Background: Daratumumab (Dara) is the first monoclonal antibody introduced into clinical practice to treat multiple myeloma (MM). It currently forms the backbone of therapy regimens in both newly diagnosed (ND) and relapsed/refractory (RR) patients. However, previous reports indicated an increased risk of infectious complications (ICs) during Dara-based treatment. In this study, we aimed to determine the profile of ICs in MM patients treated with Dara-based regimens and establish predictors of their occurrence. Methods: This retrospective, real-life study included MM patients treated with Dara-based regimens between July 2019 and March 2024 at our institution. Infectious events were evaluated using the Terminology Criteria for Adverse Events (CTCAE) version 5.0. Results: The study group consisted of a total of 139 patients, including 49 NDMM and 90 RRMM. In the RR setting, the majority (60.0%) of patients received the Dara, bortezomib, and dexamethasone (DVd) regimen, whereas ND patients were predominantly (98%) treated with the Dara, bortezomib, thalidomide, and dexamethasone (DVTd) regimen. Overall, 55 patients (39.6%) experienced ICs. The most common IC was pneumonia (37.5%), followed by upper respiratory tract infections (26.8%). Finally, twenty-five patients had severe ICs (grade ≥ 3) and required hospitalization, and eight patients died due to ICs. In the final multivariable model adjusted for setting (ND/RR) and age, hemoglobin level (OR 0.77, 95% CI: 0.61–0.96,p= 0.0037), and Eastern Cooperative Oncology Group (ECOG) >1 (OR 4.46, 95% CI: 1.63–12.26,p= 0.0037) were significant factors influencing severe IC occurrence. Additionally, we developed predictive models using the J48 decision tree, gradient boosting, and random forest algorithms. After conducting 10-fold cross-validation, these models demonstrated strong performance in predicting the occurrence of pneumonia during treatment with daratumumab-based regimens. Conclusions: Simple clinical and laboratory assessments, including hemoglobin level and ECOG scale, can be valuable in identifying patients vulnerable to infections during Dara-based regimens, facilitating personalized prophylactic strategies.
背景：达雷妥尤单抗（Dara）是首个应用于临床治疗多发性骨髓瘤（MM）的单克隆抗体，目前已成为新诊断（ND）及复发/难治性（RR）患者治疗方案的核心组成部分。然而，既往研究提示基于Dara的治疗可能增加感染并发症（ICs）的风险。本研究旨在明确接受Dara为基础方案治疗的MM患者中ICs的发生特征，并确立其发生的预测因素。 方法：这项回顾性真实世界研究纳入了2019年7月至2024年3月期间在我院接受Dara为基础方案治疗的MM患者。感染事件采用《不良事件通用术语标准》（CTCAE）5.0版进行评估。 结果：研究共纳入139例患者，包括49例NDMM和90例RRMM。在RR患者中，大多数（60.0%）接受达雷妥尤单抗、硼替佐米和地塞米松（DVd）方案治疗，而ND患者主要（98%）接受达雷妥尤单抗、硼替佐米、沙利度胺和地塞米松（DVTd）方案治疗。总体而言，55例患者（39.6%）发生了ICs。最常见的感染是肺炎（37.5%），其次是上呼吸道感染（26.8%）。最终，25例患者出现严重ICs（≥3级）需要住院治疗，8例患者因ICs死亡。在针对治疗背景（ND/RR）和年龄进行调整后的最终多变量模型中，血红蛋白水平（OR 0.77，95% CI：0.61–0.96，p=0.0037）和东部肿瘤协作组（ECOG）评分>1（OR 4.46，95% CI：1.63–12.26，p=0.0037）是影响严重ICs发生的显著因素。此外，我们利用J48决策树、梯度提升和随机森林算法构建了预测模型。经过10折交叉验证，这些模型在预测基于达雷妥尤单抗方案治疗期间肺炎发生方面表现出良好的性能。 结论：简单的临床和实验室评估，包括血红蛋白水平和ECOG评分，有助于识别接受Dara为基础方案治疗时易发生感染的患者，从而促进个体化预防策略的制定。
肿瘤(癌症)患者之家