Role of enzalutamide in primary and recurrent non-metastatic hormone sensitive prostate cancer: a systematic review of prospective clinical trials.
Journal
Prostate cancer and prostatic diseases
ISSN: 1476-5608
Titre abrégé: Prostate Cancer Prostatic Dis
Pays: England
ID NLM: 9815755
Informations de publication
Date de publication:
08 Apr 2024
08 Apr 2024
Historique:
received:
19
12
2023
accepted:
03
04
2024
revised:
27
03
2024
medline:
9
4
2024
pubmed:
9
4
2024
entrez:
8
4
2024
Statut:
aheadofprint
Résumé
Enzalutamide, a second-generation androgen receptor inhibitor, is indicated for the treatment of metastatic disease, as well as in the treatment of non-metastatic castration resistant prostate cancer (PCa). This systematic review aims to determine outcomes and toxicity in patients with non-metastatic castration sensitive prostate cancer (nmCSPC) treated with enzalutamide in the primary or salvage settings. We performed a systematic review focusing on the role of Enzalutamide in the treatment of nmCSPC, using the PubMed/Medline database. Articles focusing on androgen receptor inhibitors in nmCSPC were included, while articles discussing exclusively metastatic or castration-resistant PCa were excluded. The initial search retrieved 401 articles, of which 15 underwent a thorough assessment for relevance. Ultimately, 12 studies with pertinent outcomes were meticulously examined. Among these, seven studies were dedicated to the investigation of enzalutamide in the primary setting, while the remaining five publications specifically addressed its use in salvage settings. Regardless of the treatment setting, our data revealed two distinct therapeutic strategies. The first advocates for the substitution of enzalutamide for androgen deprivation therapy (ADT), based on the premise of achieving equivalent, if not superior, oncological outcomes while minimizing treatment-related toxicity. The second, adopting a more conventional approach, entails augmenting the effectiveness of ADT by incorporating enzalutamide. Enzalutamide has considerable potential as a therapeutic strategy for nmCSPC, either used alone or in combination with ADT in the primary or in the salvage settings. The use of enzalutamide instead of ADT is an appealing strategy. However, more trials will be required to further understand the efficacy and side-effect profile of enzalutamide monotherapy.
Identifiants
pubmed: 38589645
doi: 10.1038/s41391-024-00829-9
pii: 10.1038/s41391-024-00829-9
doi:
Types de publication
Journal Article
Review
Langues
eng
Sous-ensembles de citation
IM
Informations de copyright
© 2024. The Author(s).
Références
Carioli G, Bertuccio P, Boffetta P, Levi F, La Vecchia C, Negri E, et al. European cancer mortality predictions for the year 2020 with a focus on prostate cancer. Ann Oncol. 2020;31:650–8.
pubmed: 32321669
doi: 10.1016/j.annonc.2020.02.009
Hamid AA, Sayegh N, Tombal B, Hussain M, Sweeney CJ, Graff JN, et al. Metastatic hormone-sensitive prostate cancer: toward an era of adaptive and personalized treatment. Am Soc Clin Oncol Educ Book. 2023;43:e390166.
pubmed: 37220335
doi: 10.1200/EDBK_390166
Ferretti S, Mercinelli C, Marandino L, Litterio G, Marchioni M, Schips L. Metastatic castration-resistant prostate cancer: insights on current therapy and promising experimental drugs. Res Rep Urol. 2023;15:243–59.
pubmed: 37396015
pmcid: 10312338
Berruti A, Bracarda S, Caffo O, Cortesi E, D’Angelillo R, Del Re M, et al. nmCRPC, a look in the continuous care of prostate cancer patients: state of art and future perspectives. Cancer Treat Rev. 2023;115:102525.
pubmed: 36822009
doi: 10.1016/j.ctrv.2023.102525
Scher HI, Fizazi K, Saad F, Taplin ME, Sternberg CN, Miller K, et al. Increased survival with enzalutamide in prostate cancer after chemotherapy. N Engl J Med. 2012;367:1187–97.
pubmed: 22894553
doi: 10.1056/NEJMoa1207506
Beer TM, Armstrong AJ, Rathkopf DE, Loriot Y, Sternberg CN, Higano CS, et al. Enzalutamide in metastatic prostate cancer before chemotherapy. N Engl J Med. 2014;371:424–33.
pubmed: 24881730
pmcid: 4418931
doi: 10.1056/NEJMoa1405095
Sternberg CN, Fizazi K, Saad F, Shore ND, De Giorgi U, Penson DF, et al. Enzalutamide and survival in nonmetastatic, castration-resistant prostate cancer. N Engl J Med. 2020;382:2197–206.
pubmed: 32469184
doi: 10.1056/NEJMoa2003892
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;378:2465–74.
pubmed: 29949494
pmcid: 8288034
doi: 10.1056/NEJMoa1800536
Armstrong AJ, Szmulewitz RZ, Petrylak DP, 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;37:2974–86.
pubmed: 31329516
pmcid: 6839905
doi: 10.1200/JCO.19.00799
Sweeney CJ, Martin AJ, Stockler MR, Begbie S, Cheung L, Chi KN, et al. Testosterone suppression plus enzalutamide versus testosterone suppression plus standard antiandrogen therapy for metastatic hormone-sensitive prostate cancer (ENZAMET): an international, open-label, randomised, phase 3 trial. Lancet Oncol. 2023;24:323–34.
pubmed: 36990608
doi: 10.1016/S1470-2045(23)00063-3
Page MJ, McKenzie JE, Bossuyt PM, Boutron I, Hoffmann TC, Mulrow CD, et al. The PRISMA 2020 statement: an updated guideline for reporting systematic reviews. Bmj. 2021;372:n71.
pubmed: 33782057
pmcid: 8005924
doi: 10.1136/bmj.n71
Freedland SJ, de Almeida Luz M, De Giorgi U, Gleave M, Gotto GT, Pieczonka CM, et al. Improved outcomes with enzalutamide in biochemically recurrent prostate cancer. N Engl J Med. 2023;389:1453–65.
pubmed: 37851874
doi: 10.1056/NEJMoa2303974
Attard G, Murphy L, Clarke NW, Cross W, Jones RJ, Parker CC, et al. Abiraterone acetate and prednisolone with or without enzalutamide for high-risk non-metastatic prostate cancer: a meta-analysis of primary results from two randomised controlled phase 3 trials of the STAMPEDE platform protocol. Lancet. 2022;399:447–60.
pubmed: 34953525
pmcid: 8811484
doi: 10.1016/S0140-6736(21)02437-5
Kaplan I, Bubley GJ, Bhatt RS, Taplin ME, Dowling S, Mahoney K, et al. Enzalutamide with radiation therapy for intermediate-risk prostate cancer: a phase 2 study. Int J Radiat Oncol Biol Phys. 2021;110:1416–22.
pubmed: 33636278
doi: 10.1016/j.ijrobp.2021.02.027
Lara PC, Rodríguez-Melcón JI, Palacios-Eito A, Lozano A, Hervás-Morón A, Villafranca E, et al. Phase II study of ENZAlutamide combined with hypofractionated radiation therapy (ENZART) for localized intermediate risk prostate cancer. Front Oncol. 2022;12:891886.
pubmed: 35912190
pmcid: 9329530
doi: 10.3389/fonc.2022.891886
McKay RR, Ye H, Xie W, Lis R, Calagua C, Zhang Z, et al. Evaluation of intense androgen deprivation before prostatectomy: a randomized phase II trial of enzalutamide and leuprolide with or without abiraterone. J Clin Oncol. 2019;37:923–31.
pubmed: 30811282
pmcid: 7051849
doi: 10.1200/JCO.18.01777
Montgomery B, Tretiakova MS, Joshua AM, Gleave ME, Fleshner N, Bubley GJ, et al. Neoadjuvant enzalutamide prior to prostatectomy. Clin Cancer Res. 2017;23:2169–76.
pubmed: 28151719
doi: 10.1158/1078-0432.CCR-16-1357
Shee K, de la Calle CM, Chang AJ, Wong AC, Feng FY, Gottschalk AR, et al. Addition of enzalutamide to leuprolide and definitive radiation therapy is tolerable and effective in high-risk localized or regional nonmetastatic prostate cancer: results from a phase 2 trial. Adv Radiat Oncol. 2022;7:100941.
pubmed: 35847550
pmcid: 9280039
doi: 10.1016/j.adro.2022.100941
Shore ND, Renzulli J, Fleshner NE, Hollowell CMP, Vourganti S, Silberstein J, et al. Enzalutamide monotherapy vs active surveillance in patients with low-risk or intermediate-risk localized prostate cancer: the ENACT randomized clinical trial. JAMA Oncol. 2022;8:1128–36.
pubmed: 35708696
pmcid: 9204619
doi: 10.1001/jamaoncol.2022.1641
Bitting RL, Healy P, George DJ, Anand M, Kim S, Mayer T, et al. Phase II trial of enzalutamide and androgen deprivation therapy with salvage radiation in men with high-risk prostate-specific antigen recurrent prostate cancer: the STREAM trial. Eur Urol Oncol. 2021;4:948–54.
pubmed: 32063492
doi: 10.1016/j.euo.2020.01.005
Madan RA, Karzai F, Donahue RN, Al-Harthy M, Bilusic M, Rosner II, et al. Clinical and immunologic impact of short-course enzalutamide alone and with immunotherapy in non-metastatic castration sensitive prostate cancer. J Immunother Cancer. 2021;9:e001556.
Tombal B, Borre M, Rathenborg P, Werbrouck P, Van Poppel H, Heidenreich A, et al. Long-term antitumor activity and safety of enzalutamide monotherapy in hormone Naïve prostate cancer: 3-year open label followup results. J Urol. 2018;199:459–64.
pubmed: 28867562
doi: 10.1016/j.juro.2017.08.103
Tran PT, Lowe K, Tsai HL, Song DY, Hung AY, Hearn JWD, et al. Phase II randomized study of salvage radiation therapy plus enzalutamide or placebo for high-risk prostate-specific antigen recurrent prostate cancer after radical prostatectomy: the SALV-ENZA trial. J Clin Oncol. 2023;41:1307–17.
pubmed: 36367998
doi: 10.1200/JCO.22.01662
Mottet NCP, van den Bergh RCN, et al. EAU guidelines 2023 [Available from: https://uroweb.org/guidelines/prostate-cancer/chapter/treatment .
Gómez Rivas J, Gandaglia G, Montorsi F. Re: Neal D. Shore, Joseph Renzulli, N E. Fleshner, et al. Active Surveillance plus Enzalutamide Monotherapy vs Active Surveillance Alone in Patients with Low-risk or Intermediate-risk Localized Prostate Cancer: The ENACT Randomized Clinical Trial. JAMA Oncol 2022;8:1128-36: Let’s Not Go Back in Time! What Have We Learned in the Treatment of Localized Prostate Cancer? Applicability of the ENACT Randomized Clinical Trial in Clinical Practice. Eur Urol Open Sci. 2022;46:135–6.
pubmed: 36405303
pmcid: 9672367
doi: 10.1016/j.euros.2022.09.022
Stephenson AJ, Kattan MW, Eastham JA, Bianco FJ Jr, Yossepowitch O, Vickers AJ, et al. Prostate cancer-specific mortality after radical prostatectomy for patients treated in the prostate-specific antigen era. J Clin Oncol. 2009;27:4300–5.
pubmed: 19636023
pmcid: 3651598
doi: 10.1200/JCO.2008.18.2501
Liu W, Yao Y, Liu X, Liu Y, Zhang GM. Neoadjuvant hormone therapy for patients with high-risk prostate cancer: a systematic review and meta-analysis. Asian J Androl. 2021;23:429–36.
pubmed: 33586699
pmcid: 8269824
doi: 10.4103/aja.aja_96_20
Kumar S, Shelley M, Harrison C, Coles B, Wilt TJ, Mason MD. Neo-adjuvant and adjuvant hormone therapy for localised and locally advanced prostate cancer. Cochrane Database Syst Rev. 2006;2006:Cd006019.
pubmed: 17054269
pmcid: 8996243
Krauss DJ, Karrison T, Martinez AA, Morton G, Yan D, Bruner DW, et al. Dose-escalated radiotherapy alone or in combination with short-term androgen deprivation for intermediate-risk prostate cancer: results of a phase III multi-institutional trial. J Clin Oncol. 2023;41:3203–16.
pubmed: 37104748
doi: 10.1200/JCO.22.02390
Bolla M, Maingon P, Carrie C, Villa S, Kitsios P, Poortmans PM, et al. Short androgen suppression and radiation dose escalation for intermediate- and high-risk localized prostate cancer: results of EORTC trial 22991. J Clin Oncol. 2016;34:1748–56.
pubmed: 26976418
doi: 10.1200/JCO.2015.64.8055
Jones CU, Hunt D, McGowan DG, Amin MB, Chetner MP, Bruner DW, et al. Radiotherapy and short-term androgen deprivation for localized prostate cancer. N Engl J Med. 2011;365:107–18.
pubmed: 21751904
doi: 10.1056/NEJMoa1012348
Taylor LG, Canfield SE, Du XL. Review of major adverse effects of androgen-deprivation therapy in men with prostate cancer. Cancer. 2009;115:2388–99.
pubmed: 19399748
doi: 10.1002/cncr.24283
Roy S, Romero T, Michalski JM, Feng FY, Efstathiou JA, Lawton CAF, et al. Biochemical recurrence surrogacy for clinical outcomes after radiotherapy for adenocarcinoma of the prostate. J Clin Oncol. 2023;41:5005–14.
pubmed: 37639648
pmcid: 10642893
doi: 10.1200/JCO.23.00617
Tree A, Griffin C, Syndikus I, Birtle A, Choudhury A, Graham J, et al. Nonrandomized Comparison of Efficacy and Side Effects of Bicalutamide Compared With Luteinizing Hormone-Releasing Hormone (LHRH) analogs in combination with radiation therapy in the CHHiP trial. Int J Radiat Oncol Biol Phys. 2022;113:305–15.
pubmed: 35017008
pmcid: 9119688
doi: 10.1016/j.ijrobp.2021.12.160
Schmidt-Hegemann N-S, Zamboglou C, Mason M, Mottet N, Hinnen K, De Meerleer G, et al. ESTRO-ACROP recommendations for evidence-based use of androgen deprivation therapy in combination with external-beam radiotherapy in prostate cancer. Radiother Oncol. 2023;183:109544.
pubmed: 36813168
doi: 10.1016/j.radonc.2023.109544
Pollack A, Karrison TG, Balogh AG, Gomella LG, Low DA, Bruner DW, et al. The addition of androgen deprivation therapy and pelvic lymph node treatment to prostate bed salvage radiotherapy (NRG Oncology/RTOG 0534 SPPORT): an international, multicentre, randomised phase 3 trial. Lancet. 2022;399:1886–901.
pubmed: 35569466
pmcid: 9819649
doi: 10.1016/S0140-6736(21)01790-6
Carrie C, Magne N, Burban-Provost P, Sargos P, Latorzeff I, Lagrange JL, et al. Short-term androgen deprivation therapy combined with radiotherapy as salvage treatment after radical prostatectomy for prostate cancer (GETUG-AFU 16): a 112-month follow-up of a phase 3, randomised trial. Lancet Oncol. 2019;20:1740–9.
pubmed: 31629656
doi: 10.1016/S1470-2045(19)30486-3
Parker CC, Clarke N, Cook A, Catton C, Cross WR, Kynaston H, et al. LBA9 Duration of androgen deprivation therapy (ADT) with post-operative radiotherapy (RT) for prostate cancer: first results of the RADICALS-HD trial (ISRCTN40814031). Ann Oncol. 2022;33:S1427.
doi: 10.1016/j.annonc.2022.08.064
Burdett S, Fisher D, Parker CC, Sydes MR, Pommier P, Sargos P, et al. LBA64 Duration of androgen suppression with post-operative radiotherapy (DADSPORT): A collaborative meta-analysis of aggregate data. Ann Oncol. 2022;33:S1428–S9.
doi: 10.1016/j.annonc.2022.08.067
Dess RT, Sun Y, Jackson WC, Jairath NK, Kishan AU, Wallington DG, et al. Association of presalvage radiotherapy PSA levels after prostatectomy with outcomes of long-term antiandrogen therapy in men with prostate cancer. JAMA Oncol. 2020;6:735–43.
pubmed: 32215583
doi: 10.1001/jamaoncol.2020.0109
Shipley WU, Seiferheld W, Lukka HR, Major PP, Heney NM, Grignon DJ, et al. Radiation with or without antiandrogen therapy in recurrent prostate cancer. N Engl J Med. 2017;376:417–28.
pubmed: 28146658
pmcid: 5444881
doi: 10.1056/NEJMoa1607529
Tombal B, Borre M, Rathenborg P, Werbrouck P, Van Poppel H, Heidenreich A, et al. Long-term efficacy and safety of enzalutamide monotherapy in hormone-naïve prostate cancer: 1- and 2-year open-label follow-up results. Eur Urol. 2015;68:787–94.
pubmed: 25687533
doi: 10.1016/j.eururo.2015.01.027
Tombal B, Borre M, Rathenborg P, Werbrouck P, Van Poppel H, Heidenreich A, et al. Enzalutamide monotherapy in hormone-naive prostate cancer: primary analysis of an open-label, single-arm, phase 2 study. Lancet Oncol. 2014;15:592–600.
pubmed: 24739897
doi: 10.1016/S1470-2045(14)70129-9
Freedland SJ, De Giorgi U, Gleave M, Rosbrook B, Shen Q, Sugg J, et al. A phase 3 randomised study of enzalutamide plus leuprolide and enzalutamide monotherapy in high-risk non-metastatic hormone-sensitive prostate cancer with rising PSA after local therapy: EMBARK study design. BMJ Open. 2021;11:e046588.
pubmed: 34385241
pmcid: 8362713
doi: 10.1136/bmjopen-2020-046588
Eissa A, Elsherbiny A, Coelho RF, Rassweiler J, Davis JW, Porpiglia F, et al. The role of 68Ga-PSMA PET/CT scan in biochemical recurrence after primary treatment for prostate cancer: a systematic review of the literature. Minerva Urol Nefrol. 2018;70:462–78.
pubmed: 29664244
doi: 10.23736/S0393-2249.18.03081-3