复发或转移性食管鳞癌免疫联合放疗与否的疗效及安全性

Efficacy and safety of immunotherapy with or without radiotherapy in the treatment of recurrent or metastatic esophageal squamous cell carcinoma

目的评估免疫联合或不联合放疗治疗复发或转移性食管鳞癌(R/M ESCC)的疗效和安全性。方法回顾性分析2020年1月至2021年10月在安阳市肿瘤医院接受信迪利单抗治疗的75例R/M ESCC患者的病历资料, 根据是否接受放疗分为放疗组(RT组, 37例)和非放疗组(NRT组, 38例)。比较两组客观缓解率(ORR)、疾病控制率(DCR)、无进展生存(PFS)、总生存(OS)及不良反应情况。定性资料用例数(构成比)表示, 采用χ^(2)检验或Fisher确切概率法进行组间比较, 采用Kaplan-Meier法和log-rank检验进行生存分析。结果 RT组和NRT组之间ORR和DCR差异无统计学意义(70%比61%, P=0.375;95%比89%, P=0.414), 但RT组的完全缓解(CR)率高于NRT组(19%比3%, P=0.022)。中位随访时间为25.4个月, RT组和NRT组中位PFS和OS差异均无统计学意义(13.8个月比9.9个月, P=0.221;20.2个月比18.9个月, P=0.214)。亚组分析显示, 在转移或复发部位为局部和/或≤3个远处淋巴结的患者中, RT组和NRT组的中位PFS差异无统计学意义(15.1个月比8.4个月, P=0.115), 但RT组中位OS优于NRT组(未达到比12.3个月, P=0.036)。与NRT组相比, 除了1-2级肺炎增加外(41%比18%, P=0.035), RT组未观察到治疗相关不良反应显著增加。结论免疫治疗联合放疗在R/M ESCC患者中是安全的, 并在转移或复发部位为局部和/或≤3个远处淋巴结的患者中有生存获益。

Objective To evaluate the efficacy and safety of immunotherapy with or without radiotherapy in the treatment of recurrent or metastatic esophageal squamous cell carcinoma(R/M ESCC).Methods A retrospective analysis was conducted on the data of 75 patients with R/M ESCC treated with sintilimab at Anyang Tumor Hospital from January 2020 to October 2021.The patients were divided into the radiotherapy(RT)group(n=37)and non-radiotherapy(NRT)group(n=38)based on whether they received radiotherapy.The objective response rate(ORR),disease control rate(DCR),progression-free survival(PFS),overall survival(OS),and adverse effects were compared between two groups.Count data were expressed as composition ratios and analyzed using Chi-square test or Fisher's exact test.Survival analysis was performed using Kaplan-Meier method and log-rank test.Results There was no statistically significant difference in ORR and DCR between the RT and NRT groups(70%vs.61%,P=0.375;95%vs.89%,P=0.414).However,the complete response(CR)rate in the RT group was higher compared to that in the NRT group(19%vs.3%,P=0.022).The median follow-up duration was 25.4 months.There was no statistically significant difference in the median PFS and OS between the RT and NRT groups(13.8 months vs.9.9 months,P=0.221;20.2 months vs.18.9 months,P=0.214).Subgroup analysis demonstrated that among patients with recurrence or metastasis confined to local and/or≤3 distant lymph nodes,there was no statistically significant difference in the median PFS between the RT and NRT groups(15.1 months vs.8.4 months,P=0.115),but the median OS in the RT group was better than that in the NRT group(not reached vs.12.3 months,P=0.036).Compared to the NRT group,besides an increase in grade 1-2 pneumonitis(41%vs.18%,P=0.035),no significant increase in treatment-related toxicity was observed in the RT group.Conclusion Immunotherapy combined with radiotherapy is safe in patients with R/M ESCC,and shows survival benefit in patients with recurrence or metastasis confined to local and/or≤3 distant lymph nodes.