Home  |   Archive  |   Online Submission  |   News & Events  |   Subscribe  |   APFA  |   Society  |   Contact Us  |   中文版
Search   
 
Journal

Ahead of print
Authors' Accepted
    Manuscripts
new!
Current Issue
Archive
Acknowledgments
Special Issues
Browse by Category

Manuscript Submission

Online Submission
Online Review
Instruction for Authors
Instruction for Reviewers
English Corner new!

About AJA

About AJA
Editorial Board
Contact Us
News

Resources & Services

Advertisement
Subscription
Email alert
Proceedings
Reprints

Download area

Copyright licence
EndNote style file
Manuscript word template
Guidance for AJA figures
    preparation (in English)

Guidance for AJA figures
    preparation (in Chinese)

Proof-reading for the
    authors

AJA Club (in English)
AJA Club (in Chinese)

 
Abstract

Volume 24, Issue 2 (March 2022) 24, 161–166; 10.4103/aja.aja_64_21

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

Byung Ha Chung1, Jian Huang2, Zhang-Qun Ye3, Da-Lin He4, Hirotsugu Uemura5, Gaku Arai6, Choung Soo Kim7, Yuan-Yuan Zhang8, Yusoke Koroki9, SuYeon Jeong10, Suneel Mundle11, Spyros Triantos12, Sharon McCarthy13, Kim N Chi14, Ding-Wei Ye15

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

Correspondence: Dr. DW Ye (dwyeli@163.com)

Date of Submission 12-Jan-2021 Date of Acceptance 24-May-2021 Date of Web Publication 13-Jul-2021

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.

Keywords: apalutamide; East Asia; metastasis; prostatic neoplasm; survival

Full Text | PDF |

 
Browse:  601
 
Asian Journal of Andrology CN 31-1795/R ISSN 1008-682X  Copyright © 2023  Shanghai Materia Medica, Chinese Academy of Sciences.  All rights reserved.