De Feo Maria Silvia, Filippi Luca, Bauckneht Matteo, Lodi Rizzini Elisa, Ferrari Cristina, Lavelli Valentina, Marongiu Andrea, Sambuceti Gianmario, Battisti Claudia, Mura Antonio, Fornarini Giuseppe, Rebuzzi Sara Elena, Farcomeni Alessio, Murabito Alessandra, Nuvoli Susanna, Conte Miriam, Montebello Melissa, Costa Renato Patrizio, Golemi Arber, Mascia Manlio, Travascio Laura, Monari Fabio, Rubini Giuseppe, Spanu Angela, De Vincentis Giuseppe, Frantellizzi Viviana
Department of Radiological Sciences, Oncology and Anatomo Pathology, Sapienza, University of Rome, 00161 Rome, Italy.
Department of Biomedicine and Prevention, University of Rome "Tor Vergata", Via Montpellier 1, 00133 Rome, Italy.
Diagnostics (Basel). 2025 Jan 31;15(3):339. doi: 10.3390/diagnostics15030339.
The prognostic value of baseline clinical parameters in predicting the survival prolonging effect of Radium-223-dichloride (RaCl) for metastatic castration resistant prostate cancer (mCRPC) patients has been the object of intensive research and remains an open issue. This national multicenter study aimed to corroborate the evidence of ten years of clinical experience with RaCl by collecting data from eight Italian Nuclear Medicine Units. Data from 581 consecutive mCRPC patients treated with RaCl were retrospectively analyzed. Several baseline variables relevant to the overall survival (OS) analysis were considered, including age, previous radical prostatectomy/radiotherapy, number of previous treatment lines, prior chemotherapy, Gleason score, presence of lymphoadenopaties, number of bone metastases, concomitant use of bisphosphonates/Denosumab, Eastern Cooperative Oncology Group Performance Status (ECOG-PS), as well as baseline values of hemoglobin (Hb), platelets, Total Alkaline Phosphatase (tALP), Lactate Dehydrogenase (LDH), and Prostate-Specific Antigen (PSA). Data were summarized using descriptive statistics, univariate analysis and multivariate analysis with the Cox model. The median OS time was 14 months (95%CI 12-17 months). At univariate analysis age, the number of previous treatment lines, number of bone metastases, ECOG-PS, presence of lymphadenopathies at the time of enrollment, as well as baseline tALP, PSA, and Hb, were independently associated with OS. After multivariate analysis, the number of previous treatment lines (HR = 1.1670, CI = 1.0095-1.3491, = 0.0368), the prior chemotherapy (HR = 0.6461, CI = 0.4372-0.9549, = 0.0284), the presence of lymphadenopathies (HR = 1.5083, CI = 1.1210-2.0296, = 0.0066), the number of bone metastases (HR = 0.6990, CI = 0.5416-0.9020, = 0.0059), ECOG-PS (HR = 1.3551, CI = 1.1238-1.6339, = 0.0015), and baseline values of tALP (HR = 1.0008, CI = 1.0003-1.0013, = 0.0016) and PSA (HR = 1.0004, CI = 1.0002-1.0006, = 0.0005) remained statistically significant. In the era of precision medicine and in the landscape of novel therapies for mCRPC, the prognostic stratification of patients undergoing RaCl has a fundamental role for clinical decision-making, ranging from treatment choice to optimal sequencing and potential associations. This large Italian multicenter study corroborated the prognostic value of several variables, emerging from ten years of clinical experience with RaCl.
基线临床参数对预测二氯化镭（RaCl）延长转移性去势抵抗性前列腺癌（mCRPC）患者生存期的预后价值一直是深入研究的对象，且仍是一个未解决的问题。这项全国性多中心研究旨在通过收集来自八个意大利核医学科室的数据，证实十年使用RaCl的临床经验证据。对581例连续接受RaCl治疗的mCRPC患者的数据进行了回顾性分析。考虑了几个与总生存期（OS）分析相关的基线变量，包括年龄、既往根治性前列腺切除术/放疗、既往治疗线数、既往化疗、 Gleason评分、淋巴结病的存在、骨转移数量、双膦酸盐/地诺单抗的联合使用、东部肿瘤协作组体能状态（ECOG-PS），以及血红蛋白（Hb）、血小板、总碱性磷酸酶（tALP）、乳酸脱氢酶（LDH）和前列腺特异性抗原（PSA）的基线值。使用描述性统计、单因素分析和Cox模型进行多因素分析对数据进行总结。中位OS时间为14个月（95%CI 12 - 17个月）。在单因素分析中，年龄、既往治疗线数、骨转移数量、ECOG-PS、入组时淋巴结病的存在，以及基线tALP、PSA和Hb与OS独立相关。多因素分析后，既往治疗线数（HR = 1.1670，CI = 1.0095 - 1.3491，P = 0.0368）、既往化疗（HR = 0.6461，CI = 0.4372 - 0.9549，P = 0.0284）、淋巴结病的存在（HR = 1.5083，CI = 1.1210 - 2.0296，P = 0.0066）、骨转移数量（HR = 0.6990，CI = 0.5416 - 0.9020，P = 0.0059）、ECOG-PS（HR = 1.3551，CI = 1.1238 - 1.6339，P = 0.0015），以及tALP（HR = 1.0008，CI = 1.0003 - 1.0013，P = 0.0016）和PSA（HR = 1.0004，CI = 1.0002 - 1.0006，P = 0.0005）的基线值仍具有统计学意义。在精准医学时代以及mCRPC新型疗法的背景下，接受RaCl治疗患者的预后分层对于临床决策具有重要作用，范围涵盖治疗选择、最佳序贯治疗以及潜在联合治疗。这项大型意大利多中心研究证实了从十年使用RaCl的临床经验中得出的几个变量的预后价值。
