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Онкоурология

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Диферелин® как эффективный препарат кастрационной терапии у больных раком предстательной железы

https://doi.org/10.17650/1726-9776-2020-16-4-191-196

Полный текст:

Аннотация

Андроген-депривационная терапия является одним из основных методов лечения больных местно-распространенным и метастатическим раком предстательной железы. Она направлена на снижение уровня тестостерона. Несмотря на появление в последние годы новых эффективных препаратов, в качестве андроген-депривационной терапии чаще применяют агонисты лютеинизирующего гонадотропин-рилизинг-гормона. Одним из наиболее часто используемых препаратов 1-й линии является трипторелин (диферелин®). В России трипторелин применяется в лекарственных формах с замедленным высвобождением с частотой введения 1 раз в 1, 3 мес при внутримышечных инъекциях, а также при подкожных инъекциях с частотой введения 1 раз в 3 мес, при этом результат применения разных лекарственных форм сопоставим между собой. Трипторелин эффективно обеспечивает и поддерживает уровень тестостерона в сыворотке крови ниже 20 нг/дл, что увеличивает время до развития кастрационно-резистентного рака предстательной железы, увеличивает общую выживаемость больных при комбинированной терапии с применением лучевого лечения, а также снижает степень тяжести симптомов со стороны нижних мочевыводящих путей. Трипторелин имеет известный профиль безопасности и в целом хорошо переносится пациентами.

Об авторах

К. М. Нюшко
ФГБУ Национальный медицинский исследовательский центр радиологии» Минздрава России;
Россия
125284 Москва, 2-й Боткинский проезд, 3
Конфликт интересов: нет


В. М. Перепухов
ФГБУ Национальный медицинский исследовательский центр радиологии» Минздрава России
Россия
125284 Москва, 2-й Боткинский проезд, 3
Конфликт интересов: нет


Б. Я. Алексеев
ФГБУ Национальный медицинский исследовательский центр радиологии» Минздрава России; Медицинский институт непрерывного образования, ФГБОУ ВО Московский государственный университет пищевых производств
Россия

125284 Москва, 2-й Боткинский проезд, 3; 125080 Москва, Волоколамское шоссе, 11


Конфликт интересов: нет


Список литературы

1. Состояние онкологической помощи населению России в 2019 году. Под ред. А.Д. Каприна, В.В. Старинского, Г.В. Петровой. М.: МНИОИ им. П.А. Герцена - филиал ФГБУ «НМИЦ радиологии» Минздрава России, 2020. 236 с.

2. Huggins C., Hodges C.V. Studies on prostatic cancer: I. The effect of castration, of estrogen and of androgen injection on serum phosphatases in metastatic carcinoma of the prostate. Cancer Res 1941;19:293-7.

3. Crawford E.D. Hormonal therapy in prostate cancer: historical approaches. Rev Urol 2004;6(Suppl 7):S3-11.

4. Mottet N., Bellmunt J., Briers E. et al. Guidelines on prostate cancer. 2016. Available at: https://uroweb.org/guideline/prostate-cancer/.

5. Tunn U.W., Wiedey K. Safety and clinical efficacy of a new 6-month depot formulation of leuprorelin acetate in patients with prostate cancer in Europe. Prostate Cancer Prostatic Dis 2009;12(1):83-7. DOI: 10.1038/pcan.2008.52.

6. Lundstrom E.A., Rencken R.K., van Wyk J.H. et al. Triptorelin 6-month formulation in the management of patients with locally advanced and metastatic prostate cancer: an open-label, noncomparative, multicentre, phase III study. Clin Drug Investig 2009;29(12):757-65. DOI: 10.2165/11319690-00000000000000.

7. Akaza H., Hinotsu S., Usami M. et al. Combined androgen blockade with bicalutamide for advanced prostate cancer: long-term follow-up of a phase 3, doubleblind, randomized study for survival. Cancer 2009;115(15):3437-45. DOI: 10.1002/cncr.24395.

8. Oefelein M.G., Feng A., Scolieri M.J. et al. Reassessment of the definition of castrate levels of testosterone: implications for clinical decision making. Urology 2000;56(6):1021-4. DOI: 10.1016/s0090-4295(00)00793-7.

9. NCCN. Guidelines for treatment of cancer by site: prostate cancer. National comprehensive cancer network (NCCN), 2016. MT/W/0001/pdWS/001.

10. European association of urology (EAU) Guidelines on prostate cancer. 2016. MT/W/0001/pdWS/001.

11. Breul J., Lundstrom E., Purcea D. et al. Efficacy of testosterone suppression with sustained-release triptorelin in advanced prostate cancer. Adv Ther 2017;34(2):513-23. DOI: 10.1007/s12325-016-0466-7.

12. Kamada S., Sakamoto S., Ando K. et al. Nadir testosterone after longterm followup predicts prognosis in patients with prostate cancer treated with combined androgen blockade. J Urol 2015;194(5):1264-70. DOI: 10.1016/j.juro.2015.03.120.

13. Shim M., Bang W.J., Oh C.Y. et al. Effectiveness of three different luteinizing hormone-releasing hormone agonists in the chemical castration of patients with prostate cancer: goserelin versus triptorelin versus leuprolide. Investig Clin Urol 2019;60(4):244-50. DOI: 10.4111/icu.2019.60.4.244.

14. Klotz L., O’Callaghan C., Ding K. et al. Nadir testosterone within first year of androgen-deprivation therapy (ADT) predicts for time to castration-resistant progression: a secondary analysis of the PR-7 trial of intermittent versus continuous ADT. J Clin Oncol 2015;33(10):1151-6. DOI: 10.1200/JCO.2014.58.2973.

15. Dason S., Allard C.B., Tong J., Shayegan B. Defining a new testosterone threshold for medical castration: results from a prospective cohort series. Can Urol Assoc J 2013;7(5-6):E263-7. DOI: 10.5489/cuaj.471.

16. Bertaglia V., Tucci M., Fiori C. et al. Effects of serum testosterone levels after 6 months of androgen deprivation therapy on the outcome of patients with prostate cancer. Clin Genitourin Cancer 2013;11(3):325-30. DOI: 10.1016/j.clgc.2013.01.002.

17. Helgstrand J.T., Berg K.D., Lippert S. et al. Systematic review: does endocrine therapy prolong survival in patients with prostate cancer? Scand J Urol 2016;50(3):135-43. DOI: 10.3109/21681805.2016.1142472.

18. Ipsen Ltd. Decapeptyl SR. 3 mg. Summary of product characteristics. 2015. Available at: https://www.medicines.org.uk/emc/medicine/868.

19. Ipsen Ltd. Decapeptyl SR. 11.25 mg. Summary of product characteristics. 2015. Available at: https://www.medicines.org.uk/emc/medicine/13851.

20. Heyns C.F., Simonin M.P., Grosgurin P. et al. Comparative efficacy of triptorelin pamoate and leuprolide acetate in men with advanced prostate cancer. BJU Int 2003;92(3):226-31. DOI: 10.1046/j.1464-410x.2003.04308.x.

21. Kuhn J.M., Abourachid H., Brucher P. et al. A randomized comparison of the clinical and hormonal effects of two GnRH agonists in patients with prostate cancer. Eur Urol 1997;32(4):397-403.

22. Kao C.C., Chang Y.H., Wu T. et al. Open, multi-center, phase IV study to assess the efficacy and tolerability of triptorelin in Taiwanese patients with advanced prostate cancer. J Chin Med Assoc 2012;75(6):255-61. DOI: 10.1016/j.jcma.2012.04.010.

23. Romero E., Velez de Mendizabal N., Cendros J.M. et al. Pharmacokinetic/ pharmacodynamic model of the testosterone effects of tripto-relin administered in sustained release formulations in patients with prostate cancer. J Pharmacol Exp Ther 2012;342(3):788-98. DOI: 10.1124/jpet.112.195560.

24. Bouchot O., Soret J.Y., Jacqmin D. et al. Three-month sustained-release form of triptorelin in patients with advanced prostatic adenocarcinoma: results of an open pharmacodynamic and pharmacokinetic multicenter study. Horm Res 1998;50(2):89-93. DOI: 10.1159/000023241.

25. Lebret T., Rouanne M., Hublarov O. et al. Efficacy of triptorelin pamoate 11.25 mg administered subcutaneously for achieving medical castration levels of testosterone in patients with locally advanced or metastatic prostate cancer. Ther Adv Urol 2015;7(3):125-34. DOI: 10.1177/1756287215577329.

26. Lee C.R. Thrombosis and anti-thrombotic therapy. In: Wintrobe’s clinical hematology. 9th edn. Eds.: G.R. Lee, T.C. Bithell, J. Foerster et al. Philadelphia, PA: Lippincott Williams & Wilkins, 1993. 1533 p.

27. Gil T., Aoun F., Cabri P. et al. Triptorelin for the relief of lower urinary tract symptoms in men with advanced prostate cancer: results of a prospective, observational, grouped-analysis study. Ther Adv Urol 2017;9(7):179-90. DOI: 10.1177/1756287217712379.

28. Gil T., Aoun F., Cabri P. et al. A prospective, observational grouped analysis to evaluate the effect of triptorelin on lower urinary tract symptoms in patients with advanced prostate cancer. Ther Adv Urol 2015;7(3):116-24. DOI: 10.1177/1756287215574480.

29. Madersbacher S., Alivizatos G., Nordling J. EAU 2004 guidelines on assessment, therapy and follow-up of men with lower urinary tract symptoms suggestive of benign prostatic obstruction (BPH guidelines). Eur Urol 2004;46(5):547-54. DOI: 10.1016/j.eururo.2004.07.016.

30. Crawford E.D., Tombal B., Miller K. et al. A phase III extension trial with a 1-arm crossover from leuprolide to degarelix: comparison of gonadotropin-releasing hormone agonist and antagonist effect on prostate cancer. J Urol 2011;186(3):889-97. DOI: 10.1016/j.juro.2011.04.083.

31. Geiges G., Harms T., Rodemer G. et al. Degarelix therapy for prostate cancer in a real-world setting: experience from the German IQUO (Association for Uro-Oncological Quality Assurance) Firmagon (R) registry. BMC Urol 2015;15:122. DOI: 10.1186/s12894-015-0116-4.

32. Mason M., Maldonado Pijoan X., Steidle C. et al. Neoadjuvant androgen deprivation therapy for prostate volume reduction, lower urinary tract symptom relief and quality of life improvement in men with intermediate- to high-risk prostate cancer: a randomised non-inferiority trial of degarelix versus goserelin plus bicalutamide. Clin Oncol 2013;25(3):190-6. DOI: 10.1016/j.clon.2012.09.010.

33. Garnick M.B., Mottet N. New treatment paradigm for prostate cancer: abarelix initiation therapy for immediate testosterone suppression followed by a luteinizing hormone-releasing hormone agonist. BJU Int 2012;110(4):499-504. DOI: 10.1111/j.1464-410X.2011.10708.x.

34. Iversen P., Damber J.E., Malmberg A. et al. Degarelix monotherapy compared with luteinizing hormone-releasing hormone (LHRH) agonists plus anti-androgen flare protection in advanced prostate cancer: an analysis of two randomized controlled trials. Ther Adv Urol 2016;8:75-82.

35. Ahmadi H., Daneshmand S. Androgen deprivation therapy for prostate cancer: long-term safety and patient outcomes. Patient Relat Outcome Meas 2014;5:63-70. DOI: 10.2147/PROM.S52788.

36. Salonen A.J., Taari K., Ala-Opas M. et al. Advanced prostate cancer treated with intermittent or continuous androgen deprivation in the randomised FinnProstate Study VII: quality of life and adverse effects. Eur Urol 2013;63(1):111-20. DOI: 10.1016/j.eururo.2012.07.040.

37. Garcia-Cruz E., Leibar-Tamayo A., Romero J. et al. Metabolic syndrome in men with low testosterone levels: relationship with cardiovascular risk factors and comorbidities and with erectile dysfunction. J Sex Med 2013;10(10):2529-38. DOI: 10.1111/jsm.12265.

38. Khaw K.T., Barrett-Connor E. Lower endogenous androgens predict central adiposity in men. Ann Epidemiol 1992;2(5):675-82. DOI: 10.1016/1047-2797(92)90012-f.

39. Pouliot M.C., Despres J.P., Nadeau A. et al. Visceral obesity in men. Associations with glucose tolerance, plasma insulin, and lipoprotein levels. Diabetes 1992;41(7):826-34. DOI: 10.2337/diab.41.7.826.

40. Bradley M.C., Zhou Y., Freedman A.N. et al. Risk of diabetes complications among those with diabetes receiving androgen deprivation therapy for localized prostate cancer. Cancer Causes Control 2018;29(8):785-91. DOI: 10.1007/s10552-018-1050-z.

41. Keating N.L., O’Malley A.J., Freedland S.J., Smith M.R. Diabetes and cardiovascular disease during androgen deprivation therapy: observational study of veterans with prostate cancer. J Natl Cancer Inst 2010;102:39-46. DOI: 10.1093/jnci/djp404.

42. Wang H., Sun X., Zhao L. et al. Androgen deprivation therapy is associated with diabetes: evidence from meta-analysis. J Diabetes Investig 2016;7(4):629-36. DOI: 10.1111/jdi.12472.

43. Nguyen P.L., Je Y., Schutz F.A. et al. Association of androgen deprivation therapy with cardiovascular death in patients with prostate cancer: a meta-analysis of randomized trials. JAMA 2011;306(21):2359-66. DOI: 10.1001/jama.2011.1745.

44. O’Farrell S., Garmo H., Holmberg L. et al. Risk and timing of cardiovascular disease after androgen-deprivation therapy in men with prostate cancer. J Clin Oncol 2015;33(11):1243-51. DOI: 10.1200/JCO.2014.59.1792.

45. Bosco C., Bosnyak Z., Malmberg A. et al. Quantifying observational evidence for risk of fatal and nonfatal cardiovascular disease following androgen deprivation therapy for prostate cancer: a meta-analysis. Eur Urol 2015;68(3):386-96. DOI: 10.1016/j.eururo.2014.11.039.

46. Gandaglia G., Sun M., Popa I. et al. Cardiovascular mortality in patients with metastatic prostate cancer exposed to androgen deprivation therapy: a population-based study. Clin Genitourin Cancer 2015;13(3):e123-30. DOI: 10.1016/j.clgc.2014.12.003.

47. Nanda A., Chen M.H., Braccioforte M.H. et al. Hormonal therapy use for prostate cancer and mortality in men with coronary artery disease-induced congestive heart failure or myocardial infarction. JAMA 2009;302(8):866-73. DOI: 10.1001/jama.2009.1137.

48. Hedlund P.O., Johansson R., Damber J.E. et al. Significance of pretreatment cardiovascular morbidity as a risk factor during treatment with parenteral oestrogen or combined androgen deprivation of 915 patients with metastasized prostate cancer: evaluation of cardiovascular events in a randomized trial. Scand J Urol Nephrol 2011;45(5):346-53. DOI: 10.3109/00365599.2011.585820.

49. Keating N.L., O’Malley A.J., Smith M.R. Diabetes and cardiovascular disease during androgen deprivation therapy for prostate cancer. J Clin Oncol 2006;24(27):4448-56. DOI: 10.1200/JCO.2006.06.2497.

50. D’Amico A.V., Denham J.W., Crook J. et al. Influence of androgen suppression therapy for prostate cancer on the frequency and timing of fatal myocardial infarctions. J Clin Oncol 2007;25(17):2420-5. DOI: 10.1200/JCO.2006.09.3369.

51. Kintzel P.E., Chase S.L., Schultz L.M., O’Rourke T.J. Increased risk of metabolic syndrome, diabetes mellitus, and cardio-vascular disease in men receiving androgen deprivation therapy for prostate cancer. Pharmacotherapy 2008;28(12):1511-22. DOI: 10.1592/phco.28.12.1511


Для цитирования:


Нюшко К.М., Перепухов В.М., Алексеев Б.Я. Диферелин® как эффективный препарат кастрационной терапии у больных раком предстательной железы. Онкоурология. 2020;16(4):191-196. https://doi.org/10.17650/1726-9776-2020-16-4-191-196

For citation:


Nyushko K.M., Perepukhov V.M., Alekseev B.Y. Diferelin® as an effective chemical castration agent for patients with prostate cancer. Cancer Urology. 2020;16(4):191-196. (In Russ.) https://doi.org/10.17650/1726-9776-2020-16-4-191-196

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ISSN 1726-9776 (Print)
ISSN 1996-1812 (Online)
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