信迪利单抗联合化疗治疗复发晚期食管癌临床观察

Clinical Observation of Sintilimab Combined with Chemotherapy in the Treatment of Recurrent Advanced Esophageal Cancer

目的:观察信迪利单抗联合化疗治疗复发晚期食管癌的疗效及安全性。方法:69例复发晚期食管癌患者随机分为对照组(n=35,采用PPT化疗方案)和观察组(n=34,在对照组基础上联合信迪利单抗治疗)。连续治疗3个周期后,比较两组临床疗效、治疗前后KPS评分变化、药品不良反应发生情况、预后及肿瘤突变负荷(TMB)情况。结果:治疗后观察组患者客观缓解率(ORR)、疾病控制率(DCR)均高于对照组(P<0.05)。治疗后两组患者KPS评分均较前明显提高(P<0.05),且观察组高于对照组(P<0.05)。治疗期间两组不良反应总发生率及1~2级和3~4级不良反应发生率差异均无统计学意义(P>0.05)。观察组患者中位无进展生存期(PFS)及中位总生存期(OS)均长于对照组,程序性死亡受体配体1(PD⁃L1)表达情况低于对照组(P<0.05)。观察组TMB⁃H患者数显著多于对照组(P<0.05)。结论:在化疗基础上联合信迪利单抗对复发晚期食管癌的抗肿瘤效应更好,可更有效地延长患者生存时间,提高患者生存质量,安全有效。

Objective:To observe the clinical efficacy of sintilimab combined with chemotherapy in the treatment of recurrent ad⁃vanced esophageal cancer.Methods:Totally 69 patients with recurrent advanced esophageal cancer were divided into control group(n=35)and observation group(n=34)according to the random number table method.The control group was treated with PPT chemotherapy,and the observation group was treated with sintilimab on the basis of the control group for 3 consecutive cycles.Clinical efficacy,KPS score,adverse drug reactions,prognosis and tumor mulational burden(TMB)were compared between the two groups.Results:The overall response rate(ORR)and disease control rate(DCR)after 3 courses of treatment in the observation group were higher than those in the control group(P<0.05).The KPS scores after treatment of the two groups were higher than those before treat⁃ment,and that in the observation group was higher than that in the control group(P<0.05).During the treatment period,there were no significant differences in the total incidence of adverse reactions and the incidence of grade 1⁃2 and grade 3⁃4 adverse reactions between the two groups(P>0.05).The median PFS and median OS of the observation group were longer than those of the control group(P<0.05).The TMB⁃H patients in the observation group were significantly more than those in control group(P<0.05).Conclusion:Com⁃bination of sintilimab and chemotherapy has better anti⁃tumor effects on recurrent advanced esophageal cancer,which can more effectively prolong the survival time of patients and improve the quality of life of patients with promising safety and efficacy.