Hassi Roman M, Mate K, de Pablos-RodrIguez P, Zamora Horcajada Á, Guijarro Cascales A, Sanchís Bonet Á, Vilaseca A, Vázquez-Martul Pazos D, Linares Espinós E, Muñoz Rodríguez J, de la Morena Gallego J M, Alemán J R, Gómez Rivas J, Formisano L, Juan Fita M J, Costa Planells M, Domínguez Esteban M, Pérez Márquez M, García Sanz M, García Expósito N, Picola N, Servian Vives P, Sopeña Sutil R, Climent Durán M A, Ramírez Backhaus M
Hospital DIPRECA, Santiago, Chile.
Hospital-Clínica y Centro de Traumatología Péterfy Sándor Utcai, Budapest, Hungary.
Actas Urol Esp (Engl Ed). 2025 Jun;49(5):501742. doi: 10.1016/j.acuroe.2025.501742. Epub 2025 Mar 15.
Apalutamide has shown significantly increases in radiographic progression-free survival (rPFS) and overall survival (OS) in metastatic hormone-sensitive prostate cancer (mHSPC) patients diagnosed by conventional imaging (CI). However, there is scarce knowledge on the use of apalutamide in mHSPC population diagnosed by NGI.
Retrospective multicenter study of mHSPC patients treated with apalutamide from May 2018 to September 2023 registered in the Real-World Evidence APA (RWE-APA). CI and NGI group were defined, according to the diagnostic tool of metastatic disease. Primary objective was rPFS at 24 mo in CI vs NGI group. Secondary objectives were OS in CI vs NGI group and rPFS in synchronic/metachronic, low volume (LV)/high volume (HV) in CI and NGI groups and risk of developing new metastasis according to the imaging technique, metastasis volume and location of the metastasis.
772 mHSPC patients were included. 47% (359) of patients were diagnosed with CI and 53% (413) of patients with NGI. rPFS at 24 mo was 80% in the CI group vs 84% in the NGI group (Hazard ratio (HR): 0.57 (0.35-0.92) 95% Confidence Interval [CI], p = 0.023). OS at 24 mo was 89.5% in the CI group and 95.8% in the NGI group (HR 0.35; 95% CI, 0.16-0.75, p = 0.007). In the multivariable analysis, only HV was significantly associated with metastatic progression (HR 0.33 (0.18-0.59) 95% CI; p < 0.001).
mHSPC patients treated with apalutamide and NGI-diagnosed exhibited superior rPFS and OS in comparison with CI-diagnosed patients.
阿帕鲁胺已显示出，在经传统成像（CI）诊断的转移性激素敏感性前列腺癌（mHSPC）患者中，其影像学无进展生存期（rPFS）和总生存期（OS）显著延长。然而，对于阿帕鲁胺在经下一代成像（NGI）诊断的mHSPC人群中的应用，了解甚少。
对2018年5月至2023年9月在真实世界证据阿帕鲁胺（RWE-APA）中登记的接受阿帕鲁胺治疗的mHSPC患者进行回顾性多中心研究。根据转移性疾病的诊断工具定义CI组和NGI组。主要目标是CI组与NGI组24个月时的rPFS。次要目标是CI组与NGI组的OS，以及CI组和NGI组同步/异时、低体积（LV）/高体积（HV）情况下的rPFS，以及根据成像技术、转移灶体积和转移灶位置发生新转移的风险。
纳入772例mHSPC患者。47%（359例）患者经CI诊断，53%（413例）患者经NGI诊断。CI组24个月时的rPFS为80%，NGI组为84%（风险比（HR）：0.57（0.35 - 0.92），95%置信区间[CI]，p = 0.023）。CI组24个月时的OS为89.5%，NGI组为95.8%（HR 0.35；95% CI，0.16 - 0.75，p = 0.007）。在多变量分析中，只有HV与转移进展显著相关（HR 0.33（0.18 - 0.59），95% CI；p < 0.001）。
与经CI诊断的患者相比，接受阿帕鲁胺治疗且经NGI诊断的mHSPC患者表现出更优的rPFS和OS。
