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Volume 25, Issue 6 (November 2023) 25, 653–661; 10.4103/aja202320
Apalutamide for metastatic castration-sensitive prostate cancer: final analysis of the Asian subpopulation in the TITAN trial
Byung Ha Chung 1, Jian Huang 2, Hiroji Uemura 3, Young Deuk Choi 4, Zhang-Qun Ye 5, Hiroyoshi Suzuki 6, Taek Won Kang 7, Da-Lin He 8, Jae Young Joung 9, Sabine D Brookman-May 10 11, Sharon McCarthy 12, Amitabha Bhaumik 12, Anildeep Singh 13, Suneel Mundle 12, Simon Chowdhury 14, Neeraj Agarwal 15, Ding-Wei Ye 16, Kim N Chi 17, Hirotsugu Uemura 18
1Gangnam Severance Hospital, Yonsei University College of Medicine, Seoul 06273, South Korea.
2Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University, Guangzhou 510123, China.
3Yokohama City University Medical Center, Minami-ku, Yokohama, Kanagwa 232-0024, Japan.
4Severance Hospital, Yonsei University College of Medicine, Seoul 03722, South Korea.
5Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan 430030, China.
6Toho University Sakura Medical Center, Chiba 285-0841, Japan.
7Chonnam National University Hospital and Medical School, Gwangju 61469, South Korea.
8Department of Urology, The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an 710061, China.
9Prostate Cancer Center, National Cancer Center, Goyang 10408, South Korea.
10Janssen Research and Development, Spring House, PA 19002, USA.
11Ludwig Maximilians University, Munich 80539, Germany.
12Janssen Research and Development, Raritan, NJ 08869, USA.
13Janssen Medical Affairs, Asia Pacific, Singapore 118222, Singapore.
14Guy's and St Thomas' NHS Foundation Trust, London SE1 4YB, UK.
15University of Utah Huntsman Cancer Institute, Salt Lake City, UT 84112, USA.
16Fudan University Shanghai Cancer Center, Shanghai 200032, China.
17Vancouver Prostate Centre, University of British Columbia, Vancouver, British Columbia V6H 3Z6, Canada.
18Kindai University, Faculty of Medicine, Osaka-Sayama 589-8511, Japan.
Correspondence: Dr. H Uemura (huemura@med.kindai.ac.jp)
Originally published: June 06, 2023 Received: October 27, 2022 Accepted: April 17, 2023
| Abstract |
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The final analysis of the phase 3 Targeted Investigational Treatment Analysis of Novel Anti-androgen (TITAN) trial showed improvement in overall survival (OS) and other efficacy endpoints with apalutamide plus androgen deprivation therapy (ADT) versus ADT alone in patients with metastatic castration-sensitive prostate cancer (mCSPC). As ethnicity and regional differences may affect treatment outcomes in advanced prostate cancer, a post hoc final analysis was conducted to assess the efficacy and safety of apalutamide in the Asian subpopulation. Event-driven endpoints were OS, and time from randomization to initiation of castration resistance, prostate-specific antigen (PSA) progression, and second progression-free survival (PFS2) on first subsequent therapy or death. Efficacy endpoints were assessed using the Kaplan-Meier method and Cox proportional-hazards models without formal statistical testing and adjustment for multiplicity. Participating Asian patients received once-daily apalutamide 240 mg (n = 111) or placebo (n = 110) plus ADT. After a median follow-up of 42.5 months and despite crossover of 47 placebo recipients to open-label apalutamide, apalutamide reduced the risk of death by 32% (hazard ratio [HR]: 0.68; 95% confidence interval [CI]: 0.42-1.13), risk of castration resistance by 69% (HR: 0.31; 95% CI: 0.21-0.46), PSA progression by 79% (HR: 0.21; 95% CI: 0.13-0.35) and PFS2 by 24% (HR: 0.76; 95% CI: 0.44-1.29) relative to placebo. The outcomes were comparable between subgroups with low- and high-volume disease at baseline. No new safety issues were identified. Apalutamide provides valuable clinical benefits to Asian patients with mCSPC, with an efficacy and safety profile consistent with that in the overall patient population.
Keywords: Asia; apalutamide; event-driven analysis; metastatic castration-sensitive prostate cancer; overall survival.
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