研究动态
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临床分析高级食管鳞状细胞癌患者中,SHR-1210单独或联合阿帕替尼和化疗引起的肝功能障碍。

[Clinical analysis of liver dysfunction induced by SHR-1210 alone or combined with apatinib and chemotherapy in patients with advanced esophageal squamous cell carcinoma].

发表日期:2023 Mar 23
作者: L Qi, B Zhang, Y Liu, L Mu, Q Li, X Wang, J P Xu, X Y Wang, J Huang
来源: Cell Death & Disease

摘要:

目的:探讨应用PD-1抗体SHR-1210单独或联合阿帕替尼和化疗治疗晚期食管鳞状细胞癌的患者异常肝功能的临床特点。方法:分析2016年5月11日至2019年11月19日在中国医学科学院肿瘤医院进行的两项前瞻性临床研究中73名食管鳞状细胞癌患者的临床数据,并采用Logistic回归分析影响因素。结果:73例患者中,35例患者出现异常肝功能。43例接受PD-1单抗治疗的患者中,有13例出现异常肝功能,首次异常肝功能的中位数时间为55天。30例接受PD-1单抗联合阿帕替尼和化疗的患者中,22例出现异常肝功能,首次异常肝功能的中位数时间为41天。35例患者中有2例出现临床症状,包括乏力和食欲减退,1例有黄疸。35例异常肝功能患者中,28例恢复正常,7例改善到1级,没有患者出现严重危及生命或致死的肝功能异常。联合治疗是患者发生异常肝功能的危险因素(P=0.007)。结论:应用PD-1抗体SHR-1210单独或联合阿帕替尼和化疗治疗时,大多数肝功能异常都是轻度的,肝功能可以通过对症治疗恢复正常或改善。对于接受PD-1联合靶向治疗和化疗的患者,如果有长期吸烟、饮酒和乙型肝炎感染史,应及时监测和积极管理肝功能。
Objective: To investigate the clinical characteristics of abnormal liver function in patients with advanced esophageal squamous carcinoma treated with programmed death-1 (PD-1) antibody SHR-1210 alone or in combination with apatinib and chemotherapy. Methods: Clinical data of 73 patients with esophageal squamous carcinoma from 2 prospective clinical studies conducted at the Cancer Hospital Chinese Academy of Medical Sciences from May 11, 2016, to November 19, 2019, were analyzed, and logistic regression analysis was used for the analysis of influencing factors. Results: Of the 73 patients, 35 had abnormal liver function. 13 of the 43 patients treated with PD-1 antibody monotherapy (PD-1 monotherapy group) had abnormal liver function, and the median time to first abnormal liver function was 55 days. Of the 30 patients treated with PD-1 antibody in combination with apatinib and chemotherapy (PD-1 combination group), 22 had abnormal liver function, and the median time to first abnormal liver function was 41 days. Of the 35 patients with abnormal liver function, 2 had clinical symptoms, including malaise and loss of appetite, and 1 had jaundice. 28 of the 35 patients with abnormal liver function returned to normal and 7 improved to grade 1, and none of the patients had serious life-threatening or fatal liver function abnormalities. Combination therapy was a risk factor for patients to develop abnormal liver function (P=0.007). Conclusions: Most of the liver function abnormalities that occur during treatment with PD-1 antibody SHR-1210 alone or in combination with apatinib and chemotherapy are mild, and liver function can return to normal or improve with symptomatic treatment. For patients who receive PD-1 antibody in combination with targeted therapy and chemotherapy and have a history of long-term previous smoking, alcohol consumption and hepatitis B virus infection, liver function should be monitored and actively managed in a timely manner.