Malek Rohan, Wu Sheng-Tang, Serrano Dennis, Tho Tran, Umbas Rainy, Teoh Jeremy, Lojanapiwat Bannakji, Ong Teng Aik, On Weber Kam, Thai Sam Minh, Kim Janet, Pophale Rupesh, Chiong Edmund
Department of Urology, Hospital Selayang, Selangor, Malaysia.
Division of Urology, Department of Surgery, Tri-Service General Hospital, Taipei.
Transl Androl Urol. 2022 Feb;11(2):179-189. doi: 10.21037/tau-21-723.
The incidence and mortality rate of men with prostate cancer have been increasing in Asia. ELIGARD is a formulation of leuprorelin acetate whose safety and efficacy have been well-established in Western regions. However, limited safety data are available for Asian populations.
ELIGANT (ELIGard AsiaN sTudy) was a Phase 4, multicenter, prospective, single-arm, interventional study. Men with locally advanced or metastatic prostate cancer without concomitant chemotherapy, or another androgen receptor pathway inhibitor, were enrolled across Asia to receive ELIGARD (22.5 mg subcutaneous depot injection) every 3 months for 15 months, with a follow-up visit at 18 months. The primary objective was to establish the safety of ELIGARD in Asian men with hormone-dependent prostate cancer. The secondary objectives were to assess efficacy, via prostate-specific antigen (PSA) progression and testosterone levels, and health-related quality of life (HRQoL).
In total, 106 patients were included in the safety analysis set (SAF). The most common treatment-emergent adverse events (TEAEs) included PSA increase, cough, back pain, hot flush, anemia, and upper respiratory tract infection. TEAEs considered related to ELIGARD were reported in 13.2% of patients (n=14), two of which were serious. In the full analysis set (FAS) (n=105), 81.2% (n=56) and 68.5% (n=61) of patients achieved a PSA reduction of ≥90% from baseline at 12 and 18 months, respectively. At 18 months, the numbers of patients with testosterone levels <20, 20-50, and >50 ng/dL were 65 (61.9%), 17 (16.2%), and two (1.9%), respectively; 20% had missing testosterone measurements. HRQoL remained stable throughout the study with minimal change from baseline at study completion.
In conclusion, the safety profile of ELIGARD (22.5 mg) in Asian men with hormone-dependent prostate cancer is comparable to previous studies in Western regions.
Clinical trial registration number NCT03035032.
亚洲前列腺癌男性的发病率和死亡率一直在上升。益列治（ELIGARD）是一种醋酸亮丙瑞林制剂，其安全性和有效性在西方地区已得到充分确立。然而，针对亚洲人群的安全性数据有限。
益列治亚洲研究（ELIGANT）是一项4期、多中心、前瞻性、单臂干预性研究。亚洲各地招募了未接受过同步化疗或其他雄激素受体途径抑制剂治疗的局部晚期或转移性前列腺癌男性患者，每3个月接受一次益列治（22.5毫克皮下长效注射剂）治疗，为期15个月，并在18个月时进行随访。主要目标是确立益列治在亚洲激素依赖性前列腺癌男性患者中的安全性。次要目标是通过前列腺特异性抗原（PSA）进展和睾酮水平评估疗效，以及评估健康相关生活质量（HRQoL）。
安全性分析集（SAF）共纳入106例患者。最常见的治疗中出现的不良事件（TEAE）包括PSA升高、咳嗽、背痛、潮热、贫血和上呼吸道感染。13.2%（n = 14）的患者报告了被认为与益列治相关的TEAE，其中2例为严重不良事件。在全分析集（FAS）（n = 105）中，分别有81.2%（n = 56）和68.5%（n = 61）的患者在12个月和18个月时PSA从基线水平降低≥90%。在18个月时，睾酮水平<20、20 - 50和>50 ng/dL的患者人数分别为65例（61.9%）、17例（16.2%）和2例（1.9%）；20%的患者睾酮测量值缺失。在整个研究过程中，HRQoL保持稳定，研究结束时与基线相比变化最小。
总之，益列治（22.5毫克）在亚洲激素依赖性前列腺癌男性患者中的安全性与先前在西方地区的研究相当。
临床试验注册号NCT03035032。
