来自 3 期随机临床研究 TITAN 和 SPARTAN 的 Apalutamide 对老年晚期前列腺癌患者的疗效、安全性和健康状况。
Apalutamide efficacy, safety and wellbeing in older patients with advanced prostate cancer from Phase 3 randomised clinical studies TITAN and SPARTAN.
发表日期：2023 Nov 11
作者：
John Shen, Simon Chowdhury, Neeraj Agarwal, Lawrence I Karsh, Stéphane Oudard, Benjamin A Gartrell, Susan Feyerabend, Fred Saad, Christopher M Pieczonka, Kim N Chi, Sabine D Brookman-May, Brendan Rooney, Amitabha Bhaumik, Sharon A McCarthy, Katherine B Bevans, Suneel D Mundle, Eric J Small, Matthew R Smith, Julie N Graff
来源：
BRITISH JOURNAL OF CANCER
摘要：
在 3 期随机 TITAN 和 SPARTAN 研究中，Apalutamide 联合雄激素剥夺疗法 (ADT) 分别改善了转移性去势敏感型前列腺癌 (mCSPC) 和非转移性去势抵抗性 PC (nmCRPC) 的结局，并维持了健康相关质量生活质量 (HRQoL)。需要根据患者年龄评估阿帕鲁胺的治疗效果。事后分析评估了接受 240mg/天阿帕鲁胺（525 TITAN 和 806 SPARTAN）或安慰剂（527 TITAN 和 401 SPARTAN）并持续进行 ADT 的患者，按年龄组分层。使用描述性统计、Kaplan-Meier 方法、Cox 比例风险模型和重复测量的混合效应模型评估前列腺特异性抗原下降、影像学无进展生存期、无转移生存期、总生存期 (OS)、HRQoL 和安全性.无论年龄大小，在所有终点上，风险比（95% 置信区间）通常倾向于阿帕鲁胺加 ADT，而不是单独 ADT；例如，OS 值为 0.57 (0.40-0.80)、0.70 (0.54-0.91) 和 0.74 (0.40-1.39) (TITAN) 以及 0.39 (0.19-0.78)、0.89 (0.69-1.16) 和 0.81 (0.58-1.15) ( SPARTAN）适用于年龄<65岁、65-79岁和≥80岁的患者。无论年龄大小，阿帕鲁胺都能维持 HRQoL，并且耐受性良好，不良事件发生率有随年龄增加的潜在趋势。局限性包括事后性质和年龄组样本量的变异性。Apalutamide 加 ADT 是一种有效且耐受性良好的选择，可维持 mCSPC 和 nmCRPC 患者的 HRQoL，无论年龄如何。TITAN (NCT02489318)； SPARTAN (NCT01946204).© 2023。作者。
Apalutamide plus androgen-deprivation therapy (ADT) improved outcomes in metastatic castration-sensitive prostate cancer (mCSPC) and non-metastatic castration-resistant PC (nmCRPC) in the Phase 3 randomised TITAN and SPARTAN studies, respectively, and maintained health-related quality of life (HRQoL). Apalutamide treatment effect by patient age requires assessment.Post-hoc analysis assessed patients receiving 240 mg/day apalutamide (525 TITAN and 806 SPARTAN) or placebo (527 TITAN and 401 SPARTAN) with ongoing ADT, stratified by age groups. Prostate-specific antigen declines, radiographic progression-free survival, metastasis-free survival, overall survival (OS), HRQoL and safety were assessed using descriptive statistics, Kaplan-Meier method, Cox proportional-hazards model and mixed-effects model for repeated measures.Hazard ratios (95% confidence intervals) generally favoured apalutamide plus ADT versus ADT alone across all endpoints regardless of age; e.g., OS values were 0.57 (0.40-0.80), 0.70 (0.54-0.91) and 0.74 (0.40-1.39) (TITAN) and 0.39 (0.19-0.78), 0.89 (0.69-1.16) and 0.81 (0.58-1.15) (SPARTAN) in patients aged <65, 65-79 and ≥80 years. Regardless of age, apalutamide also maintained HRQoL and was tolerated well with a potential trend in rates of adverse events increasing with age. Limitations include post-hoc nature and variability in sample size of age groups.Apalutamide plus ADT was an effective and well-tolerated option maintaining HRQoL in patients with mCSPC and nmCRPC regardless of age.TITAN (NCT02489318); SPARTAN (NCT01946204).© 2023. The Author(s).