных является достоинством и преимуществом предлагаемого способа по сравнению с прототипом. При этом основные положительные эффекты усиливаются, а токсические эффекты уменьшаются за счет системно назначаемых препаратов янтарной кислоты, которые уменьшают гипоксию и через метаболическую митохондриальную поддержку способствуют усилению функции систем клеточного иммунитета.Improving the effectiveness of prostate cancer treatment, as well as reducing the toxic side effects of chemotherapy with an increase in the quality of life of cancer patients is the advantage and advantage of the proposed method compared to the prototype. At the same time, the main positive effects are enhanced, and toxic effects are reduced due to systemically prescribed preparations of succinic acid, which reduce hypoxia and, through metabolic mitochondrial support, contribute to enhancing the function of cellular immunity systems.
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Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| RU2519948C2 (en) * | 2008-08-22 | 2014-06-20 | Бритиш Коламбиа Кэнсер Эйдженси Бранч | Low-molecular inhibitors of n-terminus activation of androgen receptor |
| NZ707930A (en) * | 2010-09-27 | 2016-09-30 | Exelixis Inc | Dual inhibitors of met and vegf for the treatment of castration-resistant prostate cancer and osteoblastic bone metastases |
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| RU2519948C2 (en) * | 2008-08-22 | 2014-06-20 | Бритиш Коламбиа Кэнсер Эйдженси Бранч | Low-molecular inhibitors of n-terminus activation of androgen receptor |
| NZ707930A (en) * | 2010-09-27 | 2016-09-30 | Exelixis Inc | Dual inhibitors of met and vegf for the treatment of castration-resistant prostate cancer and osteoblastic bone metastases |
Non-Patent Citations (1)
| Title |
|---|
| BONO J.S. et al. Prednisone plus cabazitaxel or mitoxantrone for metastatic castration-resistant prostate cancer progressing after docetaxel treatment: a randomised open-label trial// Lancet. 2010 Oct 2;376(9747):1147-54. ЧИССОВ В.И. и др. Онкология. Национальное руководство//М., "ГЭОТАР-Медиа", 2008, с.792-797. * |
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