Кабазитаксел в лечении метастатического кастрационно-резистентного рака предстательной железы

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Рак предстательной железы в структуре заболеваемости злокачественными новообразованиями занимает 4-е место, что составляет 7,3%. В 2020 г. в мире было выявлено 1 414 259 новых случаев, за этот же период умерли 375 304 человека. В последние десятилетия отмечается значительный рост числа случаев метастатического кастрационно-резистентного рака предстательной железы (мКРРПЖ). В настоящее время не существует единого мнения по выбору оптимальной тактики лечения. Для этих целей предложены различные лечебные опции. Однако режимы и последовательность их применения являются спорными и далеки от решения. Целью данного обзора является анализ исследований, посвященных применению кабазитаксела в лечении мКРРПЖ. История применения таксанов при распространенном и метастатическом раке предстательной железы берет начало в 2004 г., когда Управление по контролю пищевых продуктов и лекарств в США зарегистрировало доцетаксел в качестве терапии 1-й линии при метастатическом раке предстательной железы. В 2010 г. появился новый таксан II поколения – кабазитаксел, показавший активность при развитии кастрационной резистентности. Он продемонстрировал высокую противоопухолевую активность и значимую эффективность при прогрессировании на фоне лечения доцетакселом и ингибиторами рецепторов андрогена. В настоящее время анализу доступны результаты ряда рандомизированных клинических исследований, посвященных различным аспектам лечебной тактики при мКРРПЖ. Однако их данные и особенно клиническая польза неоднозначны, а порой и противоречивы. В обзоре приведены результаты научных изысканий, международных клинических исследований, касающихся различных аспектов мКРРПЖ, в особенности выбора современной оптимальной лечебной тактики.

Об авторах

Николай Алексеевич Огнерубов

ФГБОУ ВО «Тамбовский государственный университет им. Г.Р. Державина»; ГБУЗ «Тамбовский областной онкологический диспансер»

Автор, ответственный за переписку.
Email: ognerubov_n.a@mail.ru
ORCID iD: 0000-0003-4045-1247
SPIN-код: 3576-3592

д-р мед. наук, канд. юрид. наук, проф., зав. каф. онкологии, зам. глав. врача по КЭР, засл. работник высшей школы РФ, засл. врач РФ

Россия, Тамбов

Список литературы

  1. Shiota M, Eto M. Current status of primary pharmacotherapy and future perspectives toward upfront therapy for metastatic hormone-sensitive prostate cancer. Int J Urol. 2016;23(5):360-9.
  2. Sathianathen NJ, Koschel S, Thangasamy IA, et al. Indirect comparisons of efficacy between combination approaches in metastatic hormone-sensitive prostate cancer: a systematic review and network meta-analysis. Eur Urol. 2020;77:365-72. doi: 10.1016/j.eururo.2019.09.004
  3. Harris WP, Mostaghel EA, Nelson PS, Montgomery B. Androgen deprivation therapy: progress in understanding mechanisms of resistance and optimizing androgen depletion. Nat Clin Pract Urol. 2009;6(2):76-85.
  4. Tannock IF, de Wit R, Berry WR, et al. Docetaxel plus prednisone or mitoxantrone plus prednisone for advanced prostate cancer. N Engl J Med. 2004;351(15):1502-12.
  5. De Bono JS, Oudard S, Ozguroglu M, et al. Predonisone plus cabazitaxel or mitoxantrone for metastatic castration-resistant prostate cancer progressing after docetaxel treatment: a randomised open-label trial. Lancet. 2010;376(9794):1147-54.
  6. Parker C, Nilsson S, Heinrich D, et al. Alpha emitter radium-223 and survival in metastatic prostate cancer. N Engl J Med. 2013;369(3):213-23.
  7. Angelergues A, Efstathiou E, Gyftaki R, et al. Results of the FLAC European Database of metastatic castration-resistant prostate cancer patients treated with docetaxel, cabazitaxel, and androgen receptor-targeted agents. Clin Genitourin Cancer. 2018;16(4):e777-e784.
  8. Oudard S. TROPIC: Phase III trial of cabazitaxel for the treatment of metastatic castration-resistant prostate cancer. Future Oncol. 2011;7(4):497-506.
  9. Eisenberger M, Hardy-Bessard AC, Kim CS, et al. Phase III Study Comparing a Reduced Dose of Cabazitaxel (20 mg/m2) and the Currently Approved Dose (25 mg/m2) in Postdocetaxel Patients With Metastatic Castration-Resistant Prostate Cancer – PROSELICA. J Clin Oncol. 2017;35(28):3198-206.
  10. De Wit R, de Bono J, Sternberg CN, et al.; CARD Investigators. Cabazitaxel versus Abiraterone or Enzalutamide in Metastatic Prostate Cancer. N Engl J Med. 2019;381:2506-18. doi: 10.1056/NEJMoa1911206
  11. Sung H, Ferlay J, Siegel RL, et al. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021;71(3):209-49. doi: 10.3322/caac.21660
  12. Состояние онкологической помощи населению России в 2019 году. Под ред. А.Д. Каприна, В.В. Старинского, А.О. Шахзадовой. М.: МНИОИ им. П.А. Герцена − филиал ФГБУ «НМИЦ радиологии» Минздрава России, 2020 [Sostoianie onkologicheskoi pomoshchi naseleniiu Rossii v 2019 godu. Pod red. AD Kaprina, VV Starinskogo, AO Shakhzadovoi. Moscow: MNIOI im. P.A. Gertsena − filial FGBU “NMITs radiologii” Minzdrava Rossii, 2020 (in Russian)].
  13. Shore N, Oliver L, Shui I, et al. Systematic Literature Review of the Epidemiology of Advanced Prostate Cancer and Associated Homologous Recombination Repair Gene Alterations. J Urol. 2021;205(4):977-86. doi: 10.1097/JU.0000000000001570
  14. Scher HI, 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;10:e0139440.
  15. Morgan C, McEwan P, Chamberlain G, et al. PCN17 castration-resistant prostate cancer (CRPC): A UK epidemiology study. Value in Health. 2010;13:A26. doi: 10.1016/S1098-3015(10)72108-2
  16. Fuld AD, Young-Xu Y, Li S, et al. Predictors of overall survival (OS) in veterans with non-metastatic castration resistant prostate cancer (nmCRPC). J Clin Oncol. Conf. suppl., 2018; p. 36. doi: 10.1200/JCO.2018.36.15_suppl.e17057
  17. Hirst CJ, Cabrera C, Kirby M. Epidemiology of castration resistant prostate cancer: A longitudinal analysis using a UK primary care database. Cancer Epidemiol. 2012;36:e349.
  18. Saad F, Mehra M, Small EJ, et al. A 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:e229. doi: 10.1016/j.juro.2018.02.614
  19. Parihar N. The global forecast of prostate cancer drug-treatable populations eligible for targeted anticancer therapies (2017–2027). Ann Oncol. 2018;29 (Suppl. 3):iii30. doi: 10.1093/annonc/mdy047.080
  20. Berthold DR, Pond GR, Soban F, et al. Docetaxel plus prednisone or mitoxantrone plus prednisone for advanced prostate cancer: updated survival in the TAX 327 study. J Clin Oncol. 2008;26(2):242-5.
  21. Petrylak DP, Tangen CM, Hussain MH, et al. Docetaxel and estramustine compared with mitoxantrone and prednisone for advanced refractory prostate cancer. N Engl J Med. 2004;351(15):1513-20.
  22. Sternberg CN, Petrylak DP, Sartor O, et al. Multinational, double-blind, Phase III study of prednisone and either satraplatin or placebo in patients with castraterefractory prostate cancer progressing after prior chemotherapy: the SPARC trial. J Clin Oncol. 2009;27(32):5431-8.
  23. Oudard S, Banu E, Medioni J, et al. What is the real impact of bone pain on survival in patients with metastatic hormone-refractory prostate cancer treated with docetaxel? BJU Int. 2009;103(12):1641-6.
  24. Oudard S, Banu E, Scotte F, et al. Prostatespecific antigen doubling time before onset of chemotherapy as a predictor of survival for hormone-refractory prostate cancer patients. Ann Oncol. 2007;18(11):1828-33.
  25. Rowinsky EK, Tolcher AW. Antimicrotubule agents. In: Cancer: principle and practice of oncology. Ed. V DeVita, S Hellman, SA Rosenberg. Philadelphia (PA): Lippincott, Williams and Wilkins, 2001; p. 431-51.
  26. Lockhart AC, Tirona RG, Kim RB. Pharmacogenetics of ATP-binding cassette transporters in cancer and chemotherapy. Mol Cancer Ther. 2003;2:685-98.
  27. Sanofi-aventis. XRP6258 investigator’s brochure. Antony (France): Sanofi-aventis, 2000.
  28. Bart J, Groen HJ, Hendrikse NH, et al. The blood-brain barrier and oncology: new insights into function and modulation. Cancer Treat Rev. 2000;26:449-62.
  29. Hunter J, Jepson MA, Tsuruo T, et al. Functional expression of P-glycoprotein in apical membranes of human intestinal Caco-2 cells. Kinetics of vinblastine secretion and interaction with modulators. J Biol Chem. 1993;268:14991-7.
  30. Mita AC, Denis LJ, Rowinsky EK, et al. Phase I and Pharmacokinetic Study of XRP6258 (RPR 116258A), a Novel Taxane, Administered as a 1-Hour Infusion Every 3 Weeks in Patients with Advanced Solid Tumors. Clin Cancer Res. 2009;15(2):723-30. doi: 10.1158/1078-0432.CCR-08-0596
  31. Pivot X, Koralewski P, Hidalgo JL, et al. A multicenter phase II study of XRP6258 administered as a 1-h i.v. infusion every 3 weeks in taxane-resistant metastatic breast cancer patients. Ann Oncol. 2008;19(9):1547-52. doi: 10.1093/annonc/mdn171
  32. Oudard SM, de Bono JS, Ozguroglu M, et al. Cabazitaxel plus prednisone/prednisolone significantly increases overall survival compared to mitoxantrone plus prednisone/prednisolone in patients with metastatic castration-resistant prostate cancer (mCRPC) previously treated with docetaxel: final results with updated overall survival of a multinational Phase III trial (TROPIC). Ann Oncol. 2010;21 (Suppl. 8):VIII271.
  33. Schweizer MT, Antonarakis ES. Chemotherapy and its evolving role in the management of advanced prostate cancer. Asian J Androl. 2014;16:334-40.
  34. Center for Drug Evaluation and Research: NDA 20-1023 review: Cabazitaxel. Updated 2016. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/ nda/2010/201023s000Approv.pdf. Accessed: 23.06.2021
  35. Shiota M, Nakamura M, Yokomizo A, et al. Efficacy and safety of cabazitaxel for castration-resistant prostate cancer in patients with >10 cycles of docetaxel chemotherapy: a multi-institutional study. Med Oncol. 2019;36(4):32. doi: 10.1007/s12032-019-1257-1
  36. Pond GR, Armstrong AJ, Wood BA, et al. Evaluating the Value of Number of Cycles of Docetaxel and Prednisone in Men With Metastatic Castration-Resistant Prostate Cancer. Eur Urol. 2012;61(2):363-9. doi: 10.1016/j.eururo.2011.06.034
  37. Kato S, Takai M, Iinuma K, et al. Sequential Docetaxel in ≥7 Cycles Followed by Cabazitaxel Improves Oncological Outcomes in Patients with Metastatic Castration-Resistant Prostate Cancer. Scientific World Journal. 2021. Available at: https://www.hindawi.com/journals/tswj/2021/8824140/. Accessed: 27.06.2021
  38. Sonpavde G, Bhor M, Hennessy D, et al. Sequencing of cabazitaxel and abiraterone acetate after docetaxel in metastatic castration-resistant prostate cancer: treatment patterns and clinical outcomes in multicenter community-based US oncology practices. Clin Genitourin Cancer. 2015;13:309-18.
  39. Maines F, Caffo O, Veccia A, et al. Sequencing new agents after docetaxel in patients with metastatic castration-resistant prostate cancer. Crit Rev Oncol Hematol. 2015;96:498-506.
  40. Van Soest RJ, van Royen ME, de Morree ES, et al. Cross-resistance between taxanes and new hormonal agents abiraterone and enzalutamide may affect drug sequence choices in metastatic castration-resistant prostate cancer. Eur J Cancer.2013;49:3821-30.
  41. Fitzpatrick JM, de Wit R. Taxane mechanisms of action: potential implications for treatment sequencing in metastatic castration-resistant prostate cancer. Eur Urol. 2014;65:1198-204.
  42. Suzuki H, Castellano D, de Bono J, et al. Cabazitaxel versus abiraterone or enzalutamide in metastatic castration-resistant prostate cancer: post hoc analysis of the CARD study excluding chemohormonal therapy for castrate-naive disease. Jpn J Clin Oncol. 2021;51(8):1287-97. doi: 10.1093/jjco/hyab028
  43. Suzuki H, Shin T, Fukasawa S, et al. Efficacy and safety of abiraterone acetate plus prednisone in Japanese patients with newly diagnosed, metastatic hormone-naive prostate cancer: final subgroup analysis of LATITUDE, a randomized, double-blind, placebo-controlled, phase 3 study. Jpn J Clin Oncol. 2020;50:810-20.
  44. Droz JP, Efstathiou E, Yildirim A, et al. First-line treatment in senior adults with metastatic castration-resistant prostate cancer: A prospective international registry. Urol Oncol. 2016;34(5):234.e21-9.
  45. Matsumoto T, Shiota M, Nakamura M, et al. Efficacy and safety of cabazitaxel therapy in elderly (≥75 years) patients with castration-resistant prostate cancer: A multiinstitutional study. Prostate Int. 2021;9(2):96-100.
  46. Armstrong AJ, Lin P, Higano CS, et al. Development and validation of a prognostic model for overall survival in chemotherapy-naïve men with metastatic castration-resistant prostate cancer. Ann Oncol. 2018;29:2200-7.
  47. Khalaf DJ, Avilés CM, Azad AA, et al. A prognostic model for stratifying clinical outcomes in chemotherapy-naive metastatic castration-resistant prostate cancer patients treated with abiraterone acetate. Can Urol Assoc J. 2018;12:E47-E52.
  48. Abida W, Cyrta J, Heller G, et al. Genomic correlates of clinical outcome in advanced prostate cancer. Proc Natl Acad Sci U S A. 2019;116:11428-36.
  49. Corn PG, Heath EI, Zurita A, et al. Cabazitaxel plus carboplatin for the treatment of men with metastatic castration-resistant prostate cancers: a randomised, open-label, phase 1–2 trial. Lancet Oncol. 2019;20(10):1432-43.
  50. Loriot Y, Fizazi K, de Bono JS, et al. Enzalutamide in castration-resistant prostate cancer patients with visceral disease in the liver and/or lung: outcomes from the randomized controlled phase 3 AFFIRM trial. Cancer. 2017;123(2):253-62.
  51. Alumkal JJ, Chowdhury S, Loriot Y, et al. Effect of visceral disease site on outcomes in patients with metastatic castration-resistant prostate cancer treated with Enzalutamide in the PREVAIL trial. Clin Genitourin Cancer. 2017;15(5):610-17.e3.
  52. Gillessen S, Attard G, Beer TM, et al. Management of patients with advanced prostate cancer: the report of the advanced prostate cancer consensus conference APCCC 2017. Eur Urol. 2018;73(2):178-211.
  53. Annala M, Fu S, Bacon JVW, et al. Cabazitaxel versus abiraterone or enzalutamide in poor prognosis metastatic castration-resistant prostate cancer: a multicentre, randomised, open-label, phase II trial. Ann Oncol. 2021;32(7):896-905. doi: 10.1016/j.annonc.2021.03.205.
  54. Van der Zande K, van der Noort V, Busard M, et al. First results from a randomized phase II study of cabazitaxel (CBZ) versus an androgen receptor targeted agent (ARTA) in patients with poor-prognosis castration-resistant prostate cancer (mCRPC). J Clin Oncol. 2021;39(15, Suppl.):5059. doi: 10.1200/JCO.2021.39.15_suppl.5059
  55. Wallis CJD. First Results from a Randomized Phase II Study of Cabazitaxel vs an Androgen Receptor Targeted Agent in Patients with Poor-Prognosis Castration-Resistant Prostate Cancer at the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting #ASCO21. June, 4–8, 2021.

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