Андрология и генитальная хирургия. 2018; 19: 68-76
БИОМАРКЕРЫ РАКА ПРЕДСТАТЕЛЬНОЙ ЖЕЛЕЗЫ: НАСТОЯЩЕЕ И БУДУЩЕЕ
Рапопорт Л. М., Безруков Е. А., Суханов Р. Б., Крупинов Г. Е., Цариченко Д. Г., Мартиросян Г. А., Авакян С. К.
https://doi.org/10.17650/2070-9781-2018-19-1-68-76Аннотация
В обзоре литературы проанализированы данные клинических исследований, систематических обзоров и метаанализов, в которых оценивались чувствительность и специфичность тех или иных диагностических биомаркеров рака предстательной железы до проведения ее первичной биопсии или после получения отрицательных результатов первичной биопсии.
Список литературы
1. Алексеев Б.Я., Каприн А.Д., Матвеев В.Б., Нюшко К.М. Клинические рекомендации по диагностике и лечению рака предстательной железы. М., 2014. 44 с. Доступно по: http://oncology-association.ru/docs/recomend/may2015/39vz-rek.pdf
2. American Cancer Society. Cancer Facts & Figures. 2017. Available at: https://www.cancer.org/content/dam/cancer-org/research/cancer-facts-and-statistics/annual-cancer-facts-and-figures/2017/cancer-facts-and-figures-2017.pdf.
3. Vickers A., Cronin A., Roobol M. et al. Reducing unnecessary biopsy during prostate cancer screening using a fourkallikrein panel: an independent replication. J Clin Oncol 2010;28(15):2493–8. DOI: 10.1200/JCO.2009.24.1968. PMID: 20421547.
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5. Архипова О.Е., Черногубова Е.А., Куролап С.А., Епринцев С.А. Эпидемиология рака предстательной железы в Воронежской области: пространственно-временная статистика. Вестник урологии 2016;(4):45–55. DOI: 10.1234/XXXX-XXXX-2016-4-45-55.
6. Gathirua-Mwangi W.G., Zhang J. Dietary factors and risk for advanced prostate cancer. Eur J Cancer Prev 2014;23(2):96–109. DOI: 10.1097/CEJ.0b013e3283647394. PMID: 23872953.
7. Schröder F.H., Hugosson J., Roobol M.J. et al. Screening and prostate cancer mortality: results of the European Randomised Study of Screening for Prostate Cancer (ERSPC) at 13 years of follow-up. Lancet 2014;384(9959):2027–35. DOI: 10.1016/S0140-6736(14)60525-0. PMID: 25108889.
8. Thompson I.M., Pauler D.K., Goodman P.J. et al. Prevalence of prostate cancer among men with a prostatespecific antigen level < or =4.0 ng per milliliter. N Engl J Med 2004;350(22): 2239–46. DOI: 10.1056/NEJMoa031918. PMID: 15163773.
9. Kretschmer A., Tilki D. Biomarkers in prostate cancer – current clinical utility and future perspectives. Crit Rev Oncol Hematol 2017;120:180–93. DOI: 10.1016/j.critrevonc.2017.11.007. PMID: 29198331.
10. Stamey T.A., Yang N., Hay A.R. et al. Prostate-specific antigen as a serum marker for adenocarcinoma of the prostate. N Engl J Med 1987;317(15):909–16. DOI: 10.1056/NEJM198710083171501. PMID: 2442609.
11. Semjonow A., Brandt B., Oberpenning F. et al. Discordance of assay methods creates pitfalls for the interpretation of prostate-specific antigen values. Prostate Suppl 1996;7:3–16. PMID: 8950358.
12. Parekh D.J., Punnen S., Sjoberg D.D. et al. A multi-institutional prospective trial in the USA confirms that the 4Kscore accurately identifies men with high-grade prostate cancer. Eur Urol 2015;68(3):464–70. DOI: 10.1016/j. eururo.2014.10.021. PMID: 25454615.
13. Salami S.S., Schmidt F., Laxman B. et al. Combining urinary detection of TMPRSS2: ERG and PCA3 with serum PSA to predict diagnosis of prostate cancer. Urol Oncol 2013;31(5):566–71. DOI: 10.1016/j.urolonc.2011.04.001. PMID: 21600800.
14. Пушкарь Д.Ю., Говоров А.В., Сидоренков А.В. и др. Ранняя диагностика рака предстательной железы: методические рекомендации № 19. М.: АБВ-пресс, 2015. 54 с.
15. Catalona W.J., Smith D.S., Ornstein D.K. Prostate cancer detection in men with serum PSA concentrations of 2.6 to 4.0 ng/mL and benign prostate examination. Enhancement of specificity with free PSA measurements. JAMA, 1997. 277(18): p. 1452–5.
16. Catalona W.J., Partin A.W., Slawin K.M. et al. Use of the percentage of free prostate-specific antigen to enhance differentiation of prostate cancer from benign prostatic disease: a prospective multicenter clinical trial. JAMA 1998;279(19):1542–7. PMID: 9605898.
17. Catalona W.J., Smith D.S., Wolfert R.L. et al. Evaluation of percentage of free serum prostate-specific antigen to improve specificity of prostate cancer screening. JAMA 1995;274(15):1214–20. PMID: 7563511.
18. Filella X., Gimenez N. Evaluation of [-2] proPSA and Prostate Health Index (phi) for the detection of prostate cancer: a systematic review and meta-analysis. Clin Chem Lab Med 2013;51(4):729–39. DOI: 10.1515/cclm-2012-0410. PMID: 23154423.
19. Ito K., Miyakubo M., Sekine Y. et al. Diagnostic significance of [-2] pro-PSA and prostate dimension-adjusted PSArelated indices in men with total PSA in the 2.0–10.0 ng/mL range. World J Urol 2013;31(2):305–11. DOI: 10.1007/s00345-012-0927-9. PMID: 22903772.
20. Tosoian J.J., Druskin S.C., Andreas D. et al. Prostate Health Index density improves detection of clinically significant prostate cancer. BJU Int 2017;120(6):793–8. DOI: 10.1111/bju.13762. PMID: 28058757.
21. Mottet N., Bellmunt J., Bolla M. et al. EAU-ESTRO-SIOG Guidelines on Prostate Cancer. Part 1: Screening, Diagnosis, and Local Treatment with Curative Intent. Eur Urol 2017;71(4):618–29. DOI: 10.1016/j.eururo.2016.08.003. PMID: 27568654.
22. NCCN Clinical Practice Guidelines in Oncology. Available at: https://www.nccn.org/professionals/physician_gls/default.aspx.
23. Leyten G.H., Hessels D., Smit F.P. et al. Identification of a candidate gene panel for the early diagnosis of prostate cancer. Clin Cancer Res 2015;21(13):3061–70. DOI: 10.1158/107800432.CCR-140-3334. PMID: 25788493.
24. Van Neste L., Hendriks R.J., Dijkstra S. et al. Detection of high-grade prostate cancer using a Urinary Molecular Biomarker-Based Risk Score. Eur Urol 2016;70(5):740–8. DOI: 10.1016/j.eururo.2016.04.012. PMID: 27108162.
25. Chan T.A., Glockner S., Yi J.M. et al. Convergence of mutation and epigenetic alterations identifies common genes in cancer that predict for poor prognosis. PLoS Med 2008;5(5):e114. DOI: 10.1371/journal.pmed.0050114. PMID: 18507500.
26. Van Neste L., Herman J.G., Otto G. et al. The epigenetic promise for prostate cancer diagnosis. Prostate 2012;72(11):1248–61. DOI: 10.1002/pros.22459. PMID: 22161815.
27. Henrique R., Jerόnimo C., Teixeira M.R. et al. Epigenetic heterogeneity of highgrade prostatic intraepithelial neoplasia: clues for clonal progression in prostate carcinogenesis. Mol Cancer Res 2006;4(1):1–8. DOI: 10.1158/1541-7786.MCR-05-0113. PMID: 16446401.
28. Henrique R., Jerόnimo C. Molecular detection of prostate cancer: a role for GSTP1 hypermethylation. Eur Urol 2004;46(5):660–9. DOI: 10.1016/j.eururo.2004.06.014. PMID: 15474280.
29. Woodson K., O’Reilly K.J., Hanson J.C. et al. The usefulness of the detection of GSTP1 methylation in urine as a biomarker in the diagnosis of prostate cancer. J Urol 2008;179(2):508–11. DOI: 10.1016/j.juro.2007.09.073. PMID: 18076912.
30. Gurioli G., Martignano F., Salvi S. et al. GSTP1 methylation in cancer: a liquid biopsy biomarker? Clin Chem Lab Med 2018 Jan 6. DOI: 10.1515/cclm-2017-0703. PMID: 29305565.
31. Fradet Y., Saad F., Aprikian A. et al. uPM3, a new molecular urine test for the detection of prostate cancer. Urology 2004;64(2):311–5. DOI: 10.1016/j.urology.2004.03.052. PMID: 15302485.
32. Hansen J., Auprich M., Ahyai S.A. et al. Initial prostate biopsy: development and internal validation of a biopsy-specific nomogram based on the prostate cancer antigen 3 assay. Eur Urol 2013;63(2):201–9. DOI: 10.1016/j.eururo.2012.07.030. PMID: 22854248.
33. De la Taille A., Irani J., Graefen M. et al. Clinical evaluation of the PCA3 assay in guiding initial biopsy decisions. J Urol 2011;185(6):2119–25. DOI: 10.1016/j.juro.2011.01.075. PMID: 21496856.
34. Tomlins S.A., Day J.R., Lonigro R.J. et al. Urine TMPRSS2: ERG Plus PCA3 for Individualized Prostate Cancer Risk Assessment. Eur Urol 2016;70(1):45–53. DOI: 10.1016/j.eururo.2015.04.039. PMID: 25985884.
35. Nilsson J., Skog J., Nordstrand A. et al. Prostate cancer-derived urine exosomes: a novel approach to biomarkers for prostate cancer. Br J Cancer 2009;100(10):1603–7. PMID: 19401683.
36. Donovan M.J., Noerholm M., Bentink S. et al. A molecular signature of PCA3 and ERG exosomal RNA from non-DRE urine is predictive of initial prostate biopsy result. Prostate Cancer Prostatic Dis 2015;18(4):370–5. DOI: 10.1038/pcan.2015.40. PMID: 26345389.
37. McKiernan J., Donovan M.J., O»Neill V. et al. A novel urine exosome gene expression assay to predict high-grade prostate cancer at initial biopsy. JAMA Oncol 2016;2(7):882–9. DOI: 10.1001/jamaoncol.2016.0097. PMID: 27032035.
Andrology and Genital Surgery. 2018; 19: 68-76
BIOMARKERS FOR DIAGNOSING OF PROSTATE CANCER: THE PRESENT AND THE FUTURE
Rapoport L. M., Bezrukov E. A., Sukhanov R. B., Krupinov G. E., Tsarichenko D. G., Martirosyan G. A., Avakyan S. K.
https://doi.org/10.17650/2070-9781-2018-19-1-68-76Abstract
This review analyze data of clinical trials, systematic reviews and meta-analyses, which evaluated the sensitivity and specificity of any biomarkers using for diagnostics of prostate cancer before an initial prostate biopsy or after a negative initial biopsy.
References
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2. American Cancer Society. Cancer Facts & Figures. 2017. Available at: https://www.cancer.org/content/dam/cancer-org/research/cancer-facts-and-statistics/annual-cancer-facts-and-figures/2017/cancer-facts-and-figures-2017.pdf.
3. Vickers A., Cronin A., Roobol M. et al. Reducing unnecessary biopsy during prostate cancer screening using a fourkallikrein panel: an independent replication. J Clin Oncol 2010;28(15):2493–8. DOI: 10.1200/JCO.2009.24.1968. PMID: 20421547.
4. Kuplevatskii V.I., Cherkashin M.A., Roshchin D.A. i dr. Biopsiya predstatel'noi zhelezy pod kontrolem magnitno-rezonansnoi tomografii. Vestnik rentgenologii i radiologii 2016;97(1):48–55. DOI: 10.20862/0042-4676-2016-97-1-48-55.
5. Arkhipova O.E., Chernogubova E.A., Kurolap S.A., Eprintsev S.A. Epidemiologiya raka predstatel'noi zhelezy v Voronezhskoi oblasti: prostranstvenno-vremennaya statistika. Vestnik urologii 2016;(4):45–55. DOI: 10.1234/XXXX-XXXX-2016-4-45-55.
6. Gathirua-Mwangi W.G., Zhang J. Dietary factors and risk for advanced prostate cancer. Eur J Cancer Prev 2014;23(2):96–109. DOI: 10.1097/CEJ.0b013e3283647394. PMID: 23872953.
7. Schröder F.H., Hugosson J., Roobol M.J. et al. Screening and prostate cancer mortality: results of the European Randomised Study of Screening for Prostate Cancer (ERSPC) at 13 years of follow-up. Lancet 2014;384(9959):2027–35. DOI: 10.1016/S0140-6736(14)60525-0. PMID: 25108889.
8. Thompson I.M., Pauler D.K., Goodman P.J. et al. Prevalence of prostate cancer among men with a prostatespecific antigen level < or =4.0 ng per milliliter. N Engl J Med 2004;350(22): 2239–46. DOI: 10.1056/NEJMoa031918. PMID: 15163773.
9. Kretschmer A., Tilki D. Biomarkers in prostate cancer – current clinical utility and future perspectives. Crit Rev Oncol Hematol 2017;120:180–93. DOI: 10.1016/j.critrevonc.2017.11.007. PMID: 29198331.
10. Stamey T.A., Yang N., Hay A.R. et al. Prostate-specific antigen as a serum marker for adenocarcinoma of the prostate. N Engl J Med 1987;317(15):909–16. DOI: 10.1056/NEJM198710083171501. PMID: 2442609.
11. Semjonow A., Brandt B., Oberpenning F. et al. Discordance of assay methods creates pitfalls for the interpretation of prostate-specific antigen values. Prostate Suppl 1996;7:3–16. PMID: 8950358.
12. Parekh D.J., Punnen S., Sjoberg D.D. et al. A multi-institutional prospective trial in the USA confirms that the 4Kscore accurately identifies men with high-grade prostate cancer. Eur Urol 2015;68(3):464–70. DOI: 10.1016/j. eururo.2014.10.021. PMID: 25454615.
13. Salami S.S., Schmidt F., Laxman B. et al. Combining urinary detection of TMPRSS2: ERG and PCA3 with serum PSA to predict diagnosis of prostate cancer. Urol Oncol 2013;31(5):566–71. DOI: 10.1016/j.urolonc.2011.04.001. PMID: 21600800.
14. Pushkar' D.Yu., Govorov A.V., Sidorenkov A.V. i dr. Rannyaya diagnostika raka predstatel'noi zhelezy: metodicheskie rekomendatsii № 19. M.: ABV-press, 2015. 54 s.
15. Catalona W.J., Smith D.S., Ornstein D.K. Prostate cancer detection in men with serum PSA concentrations of 2.6 to 4.0 ng/mL and benign prostate examination. Enhancement of specificity with free PSA measurements. JAMA, 1997. 277(18): p. 1452–5.
16. Catalona W.J., Partin A.W., Slawin K.M. et al. Use of the percentage of free prostate-specific antigen to enhance differentiation of prostate cancer from benign prostatic disease: a prospective multicenter clinical trial. JAMA 1998;279(19):1542–7. PMID: 9605898.
17. Catalona W.J., Smith D.S., Wolfert R.L. et al. Evaluation of percentage of free serum prostate-specific antigen to improve specificity of prostate cancer screening. JAMA 1995;274(15):1214–20. PMID: 7563511.
18. Filella X., Gimenez N. Evaluation of [-2] proPSA and Prostate Health Index (phi) for the detection of prostate cancer: a systematic review and meta-analysis. Clin Chem Lab Med 2013;51(4):729–39. DOI: 10.1515/cclm-2012-0410. PMID: 23154423.
19. Ito K., Miyakubo M., Sekine Y. et al. Diagnostic significance of [-2] pro-PSA and prostate dimension-adjusted PSArelated indices in men with total PSA in the 2.0–10.0 ng/mL range. World J Urol 2013;31(2):305–11. DOI: 10.1007/s00345-012-0927-9. PMID: 22903772.
20. Tosoian J.J., Druskin S.C., Andreas D. et al. Prostate Health Index density improves detection of clinically significant prostate cancer. BJU Int 2017;120(6):793–8. DOI: 10.1111/bju.13762. PMID: 28058757.
21. Mottet N., Bellmunt J., Bolla M. et al. EAU-ESTRO-SIOG Guidelines on Prostate Cancer. Part 1: Screening, Diagnosis, and Local Treatment with Curative Intent. Eur Urol 2017;71(4):618–29. DOI: 10.1016/j.eururo.2016.08.003. PMID: 27568654.
22. NCCN Clinical Practice Guidelines in Oncology. Available at: https://www.nccn.org/professionals/physician_gls/default.aspx.
23. Leyten G.H., Hessels D., Smit F.P. et al. Identification of a candidate gene panel for the early diagnosis of prostate cancer. Clin Cancer Res 2015;21(13):3061–70. DOI: 10.1158/107800432.CCR-140-3334. PMID: 25788493.
24. Van Neste L., Hendriks R.J., Dijkstra S. et al. Detection of high-grade prostate cancer using a Urinary Molecular Biomarker-Based Risk Score. Eur Urol 2016;70(5):740–8. DOI: 10.1016/j.eururo.2016.04.012. PMID: 27108162.
25. Chan T.A., Glockner S., Yi J.M. et al. Convergence of mutation and epigenetic alterations identifies common genes in cancer that predict for poor prognosis. PLoS Med 2008;5(5):e114. DOI: 10.1371/journal.pmed.0050114. PMID: 18507500.
26. Van Neste L., Herman J.G., Otto G. et al. The epigenetic promise for prostate cancer diagnosis. Prostate 2012;72(11):1248–61. DOI: 10.1002/pros.22459. PMID: 22161815.
27. Henrique R., Jerόnimo C., Teixeira M.R. et al. Epigenetic heterogeneity of highgrade prostatic intraepithelial neoplasia: clues for clonal progression in prostate carcinogenesis. Mol Cancer Res 2006;4(1):1–8. DOI: 10.1158/1541-7786.MCR-05-0113. PMID: 16446401.
28. Henrique R., Jerόnimo C. Molecular detection of prostate cancer: a role for GSTP1 hypermethylation. Eur Urol 2004;46(5):660–9. DOI: 10.1016/j.eururo.2004.06.014. PMID: 15474280.
29. Woodson K., O’Reilly K.J., Hanson J.C. et al. The usefulness of the detection of GSTP1 methylation in urine as a biomarker in the diagnosis of prostate cancer. J Urol 2008;179(2):508–11. DOI: 10.1016/j.juro.2007.09.073. PMID: 18076912.
30. Gurioli G., Martignano F., Salvi S. et al. GSTP1 methylation in cancer: a liquid biopsy biomarker? Clin Chem Lab Med 2018 Jan 6. DOI: 10.1515/cclm-2017-0703. PMID: 29305565.
31. Fradet Y., Saad F., Aprikian A. et al. uPM3, a new molecular urine test for the detection of prostate cancer. Urology 2004;64(2):311–5. DOI: 10.1016/j.urology.2004.03.052. PMID: 15302485.
32. Hansen J., Auprich M., Ahyai S.A. et al. Initial prostate biopsy: development and internal validation of a biopsy-specific nomogram based on the prostate cancer antigen 3 assay. Eur Urol 2013;63(2):201–9. DOI: 10.1016/j.eururo.2012.07.030. PMID: 22854248.
33. De la Taille A., Irani J., Graefen M. et al. Clinical evaluation of the PCA3 assay in guiding initial biopsy decisions. J Urol 2011;185(6):2119–25. DOI: 10.1016/j.juro.2011.01.075. PMID: 21496856.
34. Tomlins S.A., Day J.R., Lonigro R.J. et al. Urine TMPRSS2: ERG Plus PCA3 for Individualized Prostate Cancer Risk Assessment. Eur Urol 2016;70(1):45–53. DOI: 10.1016/j.eururo.2015.04.039. PMID: 25985884.
35. Nilsson J., Skog J., Nordstrand A. et al. Prostate cancer-derived urine exosomes: a novel approach to biomarkers for prostate cancer. Br J Cancer 2009;100(10):1603–7. PMID: 19401683.
36. Donovan M.J., Noerholm M., Bentink S. et al. A molecular signature of PCA3 and ERG exosomal RNA from non-DRE urine is predictive of initial prostate biopsy result. Prostate Cancer Prostatic Dis 2015;18(4):370–5. DOI: 10.1038/pcan.2015.40. PMID: 26345389.
37. McKiernan J., Donovan M.J., O»Neill V. et al. A novel urine exosome gene expression assay to predict high-grade prostate cancer at initial biopsy. JAMA Oncol 2016;2(7):882–9. DOI: 10.1001/jamaoncol.2016.0097. PMID: 27032035.
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