免疫检查点抑制剂单用或联合治疗恶性肿瘤患者安全性的临床观察

Clinical observation on the safety of immune checkpoint inhibitors alone or in combination in patients with advanced cancer

目的观察及评价真实世界中含免疫检查点抑制剂方案在晚期恶性肿瘤中的安全性。方法对海军军医大学第二附属医院接受含免疫检查点抑制剂药物方案进行治疗的50例晚期恶性肿瘤患者进行临床观察直至出现进展、不可接受的毒性或停药。观察指标包括基本资料、用药情况、不良反应发生器官、严重程度及发生时间等。结果50例患者共发生68例次不良反应,不良反应发生在多个系统和器官,包括肝脏(25%)、神经系统(18%)、胃肠道(14%)、血液系统(10%)等,发生中位时间为8周(1~70周)。1~2级不良反应发生率为84%,3~4级不良反应发生率为16%。结论含免疫检查点抑制剂的药物治疗方案对晚期恶性肿瘤治疗的严重不良反应发生率低,有一定的安全性,但不良反应可累及全身各个器官系统。

ObjectiveTo observe and evaluate the adverse effects of drug regimens containing immune checkpoint inhibitors(ICIs)in treating advanced cancer in real world clinical practice.MethodsTo observe 50 patients with advanced malignant tumors receiving immunotherapy combined chemtherapy in Second Affiliated Hospital of Naval Medical University,until they experienced progression,unacceptable toxicity,or discontinuation of the medication.The observation indexes included the basic data of patients,the drug regimen of tumor,the adverse reaction of organ,the severity of adverse reaction and the time of adverse reaction.ResultsThere were 50 patients enrolled in this study and 68 cases of immune-related adverse events(irAEs),the irAEs occurred in multiple systems and organs of the body,including liver(25.49%),nervous system(17.64%),gastrointestinal tract(13.73%)and blood system(9.80%),the median time of adverse reactions was 8 weeks(1,70).In this observation,the incidence of grade 1-2 adverse reactions was 84.31%,and the incidence of grade 3-4 adverse reactions was 15.69%.ConclusionIn the treatment of advanced cancer with drug treatment regimens containing ICIs,there′s a low incidence of serious adverse reactions and a certain degree of safety,but the adverse reactions can affect all organs and systems of the whole body.