Apalutamide for patients with metastatic castrationsensitive prostate cancer in East Asia: a subgroup analysis of the TITAN trial.

Byung Ha Chung; Jian Huang; Zhang-qun YE; Da-lin HE; Hirotsugu Uemura; Gaku Arai; Choung Soo Kim; Yuan-yuan Zhang; Yusoke Koroki; Suyeon Jeong; Suneel Mundle; Spyros Triantos; Sharon Mccarthy; Kim N Chi; Ding-wei YE

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Apalutamide for patients with metastatic castrationsensitive prostate cancer in East Asia: a subgroup analysis of the TITAN trial.

Author: Byung Ha CHUNG ¹ ; Jian HUANG ² ; Zhang-Qun YE ³ ; Da-Lin HE ⁴ ; Hirotsugu UEMURA ⁵ ; Gaku ARAI ⁶ ; Choung Soo KIM ⁷ ; Yuan-Yuan ZHANG ⁸ ; Yusoke KOROKI ⁹ ; SuYeon JEONG ¹⁰ ; Suneel MUNDLE ¹¹ ; Spyros TRIANTOS ¹² ; Sharon MCCARTHY ¹³ ; Kim N CHI ¹⁴ ; Ding-Wei YE ¹⁵
Author Information

1. Department of Urology, Gangnam Severance Hospital, Yonsei University College of Medicine, 211 Eonju-ro, Gangnam-gu, Seoul 135-271, Korea.
2. Sun Yat-Sen Memorial Hospital, Sun Yat-sen University, Guangzhou 510120, China.
3. Wuhan Tongji Hospital, Tongji Medical College, Wuhan 430030, China.
4. First Affiliated Hospital of Xi'an Jiaotong University, Xi'an 719054, China.
5. Kindai University Hospital, Ōsakasayama 589-8511, Japan.
6. Dokkyo Medical University Saitama Medical Center, Saitama 2-1-50, Japan.
7. Asian Medical Center, University of Ulsan, Seoul 138-040, Korea.
8. Janssen Medical Affairs Department, Beijing 100025, China.
9. Janssen Medical Affairs Department, Tokyo 101-0065, Japan.
10. Janssen Medical Affairs Department, Seoul 140-012, Korea.
11. Janssen Global Medical Affairs Department, Horsham, PA 08869, USA.
12. Janssen Research and Development, Spring House, PA 19477, USA.
13. Janssen Research and Development, Raritan, NJ 08869, USA.
14. BC Cancer and Vancouver Prostate Centre, Vancouver, BC V5Z 1G1, Canada.
15. Fudan University Shanghai Cancer Center, Shanghai 200032, China.
Publication Type:Multicenter Study
Keywords: East Asia; apalutamide; metastasis; prostatic neoplasm; survival
MeSH: Androgen Antagonists/adverse effects*; Exanthema/chemically induced*; Far East; Humans; Male; Prostate-Specific Antigen; Prostatic Neoplasms, Castration-Resistant/pathology*; Thiohydantoins/adverse effects*
From: Asian Journal of Andrology 2022;24(2):161-166
CountryChina
Language:English
Abstract: Ethnicity might be associated with treatment outcomes in advanced prostate cancer. This study aimed to evaluate the efficacy and safety of androgen deprivation therapy (ADT) combined with apalutamide in East Asians with metastatic castration-sensitive prostate cancer (mCSPC). The original phase 3 Targeted Investigational Treatment Analysis of Novel Anti-androgen (TITAN) trial was conducted at 260 sites in 23 countries. This subgroup analysis included patients enrolled in 62 participating centers in China, Japan, and Korea. Radiographic progression-free survival (PFS), time to prostate-specific antigen (PSA) progression, and PSA changes from baseline were compared between groups in the East Asian population. The intent-to-treat East Asian population included 111 and 110 participants in the apalutamide and placebo groups, respectively. The 24-month radiographic PFS rates were 76.1% and 52.3% in the apalutamide and placebo groups, respectively (apalutamide vs placebo: hazard ratio [HR] = 0.506; 95% confidence interval [CI], 0.302-0.849; P = 0.009). Median time to PSA progression was more favorable with apalutamide than placebo (HR = 0.210; 95% CI, 0.124-0.357; P < 0.001). Median maximum percentages of PSA decline from baseline were 99.0% and 73.9% in the apalutamide and placebo groups, respectively. The most common adverse event (AE) was rash in the apalutamide group, with a higher rate than that in the placebo group (37.3% vs 9.1%). The most common grade 3 or 4 AEs were rash (12 [10.9%]) and hypertension (12 [10.9%]) for apalutamide. The efficacy and safety of apalutamide in the East Asian subgroup of the TITAN trial are consistent with the global results.