晚期恶性肿瘤患者的免疫相关不良反应发生情况与免疫治疗效果的相关性分析

Correlation analysis between occurrence of immune-related adverse reactions and immunotherapy effect in patients with advanced malignant tumors

目的探讨分析使用免疫治疗晚期恶性肿瘤患者的免疫相关不良反应(irAE)发生情况及其与免疫治疗效果的相关性。方法选取2000年1月~2023年3月98例接受免疫治疗的晚期恶性肿瘤患者,根据患者是否出现irAE分为irAE组(n=57)和非irAE组(n=41),分析对比两组患者的基线临床资料、irAE发生情况以及免疫治疗的效果。并分析irAE发生与免疫治疗效果的相关性。结果两组患者的基线临床资料经对比差异均无统计学意义(P>0.05);98例患者中56例(57.14%)发生了irAE,其中38例(67.86%)发生了复合irAE,发生率最高的为皮肤反应25例(25.51%),其次为免疫性肝炎16例(16.33%)、疲乏15例(15.31%)、内分泌毒性13例(13.27%)、免疫性肺炎11例(11.22%)、胃肠道反应9例(9.18%)等irAE,irAE发生多为1~2级,3~4级多为免疫性肺炎;irAE组的ORR、DCR、PFS均高于非irAE组(P<0.05);单因素分析显示,皮肤毒性、免疫性肝炎、口腔黏膜炎、牙龈痛为影响PFS的因素(P<0.05);多因素分析显示,皮肤毒性是影响患者预后的独立危险因素(P<0.05);存在皮肤反应相较于非皮肤反应患者的预后要好。结论晚期恶性肿瘤患者多发生1~2级irAE,3~4级irAE多为免疫性肺炎,irAE发生情况与恶性肿瘤患者的免疫治疗效果具有一定的关系。

Objective To investigate the incidence of immune-related adverse reactions(irAE)in patients with advanced malignant tumors treated with immunotherapy and its correlation with the effect of immunotherapy.Methods 98 patients with advanced malignant tumors who received immunotherapy in our hospital from January 2000 to March 2023 were selected and divided into irAE group(n=57)and non-irAE group(n=41)according to whether they developed irAE.The baseline clinical data,occurrence of irAE and efficacy of immunotherapy of the two groups were analyzed and compared.The correlation between irAE occurrence and immunotherapy effect was analyzed.Results There was no significant difference in baseline clinical data between the two groups(P>0.05).irAE occurred in 56 of 98 patients(57.14%),of which 38 patients(67.86%)developed composite irAE,and the highest incidence was skin reaction in 25 patients(25.51%).It was followed by immune hepatitis in 16 cases(16.33%),fatigue in 15 cases(15.31%),endocrine toxicity in 13 cases(13.27%),immune pneumonia in 11 cases(11.22%),gastrointestinal reaction in 9 cases(9.18%),etc.irAE occurred mostly in grade 1~2,grade 3~4 was mostly immune pneumonia.The ORR,DCR and PFS in irAE group were higher than those in non-irAE group(P<0.05).Single factor analysis showed that skin toxicity,immune hepatitis,oral mucous inflammation and gingival pain were the factors affecting PFS(P<0.05).Multifactor analysis showed that skin toxicity was an independent risk factor affecting the prognosis of patients(P<0.05).The prognosis of patients with skin reaction was better than that of patients without skin reaction.Conclusion The occurrence of irAE is mostly grade 1~2,and grade 3~4 is mostly immune pneumonia.There is a certain relationship between the occurrence of irAE and immunotherapy in malignant tumor patients.