Immunotherapy (IT) is a major therapeutic strategy for lymphoma, significantly improving patient prognosis. IT remains ineffective for a significant number of patients, however, and exposes them to specific toxicities. The identification predictive factors around efficacy and toxicity would allow better targeting of patients with a higher ratio of benefit to risk. PRONOSTIM is a multicenter and retrospective study using the Clinical Data Warehouse (CDW) of the Greater Paris University Hospitals network. Adult patients with Hodgkin lymphoma or diffuse large-cell B lymphoma treated with immune checkpoint inhibitors or CAR T (Chimeric antigen receptor T) cells between 2017 and 2022 were included. Analysis of covariates influencing progression-free survival (PFS) or the occurrence of grade ≥3 toxicity was performed. In total, 249 patients were included. From this study, already known predictors for response or toxicity of CAR T cells such as age, elevated lactate dehydrogenase, and elevated C-Reactive Protein at the time of infusion were confirmed. In addition, male gender, low hemoglobin, and hypo- or hyperkalemia were demonstrated to be potential predictive factors for progression after CAR T cell therapy. These findings prove the attractiveness of CDW in generating real-world data, and show its essential contribution to identifying new predictors for decision support before starting IT.
免疫疗法是淋巴瘤的主要治疗策略，显著改善了患者预后。然而，该疗法对大量患者仍无效，并使其面临特定毒性风险。明确疗效与毒性的预测因素有助于更精准地筛选获益风险比更高的患者。PRONOSTIM是一项利用大巴黎大学医院网络临床数据仓库开展的多中心回顾性研究，纳入了2017年至2022年间接受免疫检查点抑制剂或CAR T（嵌合抗原受体T）细胞治疗的霍奇金淋巴瘤或弥漫大B细胞淋巴瘤成年患者，并对影响无进展生存期或≥3级毒性发生的协变量进行分析。研究共纳入249例患者，其中确认了CAR T细胞疗法已知的疗效与毒性预测因素，如输注时的年龄、乳酸脱氢酶升高和C反应蛋白升高。此外，研究还发现男性、低血红蛋白以及血钾异常可能是CAR T细胞治疗后疾病进展的潜在预测因素。这些结果证明了临床数据仓库在生成真实世界数据方面的优势，并凸显了其在识别新型预测因子以支持免疫治疗决策中的重要作用。
肿瘤(癌症)患者之家