Martínez Osorio Christian Andrés, Sopeña Sutil Raquel, Vilaseca Cabo Antoni, Linares Espinós Estefanía, Ramírez Backhaus Miguel, Gómez Rivas Juan, Costa Planells Marc, Martinez Breijo Sara, Picola Brau Natalia, Domínguez Esteban Natalia, Muñoz Rodríguez Jesús, Sanchís Bonet Angeles, Guijarro Cascales Ana, Beamud Cortés Manel, Servian Vives Pol, de la Morena Gallego José Manuel, Pérez Márquez Meritxell, García Sanz Miguel, Ramón Alemán José, Zamora Horcajada Álvaro, Rodríguez Part Victor, Hassi Roman Mario, Rodriguez Concha Cristian, Rios González Emilio, de Pablos-Rodríguez Pedro
Instituto Valenciano de Oncología, Valencia, Spain.
Universidad de Chile, Santiago, Chile.
Prostate. 2025 Sep 4. doi: 10.1002/pros.70040.
PSA response to apalutamide combined with androgen deprivation therapy (ADT) in metastatic hormone-sensitive prostate cancer (mHSPC) has been linked to prognosis. Post hoc analyses from clinical trials suggest that PSA levels at 6 months are critical for predicting radiographic progression-free survival (rPFS) and overall survival (OS). Real-world evidence (RWE) is needed to confirm these findings.
This multicentre, retrospective study included patients with mHSPC treated with apalutamide plus ADT from May 2018 to January 2025 across 18 Spanish centers. Patients were stratified according to PSA level at 6 months: Complete response (CR; ≤ 0.2 ng/mL) or incomplete response (IR; > 0.2 ng/mL). The primary objective was to evaluate the association between PSA response and rPFS at 24 and 36 months. Univariate and multivariate Cox regression analyses were used to identify predictors of progression.
Among 812 patients, 65% achieved a CR at 6 months, associated with higher rPFS at 24 (94%) and 36 (81%) months compared to the IR group (73% and 60%, respectively; p < 0.0001). CR (hazard ratio: 0.38; p < 0.001) and low-volume disease (hazard ratio: 0.41; p < 0.001) were independent predictors of rPFS. Baseline PSA, disease volume, and positron emission tomography imaging predicted achieving a CR.
In this large real-world cohort, PSA response at 6 months was a strong predictor of disease progression, supporting its use as a dynamic prognostic biomarker.
在转移性激素敏感性前列腺癌（mHSPC）中，前列腺特异性抗原（PSA）对阿帕鲁胺联合雄激素剥夺治疗（ADT）的反应与预后相关。临床试验的事后分析表明，6个月时的PSA水平对于预测影像学无进展生存期（rPFS）和总生存期（OS）至关重要。需要真实世界证据（RWE）来证实这些发现。
这项多中心回顾性研究纳入了2018年5月至2025年1月期间在西班牙18个中心接受阿帕鲁胺加ADT治疗的mHSPC患者。根据6个月时的PSA水平对患者进行分层：完全缓解（CR；≤0.2 ng/mL）或不完全缓解（IR；>0.2 ng/mL）。主要目的是评估PSA反应与24个月和36个月时rPFS之间的关联。采用单因素和多因素Cox回归分析来确定进展的预测因素。
在812例患者中，65%在6个月时达到CR，与IR组相比，24个月（94%）和36个月（81%）时的rPFS更高（IR组分别为73%和60%；p<0.0001）。CR（风险比：0.38；p<0.001）和低肿瘤负荷疾病（风险比：0.41；p<0.001）是rPFS的独立预测因素。基线PSA、疾病体积和正电子发射断层扫描成像可预测达到CR。
在这个大型真实世界队列中，6个月时的PSA反应是疾病进展的有力预测因素，支持将其用作动态预后生物标志物。
