Preview

Meditsinskiy sovet = Medical Council

Advanced search

Efficacy of enzalutamide in patients with metastatic hormone-sensitive and castration-refractory prostate cancer: authors’ experience

https://doi.org/10.21518/2079-701X-2021-20-130-136

Abstract

Prostate cancer is one of the most common neoplasms in men. It currently ranks second in Russian Federation amongst male population in overall number of cases after only lung cancer and third in cancer mortality. Prostate cancer is rarely diagnosed in patients younger than 40 years old, with overage age of diagnosis being between 50 and 70 years. A lot of different new treatment options were developed in the last decade for patients with metastatic prostate cancer (mPC). Despite androgen-deprivation remaining the standard of therapy, it has been proven that the addition of cytotoxic and hormonal drugs of new generation improves overall survival of patients with castration-sensitive and castration-resistant metastatic disease. Recently, enzalutamide became the new standard of care not only in castration-resistant mPC, but also in the setting of metastatic castration-sensitive prostate cancer, due to the data acquired in two large randomized trials ARCHES and ENZAMET. This article provides clinical examples demonstrating the effectiveness of enzalutamide in various forms of prostate cancer. In the first clinical case enzalutamide was used in the treatment of castration-sensitive mPC. Currently, patient continues to receive this therapy with progression-free interval exceeding 11  months. In  the  second clinical case, enzalutamide has shown its efficacy in  the  setting of  castration-resistant PC. Stable disease was achieved and as of  right now patient has shown no signs of  progression for 9 months, which is already a significantly better result in comparison with previous lines of treatment. 

About the Authors

T. V. Ustinova
Hertzen Moscow Oncology Research Institute – branch of the National Medical Research Center of Radiology
Russian Federation

Oncologist, Department of Chemotherapy, Department of Drug Treatment of Tumors, 

3, 2nd Botkinskiy Proezd, Moscow, 125284



L. V. Bolotina
Hertzen Moscow Oncology Research Institute – branch of the National Medical Research Center of Radiology
Russian Federation

Dr. Sci. (Med.), Head of the Department of Chemotherapy, Department of Drug Treatment of Tumors, 

3, 2nd Botkinskiy Proezd, Moscow, 125284



A. A. Paichadze
Hertzen Moscow Oncology Research Institute – branch of the National Medical Research Center of Radiology
Russian Federation

Cand. Sci. (Med.), Researcher, Chemotherapy Department, Department of Tumor Drug Treatment, 

3, 2nd Botkinskiy Proezd, Moscow, 125284



A. A. Kachmazov
Hertzen Moscow Oncology Research Institute – branch of the National Medical Research Center of Radiology
Russian Federation

Junior Researcher, Department of Chemotherapy, Department of Drug Treatment of Tumors, 

3, 2nd Botkinskiy Proezd, Moscow, 125284



A. A. Fedenko
Hertzen Moscow Oncology Research Institute – branch of the National Medical Research Center of Radiology
Russian Federation

Dr. Sci. (Med.), Head of the Department of Tumor Drug Treatment, 

3, 2nd Botkinskiy Proezd, Moscow, 125284



A. D. Kaprin
Hertzen Moscow Oncology Research Institute – branch of the National Medical Research Center of Radiology
Russian Federation

Acad. RAS, Professor, General Director, 

3, 2nd Botkinskiy Proezd, Moscow, 125284



References

1. Kaprin A.D., Starinskiy V.V., Shahzadova A.O. Malignant neoplasms in Russia in 2019 (morbidity and mortality). Moscow: Hertsen Moscow Oncology Research Institute – Branch of the National Medical Research Radiological Center; 2020. 252 p. (In Russ.).

2. Tannock I.F., Osoba D., Stockler M.R., Ernst D.S., Neville A.J., Moore M.J. et al. Chemotherapy with mitoxantrone plus prednisone or prednisone alone for symptomatic hormone-resistant prostate cancer: a Canadian randomized trial with palliative end points. J Clin Oncol. 1996;14(6):1756–1764. https://doi.org/10.1200/jco.1996.14.6.1756.

3. Sweeney C.J., Monaco F.J., Jung S.H., Wasielewski M.J., Picus J., Ansari R.H. et al. A phase II Hoosier Oncology Group study of vinorelbine and estramustine phosphate in hormone-refractory prostate cancer. Ann Oncol. 2002;13(3):435–440. https://doi.org/10.1093/annonc/mdf029.

4. Nakabayashi M., Ling J., Xie W., Regan M.M., Oh W.K. Response to vinorelbine with or without estramustine as second-line chemotherapy in patients with hormone-refractory prostate cancer. Cancer J. 2007;13(2):125–129. https://doi.org/10.1097/PPO.0b013e3180465940.

5. Tannock I.F., de Wit R., Berry W.R., Horti J., Pluzanska A., Chi K.N. et al. Docetaxel plus prednisone or mitoxantrone plus prednisone for advanced prostate cancer. N Engl J Med. 2004;351(15):1502–1512. https://doi.org/10.1056/NEJMoa040720.

6. Petrylak D.P., Tangen C.M., Hussain M.H., Lara P.N. Jr, Jones J.A., Taplin M.E. et al. Docetaxel and estramustine compared with mitoxantrone and prednisone for advanced refractory prostate cancer. N Engl J Med. 2004;351(15):1513–1520. https://doi.org/10.1056/NEJMoa041318.

7. Ryan C.J., Smith M.R., de Bono J.S., Molina A., Logothetis C.J., de Souza P. et al. Abiraterone in metastatic prostate cancer without previous chemotherapy. N Engl J Med. 2013;368(2):138–148. https://doi.org/10.1056/NEJMoa1209096.

8. Beer T.M., Armstrong A.J., Rathkopf D.E., Loriot Y., Sternberg C.N., Higano C.S. et al. Enzalutamide in metastatic prostate cancer before chemotherapy. N Engl J Med. 2014;371(5):424–433. https://doi.org/10.1056/NEJMoa1405095.

9. Scher H.I., Fizazi K., Saad F., Taplin M.E., Sternberg C.N., Miller K. et al. Increased survival with enzalutamide in prostate cancer after chemotherapy. N Engl J Med. 2012;367(13):1187–197. https://doi.org/10.1056/NEJMoa1207506.

10. Fizazi K., Scher H.I., Molina A., Logothetis C.J., Chi K.N., Jones R.J. et al. Abiraterone acetate for treatment of metastatic castration-resistant prostate cancer: final overall survival analysis of the COU-AA-301 randomised, double-blind, placebo-controlled phase 3 study. Lancet Oncol. 2012;13(10):983–992. https://doi.org/10.1016/S1470-2045(12)70379-0.

11. Kyriakopoulos C.E., Chen Y.H., Carducci M.A., Liu G., Jarrard D.F., Hahn N.M. et al. Chemohormonal Therapy in Metastatic Hormone-Sensitive Prostate Cancer: Long-Term Survival Analysis of the Randomized Phase III E3805 CHAARTED Trial. J Clin Oncol. 2018;36(11):1080–1087. https://doi.org/10.1200/JCO.2017.75.3657.

12. James N.D., Sydes M.R., Clarke N.W., Mason M.D., Dearnaley D.P., Spears M.R. et al. Addition of docetaxel, zoledronic acid, or both to first-line long-term hormone therapy in prostate cancer (STAMPEDE): survival results from an adaptive, multiarm, multistage, platform randomised controlled trial. Lancet. 2016;387(10024):1163–1177. https://doi.org/10.1016/S0140-6736(15)01037-5.

13. Gravis G., Fizazi K., Joly F., Oudard S., Priou F., Esterni B. et al. Androgendeprivation therapy alone or with docetaxel in non-castrate metastatic prostate cancer (GETUG-AFU 15): a randomised, open-label, phase 3 trial. Lancet Oncol. 2013;14(2):149–158. https://doi.org/10.1016/S1470-2045(12)70560-0.

14. Gravis G., Boher J.M., Joly F., Soulié M., Albiges L., Priou F. et al. Androgen Deprivation Therapy (ADT) Plus Docetaxel Versus ADT Alone in Metastatic Non castrate Prostate Cancer: Impact of Metastatic Burden and Long-term Survival Analysis of the Randomized Phase 3 GETUG-AFU15 Trial. Eur Urol. 2016;70(2):256–262. https://doi.org/10.1016/j.eururo.2015.11.005.

15. Fizazi K., Tran N., Fein L., Matsubara N., Rodriguez-Antolin A., Alekseev B.Y. et al. Abiraterone acetate plus prednisone in patients with newly diagnosed high-risk metastatic castration-sensitive prostate cancer (LATITUDE): final overall survival analysis of a randomised, double-blind, phase 3 trial. Lancet Oncol. 2019;20(5):686–700. https://doi.org/10.1016/S1470-2045(19)30082-8.

16. James N.D., de Bono J.S., Spears M.R., Clarke N.W., Mason M.D., Dearnaley D.P. et al. Abiraterone for Prostate Cancer Not Previously Treated with Hormone Therapy. N Engl J Med. 2017;377(4):338–351. https://doi.org/10.1056/NEJMoa1702900.

17. Beer T.M., Armstrong A.J., Rathkopf D.E., Loriot Y., Sternberg C.N., Higano C.S. et al. Enzalutamide in metastatic prostate cancer before chemotherapy. N Engl J Med. 2014;371(5):424–433. https://doi.org/10.1056/NEJMoa1405095.

18. Scher H.I., Fizazi K., Saad F., Taplin M.E., Sternberg C.N., Miller K. et al. Increased survival with enzalutamide in prostate cancer after chemotherapy. N Engl J Med. 2012;367(13):1187–1197. https://doi.org/10.1056/NEJMoa1207506.

19. Hussain M., Fizazi K., Saad F., Rathenborg P., Shore N., Ferreira U. et al. Enzalutamide in Men with Nonmetastatic, Castration-Resistant Prostate Cancer. N Engl J Med. 2018;378(26):2465–2474. https://doi.org/10.1056/NEJMoa1800536.

20. Armstrong A.J., Szmulewitz R.Z., Petrylak D.P., Holzbeierlein J., Villers A., Azad A. et al. ARCHES: A Randomized, Phase III Study of Androgen Deprivation Therapy With Enzalutamide or Placebo in Men With Metastatic Hormone-Sensitive Prostate Cancer. J Clin Oncol. 2019;37(32):2974–2986. https://doi.org/10.1200/JCO.19.00799.

21. Armstrong A.J., Iguchi T., Azad A.A., Szmulewitz R.Z., Holzbeierlein J., Villers A. et al. LBA25 – Final overall survival (OS) analysis from ARCHES: A phase III, randomized, double-blind, placebo (PBO)-controlled study of enzalutamide (ENZA) + androgen deprivation therapy (ADT) in men with metastatic hormone-sensitive prostate cancer (mHSPC). Ann Oncol. 2021;32(5 Suppl.): S1300–S1301. https://doi.org/10.1016/j.annonc.2021.08.2101.

22. Davis I.D., Martin A.J., Stockler M.R., Begbie S., Chi K.N., Chowdhury S. et al. Enzalutamide with Standard First-Line Therapy in Metastatic Prostate Cancer. N Engl J Med. 2019;381(2):121–131. https://doi.org/10.1056/NEJMoa1903835.

23. Nosov D.A., Volkova M.I., Gladkov O.A., Karabina E.V., Krylov V.V., Matveev V.B. et al. Practical guidelines for the treatment of prostate cancer. Zlokachestvennyye opukholi = Malignant Tumors. 2020;10(3s2–1):556–572. (In Russ.) https://doi.org/10.18027/2224-5057-2020-10-3s2-33.

24. Fizazi K., Scher H.I., Miller K., Basch E., Sternberg C.N., Cella D. et al. Effect of enzalutamide on time to first skeletal-related event, pain, and quality of life in men with castration-resistant prostate cancer: results from the randomised, phase 3 AFFIRM trial. Lancet Oncol. 2014;15(10):1147–1156. https://doi.org/10.1016/S1470-2045(14)70303-1.


Review

For citations:


Ustinova TV, Bolotina LV, Paichadze AA, Kachmazov AA, Fedenko AA, Kaprin AD. Efficacy of enzalutamide in patients with metastatic hormone-sensitive and castration-refractory prostate cancer: authors’ experience. Meditsinskiy sovet = Medical Council. 2021;(20):130-136. (In Russ.) https://doi.org/10.21518/2079-701X-2021-20-130-136

Views: 596


Creative Commons License
This work is licensed under a Creative Commons Attribution 4.0 License.


ISSN 2079-701X (Print)
ISSN 2658-5790 (Online)