Lorlatinib has been FDA-approved as a systemic therapy for ALK/ROS1-positive non-small cell lung cancer (NSCLC) patients. However, it has been associated with an increased frequency of neurocognitive adverse events (NAEs). Therefore, we conducted a systematic review and meta-analysis to assess the NAEs related to lorlatinib therapy in NSCLC patients. PubMed, Scopus, the Cochrane Library, and prominent conference proceedings were searched for eligible studies of lorlatinib in NSCLC patients. NAEs included cognitive, mood, speech, and psychotic effects. A total of 1147 patients from 12 studies were included; 62% had brain metastases. A pooled analysis of NAEs showed frequencies of cognitive effects of 14.57% (95% CI, 8.37 to 24.14, I2 = 84%), mood effects of 11.17% (95% CI, 5.93 to 20.07, I2 = 84%), speech effects of 7.24% (95% CI, 3.39 to 15.20, I2 = 72%), and psychotic effects of 4.97% (95% CI, 3.27 to 7.49, I2 = 21%). Clinical trials reported a significantly higher frequency of mood effects than was indicated by real-world data. These results highlight the importance of educating patients and healthcare professionals about lorlatinib-related NAEs for early detection and management to improve NSCLC patients’ quality of life.
劳拉替尼已获美国食品药品监督管理局批准用于治疗ALK/ROS1阳性非小细胞肺癌患者的全身治疗。然而,该药物与神经认知不良事件发生频率增加相关。为此,我们开展了一项系统综述与荟萃分析,旨在评估非小细胞肺癌患者接受劳拉替尼治疗相关的神经认知不良事件。通过检索PubMed、Scopus、Cochrane图书馆及重要会议论文集,筛选出符合标准的劳拉替尼治疗非小细胞肺癌研究。神经认知不良事件涵盖认知、情绪、言语及精神症状。共纳入12项研究的1147例患者,其中62%存在脑转移。神经认知不良事件的汇总分析显示:认知症状发生率为14.57%(95% CI:8.37-24.14,I²=84%),情绪症状为11.17%(95% CI:5.93-20.07,I²=84%),言语症状为7.24%(95% CI:3.39-15.20,I²=72%),精神症状为4.97%(95% CI:3.27-7.49,I²=21%)。临床试验报告的情绪症状发生率显著高于真实世界数据。这些结果凸显了对患者及医疗专业人员进行劳拉替尼相关神经认知不良事件教育的重要性,通过早期识别与管理以提升非小细胞肺癌患者的生活质量。