NEW TREATMENT STANDARD FOR PATIENTS WITH NON-METASTATIC CASTRATION-RESISTANT PROSTATE CANCER
https://doi.org/10.17650/1726-9776-2018-14-3-68-77
Abstract
Men with nonmetastatic, castration-resistant prostate cancer and a rapidly rising prostate-specific antigen level are at high risk for metastasis. Until recently there was no standard of treatment for this category of patients. A total of 1401 patients with nonmetastatic, castration-resistant prostate cancer and a prostate-specific antigen doubling time of 10 months or less underwent randomization to double-blind, phase III PROSPER trial. Patients were continuing androgen-deprivation therapy in combination with enzalutamide (at a dose of 160 mg) or placebo once daily. The median metastasis-free survival was 36.6 months in the enzalutamide group versus 14.7 months in the placebo group. Enzalutamide treatment resulted in a 71 % lower risk of radiographic progression or death than did placebo (hazard ratio 0.29; 95 % confidence interval 0.24 to 0.35; p <0.001). Adverse events were consistent with the established safety profile of enzalutamide.
About the Author
B. Ya. Alekseev
National Medical Research Center of Radiology, Ministry of Health of Russia
Russian Federation
3 2nd Botkinskiy Proezd, Moscow 125284.
Competing Interests: No conflict of interest.
Russian Federation
3 2nd Botkinskiy Proezd, Moscow 125284.
Competing Interests: No conflict of interest.
References
1. State of oncological care in Russia in 2017. Eds.: А.D. Kaprin, V.V. Starinskiy, G.V. Petrova. Moscow: MNIOI im. P.A. Gertsena – filial FGBU “NMIRTS” Minzdrava Rossii, 2018. 236 p. (In Russ.).
2. EAU guidelines 2018. Available at: http://uroweb.org/guidelines/.
3. Tannock I.F., de Wit R., Berry W.R. et al. Docetaxel plus prednisone or mitoxantrone plus prednisone for advanced prostate cancer. N Engl J Med 2004;351(15):1502–12.
4. Ryan C.J., Smith M.R., de Bono J.S. et al. Abiraterone in metastatic prostate cancer without previous chemotherapy. N Engl J Med 2013;368(2):138–48. DOI: 10.1056/NEJMoa1209096. PMID: 23228172.
5. Beer T.M., Armstrong A.J., Rathkopf D.E. et al. Enzalutamide in metastatic prostate cancer before chemotherapy. N Engl J Med 2014;371(18):424–33. DOI: 10.1056/NEJMc1410239. PMID: 25354111.
6. Xie W., Regan M.M., Buyse M. et al. Metastasis-free survival is a strong surrogate of overall survival in localized prostate cancer. J Clin Oncol 2017;35(27):3097–104. DOI: 10.1200/JCO.2017.73.9987. PMID: 28796587.
7. Smith M.R., Kabbinavar F., Saad F. et al. Natural history of rising serum prostate-specific antigen in men with castrate non-metastatic prostate cancer. J Clin Oncol 2005;23:2918–25. DOI: 10.1200/JCO.2005.01.529. PMID: 15860850.
8. Smith M.R., Cook R., Lee K.A., Nelson J.B. Disease and host characteristics as predictors of time to first bone metastasis and death in men with progressive castration-resistant nonmetastatic prostate cancer. Cancer 2011;117(10):2077–85. DOI: 10.1002/cncr.25762. PMID: 21523719.
9. Smith M.R., Saad F., Oudard S. et al. Denosumab and bone metastasis-free survival in men with nonmetastatic castration-re-sistant prostate cancer: exploratory analyses by baseline prostate-specific antigen doubling time. J Clin Oncol 2013;31(30):3800–6. DOI: 10.1200/JCO.2012.44.6716. PMID: 24043751.
10. NCCN guidelines version 2.2017. February 21, 2017. Available at: https://www.nccn.org/professionals/physician_gls/default.aspx
11. Smith M.R., Saad F., Coleman R. et al. Denosumab and bone-metastasis-free survival in men with castration-resistant prostate cancer: results of a phase 3, randomised, placebo-controlled trial. Lancet 2012;379(9810):39–46. DOI: 10.1016/S0140-6736(11)61226-9. PMID: 22093187.
12. Scher H.I., Fizazi K., Saad F. et al. Increased survival with enzalutamide in prostate cancer after chemotherapy. N Engl J Med 2012;367(13):1187–97. DOI: 10.1056/NEJMoa1207506. PMID: 22894553.
13. Penson D.F., Armstrong A.J., Concepcion R. et al. Еnzalutamide versus bicalutamide in castration-resistant prostate cancer: the STRIVE trial. J Clin Oncol 2016;34(18):2098–106. DOI: 10.1200/JCO.2015.64.9285. PMID: 26811535.
14. Hussain M., Fizazi K., Saad F. et al. Enzalutamide in men with nonmetastatic, castrate-resistant prostate cancer. N Engl J Med 2018;378:2465–74.
15. NCCN guidelines 2018. Available at: https://www.nccn.org/professionals/physi-cian_gls/default.aspx.
16. AUA guidelines 2018. Available at: https://www.auanet.org/guidelines/prostate-cancer-castration-resistant-(2013-amen-ded-2018).
Review
For citations:
Alekseev B.Ya. NEW TREATMENT STANDARD FOR PATIENTS WITH NON-METASTATIC CASTRATION-RESISTANT PROSTATE CANCER. Cancer Urology. 2018;14(3):68-77. (In Russ.) https://doi.org/10.17650/1726-9776-2018-14-3-68-77
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