RU2673816C1 - Method of treating castration-resistant prostate cancer - Google Patents
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- 206010060862 Prostate cancer Diseases 0.000 title claims abstract description 11
- 208000000236 Prostatic Neoplasms Diseases 0.000 title claims abstract description 11
- 238000000034 method Methods 0.000 title claims description 5
- KDYFGRWQOYBRFD-UHFFFAOYSA-N succinic acid Chemical compound OC(=O)CCC(O)=O KDYFGRWQOYBRFD-UHFFFAOYSA-N 0.000 claims abstract description 18
- 238000011282 treatment Methods 0.000 claims abstract description 12
- 239000003814 drug Substances 0.000 claims abstract description 11
- 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 claims abstract description 9
- 229960003668 docetaxel Drugs 0.000 claims abstract description 9
- 229940079593 drug Drugs 0.000 claims abstract description 9
- 229960000853 abiraterone Drugs 0.000 claims abstract description 6
- GZOSMCIZMLWJML-VJLLXTKPSA-N abiraterone Chemical compound C([C@H]1[C@H]2[C@@H]([C@]3(CC[C@H](O)CC3=CC2)C)CC[C@@]11C)C=C1C1=CC=CN=C1 GZOSMCIZMLWJML-VJLLXTKPSA-N 0.000 claims abstract description 6
- 235000012054 meals Nutrition 0.000 claims abstract description 4
- 238000002560 therapeutic procedure Methods 0.000 claims abstract description 3
- 229940066263 prednisolone 10 mg Drugs 0.000 claims description 3
- 239000001384 succinic acid Substances 0.000 abstract description 8
- 231100000331 toxic Toxicity 0.000 abstract description 5
- 230000002588 toxic effect Effects 0.000 abstract description 5
- 230000000694 effects Effects 0.000 abstract description 4
- 206010021143 Hypoxia Diseases 0.000 abstract description 3
- 230000007969 cellular immunity Effects 0.000 abstract description 2
- 230000007954 hypoxia Effects 0.000 abstract description 2
- KDYFGRWQOYBRFD-NUQCWPJISA-N butanedioic acid Chemical compound O[14C](=O)CC[14C](O)=O KDYFGRWQOYBRFD-NUQCWPJISA-N 0.000 abstract 1
- 229940095453 prednisone 10 mg Drugs 0.000 abstract 1
- 239000000126 substance Substances 0.000 abstract 1
- 229960004103 abiraterone acetate Drugs 0.000 description 5
- UVIQSJCZCSLXRZ-UBUQANBQSA-N abiraterone acetate Chemical compound C([C@@H]1[C@]2(C)CC[C@@H]3[C@@]4(C)CC[C@@H](CC4=CC[C@H]31)OC(=O)C)C=C2C1=CC=CN=C1 UVIQSJCZCSLXRZ-UBUQANBQSA-N 0.000 description 5
- 206010028980 Neoplasm Diseases 0.000 description 4
- 239000003098 androgen Substances 0.000 description 4
- 230000015572 biosynthetic process Effects 0.000 description 4
- 238000002512 chemotherapy Methods 0.000 description 4
- 201000010099 disease Diseases 0.000 description 4
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 description 4
- 238000002360 preparation method Methods 0.000 description 3
- 201000011510 cancer Diseases 0.000 description 2
- 239000000824 cytostatic agent Substances 0.000 description 2
- 230000001085 cytostatic effect Effects 0.000 description 2
- 230000018109 developmental process Effects 0.000 description 2
- 230000001394 metastastic effect Effects 0.000 description 2
- 206010061289 metastatic neoplasm Diseases 0.000 description 2
- 231100000419 toxicity Toxicity 0.000 description 2
- 230000001988 toxicity Effects 0.000 description 2
- 230000004614 tumor growth Effects 0.000 description 2
- 208000008964 Chemical and Drug Induced Liver Injury Diseases 0.000 description 1
- 206010012735 Diarrhoea Diseases 0.000 description 1
- 206010067125 Liver injury Diseases 0.000 description 1
- 208000002193 Pain Diseases 0.000 description 1
- 229940124639 Selective inhibitor Drugs 0.000 description 1
- 229940123237 Taxane Drugs 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
- 239000002246 antineoplastic agent Substances 0.000 description 1
- 230000006907 apoptotic process Effects 0.000 description 1
- 229940044683 chemotherapy drug Drugs 0.000 description 1
- 238000011260 co-administration Methods 0.000 description 1
- 230000008030 elimination Effects 0.000 description 1
- 238000003379 elimination reaction Methods 0.000 description 1
- 230000037149 energy metabolism Effects 0.000 description 1
- 230000002708 enhancing effect Effects 0.000 description 1
- WXCXUHSOUPDCQV-UHFFFAOYSA-N enzalutamide Chemical compound C1=C(F)C(C(=O)NC)=CC=C1N1C(C)(C)C(=O)N(C=2C=C(C(C#N)=CC=2)C(F)(F)F)C1=S WXCXUHSOUPDCQV-UHFFFAOYSA-N 0.000 description 1
- 229960004671 enzalutamide Drugs 0.000 description 1
- 210000001035 gastrointestinal tract Anatomy 0.000 description 1
- 230000035876 healing Effects 0.000 description 1
- 230000011132 hemopoiesis Effects 0.000 description 1
- 231100000234 hepatic damage Toxicity 0.000 description 1
- 230000003054 hormonal effect Effects 0.000 description 1
- 230000001146 hypoxic effect Effects 0.000 description 1
- 208000015181 infectious disease Diseases 0.000 description 1
- 230000002458 infectious effect Effects 0.000 description 1
- 238000001802 infusion Methods 0.000 description 1
- 239000003112 inhibitor Substances 0.000 description 1
- 210000004185 liver Anatomy 0.000 description 1
- 230000008818 liver damage Effects 0.000 description 1
- 230000003211 malignant effect Effects 0.000 description 1
- 230000002503 metabolic effect Effects 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
- 239000000203 mixture Substances 0.000 description 1
- 210000003205 muscle Anatomy 0.000 description 1
- 208000004235 neutropenia Diseases 0.000 description 1
- 230000000771 oncological effect Effects 0.000 description 1
- 230000036407 pain Effects 0.000 description 1
- 230000007170 pathology Effects 0.000 description 1
- 239000013610 patient sample Substances 0.000 description 1
- 238000001050 pharmacotherapy Methods 0.000 description 1
- 239000000902 placebo Substances 0.000 description 1
- 229940068196 placebo Drugs 0.000 description 1
- 230000008092 positive effect Effects 0.000 description 1
- 229960005205 prednisolone Drugs 0.000 description 1
- OIGNJSKKLXVSLS-VWUMJDOOSA-N prednisolone Chemical compound O=C1C=C[C@]2(C)[C@H]3[C@@H](O)C[C@](C)([C@@](CC4)(O)C(=O)CO)[C@@H]4[C@@H]3CCC2=C1 OIGNJSKKLXVSLS-VWUMJDOOSA-N 0.000 description 1
- 229960004618 prednisone Drugs 0.000 description 1
- 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 1
- 238000011321 prophylaxis Methods 0.000 description 1
- 210000002307 prostate Anatomy 0.000 description 1
- 208000016691 refractory malignant neoplasm Diseases 0.000 description 1
- 230000000638 stimulation Effects 0.000 description 1
- KDYFGRWQOYBRFD-UHFFFAOYSA-L succinate(2-) Chemical compound [O-]C(=O)CCC([O-])=O KDYFGRWQOYBRFD-UHFFFAOYSA-L 0.000 description 1
- 238000001356 surgical procedure Methods 0.000 description 1
- 230000004083 survival effect Effects 0.000 description 1
- 230000009897 systematic effect Effects 0.000 description 1
- 230000009885 systemic effect Effects 0.000 description 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 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
Classifications
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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
-
- 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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- Pharmacology & Pharmacy (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (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)
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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. Одним из них является селективный ингибитор биосинтеза андрогенов абиратерона ацетат, появившийся на рынке лекарственных средств после 2012 года (библиографическая ссылка: Fizazi К, Scher Н, Molina A, Legothetis Ch et al. Abiraterone acetate for treatment of metastatic castration-resistant prostate cancer: final overall survival analysis of the COU-AA-301 randomised, double-blind, placebo-controlled phase 3 study. Lancet Oncol 2012; 13: 983-92). В последние годы активно исследуются различные сочетания абиратерона ацетата с другими химиотерапевтическими препаратами: энзалутамид, доцетаксель и др. Однако схемы совместного применения таких препаратов в едином курсе химиотерапии пока не получают должного развития по причине резкого утяжеления нежелательных побочных эффектов, свойственных цитостатикам.Prostate cancer is a serious 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 backdrop of ineffective treatment and requires expensive patient management techniques. Recently, highly effective drugs for the treatment of castration-resistant forms of this disease have been launched on the market. One of them is the selective inhibitor of the androgen biosynthesis of abiraterone acetate, which appeared on the drug market after 2012 (bibliography link: Fizazi K, Scher H, Molina A, Legothetis Ch et al. Abiraterone acetate for treatment of metastatic castration-resistant prostate cancer: final overall survival analysis of the COU-AA-301 randomized, double-blind, placebo-controlled phase 3 study. Lancet Oncol 2012; 13: 983-92). In recent years, various combinations of abiraterone acetate with other chemotherapeutic drugs have been actively investigated: enzalutamide, docetaxel, etc. However, the co-administration of such drugs in a single course of chemotherapy has not yet been adequately developed due to the sharp increase in undesirable side effects characteristic of cytostatics.
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). Наиболее часто на практике используют пероральный прием янтарной кислоты в таблетированной форме из расчета 50-300 мг в сутки на 1-2 приема после еды. 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 ингибиторами биосинтеза андрогенов нового поколения не изучались, научные сообщения такого рода отсутствуют.Succinic acid preparations 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.K., “Systematic approach to the rationale for the use of energy metabolism regulators in pharmacotherapy and healing regimens ". Abstract of dissertation for the degree of Doctor of Medical Sciences Tomsk, 2007). Most often, in practice, oral administration of succinic acid in tablet form is used at the rate of 50-300 mg per day for 1-2 doses after a meal. In oncological practice, methglucamine succinic acid mixtures were used to mitigate the toxic effects of tumor chemotherapy (in particular, for the prophylaxis of toxic hepatitis against the background of cytostatic prescriptions, bibliography link: Mazina N.K., Mazin P.V. Meta-analytical approach to assessing the clinical efficacy of an infusion succinate-containing drug remaxol in liver pathology of various origins (Antibiotics and chemotherapy, 2015, Volume 60, No. 11-12, pp. 43-49). However, the properties of the combined use of succinic acid preparations in schemes with new generation androgen biosynthesis inhibitors have not been studied, there are no scientific reports of this kind.
Наиболее близким по технической сущности к предлагаемому является способ Тагавы-Посадаса, при котором абиратерон назначается с доцетакселем и преднизолоном из расчета доцетаксель 75 мг/м2 поверхности тела 1 раз в 3 недели + абиратерон 1000 мг в сутки + преднизолон 10 мг в сутки (библиографическая ссылка: Tagawa ST, Posadas ЕМ et al. Phase 1b Study of Abiraterone Acetate Plus Prednisone and Docetaxel in Patients with Metastatic Castration-resistant Prostate Cancer. Eur Urol. 2016 Feb 3. pii: S0302-2838(16)00130-5). Данная схема лечения в настоящий момент исследуется в режиме 1-й фазы на предмет эффективности и безопасности у небольших выборок пациентов. Способы уменьшения возрастающей токсичности от совместного использования данной комбинации таксана и блокатора биосинтеза андрогенов при лечении рака простаты не разработаны, что и является самым крупным недостатком схемы Тагавы-Посадаса.The closest in technical essence to the proposed one is the Tagawa-Posadas method, in which abiraterone is prescribed with docetaxel and prednisolone based on docetaxel 75 mg / m 2 of the body surface once every 3 weeks + abiraterone 1000 mg per day + prednisolone 10 mg per day (bibliographic reference: Tagawa ST, Posadas EM et al. Phase 1b Study of Abiraterone Acetate Plus Prednisone and Docetaxel in Patients with Metastatic Castration-resistant Prostate Cancer. Eur Urol. 2016 Feb 3. pii: S0302-2838 (16) 00130-5). This treatment regimen is currently being investigated in the 1st phase regimen for efficacy and safety in small patient samples. Ways to reduce the increasing toxicity from the combined use of this combination of taxane and the androgen biosynthesis blocker in the treatment of prostate cancer have not been developed, which is the biggest drawback of the Tagawa-Posadas regimen.
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 efficiency 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 доцетаксель 75 мг/м2 поверхности тела 1 раз в 3 недели + абиратерон 1000 мг в сутки + преднизолон 10 мг в сутки производят назначение янтарной кислоты в виде перорального приема 2 раза в сутки по 50 - 200 мг после еды с длительностью курса данной терапии в течение 3-х недель.The technical result is achieved in that for the treatment of castration-resistant prostate cancer, in addition to the combination of docetaxel 75 mg / m 2 of the body surface once every 3 weeks + abiraterone 1000 mg per day + prednisolone 10 mg per day, succinic acid is administered as an oral dose 2 times a day, 50-200 mg after meals with a duration of the course of this therapy for 3 weeks.
Доцетаксель нарушает митоз раковых клеток, абиратерон за счет блокады биосинтеза андрогенов подавляет гормональную стимуляцию роста опухоли и способствует ее апоптозу. Данные два препарата, таким образом, усиливают действие друг друга, при этом негативно влияя на пищеварительный тракт, кроветворение и баланс микроэлементов. Усиление эффективности, таким образом, сопровождается и ростом токсичности, которая может приводить к угрожающим жизни осложнениям (диарея, нейтропения, поражения печени, 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.Docetaxel disrupts mitosis of cancer cells, abiraterone, due to blockade of androgen biosynthesis, suppresses hormonal stimulation of tumor growth and promotes its apoptosis. These two drugs, thus, enhance the effect of each other, while negatively affecting the digestive tract, hematopoiesis and the balance of trace elements. The increase in effectiveness is thus accompanied by an increase in toxicity, which can lead to life-threatening complications (diarrhea, neutropenia, liver damage, nausea and vomiting, pain in the skeleton and muscles, infectious complications, etc.). Succinic acid not only prevents the development of toxic effects through the elimination of their hypoxic component and the relief of mitochondrial dysfunctions, but also slows down tumor growth by enhancing 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 абиратерона ацетата и доцетакселя 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 treatment of prostate cancer, 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 of abiraterone acetate and docetaxel are enhanced, and toxic effects are reduced due to systemically prescribed succinic acid preparations, which reduce hypoxia and, through metabolic mitochondrial support, enhance the function of cellular immunity systems.
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RU2295336C2 (en) * | 2004-06-01 | 2007-03-20 | Вениамин Абрамович Хазанов | Means for correcting urologic andrological pathologies |
WO2015065919A1 (en) * | 2013-10-28 | 2015-05-07 | The Regents Of The University Of California | Treatment of metastatic prostate cancer |
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RU2295336C2 (en) * | 2004-06-01 | 2007-03-20 | Вениамин Абрамович Хазанов | Means for correcting urologic andrological pathologies |
WO2015065919A1 (en) * | 2013-10-28 | 2015-05-07 | The Regents Of The University Of California | Treatment of metastatic prostate cancer |
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