肿瘤患者免疫检查点抑制药用药安全性的回顾性研究

A Retrospective Study on the Safety of Immunocheckpoint Inhibition in Cancer Patients

目的:对国内已上市的免疫检查点抑制药(ICIs)在肿瘤患者临床使用中的用药安全性进行回顾性研究。方法:收集某肿瘤专科医院2018年7月~2019年7月使用帕博利珠单抗、纳武利尤单抗、信迪利单抗、特瑞普利单抗等ICIs的处方情况,包括患者信息、用药信息及免疫相关不良反应发生情况等,分析处方是否超适应证用药,评价其临床用药安全性。结果:共收集174例使用ICIs的肿瘤患者病例资料,其中男112例,女62例;患非小细胞肺癌的人数最多,其次是肝癌。ICIs单药使用的病例63例(36.21%),111例(63.79%)患者同时联合其他抗肿瘤药物。136例(78.16%)患者为超适应证用药,超适应证使用者大部分为肝癌、非小细胞肺癌患者。88例患者发生免疫相关不良反应,发生率为50.57%,常见不良反应包括皮肤毒性、肝脏毒性、胃肠毒性等,大部分为轻度和中度毒性。结论:4种ICIs超适应证使用较为普遍,免疫相关不良反应发生较多,但程度较轻,安全性较好,大部分患者出现不良反应后经及时对症处理后可耐受。

Objective:To evaluate the safety of 4 kinds of immune checkpoint inhibitors(pembrolizumab, nivolumab, sintilimab, toripalimab) in clinical use of cancer patients. Methods:Information of patients using pembrolizumab, nivolumab, sintilimab or toripalimab from July 2018 to July 2019 were collected from a cancer hospital, including the general condition, medication information and immune-related adverse reactions(irAEs), and off-label use of these ICIs as well as their clinical drug safety were analyzed. Results:Among the 174 cases, 112 were male and 62 were female, mainly were patients with non-small cell lung cancer(NSCLC) or liver cancer. 63 cases(36.21%) used ICIs as single agent, while 111 cases(63.79%) used in combination with other antineoplastic agents. 136(78.16%) cases were off-label used, in which mainly were liver cancer and NSCLC patients. The overall incidence of irAEs was 50.57%(88 cases), mainly were mild to moderate skin toxicity, liver toxicity, gastrointestinal toxicity. Conclusion:Off-label use of ICIs is usual in clinical practice and irAEs were common. However, most of the irAEs observed in our study were not serious and treatable, which showed the ICIs were well tolerated.