Boegemann Martin, Bennamoun Mostefa, Dourthe Louis Marie, Encarnacion Juan Antonio, Hegele Axel, Hellmis Eva, Latorzeff Igor, Leicht Wolfgang, Oñate-Celdrán Julián, Rosino-Sánchez Antonio, Hanna Krystelle, Lencart Joana, Lukac Martin, Schioppa Claudio A, Van Sanden Suzy, Kramer Gero
Department of Urology, University Hospital Münster, Münster, Germany.
Oncology Department, Institut Mutualiste Montsouris, Paris, France.
BMC Cancer. 2025 Jul 1;25(1):1119. doi: 10.1186/s12885-025-14294-7.
We examined real-world outcomes of patients with metastatic hormone-sensitive prostate cancer (mHSPC) treated with apalutamide plus androgen deprivation therapy (ADT). The current study, reflecting real-life practice, included specific subpopulations not evaluated in the pivotal phase III TITAN study: patients diagnosed with novel imaging, patients with M1a disease only, and patients treated with concomitant radiotherapy.
ArtemisR is the first European multi-country observational study to retrospectively collect data from medical records of patients with mHSPC treated with apalutamide plus ADT in routine clinical practice. Response rates of patients with 50% and 90% decrease in PSA level (PSA50 and PSA90) compared with baseline and undetectable PSA (uPSA, < 0.2 ng/mL) were reported. Time to PSA response, time to metastatic castration-resistant prostate cancer (mCRPC), proportion of apalutamide discontinuation, and survival at 12 months were also examined using the Kaplan-Meier method.
The analysis included 242 patients from Germany, France, Spain, and Austria; median age was 71 years. Median follow-up was 25.5 months from treatment initiation. Within 12 months of apalutamide initiation, 96% of patients achieved PSA50, 82% achieved PSA90, and 61% achieved uPSA. The median times to PSA50, PSA90, and uPSA were 1.08 months (95% confidence interval [CI]: 0.99-1.28), 1.94 months (95% CI: 1.54-2.27), and 3.48 months (95% CI: 2.92-5.68), respectively. At 12 months after treatment initiation, 94% of patients were alive, 91% had not progressed to mCRPC, and 81% remained on apalutamide plus ADT. Patients diagnosed with novel imaging, patients with M1a disease only, and patients treated with concomitant radiotherapy also showed deep and fast PSA responses (PSA90 and uPSA) with apalutamide plus ADT. Apalutamide-related adverse events (AEs) were reported in 90 patients (37%), and six patients (2.5%) discontinued apalutamide due to AEs. No new safety signals were detected.
The ArtemisR European multi-centre study examined the efficacy and safety of apalutamide plus ADT for patients with mHSPC, further validating the deep and fast PSA response associated with this treatment regimen. These real-world outcomes were additionally observed in a more diverse patient population than that included in the pivotal TITAN study.
我们研究了接受阿帕他胺联合雄激素剥夺疗法（ADT）治疗的转移性激素敏感性前列腺癌（mHSPC）患者的真实世界结局。本项反映现实临床实践的研究纳入了关键的III期TITAN研究中未评估的特定亚组人群：经新型影像学诊断的患者、仅患有M1a期疾病的患者以及接受同步放疗的患者。
ArtemisR是第一项欧洲多国家观察性研究，旨在回顾性收集常规临床实践中接受阿帕他胺联合ADT治疗的mHSPC患者的病历数据。报告了与基线相比PSA水平降低50%和90%（PSA50和PSA90）以及PSA不可检测（uPSA，<0.2 ng/mL）的患者的缓解率。还采用Kaplan-Meier法检查了PSA缓解时间、发生转移性去势抵抗性前列腺癌（mCRPC）的时间、阿帕他胺停药比例以及12个月时的生存率。
分析纳入了来自德国、法国、西班牙和奥地利的242例患者；中位年龄为71岁。从治疗开始的中位随访时间为25.5个月。在开始使用阿帕他胺的12个月内，96%的患者达到PSA50，82%的患者达到PSA90，61%的患者达到uPSA。达到PSA50、PSA90和uPSA的中位时间分别为1.08个月（95%置信区间[CI]：0.99-1.28）、1.94个月（95%CI：1.54-2.27）和3.48个月（95%CI：2.92-5.68）。在治疗开始12个月时，94%的患者存活，91%的患者未进展至mCRPC，81%的患者仍在接受阿帕他胺联合ADT治疗。经新型影像学诊断的患者、仅患有M1a期疾病的患者以及接受同步放疗的患者在接受阿帕他胺联合ADT治疗时也显示出深度且快速的PSA反应（PSA90和uPSA）。90例患者（37%）报告了与阿帕他胺相关的不良事件（AE），6例患者（2.5%）因AE停用阿帕他胺。未检测到新的安全信号。
ArtemisR欧洲多中心研究考察了阿帕他胺联合ADT治疗mHSPC患者的疗效和安全性，进一步验证了与该治疗方案相关的深度且快速的PSA反应。在比关键的TITAN研究纳入的人群更多样化的患者群体中也观察到了这些真实世界结局。
