Clinical Pharmacology and Quantitative Pharmacology, CPSS, BioPharmaceuticals R&D, AstraZeneca, Cambridge, UK.
Clinical Pharmacology and Quantitative Pharmacology, CPSS, BioPharmaceuticals R&D, AstraZeneca, Gaithersburg, Maryland, USA.
Clin Transl Sci. 2024 Aug;17(8):e13905. doi: 10.1111/cts.13905.
Association between measurable residual disease (MRD) and survival outcomes in chronic lymphocytic leukemia (CLL) has often been reported. However, limited quantitative analyses over large datasets have been undertaken to establish the predictive power of MRD. Here, we provide a comprehensive assessment of published MRD data to explore the utility of MRD in the prediction of progression-free survival (PFS). We undertook two independent analyses, which leveraged available published data to address two complimentary questions. In the first, data from eight clinical trials was modeled via a meta-regression approach, showing that median PFS can be predicted from undetectable MRD rates at 3-6 months of post-treatment. The resulting model can be used to predict the probability of technical success of a planned clinical trial in chemotherapy. In the second, we investigated the evidence for predicting PFS from competing MRD metrics, for example baseline value and instantaneous MRD value, via a joint modeling approach. Using data from four small studies, we found strong evidence that including MRD metrics in joint models improves predictions of PFS compared with not including them. This analysis suggests that incorporating MRD is likely to better inform individual progression predictions. It is therefore proposed that systematic MRD collection should be accompanied by modeling to generate algorithms that inform patients' progression.
可测量残留疾病(MRD)与慢性淋巴细胞白血病(CLL)生存结局的相关性经常被报道。然而,为了确定 MRD 的预测能力,对大型数据集进行的定量分析十分有限。在这里,我们提供了对已发表的 MRD 数据的综合评估,以探讨 MRD 在预测无进展生存期(PFS)中的作用。我们进行了两项独立的分析,利用现有的已发表数据来解决两个互补的问题。在第一项分析中,通过荟萃回归方法对八项临床试验的数据进行建模,结果表明,从治疗后 3-6 个月的不可检测 MRD 率可以预测中位 PFS。由此产生的模型可用于预测计划化疗临床试验的技术成功率。在第二项分析中,我们通过联合建模的方法,研究了从基线值和即时 MRD 值等竞争 MRD 指标预测 PFS 的证据。使用来自四项小型研究的数据,我们发现有力的证据表明,与不包括 MRD 指标相比,将其纳入联合模型可以提高 PFS 的预测准确性。这项分析表明,纳入 MRD 可能会更好地告知个体进展预测。因此,建议系统地采集 MRD 并进行建模,以生成告知患者进展的算法。