Аннотация
В статье обсуждается роль ингибиторов андрогенных рецепторов (ИАР) 2 поколения в лечении неметастатического кастрационно-резистентного рака предстательной железы (нмКРРПЖ). Исследования III фазы PROSPER (энзалутамид), SPARTAN (апалутамид) и ARAMIS (даролутамид) показали, что эти препараты при применении в комбинации с андрогенной депривационной терапией (АДТ) позволяют существенно по сравнению с плацебо улучшить выживаемость без метастазов и общую выживаемость пациентов с нмКРРПЖ. При выборе конкретного препарата данной группы важную роль играет профиль его безопасности, включая потенциал лекарственных взаимодействий, и влияние на качество жизни пациента. С этой точки зрения даролутамид имеет ряд преимущества перед апалутамидом и энзалутамидом. Частота центральных (когнитивных, психических, судорожных) и других нежелательных реакций, существенно ухудшающих качество жизни больных (падения, переломы, гипертензия и др.) при применении даролутамида не отличается от таковой плацебо. Кроме того, препарат сохраняет антагонистические свойства в отношении всех клинически значимых мутаций AР, которые вызывают развитие резистентности к энзалутамиду и апалутамиду.
Библиографические ссылки
Bray F., Ferlay J., Soerjomataram I. et al. Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2018;68(6):394–424. doi: 10.3322/caac.21492.
Злокачественные новообразования в России в 2018 году (заболеваемость и смертность) / А.Д. Каприн, В.В. Старинский, Г.В. Петрова. - Москва: МНИОИ им. П.А. Герцена филиал ФГБУ «ФМИЦ им. П.А. Герцена» Минздрава России, 2019:250. [Malignancies in Russia in 2018 (morbidity and mortality). Ed. A.D. Kaprin, V.V. Starinskii, G.V. Petrova. - Moscow, Moskovskii nauchno-issledovatel’skii onkologicheskii institut imeni P.A. Gertsena, 2019:250 (In Russ.)].
Boyle H.J., Alibhai S., Decoster L. et al. Updated recommendations of the International Society of Geriatric Oncology on prostate cancer management in older patients. Eur J Cancer. 2019 Jul;116:116-136. doi: 10.1016/j.ejca.2019.04.031.
Fizazi K., Smith M.R., Tombal B. Clinical Development of Darolutamide: A Novel Androgen Receptor Antagonist for the Treatment of Prostate Cancer. Clin Genitourin Cancer. 2018 Oct;16(5):332-340. doi: 10.1016/j.clgc.2018.07.017.
Ritch C, Cookson M. Recent trends in the management of advanced prostate cancer. F1000Res. 2018 Sep 21;7:F1000 Faculty Rev-1513. doi: 10.12688/f1000research.15382.1.
Tombal B., Miller K., Boccon-Gibod L. et al. Additional analysis of the secondary end point of biochemical recurrence rate in a phase 3 trial (CS21) comparing degarelix 80 mg versus leuprolide in prostate cancer patients segmented by baseline characteristics. Eur Urol. 2010;57 (5):836–42.
Lowrance W.T., Murad M.H., Oh W.K. et al. Castration-resistant prostate cancer: AUA guideline amendment 2018. J Urol. 2018;200(6):1264–1272. doi:10.1016/j.juro.2018.07.090.2.
Алексеев Б.Я., Нюшко К.М., Козлова П.С. и др. Современные возможности терапии больных неметастатическим кастрационно-рефрактерным раком предстательной железы. Онкоурология 2020; 16 (3): 190-197. [Alekseev B.Y., Nushko K.M., Kozlova P.S. et al. Current opportunities of therapy for patients with non-metastatic castration-resistant prostate cancer. Cancer Urology. 2020;16(3):190-197. (In Russ.)].
Sumanasuriya S., De Bono J. Treatment of Advanced Prostate Cancer-A Review of Current Therapies and Future Promise. Cold Spring Harb Perspect Med. 2018 Jun 1;8(6):a030635. doi: 10.1101/cshperspect.a030635.
Liede A.J. Arellano, G. Hechmati, B. Bennett, Wong S. International prevalence of nonmetastatic (M0) castration-resistant prostate cancer (CRPC). J Clin Oncol. 2013;31(suppl 15):e16052.
Mansinho A., Macedo D., Fernandes I., Costa L. Castration-Resistant Prostate Cancer: Mechanisms, Targets and Treatment. Adv Exp Med Biol. 2018;1096:117-133. doi: 10.1007/978-3-319-99286-0_7.
Kirby M., Hirst C., Crawford E.D. Characterising the castration-resistant prostate cancer population: a systematic review. Int J Clin Pract. 2011 Nov;65(11):1180-92. doi: 10.1111/j.1742-1241.2011.02799.x.
Hirst C.J., Cabrera C., Kirby M. Epidemiology of castration resistant prostate cancer: a longitudinal analysis using a UK primary care database. Cancer Epidemiol. 2012 Dec;36(6):e349-53. doi: 10.1016/j.canep.2012.07.012.
Smith M.R., Kabbinavar F., Saad F. et al. Natural history of rising serum prostate-specific antigen in men with castrate nonmetastatic prostate cancer. J Clin Oncol. 2005;23(13):2918–25. 10.1200/JCO.2005.01.529.
Alpajaro S.I.R., Harris J.A.K., Evans C.P. Non-metastatic castration resistant prostate cancer: a review of current and emerging medical therapies. Prostate Cancer Prostatic Dis. 2019 Mar;22(1):16-23. doi: 10.1038/s41391-018-0078-1.
Donovan K.A., Walker L.M., Wassersug R.J. et al. Psychological effects of androgen deprivation therapy on men with prostate cancer and their partners. Cancer. 2015;121(24):4286-4299. doi:10.1002/cncr.29672.
Sartor O., Flood E., Beusterien K. et al. Health-related quality of life in advanced prostate cancer and its treatments: biochemical failure and metastatic disease populations. Clin Genitourin Cancer. 2015 Apr;13(2):101-12. doi: 10.1016/j.clgc.2014.08.001.
Northouse L.L., Mood D.W., Montie J.E. et al. Living with prostate cancer: patients' and spouses' psychosocial status and quality of life. J Clin Oncol. 2007 Sep 20;25(27):4171-7. doi: 10.1200/JCO.2006.09.6503.
Shevach J., Weiner A., Morgans A.K. Quality of Life-Focused Decision-Making for Prostate Cancer. Curr Urol Rep. 2019 Aug 29;20(10):57. doi: 10.1007/s11934-019-0924-2.
Beijer H.J., de Blaey C.J. Hospitalisations caused by adverse drug reactions (ADR): a meta-analysis of observational studies. Pharm World Sci. 2002 Apr;24(2):46-54. doi: 10.1023/a:1015570104121.
Alhawassi T.M., Krass I., Bajorek B.V., Pont L.G. A systematic review of the prevalence and risk factors for adverse drug reactions in the elderly in the acute care setting. Clin Interv Aging. 2014 Dec 1;9:2079-86. doi: 10.2147/CIA.S71178.
Putilina M.V. [Comorbidity in elderly patients]. Zh Nevrol Psikhiatr Im S S Korsakova. 2016;116(5):106-111. Russian. doi: 10.17116/jnevro201611651106-111.
Carneiro J.A., Cardoso R.R., Durães M.S. et al. Frailty in the elderly: prevalence and associated factors. Rev Bras Enferm. 2017 Jul-Aug;70(4):747-752. doi: 10.1590/0034-7167-2016-0633.
Srinivas S., Mohamed A.F., Appukkuttan S. et al. Patient and caregiver benefit-risk preferences for nonmetastatic castration-resistant prostate cancer treatment. Cancer Med. 2020 Jul 29;9(18):6586–96. doi: 10.1002/cam4.3321.
Srinivas S., Mohamed A.F., Appukkuttan S. et al. Physician preferences for non-metastatic castration-resistant prostate cancer treatment. BMC Urol. 2020 Jun 22;20(1):73. doi: 10.1186/s12894-020-00631-4.
Wong R.L., Morgans A.K. Integration of Patient Reported Outcomes in Drug Development in Genitourinary Cancers. Curr Oncol Rep. 2020 Feb 8;22(3):21. doi: 10.1007/s11912-020-0890-3.
Scher H.I., Solo K., Valant J. et al. Prevalence of Prostate Cancer Clinical States and Mortality in the United States: Estimates Using a Dynamic Progression Model. PLoS One. 2015 Oct 13;10(10):e0139440. doi: 10.1371/journal.pone.0139440.
Lowrance W.T., Murad M.H., Oh W.K. et al. Castration-Resistant Prostate Cancer: AUA Guideline Amendment 2018. J Urol. 2018 Dec;200(6):1264-1272. doi: 10.1016/j.juro.2018.07.090.
Saad F., Mehra M., Small E. et al. Population-based study of the association of prostate -specific antigen doubling time (PSADT) with metastasis-free survival (MFS) and overall survival (OS) in nonmetastatic castration-resistant prostate cancer (NMCRPC) patients (PTS).J Urol 2018; 199 (4S) Supplement:e229.
Mostaghel E.A., Montgomery B., Nelson P.S. Castration-resistant prostate cancer: targeting androgen metabolic pathways in recurrent disease. Urol Oncol. 2009 May-Jun;27(3):251-7. doi: 10.1016/j.urolonc.2009.03.016.
IIsaacsson Velho P., Carducci M.A. Investigational therapies targeting the androgen signaling axis and the androgen receptor and in prostate cancer - recent developments and future directions. Expert Opin Investig Drugs. 2018 Oct;27(10):811-822. doi: 10.1080/13543784.2018.1513490.
Rice M.A., Malhotra S.V., Stoyanova T. Second-Generation Antiandrogens: From Discovery to Standard of Care in Castration Resistant Prostate Cancer. Front Oncol. 2019 Aug 28;9:801. doi: 10.3389/fonc.2019.00801.
Smith M.R., Saad F., Chowdhury S. et al. Apalutamide Treatment and Metastasis-free Survival in Prostate Cancer. N Engl J Med. 2018;378(15):1408–18. 10.1056/NEJMoa1715546.
Hussain M., Fizazi K., Saad F. et al. PROSPER: A phase 3, randomized, double-blind, placebo (PBO)-controlled study of enzalutamide (ENZA) in men with nonmetastatic castration-resistant prostate cancer (M0 CRPC). J Clin Oncol. 2018;36(6_suppl):3 10.1200/JCO.2018.36.6_suppl.3.
Fizazi K., Shore N., Tammela T.L. et al. Darolutamide in nonmetastatic, castration-resistant prostate cancer. N Engl J Med. 2019;380(13):1235–1246. doi:10.1056/NEJMoa1815671.
Small E.J., Saad F., Chowdhury S. et al. Apalutamide and overall survival in non‐metastatic castration‐resistant prostate cancer. Ann Oncol 2019;30(11):1813–1820. doi: 10.1093/annonc/mdz397.
Sternberg C.N., Fizazi K., Saad F. et al. Enzalutamide and survival in nonmetastatic, castration‐resistant prostate cancer. N Engl Med. 2020;382(23):2197–2206. doi: 10.1056/NEJMoa2003892.
Fizazi K., Shore N., Tammela T.L. et al. ARAMIS Investigators. Nonmetastatic, Castration-Resistant Prostate Cancer and Survival with Darolutamide. N Engl J Med. 2020 Sep 10;383(11):1040-1049. doi: 10.1056/NEJMoa2001342.
Fizazi K., Albiges L., Loriot Y., Massard C. ODM-201: A new-generation androgen receptor inhibitor in castration-resistant prostate cancer. Expert Rev. Anticancer Ther. 2015;15:1007–1017. doi: 10.1586/14737140.2015.1081566.
Moilanen A-M., Riikonen R., Oksala R. et al. Discovery of ODM-201, a new-generation androgen receptor inhibitor targeting resistance mechanisms to androgen signaling-directed prostate cancer therapies. Sci Rep. (2015) 5:12007 10.1038/srep12007.
Shore N.D. Darolutamide (ODM-201) for the treatment of prostate cancer. Expert Opin. Pharmacother. 2017;18:945–952. doi: 10.1080/14656566.2017.1329820.
Graff J.N., Baciarello G., Armstrong A.J. et al Efficacy and safety of enzalutamide in patients 75 years or older with chemotherapy‐naive metastatic castration‐resistant prostate cancer: results from PREVAIL. Ann Oncol 2016; 27: 286–294.
Morgans A.K., Shore N., Cope D. et al. Androgen receptor inhibitor treatments: Cardiovascular adverse events and comorbidity considerations in patients with non-metastatic prostate cancer. Urol Oncol. 2020 Sep 18:S1078-1439(20)30370-7. doi: 10.1016/j.urolonc.2020.08.003.
Di Nunno V., Mollica V., Santoni M. et al. New Hormonal Agents in Patients With Nonmetastatic Castration-Resistant Prostate Cancer: Meta-Analysis of Efficacy and Safety Outcomes. Clin Genitourin Cancer. 2019 Oct;17(5):e871-e877. doi: 10.1016/j.clgc.2019.07.001.
Crawford E.D., Stanton W., Mandair D. Darolutamide: An Evidenced-Based Review of Its Efficacy and Safety in the Treatment of Prostate Cancer. Cancer Manag Res. 2020 Jul 13;12:5667-5676. doi: 10.2147/CMAR.S227583.
Shore N., Zurth C., Fricke R. et al. Evaluation of Clinically Relevant Drug-Drug Interactions and Population Pharmacokinetics of Darolutamide in Patients with Nonmetastatic Castration-Resistant Prostate Cancer: Results of Pre-Specified and Post Hoc Analyses of the Phase III ARAMIS Trial. Target Oncol. 2019 Oct;14(5):527-539. doi: 10.1007/s11523-019-00674-0.
Zurth C., Koskinen M., Fricke R. et al. Drug–drug interaction potential of darolutamide: in vitro and clinical studies. Eur J Drug Metab Pharmacokinet. 2019 doi: 10.1007/s13318-019-00577-5.
Del Re M., Fogli S., Derosa L. et al. The role of drug-drug interactions in prostate cancer treatment: Focus on abiraterone acetate/prednisone and enzalutamide. Cancer Treat Rev. 2017 Apr;55:71-82. doi: 10.1016/j.ctrv.2017.03.001.
Benoist G.E., van Oort I.M., Smeenk S. et al. Drug-drug interaction potential in men treated with enzalutamide: Mind the gap. Br J Clin Pharmacol. 2018 Jan;84(1):122-129. doi: 10.1111/bcp.13425.
Duran I., Carles J., Bulat I. et al. Pharmacokinetic Drug-Drug Interaction of Apalutamide, Part 1: Clinical Studies in Healthy Men and Patients with Castration-Resistant Prostate Cancer. Clin Pharmacokinet. 2020 Sep;59(9):1135-1148. doi: 10.1007/s40262-020-00882-2.
Gibbons J.A., de Vries M., Krauwinkel W. et al. Pharmacokinetic Drug Interaction Studies with Enzalutamide. Clin Pharmacokinet. 2015 Oct;54(10):1057-69. doi: 10.1007/s40262-015-0283-1.
Pollock Y.G., Smith M.R., Saad F. et al. Predictors of falls and fractures in patients (pts) with nonmetastatic castration-resistant prostate cancer (nmCRPC) treated with apalutamide (APA) plus ongoing androgen deprivation therapy (ADT). J Clin Oncol. 2019;37:5025–5025.doi: 10.1200/JCO.2019.37.15_suppl.5025.
Barber M., Nguyen L.S., Wassermann J. et al. Cardiac arrhythmia considerations of hormone cancer therapies. Cardiovasc Res. 2019 Apr 15;115(5):878-894. doi: 10.1093/cvr/cvz020.
Это произведение доступно по лицензии Creative Commons «Attribution-NonCommercial-NoDerivatives» («Атрибуция — Некоммерческое использование — Без производных произведений») 4.0 Всемирная.
© АННМО «Вопросы онкологии», Copyright (c) 2021