Upfront Androgen Receptor-Axis-Targeted Therapies in Men with De Novo High-Volume Metastatic Hormone-Sensitive Prostate Cancer Upfront ARAT vs TAB
Vol. 20 (2023),
Purpose: The extent of effectiveness of upfront androgen receptor-axis-targeted therapies (ARAT) versus total androgen blockade (TAB) in improving prostate cancer-specific survival (CSS) and progression-free survival (PFS) in a real-world sample of Japanese patients with high-volume mHSPC remains unclear. We, therefore, investigated the efficacy and safety of upfront ARAT versus bicalutamide for de novo high-volume mHSPC in Japanese patients.
Material and Methods: This was a multicenter retrospective study that analyzed CSS, clinical PFS, and adverse events (AEs) in 170 patients with newly diagnosed high-volume mHSPC. Fifty-six patients were treated with upfront ARAT, and 114 of them were prescribed bicalutamide in addition to ADT between January 2018 and March 2021. The primary and secondary endpoints were CSS and PFS, respectively. A 1:1 nearest neighbor propensity score matching (PSM) with a caliper of 0.2 was performed to match the ARAT group to TAB patients.
Results: During the follow-up for a median of 21.5 months, the median CSS was not reached and 37 months in the upfront ARAT and total androgen blockade (TAB) groups, respectively (log-rank test: P=0.006) by propensity score matching (PSM). Moreover, while the PFS of ARAT was unreached, the median PFS of TAB was 9 months (log-rank test: P<0.001). Nine patients discontinued ARAT owing to grade ≥3 AEs; one patient who was treated with TAB had a grade 3 AE.
Conclusion: Upfront ARAT significantly prolonged the CSS and PFS of patients with high-volume mHSPC better than TAB, although ARAT was associated with a higher rate of grade ≥3 AEs. Upfront ARAT can be more beneficial for patients with de novo high-volume mHSPC than TAB.
- Upfront ARAT
- hormone sensitive
- prostate cancer
How to Cite
Fitzmaurice C, Akinyemiju TF, Al Lami FH, et al. Global, regional, and national cancer incidence, mortality, years of life lost, years lived with disability, and disability-adjusted life-years for 29 cancer groups, 1990-2016: A systematic analysis for the global burden of disease study. JAMA Oncol. 2018;4(11):1553-68.
Center for Cancer Control and Information Services. Cancer. Stat Interface Japan 2018;2019. Cited 29 Mar 2021 Available from URL: https://ganjoho.jp/public/qa_links/report/statistics/pdf/cancer_statistics_2019_fi g_E.pdf
Basiri A, Eshrati B, Zarehoroki A, Golshan S, et al. Incidence, Gleason Score and Ethnicity Pattern of Prostate Cancer in the Multi-ethnicity Country of Iran During 2008-2010. Urol J. 2020 May 4;17(6):602-6.
Kyriakopoulos CE, Chen YH, Carducci MA, 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 Apr 10;36(11):1080-7.
Fizazi K, Tran N, Fein L, et al. Abiraterone plus prednisone in metastatic, castration-sensitive prostate cancer. N. Engl. J. Med. 2017;377(4):352-60.
Davis ID, Martin AJ, Stockler MR, et al. ENZAMET Trial Investigators and the Australian and New Zealand Urogenital and Prostate Cancer Trials Group. Enzalutamide with Standard First-Line Therapy in Metastatic Prostate Cancer. N. Engl. J. Med. 2019 Jul 11;381(2):121-31.
Armstrong AJ, Szmulewitz RZ, Petrylak DP, 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 Nov 10;37(32):2974-86.
Chi KN, Agarwal N, Bjartell A, et al. TITAN Investigators. Apalutamide for metastatic, castration-sensitive prostate cancer. N. Engl. J. Med. 2019 Jul 4;381(1):13-24.
Sweeney CJ, Chen YH, Carducci M, et al. Chemohormonal therapy in metastatic hormone-sensitive prostate cancer. N. Engl. J. Med. 2015 Aug 20;373(8):737-46.
Naiki T, Takahara K, Ito T, et al. Comparison of clinical outcomes between androgen deprivation therapy with up-front abiraterone and bicalutamide for Japanese patients with LATITUDE high-risk prostate cancer in a real-world retrospective analysis. Int J Clin Oncol. 2022 Mar;27(3):592-601.
Yanagisawa T, Kimura T, Mori K, et al. Abiraterone acetate versus nonsteroidal antiandrogen with androgen deprivation therapy for high-risk metastatic hormone-sensitive prostate cancer. Prostate 2022 Jan;82(1):3-12.
Mottet N, Cornford P, Briers E, et al. European Association of Urology prostate cancer guidelines (2020) available from URL:https://uroweb.org/guideline/prostate-cancer/#5_2
Fukasawa S, Suzuki H, Kawaguchi K, et al. Efficacy and safety of abiraterone acetate plus prednisone in Japanese patients with newly diagnosed, metastatic hormone-naïve prostate cancer: A subgroup analysis of LATITUDE, a randomized, double-blind, placebo-controlled, Phase 3 study. Jpn. J. Clin. Oncol. 2018 Nov 1;48(11):1012-21.
Iguchi T, Kimura G, Fukasawa S, Suzuki H, et al. Enzalutamide with androgen deprivation therapy in Japanese men with metastatic hormone-sensitive prostate cancer: A subgroup analysis of the phase III ARCHES study. Int. J. Urol. 2021 Jul;28(7):765-73.
Uemura H, Arai G, Uemura H, et al. Apalutamide for metastatic, castration-sensitive prostate cancer in the Japanese population: A subgroup analysis of the randomized, double-blind, placebo-controlled phase 3 Titan study. Int. J. Urol. 2021 Mar;28(3):280-7.
Hussain M, Tangen CM, Higano C, et al. Southwest Oncology Group Trial 9346 (INT-0162). Absolute prostate-specific antigen value after androgen deprivation is a strong independent predictor of survival in new metastatic prostate cancer: Data from Southwest Oncology Group Trial 9346 (INT-0162). J Clin Oncol 2006;24(24):3984-90.
Zhang LM, Jiang HW, Tong SJ, et al. Prostate-specific antigen kinetics under androgen deprivation therapy and prostate cancer prognosis. Urol Int 2013;91(1):38-48.
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