Background:Immunotherapy has revolutionized oncology care, but clinical response to immune checkpoint inhibitors (ICIs) remains unpredictable, and treatment carries substantial risks and costs. The EpiSwitch®CiRT blood test is a novel 3D genomic assay that stratifies patients by probability of ICI benefit using a binary, blood-based classification: high (HPRR) or low (LPRR) probability of response.Methods:This interim analysis of the ongoing PROWES prospective real-world evidence study evaluates the clinical utility of CiRT in 205 patients with advanced solid tumors. The primary endpoint was treatment decision impact, assessed by pre-/post-test physician surveys. Secondary endpoints included treatment avoidance, time to ICI initiation, concordance with clinical response, early discontinuation rates, and exploratory health economic modeling. Longitudinal use, resistance monitoring, and equity analysis by social determinants of health (SDoH) were also explored.Results:CiRT results influenced clinical decision-making in a majority of cases. LPRR status was associated with higher rates of treatment avoidance and early discontinuation due to immune-related adverse events (IrAEs). In contrast, HPRR patients experienced greater clinical benefit and longer ICI exposure. CiRT classification was not associated with short-term imaging-based response outcomes, supporting its role as an independent predictor. Given that ICI therapy and supportive care can cost more than $850,000 per patient, CiRT offers potential value in avoiding ineffective treatment and associated toxicities.Conclusions:CiRT demonstrates meaningful clinical utility as a non-invasive, predictive tool for guiding immunotherapy decisions across tumor types. It enables more precise treatment selection, improves patient outcomes, and supports value-based cancer care.
背景：免疫疗法已彻底改变肿瘤治疗格局，但患者对免疫检查点抑制剂（ICIs）的临床反应仍难以预测，且治疗伴随显著风险与高昂成本。EpiSwitch®CiRT血液检测是一种新型三维基因组检测技术，通过基于血液的二元分类（高应答概率[HPRR]或低应答概率[LPRR]）对患者进行ICI获益概率分层。 方法：本研究对正在进行的PROWES前瞻性真实世界证据研究进行中期分析，评估CiRT检测在205例晚期实体瘤患者中的临床效用。主要终点为治疗决策影响，通过检测前后医师问卷调查进行评估。次要终点包括治疗规避率、ICI启动时间、与临床反应的一致性、早期停药率及探索性卫生经济学模型构建。同时探究了检测的纵向应用、耐药监测及基于健康社会决定因素（SDoH）的公平性分析。 结果：CiRT检测结果在多数病例中影响了临床决策。LPRR状态与更高的治疗规避率及因免疫相关不良事件（IrAEs）导致的早期停药率相关。相比之下，HPRR患者获得更显著的临床获益且接受ICI治疗时间更长。CiRT分类与短期影像学反应结局无显著关联，证实其作为独立预测指标的价值。鉴于每位患者的ICI治疗及支持性护理费用可超过85万美元，CiRT检测在避免无效治疗及相关毒性方面展现出潜在价值。 结论：CiRT检测作为一种无创预测工具，在指导跨瘤种免疫治疗决策方面展现出重要临床价值。该技术有助于实现更精准的治疗选择、改善患者预后，并为基于价值的癌症诊疗模式提供支持。
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